Cognitive Behavioral Interventions/Approach

To evaluate the effectiveness of psychotherapeutic and pharmacologic therapy, in depressed patients with cancer, by means of a meta-analysis and systematic review

• Researchers consulted the MEDLINE,^® CINAHL^®, EMBASE, PsycInfo, and Cochrane Collaboration databases. 7,700 references were retrieved.
• Vocabulary terms appropriate to each database were used and are available as a separate file online.
• Inclusion criteria consisted of the following characteristics: Patients were older than 17 years; had a cancer diagnosis at the time of the study; had symptoms of depression that had been measured; were randomized to study groups, to compare the intervention to any control condition; and had elevated symptoms of depression as defined by the authors.
• The study was excluded if eligibility did not include elevated symptoms of depression.

Researchers used the PEDro scale to evaluate study quality.

• 10 studies were included. One was eliminated from the meta-analysis because it was an outlier in the calculated effect size.
• 6 psychotherapy trials involved a total of 1,273 patients. 4 pharmacologic trials included 362 patients.
• Most participants were women, and their mean age was 51.

Multiple phases of care

Across all included trials, Hedges's g = 0.43 (95% CI, 0.48–1.54, p < 0.001) in favor of the intervention. Analysis of effect size at various follow-up periods showed that effect declined over time. Hedges's g effect size at 24 months poststudy entry was 0.19 and was not statistically significant. Follow-up at 18 months still showed a significant effect (g = 0.37, p < 0.001). Overall effect of pharmacologic interventions was g = 0.44 (p < 0.001); of cognitive behavioral therapy, g = 0.83 (p < 0.001); and of problem-solving therapy, g = 0.33 (p < 0.001).

For patients with cancer who had elevated symptoms of depression, psychotherapeutic and pharmacologic interventions were at least moderately effective in reducing symptoms of depression; however, efficacy may decline over time. Comparison of approaches showed that cognitive behavioral therapy had a substantially larger effect than did problem-solving therapy or medications.

Although the heterogeneity in analysis was not high, samples did vary substantially in terms of cancer stage, time elapsed since diagnosis, ethnicity, gender, and sample size.

Antidepressants, problem-solving therapy, and cognitive behavioral therapy were effective in reducing symptoms of depression in patients with cancer who had elevated symptoms of depression. Assessment of the symptoms of depression can identify patients who can benefit from these treatments. Since medication, problem-solving therapy, and cognitive behavioral therapy were efficacious, treatment selection should be based on each patient's characteristics and preferences. It appears that efficacy may diminish over time, pointing to the need for long-term follow-up and management of depression in patients such as those who met the research criteria.

STUDY PURPOSE: To describe an evidence-based approach to the use of psychosocial interventions to manage anxiety and depression in adults with cancer

TYPE OF STUDY: Combined systematic review and meta-analysis

• FINAL NUMBER OF STUDIES INCLUDED = 13
• TOTAL PATIENTS INCLUDED IN REVIEW = Not stated
• SAMPLE RANGE ACROSS STUDIES: Not described
• KEY SAMPLE CHARACTERISTICS: Not described

PHASE OF CARE: Active treatment

APPLICATIONS: Late effects and survivorship

Nine of the 13 publications reached positive conclusions about the efficacy of psychosocial interventions for depression in patients with cancer. Positive supporting evidence yielded recommendations for behavioral therapy, counseling/psychotherapy, and either of these approaches combined with education, relaxation training for patients not undergoing surgery, and cognitive-behavioral therapy.  

Six of eight publications reached positive conclusions about the efficacy of psychosocial interventions for anxiety. Recommended are behavioral interventions for patients undergoing treatment, relaxation training for patients not undergoing surgery, and cognitive-behavioral therapy in the post-treatment period.

1. Psychoeducation for new patients with cancer reported significantly less anxiety and depressive symptoms (p < 0.001) as well as greater satisfaction with their care than usual care (p < 0.01).
2. Patients randomized to problem-solving therapy demonstrated significantly less depression (p < 0.05), and results were maintained through a one-year follow-up period.
3. Stress-management techniques of paced abdominal breathing, progressive muscle relaxation with guided imagery, and the use of coping self-statements were briefly taught and provided to patients via print and audiovisual materials prior to beginning chemotherapy. Significantly less anxiety and depression (p < 0.05) was found versus usual care.
4. Cognitive therapy evaluated against a wait-list control in women with breast cancer who had clinically significant depressive symptoms demonstrated significantly less depression postintervention (p < 0.01), with even a further reduction occurring during the six-month follow-up period.
5. Group cognitive-behavioral therapy was offered to early-stage breast cancer survivors post treatment; the efficacy of this intervention in an randomized controlled trial compared with no-intervention controls indicated that the intervention group reported significantly (p < 0.05) less depression immediately postintervention and at two-year follow-up.

• Gaps regarding benefits of psychosocial interventions for diverse demographic, disease, and treatment characteristics. Men and ethnic and racial minorities were underrepresented, and most studies were based on several different types of cancer, usually early stage. 
• Inconsistency in the evaluation of interventions, the number and timing of outcome assessments, and outcome measures used
• Inadequate reporting of study methodology 
• Lack of research on patients experiencing clinically significant anxiety or depression (most patients studied were experiencing low levels when recruited)

Future research is needed, particularly focusing on men, minorities, patients with advanced disease, and patients who have completed treatment. Studies must include patients experiencing significant depression and/or anxiety prior to intervention. Combinations of interventions should also be studied. Last, timing for screening and intervening is important, but current data specify only “vulnerable times” rather than evidence to guide practice.

STUDY PURPOSE: To evaluate evidence for psychological interventions in women with breast cancer

TYPE OF STUDY: Meta analysis and systematic review

PHASE OF CARE:  Multiple phases of care

In 24 of 28 trials, cognitive behavioral therapy was the basis of the intervention. Most studies had unclear risk of bias, and for studies aimed at anxiety and depression, quality of the evidence was graded as low. Comparison of CBT versus control across multiple studies for depression showed an overall standard mean difference (SMD) of -1.01 (p = 0.02) in favor of the CBT intervention. Only two studies examined CBT delivered individually, showing no significant benefit and high heterogeneity. Examined separately, group CBT also did not consistently show significant benefit for depression. Eight studies looked at change in anxiety. Both individual- and group-delivered CBT showed significant benefit, with an overall SMD -10.48 (p = 0.0006). CBT showed a significant positive effect for stress, and only marginal effect on quality of life.

Findings showed overall benefit of CBT for anxiety and depression in women with early-stage breast cancer

Although studies have shown that psychological interventions are more effective for individuals with psychological problems, the studies included here excluded women with psychological morbidity.  There was high heterogeneity, and most studies were of low quality.

CBT delivered in a group or individual setting has been shown to have a positive effect on depression and anxiety among women with early-stage breast cancer. The strength of these results is limited by the relatively low quality of studies included in this review.

To determine the overall efficacy of psychological interventions, in patients with breast cancer, in regard to the outcome variables of anxiety, depression, and quality of life; to examine the moderating effects of disease stage, treatment type, duration, and orientation on overall treatment efficacy

Databases searched were MEDLINE (1966–January 2004), EMBASE (1980–2004), Cochrane Controlled Trials Register (1985–February 2004), PsycLIT (1973–2004), Biological Abstracts (1990–December 2003), CANCERLIT (1975–October 2002), CINAHL (1982–December 2003), and Health Start (1975–January 2004).

Search keywords were cognitive behavioral therapy, group psychotherapy, relaxation, supportive therapy, visual imagery, anxiety, depression, maladjustment, distress, and quality of life. Authors included no language or publication-status restrictions.

Studies were included if they met all these criteria:

• Were randomized controlled trials (RCTs) that evaluated the efficacy of a psychological or behavioral intervention and were aimed at alleviating psychiatric or psychological morbidity
• Included women participants who had
  • A histologically confirmed diagnosis of breast carcinoma of any stage
  • Undergone surgery
• Included at least two arms: an intervention and a control

Studies examining the efficacy of interventions to assuage surgical distress were ineligible.

• Investigators initially reviewed a total of 36 studies.
• The final number of studies assessed for the analysis was 18: 14 studies assessed anxiety and 14 assessed depression.
• Two reviewers assessed eligible trials and assigned a methodological grade by using the Jadad scale. Trials were pooled under outcome variables (anxiety, depression, and quality of life) to obtain three overall effect sizes, with negative values suggesting a favorable outcome for the treatment condition.
• Also included was an academic textbook, Psychosocial Interventions for Cancer, by Baum and Anderson (2001).
• Eight studies were carried out in facilities in the United States; four, in Canada; one, in England; two, in Australia; and one each in Japan, Italy, and China.
• Eight studies had a score of 5 or greater on the Jadad scale. Ten had a score of less than 5.  The maximum score earned by an assessed study was 7.

• Sample range across studies:
  • Anxiety: 1,278 participants, 692 in treatment group and 586 in control.
  • Depression: 1,324 participants, 713 in treatment group and 611 in control.
• Participant age range was 25–73 years.
• Of participants, 70% were married or in a committed relationship, 32% were Caucasian, 23.7% were Asian, 10.2% were African American, and 28.4% were Hispanic. The race of 28.4% was unidentified.

Depression: Authors reported a clinically moderate-to-strong effect (–1.01, 95% CI –1.48 to –0.54, N = 1,324) and robust finding (95% Cl –0.69 to –0.24) in studies treating patients with high psychological morbidity and methodologically more reliable studies. Short-term interventions compared to long-term interventions (–0.56 versus –0.40) showed a stronger clinical benefit for metastatic patients. Group interventions appeared to be moderately to strongly effective in treating depression in advanced disease (–0.56), compared to early-stage disease (–0.15). Cognitive behavioral interventions (–0.56) may be more effective than supportive expressive therapies (–0.36) for patients with advanced disease.

Anxiety: Most trials were conducted on a prophylactic basis rather than involving highly anxious patients. Findings suggested that a moderate-to-strong clinical impact may be observed in patients with breast cancer who are experiencing clinically significant anxiety. Short-term interventions were associated with clinically moderate effects; longer-term interventions also showed a clinically moderate effect (–0.40) in favor of treatment for patients with metastatic disease but not for those with early-stage breast cancer. Group interventions demonstrated a clinically moderate impact in favor of treatment (–0.40). Patients with more-advanced disease made clinically moderate gains (–0.36) with cognitive behavioral interventions, comparable to the gains made with expressive-supportive therapy (–0.40). Relaxation and guided imagery studies were of lower methodological grade; pure educational interventions failed to show any clinical benefit.

The process of attempting to pool trials and explore effects is complicated and often misleading. Key findings follow.

• In general, interventions targeting patients with clinically diagnosable levels of anxiety or depression are more beneficial than are interventions targeting patients with a lower level of anxiety or depression.
• Group psychotherapy appears to be more effective than individual therapy at treating both anxiety and depression.
• Within a group format, cognitive behavioral interventions appear to be equally effective as supportive-experiential therapies. Duration of treatment need not exceed 20 hours.

Most trials in this analysis relied solely on self-reported measures of anxiety and depression. Literature in the field of cancer indicates that patients with cancer may under-report these symptoms; therefore, self-reported measures may be unreliable and collateral data are needed. In addition, further investigation of the timing of psychological intervention, to determine when the intervention is best delivered, is needed.

To investigate the effects of cognitive behavioral therapy (CBT) and patient education on depression, anxiety, pain, physical functioning, and quality of life (QOL) in adult cancer survivors

The study involved searching MEDLINE, PsycINFO, and the Cochrane Database for the period 1993–2004.

The literature evaluated included 15 randomized controlled trials (RCTs), five of which measured depression and all of which had been published 1993–2004. Authors assessed quality of the RCTs by means of the Jadad scale.

The sample size was 1,492.

CBT is related to short-term effects on depression; individual interventions were more effective than group interventions. Neither CBT nor patient education produced significant long-term effects on depression.

STUDY PURPOSE: To assess the effectiveness of Cognitive Behavioral Therapy (CBT) or CBT approach interventions for improving depressive symptoms

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 13 
• TOTAL PATIENTS INCLUDED IN REVIEW = 966
• SAMPLE RANGE ACROSS STUDIES: Not provided
• KEY SAMPLE CHARACTERISTICS: Women with breast cancer who had undergone surgery

PHASE OF CARE: Not specified or not applicable

Analysis was conducted for each type of outcome measurement instrument used in the research. Across eight studies using the Self-Rating Depression Scale (SDS), the effect of the intervention was seen to be beneficial (standard mean difference [SMD] = –0.87, p < 0.0001). The pooled results of three studies for effects using the Hospital Anxiety and Depression Score (HADS) was also in favor of the intervention (SMD = –0.50, p = 0.04). Across all studies, the SMD comparing CBT to control was –0.92 (p < 0.00001).

Individually delivered CBT was shown to be effective in reducing the symptoms of depression among women with breast cancer.

In some studies, different cognitive behavioral approaches were used, and some delivered the intervention via a combination of face-to-face and telephonic contact. The results of the study quality evaluation were not reported. All studies excluded patients with major depression diagnoses.

Interventions using cognitive behavioral approaches can be effective to reduce the symptoms of depression in women having undergone surgery for breast cancer. Although full CBT is generally delivered by trained therapists, nurses can incorporate many of these principles into general patient teaching, counseling, and support. Patients with significant depression should be referred for appropriate management as needed.

To test the effects of a group cognitive behavioral therapy (CBT) intervention on psychosocial symptoms in women with breast cancer

One to two weeks after surgery, women who agreed to participate were randomly assigned to a psychosocial intervention or a usual-care control group. The intervention consisted of 12 hours of education over a two-week period. Education provided information about treatment modalities, side effects, social rights, healthful diet, stress management, cognitive reframing, and sexuality issues. The intervention then involved meetings of eight women. Each group met weekly, in a 2.5-hour session, for eight weeks. In the sessions, the women shared experiences to reveal negative thinking and integrate the elements of cognitive therapy. Follow-up was up at 1, 6, and 12 months.

• The sample consisted of 176 women with breast cancer.
• In the intervention group, 61% were older than age 50; in the control group, 76% were older than age 50. Mean age and range were not stated.
• The majority of patients had received treatment with chemotherapy plus radiation therapy plus hormonal therapy.
• 74% of the women were married or cohabiting.

• Single site
• Outpatient setting
• Denmark

 Randomized controlled trial

• Profile of Mood States questionnaire
• Mental Adjustment to Cancer Scale
• EORT Quality of Life questionnaire
• Barrett-Lennard Relationship Inventory

At no time in the study did differences exist between groups in regard to mood disturbances, quality of life, or marital relationships.

The psychosocial intervention, consisting of cognitive behavioral techniques, had no effect on depression, anxiety, quality of life, or marital relationship.

• The study included baseline sample and group differences.
• The study presents risk of bias because it did not include blinding or an appropriate attentional control condition.
• Patients in the control group were older than patients in the intervention group. 
• The study does not make clear whether women were actively receiving adjuvant treatment during the study.

The CBT intervention tested had no observable effect on depression or anxiety in women with breast cancer.

To evaluate the effectiveness of a combined biobehavioral intervention (CBI) and cognitive behavior therapy (CBT) for depressed patients coping with the stresses of cancer

12–20 individual 75-minute CBI and CBT sessions

Topics: Stress, coping, communication, seeking information

• N = 36
• MEAN AGE: 49 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast and gynecologic

• SITE: Single site   
• SETTING TYPE: Outpatient   
• LOCATION: Cancer Center in Northeast United States

PHASE OF CARE: Late effects and survivorship

Single group pre-post design

• Hamilton Rating Scale for Depression (HRSD)
• Beck Depression Inventory (BDI)
• Fatigue Symptom Inventory (FSI)
• Brief Pain Questionnaire
• Quality of Life

Depressive symptoms, fatigue, and mental health significantly improved following intervention.

CBI and CBT showed significant improvement in depression, fatigue, and quality of life and reduced cancer stress.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Subject withdrawals ≥ 10%

Cancer survivors who display depressive symptoms may benefit from CBI and CBT.

To examine the efficacy of an early minimal cognitive behavioral therapy (CBT) intervention for insomnia in patients with cancer

The treatment consisted of self-help CBT provided with written materials and three phone consultations. Participants completed a quiz after each booklet was read and were asked to maintain a daily sleep diary. Control patients did not receive any intervention. The study was conducted over six weeks. Study measures were obtained at baseline, at the end of six weeks, and three and six months later. Participants were paid after each assessment was completed.

• N = 35  
• MEAN AGE = 56.9 years (SD = 10 years)
• MALES: 7.9%, FEMALES: 92.1%
• KEY DISEASE CHARACTERISTICS: Most had breast cancer; various other types included
• OTHER KEY SAMPLE CHARACTERISTICS: 60% were married, 65.8% were in current treatment for cancer with radiation therapy and/or chemotherapy

• SITE: Single site  
• SETTING TYPE: Not specified    
• LOCATION: Canada

• PHASE OF CARE: Multiple phases of care

Randomized, controlled trial

• Insomnia Interview Schedule (IIS)
• Insomnia Severity Index (ISI)
• Sleep diary
• Hospital Anxiety and Depression Scale (HADS)
• Multidimensional Fatigue Inventory (MFI)
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
• Dysfunctional Beliefs and Attitudes About Sleep–Short Form (DBAS-SF)
• Sleep Behaviors Questionnaire (SBQ)

There were significant effects over time by study group on ISI scores in favor of the CBT intervention at six weeks (p < 0.001), and there were improvements in all sleep variables with effect sizes (d) ranging from 0.46–1.34. Control patients also showed improvements. There were no significant changes from the six-week to six-month time point in either group. Those in the CBT group had a reduction in hypnotic dosage (d = 0.40). There were significant improvements in anxiety scores (p < 0.001) in the CBT group at six weeks. Depression declined significantly in both groups. No significant effect on fatigue was found. A greater proportion of CBT patients achieved a sleep efficiency level greater than or equal to 85% (p = 0.01). More than 97% of patients completed the materials, and 91.2% completed the quiz on average.

The brief CBT intervention used here was effective in improving insomnia and anxiety among patients with cancer.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Other limitations/explanation: Use of hypnotics was not described after baseline

CBT interventions are effective in treating sleep–wake disturbances and psychological issues. This study demonstrated that the provision of a CBT approach via booklets and quizzes on the CBT for sleep content with follow-up and counseling by phone was an effective way to deliver the intervention. Although this sample size was small, it did approximate the size required from a power analysis. This approach to providing a CBT intervention can be practical and cost-effective. However, significant effects were only seen during the active study period, and effects were not shown to endure long-term.

To explore relationships among variables and evaluate change in symptoms following cognitive behavioral therapy for insomnia (CBTI)

This paper reports a secondary analysis of a randomized controlled trial of CBTI delivered in group sessions over five weeks. Assessments done at baseline and post-treatment were analyzed.

• N = 113     
• MEAN AGE: Intervention group: 65 years, range 55–69; usual care group: 58 years, range 54–66
• MALES: 26%, FEMALES: 74%
• KEY DISEASE CHARACTERISTICS: Had breast, prostate, bowel, or gynecologic cancer and had completed initial therapy
• OTHER KEY SAMPLE CHARACTERISTICS: Had chronic insomnia defined as greater than 30 minutes for delayed sleep onset or wake time after onset, insomnia three or more nights per week for at least three months and scored five or more on the Pittsburgh Sleep Quality Index (PSQI). Most were retired and were not being treated for depression. Average fatigue severity at baseline was 5, anxiety was 7–8, and depression was 4–5.

• SITE: Multi-site   
• SETTING TYPE: Outpatient   
• LOCATION: Scotland

PHASE OF CARE: Transition phase after active treatment

Secondary analysis of a randomized controlled trial

• 10-day sleep diary
• Hospital Anxiety and Depression Scale (HADS)
• Fatigue Symptom Inventory (FSI)

The most common symptom cluster reported was insomnia, anxiety, and fatigue (18% of patients). Clinical-level insomnia was reduced by 52% in the CBTI group compared to a 17.5% reduction in the usual care controls post-intervention (p < .001). CBTI resulted in a 10.9% reduction in rate of clinical levels of fatigue, compared with a 2.5% increase in control patients post-treatment (p = .03). Anxiety rates did not change. Most patients were not clinically depressed at baseline, and no significant differences were seen between groups in depression rates post-intervention.

The CBTI reduced prevalence of insomnia and clinically relevant fatigue.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results
• At baseline, patients in the intervention group were older; no analysis was shown to determine if this difference was significant. No information is provided regarding medications or other interventions used for sleep or fatigue. Approximately 9% of the sample was lost to follow-up but from which groups is unclear.

Findings support the use of CBTI for sleep/wake disturbance and fatigue management in patients after cancer treatment. Follow-up in this report was immediately after five weeks of the intervention only, so how long-lasting any effects are is not clear.

Patients underwent a focused assessment that corresponded with specific symptom management interventions. The interventions recommended were based on a cognitive behavioral approach. The control arm received usual care. Patients were assessed for symptoms such as nausea, vomiting, insomnia, dyspnea, anorexia, fever, cough, dry mouth, constipation, mouth sores, pain, and fatigue. Symptoms identified with depression—fatigue, insomnia, anorexia, and poor concentration—were placed in a subindex.

Of 609 eligible patients, 237 patients and their family caregivers participated in the study. Patients had been diagnosed with a solid tumor and were within two months of the first cycle of chemotherapy. Patients who were receiving radiation or who had had previous chemotherapy were ineligible. The study include men and women who had been diagnosed with a variety of tumor types in various cancer stages.

Randomized control trial

• The Center for Epidemiological Studies Depression Scale
• Two-sample t tests, a chi-square test, and a general linear model

Among those with higher levels of baseline symptoms except depression, cognitive behavioral interventions lowered depression at 10 weeks. In patients with a higher level of depression at baseline, the cognitive behavioral interventions were less effective.

Cognitive behavioral interventions may lower depression indirectly by managing symptoms that do not have a component that is primarily affective. Symptoms with a physiologic and psychological component may be more difficult to modify and require long-term intervention.

• Medications used to treat depression were not standardized. A variety of medications were used at various doses.
• The study did not detail how the intervention sessions were completed, only that researchers conducted telephone interviews and in-person sessions of 30–60 minutes.
• The study did not identify the background and training of the nurses who provided interventions.
• The study did not provide specific symptom management interventions. Knowing symptom-management strategies and specific guidelines would have been helpful.

To examine the use of cognitive-behavioral therapy (CBT) as an intervention to reduce anxiety in patients diagnosed with terminal cancer

CBT was adapted by the development of training modules targeting skills for relaxation, coping, and activity pacing. Eligibility included patients who were 18 years or older with an incurable solid tumor, four weeks post-diagnosis, and found to have anxiety as evidenced by a Hamilton Anxiety Rating Scale (HAM-A) score of 14 or higher. They were screened via telephone and met with a licensed clinical psychologist or postdoctoral psychology fellow for a baseline assessment and self-report questionnaires. If criteria was met, they were randomized to either individualized CBT or a wait-list control group. The intervention group met with a therapist for six to seven (optional) weekly sessions of CBT tailored to patient concerns. A post-treatment or eight-week assessment with a blinded independent evaluator was used, and the nonintervention patients were then able to cross over to receive CBT if desired.

• The study reported on a sample of 40 patients.
• Mean patient age was 55.90 years, with a range of 31–81 years.
• The sample was 70% female and 30% male.
• Patients were diagnosed with lung (30%), pancreatic (17%), colorectal (15%), other (38%) cancers.
• Patients had solid tumors only and were mostly white (95%).
• Demographic characteristics did not differ between the two groups.

• Single site
• Outpatient setting
• Massachusetts General Hospital Cancer Center

• Patients were undergoing active antitumor treatment.
• The study has clinical applicability for elder care and palliative care.

A pilot feasibility and randomized controlled trial design was used.

• For the clinician-administered assessment, the primary outcome measure was total score on the HAM-A
• Montgomery-Asberg Depression Rating Scale (MADRS)
• Hospital Anxiety and Depression Scale (HADS)
• Impact of Event Scale (IES)
• Functional Assessment of Cancer Therapy–General (FACT-G)

Forty patients with terminal cancers were randomized to receive CBT (n = 20) or to a wait-list control group (n = 20), with 70% completing the post-treatment assessments. In the treatment group, 80% completed at least five of the six required sessions. Analysis revealed that those receiving CBT had greater improvements in HAM-A scores compared to the control group, with an adjusted mean difference of -5.41 (95% confidence interval: -10.78 to -0.04) and a large effect size for intervention (Cohen’s d = 0.80).

It was found that the majority of patients in the intervention sample were able to complete the requirements of the trial, and beneficial effects were observed in reducing anxiety and improving quality of life over time, but no significant differences in depression between the two groups.

• The study had a small sample size, with less than 100 participants.
• Study findings are not generalizable.
• The intervention was expensive, impractical, or had training needs.
• The use of routine screening procedures would be beneficial.
• The sample lacked racial and ethnic diversity, limiting generalizability to minority patients.

Patients who are newly diagnosed with incurable cancer can be at high risk for anxiety. The early identification of these patients and assisting them in accessing care using CBT can lead to significant improvements in anxiety and quality of care.

Evaluate whether a brief cognitive behavioral (CBT) intervention can reduce stress and distress in women with breast cancer and identify characteristics of those most likely to benefit

After pre-surgery assessment, women were randomized to the intervention or control conditions. Assessments were conducted post-intervention and 12 months later in both groups. Participants were accrued over a five-year period. The intervention focused on provision of relaxation training at every session with daily home practice to address phsyiologic, cognitive, and emotional aspects of stress. Sessions were provided in a group setting for three hours per week for five weeks. Women who lived a great distance from the center where sessions were held were offered transport and/or overnight accommodations. Data also were obtained at 12 months post-intervention.

• N = 179    
• MEAN AGE = 53.7 years (SD = 10.2 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS All had breast cancer; the majority were stage II or lower. Sixty-two percent had excision, and the rest had mastectomy.

• SITE:  Single site  
• SETTING TYPE:  Outpatient

PHASE OF CARE: Transition phase after active treatment

Randomized controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• Impact of Event Scale (IES)
• Perceived Stress Scale
• Silver Lining Questionnaire

Reports of global stress were lower in the intervention group at the end of the study (p = .003), but no difference was observed between groups at 12 months. Analysis of covariance showed a significant group-by-time effect on anxiety scores, with the intervention group reporting greater decreases in anxiety immediately after the intervention (p = .03). However, no difference was observed between groups at 12 months. Depression scores did not differ between groups. Global stress and anxiety decreased more among participants with higher global stress at baseline.

A brief CBT approach intervention may be beneficial in reducing short-term stress and anxiety among women with breast cancer. However, individuals in this study had anxiety and depression levels on the HADS that are not generally deemed to be clinically relevant. No long-term benefits were observed.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• Almost 50% loss to follow-up. Baseline anxiety and depression levels were not clinically significant, so measurement may have been subject to floor effects. Whether patients were in current treatment was unclear. The cost of transportation and accommodations may be prohibitive for this type of program for providers with a large catchment area. The control condition was not clearly described.

Findings suggest that CBT approach interventions in patient group settings might have a beneficial effect on stress and anxiety, but the study has several limitations. Effects seen were short-term, showing benefit immediately after the intervention, but were not maintained over the longer term. These results suggest that ongoing interaction probably is needed for patients to continue to practice relaxation and other behaviors.

Many patients with cancer experience depression and anxiety, with an associated decrease in quality of life, during radiation therapy. The main objective of the study was to determine the benefits of psychosocial interventions for these patients with cancer, concurrent with radiation therapy.

Patients in the intervention group received psychosocial care, which consisted of psychoeducation, cognitive behavioral therapy (CBT), and supportive expressive therapy.

• N = 178
• MEAN AGE = 47 years
• MALES: 42%, FEMALES: 58%
• KEY DISEASE CHARACTERISTICS: Patients with cancer undergoing radiation therapy
• OTHER KEY SAMPLE CHARACTERISTICS: 96% of patients had Eastern Cooperative Oncology Group performance status of 1–2, meaning that they were fairly fit. Radiation therapy had to be given with curative intent, not palliative.

• SITE: Not stated/unknown  
• SETTING TYPE: Outpatient  
• LOCATION: Guilin Medical University, Guangxi Province, China

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

Patients were randomized to the intervention arm (psychoeducation, CBT, and supportive expressive therapy) or to the control arm. The control group received radiation therapy only.

• Zung Self-Rating Depression Scale for symptoms of depression
• Self-Rating Anxiety Scale
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30.  

An association also was made between intervention and survival.

Patients in the intervention group showed significant improvements in symptoms of depression and anxiety and health-related quality of life. They had better global health status and physical and emotional functioning and less insomnia. No difference was observed between groups in disease-free survival and overall survival.

Psychosocial interventions appear to be a cost-effective approach that can improve a patient’s mood and quality of life during and after radiation therapy.

Chinese study (possible cultural implications)

This is an important study for oncology nurses, especially radiation therapy oncology nurses, who often feel like they cannot make much impact on their patients' lives, except for checking for toxicities. Nurses have an important role in psychoeducational and supportive therapies. Some very brief strategies being taught regarding CBT and supportive expressive therapy could go a long way in helping many patients.

To assess, in a medical care setting, the effectiveness of a brief cognitive behavioral treatment for depression on depressed patients with cancer

• Patients were screened for depression; researchers administered the Anxiety Disorders Interview Schedule-IV (ADIS-IV) to eligible participants and considered all self-report measures.
• Participants completed nine-week one-on-one cognitive behavior therapy for depression. Sessions were weekly. The same clinical graduate student assessed and treated all patients.
• Variables were examined pretreatment, post-treatment, and at three months after the therapy.

• The study reported on a sample of 13 patients (11 females, 2 males).
• Mean patient age was 52.2 years (SD = 10.9 years).
• Tumor-type distribution was breast (n = 7), lung (n = 1), stomach (n = 1), colon (n = 1), prostate (n = 1), pancreatic (n = 1), and bone cancer (n = 1); all had stage I or II cancer.
• All participants were Caucasian. The average length of education was 14.8 years.
• Mean level of major depression was 5.7 (SD = 1.1), suggesting moderate clinical depression.
• Average time since diagnosis was 1.5 years; three participants were actively on treatment. Coexistent diagnoses included generalized anxiety disorder (n = 7), social phobia (n = 3), panic disorder (n = 1), obsessive compulsive disorder (n = 1), specific phobia (n = 1), and anxiety disorder not specified (n = 1).
• Participants were included if not on antidepressants or antianxiety medications or if stabilized for eight weeks on consistent dose prior to study assessment.

• Single site
• Outpatient setting
• Cancer institute in Tennessee

Patients were undergoing the active treatment and transition phases of care.

A pre/post-test, convenience sample design was used.

• Harvard Department of Psychiatry National Depression Screening (HANDS) scale
• 10-item Anxiety Disorders Interview Schedule–IV (ADIS-IV)
• Hamilton Rating Scale for Depression (HRSD), a 24-item semistructured interview designed to measure symptom severity
• Beck Depression Inventory–II (BDI-II)
• Center for Epidemiological Studies of Depression Scale (CESD), a 20-item self-report questionnaire regarding symptoms of depression
• Beck Anxiety Inventory (BAI), a 21-item questionnaire designed to distinguish cognitive and somatic symptoms of anxiety
• Quality of Life Inventory (QOLI), a 16-item self-report measuring life satisfaction across a range of domains
• Medical Outcomes Study Short Form–36 (SF-36)
• Multidimensional Scale of Perceived Social Support, a 12-item scale that assesses adequacy of social support
• Client satisfaction questionnaire

• Patients completed an average of 118.9 (SD = 49.8) assigned activities, resulting in an overall patient adherence score of 82%. Post hoc analysis showed significant pre- and post-treatment improvement on measures of depression, anxiety, quality of life, and medical outcomes; improvements were clinically significant as indicated by moderate-to-large effect sizes (R = 0.6 to 2.0).
• All treatment gains were maintained at three-month follow-up. Somatic anxiety did increase slightly at follow-up.
• Patients were strongly satisfied with cognitive behavior therapy for depression.
• All patients improved significantly on the RCI, and all but one patient (92% of total) improved on the BDI and HRSD.
• 54% of patients demonstrated statistically significant improvement in somatic anxiety, according to the BAI, and 62% reported increased quality of life as measured by the QOLI.
• The SF-36 showed significant clinical change as follows: physical functioning (62%), mental health (62%), role emotional (54%), role physical (54%), general health (62%), bodily pain (54%), vitality (69%), and social functioning (62%).

Behavioral therapy interventions, especially when paired with cognitive techniques, may represent a practical medical care treatment to improve psychological outcomes for and quality of life of patients with cancer.

• The study had a small sample size, with less than 30 participants.
• The study lacked randomization, had no control group, included one site, and provided no assessment of anxiety symptoms and disorders and their relation to outcome.
• The study lacked multiple-baseline design.
• Longer-term follow-up is needed.
• A clinical graduate student was used instead of an experienced therapist.
• A comprehensive protocol was not used for the interview.

Depression is a major concern for patients with cancer. To identify patients who need treatment, tools should be developed that are more nurse-friendly and easier to administer.

To evaluate a group cognitive-behavioral intervention to alleviate menopausal symptoms (hot flushes [HF] and/or night sweats [NS]) in women who have had treatment for breast cancer.

Following a two-week daily diary assessment, patients were offered six 90-minute weekly sessions of group cognitive-behavioral therapy (CBT). CBT included:  information and discussion about menopausal symptoms; monitoring and modifying stimulants that precipitate symptoms; relaxation and paced breathing; and techniques to reduce stress and manage HF, NS, and sleep. The primary outcome measures were HF frequency and HF problem rating. Secondary outcomes included scores on the Women’s Health Questionnaire (WHQ) and scores pertaining to health-related quality of life (HRQOL) as measured by the SF-36®. Beliefs about HF were monitored to examine the effects of CBT. 

• The study was comprised of 17 women receiving group CBT.
• Mean age was 53.7 years (range 46–65).
• Of the patients, 12 (71%) had undergone breast-conserving surgery; 3 (18%), modified radical mastectomy; 9 (53%), chemotherapy; 14 (82%), radiotherapy; and 12 (71%) were taking adjuvant hormonal therapies (11 were taking tamoxifen; 1 was taking anastrozole).
• At diagnosis, seven patients (41%) were premenopausal, six (35%) were in the early or late transition stage of menopause, and four (24%) were in the early or late postmenopausal stage.
• Average time since diagnosis was 23.2 months.
• Average duration of HF and NS was 2.1 years.
• Patients were treated in groups (of six, six, and five members); 12 women (59%) attended all six sessions, three women attended five sessions, and two attended three sessions. The majority (83%) completed all assessments.

• Multisite
• Outpatient
• Clinic staff recruited patients by using a database at two breast units in London, England.

• Patients were undergoing the transition phase of care:  after initial treatment and completion of chemotherapy and/or radiotherapy and with or without hormone replacement therapy.
• The study has clinical applicability for late effects and survivorship.

The study was a single-group, exploratory trial with pre- and posttreatment assessment after six weeks and three months.

• Hot Flush Frequency and Problem Rating Scale (HFRS) 
• WHQ
• Hot Flush Beliefs Scale (HFBS)
• SF-36® HRQOL ratings
• Daily diaries
   

• Weekly frequency of HF and NS was reduced from 75.7 to 46.9 (p < 0.03) at the posttreatment measure to 38.3 (p < 0.02) at the three-month follow-up. This change represents a 38% reduction at posttreatment and a 49% reduction at the three-month follow-up.
• Problem rating was reduced from 6.3 to 3.4 at posttreatment (p < 0.0001) and to 2.6 at follow-up (p < 0.0001).
• Depressed mood and anxiety significantly decreased from assessment to posttreatment (p < 0.02), and reductions were maintained at the three-month follow-up (p < 0.03).
• Sleep improved significantly (p < 0.003).
• Subscales of the SF-36® showed other significant improvements:  emotional role limitation (p < 0.0001), mental health (p < 0.01), energy/vitality (p < 0.0001), and general health (p < 0.003).
• Total scores on the HFBS decreased significantly, from 28.2 to 22.4 at posttreatment (t = 3.77; df = 16; p < 0.002), and were maintained at 22.7 at follow-up (t = 4.34; df = 16; p < 0.001). These reductions reflected a significant change in beliefs.

• Results suggest that CBT delivered in groups might offer a viable option for women with troublesome, undertreated, menopausal symptoms following breast cancer treatment, but further controlled trials are needed.
• CBT is consistent with the preferred treatment of women surveyed.
• Improvements continued after treatment, which may reflect the skills-learning aspect of CBT. HF and NS decreased, as did depressed mood and anxiety.
• Sleep improved, as reported by changes in WHQ ratings.
• Results showed no signficant improvement in specific dimensions of HRQOL, particularly emotional role limitation, energy/vitality, or mental health.

• The study had a small sample size, with less than 30 patients.
• The study is of limited generalizability.
• The main limitations of the study were lack of controls for placebo effects, attention, and spontaneous remission.
   

Nurses could be trained to conduct structured, interactive, group CBT with individual treatment goals. A randomized, controlled trial is recommended for further investigation.

To conduct a controlled pilot trial evaluating the efficacy of a brief early cognitive behavior therapy intervention (CBT) to reduce symptoms of post-traumatic stress disorder (PTSD), depression, and anxiety and to prevent chronic psychological problems within the first year following diagnosis of head and neck cancer

Patients with elevated levels of PTSD, anxiety, or depression were randomized to seven individual sessions of either CBT or nondirective supportive counseling (SC). The interventions were concurrent with radiation therapy. The primary outcomes (PTSD, anxiety, and depression) and secondary outcomes (cancer-related appraisals, quality of life)  were assessed at baseline, one month, six months, and one year postintervention. Researchers assessed participants by using diagnostic clinical interviews and self-report questionnaires. Participants completed the screening assessment conducted by trained psychologists and were then randomized to either a CBT or SC group. Assessors blinded to treatment group conducted follow-up assessments. Researchers conducted a random evaluation of 25% of participants to ensure clinician adherence to protocol.

• The study reported on a sample of 35 participants.
• Mean patient age was 54.8 years, with a range of 18–70 years.
• The sample was 80% male and 20% female.
• Patients had primary head and neck cancer, first onset.
• Patients were recommended to receive primary radiation therapy (XRT) or adjuvant XRT, had an expected prognosis of more than 12 months, and were English speaking.
• There were no differences in sociodemographic or medical variables.

• Single site
• Setting type unspecified
• Royal Prince Alfred Hospital, Sydney, Australia

• Patients were undergoing active antitumor treatment.
• The study has clinical applicability for elder care and palliative care.

A pilot randomized controlled trial design was used.

Assessors administered the following at each assessment:

• Clinician-administered PTSD scale
• Structured Clinical Interview for DSM-IV Axis IV disorders (SCID-IV)
• Posttraumatic Stress Disorder Checklist (PCL), stress-specific version
• Beck Depression Inventory (BDI)
• Posttraumatic Cognitions Inventory (PTCI)
• Functional Assessment of Cancer Therapy–General
• Treatment Credibility Scale (TCS), adapted to measure patient’s beliefs about treatment efficacy contingent on the intervention to which patient was randomized (CBT or SC)

In spite of randomization, the CBT group, compared to the SC group, had significantly elevated scores on the PTCI self-blame subscale. This finding was included as a covariate. Participants in both treatment interventions reported a decline in anxiety and symptoms of depression over time. The study found no significant interaction effects between the two groups in regard to world outlook and negative appraisals. However, a main effect of time was evident for the PTCI negative scale, with both groups reporting a reduction in negative self-referent appraisal scores at one and six months. Significant main effects of time were also evident for improvements in quality of life and on all four subscales in both treatment groups. This was most evident at 6 and 12 months post-therapy. There were no significant differences between groups, and effect size (Cohen’s d) was not significantly different for anxiety or depression outcomes.

The findings of this study indicate that early intervention with psychotherapy is useful in reducing anxiety and symptoms of depression and PTSD and for preventing chronic psychopathology in symptomatic patients with head and neck cancer.

• The study had a small sample size, with less than 100 participants.
• The study had risks of bias due to no control group, no appropriate attentional control condition, and limiting sample characteristics.
• Findings are not generalizable.
• The intervention is expensive or impractical and is accompanied by need for training.
• The study involved English-speaking patients only, and mainly Caucasian males.
• Cancer type was limited to head and neck cancer.

Early identification and intervention for patients who are newly diagnosed with head and neck cancer may be beneficial in reducing symptoms resulting from PTSD, anxiety, and symptoms of depression related to diagnosis. Early identification and intervention may prevent chronic psychological issues in the patient population studied. This study showed that both CBT and SC had similar effects. Findings are limited by lack of a control group and the fact that, with or without treatment, all patients' anxiety levels tend to decline over time.

To examine the effects of physical therapy (PT) versus physical therapy plus cognitive behavioral therapy (CBT) interventions on problem solving, anxiety, and depression in patients with cancer

Consecutive groups of patients referred to rehabilitation centers were randomly assigned to receive either PT or PT and CBT programs for 12 weeks. PT consisted of twice weekly two-hour sessions of aerobic training, muscle-strength training, and group sports and games. CBT sessions were provided in a group format in which participants learned to apply self-management skills in striving for personal goals. Psychologists gathered self-evaluations regarding the extent to which patients adhered to the intervention protocol, and the process was evaluated via case records. Study measures were obtained at baseline, 12 weeks postrehabilitation, and three and nine months postintervention. After week 6, patients started a home-based walking program.

• A total of 147 participants were analyzed, with 132 completing rehabilitation.
• Mean age of participants was 48.8 ± 10.9.
• The sample was 16.3% male and 83.7% female.
• Of the sample, 55.8% had breast cancer, all had completed treatment at least three months prior to inclusion, and the average time since treatment was 1.7 years.
• Nearly 71% were married and living with a spouse, and 86.4% had middle to high levels of education. 
• At baseline, less than one-third had anxiety or depression scores indicating clinically relevant symptoms.

• Multisite
• Setting unspecified
• Dutch rehabilitation centers

• Transition phase after initial treatment
• Late effects and survivorship

Prospective, single-blinded, randomized, two-group trial design

• Social Problem-Solving Inventory–Revised    
• Hospital Anxiety and Depression Scale (HADS)

Overall baseline anxiety and depression scores of participants were significantly higher than those in the general Dutch population (p < 0.001). Immediately after the 12-week program, both groups showed small to moderate effect-size reduction in anxiety (0.45–0.55 [p < 0.001]) and depression (0.44–0.59 [p < 0.001]). At three and nine months, average effects, as measured by HADS score, continued to be lower than baseline, with effect sizes ranging from 0.24 to 0.4. Participants in both groups showed comparable changes in problem solving, anxiety, and depression. Subgroup analysis between those with initially higher and lower levels of distress showed no difference in changes in problem solving. Patients with higher distress, in both intervention groups, showed significant reduction in anxiety (p < 0.01) and depression (p < 0.01) at all study time points. At all measurement points, patients with lower distress at baseline showed levels of distress in keeping with those of the general population.

Study findings did not show that the addition of CBT to PT resulted in effects on problem solving, anxiety, or depression that were greater than the effects of PT alone. Findings did not support the hypothesis that the addition of CBT would be of greater benefit for individuals who had higher distress levels initially. Study findings show beneficial effects of PT on anxiety and depression.

• The study had no appropriate control group.
• Subgroup analysis was done according to overall distress levels, then compared to outcomes regarding anxiety and depression. These are different concepts and patient experiences. Subgroup analysis would have been more relevant if researchers had compared actual anxiety and depression levels to each other, respectively. 
• The study provides no information about attendance rates for sessions, the amount of exercise continued after the initial 12-week session, or adherence to the home-based walking intervention.

Findings if this study support other findings regarding beneficial effects of physical activity in a supervised group setting. Findings of this study suggest that the addition of specific CBT interventions may not increase these effects. Analysis of results in those who had high versus low levels of distress demonstrates that those with low distress do not show a benefit.

The Enhancing Connections program is a five-session multicomponent cognitive behavioral educational counseling intervention delivered at two-week intervals. Each session is scripted and lasts one hour. Components include home-based interactive didactics for mothers, experiential exercises, skilled efficacy-enhancing rehearsals led by a patient educator, mother-child booklets about cancer, mother-child workbooks, and between-session telephone access to a patient educator.

13 mothers with stage 0, I, and II breast cancer and 13 school-age children

Pacific Northwest of the United States

Single-group pre- and post-test design

Maternal measures: Center for Epidemiological Studies Depression Scale, State-Trait Anxiety Inventory Form Y, and Cancer Self-Efficacy Scale.

Mother-child measures: Relatedness Scale and Family-Peer Relationship Scale.

Child measures: Illness-related Pressures Scale, Cancer-Worries Scale, Disenfranchised Grief Scale, Revised Child Manifest Anxiety Scale, Child’s Depression Inventory, and the Child Behavior Problem Checklist.

The program resulted in significant improvements between baseline and post-test in mother’s depressed mood, state anxiety, and self-efficacy in regard to caring for self and family and dealing with the impact of cancer. For children, the program resulted in significant improvements in behavior and emotional functioning, in anxiety or depressed mood, and in reduction of cancer worries.

Evidence suggests that the Enhancing Connections program helped mother and children improve functioning.

• Single-group design with very small sample.
• Results do not generalize to mother-child dyads involving children with clinically elevated anxiety or symptoms of depression or to mother-child dyads in which the mother-child relationship is poor. Results should be viewed with caution.

To examine the effect of cognitive behavioral therapy (CBT) on sleep-wake outcomes in breast cancer survivors

Women who met criteria for chronic insomnia and had completed breast cancer treatment randomly were assigned to CBT intervention or a placebo behavioral intervention. Individual, weekly CBT sessions consisted of education, stimulus control, sleep hygiene education, and cognitive therapy provided by an advanced practice nurse with specialized training. The placebo intervention was based on desensitization therapy that had been used in previous insomnia trials as a placebo treatment. For both groups, sessions 1, 3, and 6 were provided in person, and sessions 4 and 5 were provided by telephone. Sessions were audiotaped and independently reviewed by a CBT therapist to ensure fidelity. Women were evaluated at three- and six-month follow-ups.

• N = 56
• MEAN AGE = 52 years
• FEMALES:100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer and were 1–36 months post-initial treatment. Most had previous radiation and chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: The majority were Caucasian, well educated, and employed part- or full-time.

• SITE: Single site  
• SETTING TYPE: Outpatient
• LOCATION: Colorado

• PHASE OF CARE: Late effects and survivorship

• Randomized, single-blind RCT with attention control

• Sleep diary
• Piper Fatigue Scale
• Hospital Anxiety and Depression Scale
• Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16)
• Patient knowledge test
• ISI measure of perceived insomnia
• Attentional function index
• EORTC-QLQ-C30

The CBT group did not show a significantly greater improvement in sleep outcomes immediately after the intervention, but scores were significantly better by the follow-up period (p = .003). Sleep efficiency increased by more than 11% in the CBT group, compared to an increase of 6.34% in the control group (d = 0.63). Sleep latency also improved more in the CBT group (d = 0.48, p = .007). No differences between groups were found for anxiety, depression, or fatigue.

Findings show that patients receiving CBT for sleep improved several sleep outcomes compared to individuals receiving a control intervention. The intervention did not demonstrate an effect on anxiety, depression, or fatigue.

• Small sample (less than 100)
• Findings not generalizable
• Other limitations/explanation: The sample had little diversity. The average baseline scores suggested that patients did not have clinically relevant levels of anxiety or depression.

Results of this study provide evidence of a moderate and significant effect of CBT on sleep outcomes among breast cancer survivors. This adds to the body of evidence that suggests effectiveness of this approach in managing sleep-wake disturbances.

To determine if baseline intervention in persons free of depression and anxiety can prevent development of depression or anxiety at 6 and 12 months after diagnosis

Subjects were randomized to either the immediate-intervention or delayed-intervention groups. Intervention consisted of a 90-minute face-to-face interview followed by two telephone interviews (45 minutes each) at two weeks and six weeks after the initial interview. Therapeutic intervention included storytelling about initial experiences with diagnosis, exploration of thoughts about cancer-related events and concerns, and use of a booklet for examples of ineffective coping strategies.

• At 6 months, 355 patients were evaluated for the outcome variable; at 12 months, 313 patients were evaluated for the outcome variable.
• Mean patient age was 51.4 years; age range was 18.6–70.9 years.
• Female: 321; male: 144. There were 48 men in each of the three groups. (Assignment of women and men was randomized, final sample was not described.) 
• Participants:
  • Had various cancer diagnoses.
  • Were newly diagnosed with first episode of cancer.
  • Had a judged life expectancy of at least two years.

• Single site
• Outpatient
• Manchester, Greater Manchester, England

Active treatment

Randomized controlled trial

• A concerns checklist, a 14-item checklist to measure level of concern (0–5) regarding the physical, practical, relationship, or existential aspects of cancer and its treatment. A score of 8 or above indicated risk of developing depression.
• Structured Clinical Interview for DSM-IIIR (SCID), administered by trained interviewers at 6 and 12 months.
• Hospital Anxiety and Depression Scale (HADS).

• At the 6- or 12-month follow-up, 71 patients were diagnosed with an anxiety or depression disorder. At both follow-up evaluations, 13 were diagnosed with such a disorder.
• The six-month evaluation revealed no difference between anxiety or depression development in the immediate intervention group (14.3%) and the delayed intervention group (12.3%). Therefore, the two groups were evaluated as one group in the final analysis.
• Patients in the high-risk group who received the intervention showed odds of developing anxiety or depression that were lower than those of patients in the usual-care group (p = 0.05).

The therapeutic psychological intervention demonstrated the potential to prevent disorders relating to depression and anxiety in cancer patients at high risk for development of depression.

• The study did not include an appropriate control group.
• The study confirmed inter-rater reliability of the two therapists but presented no external confirmation of the proficiency with which each adhered to the protocol.
• A large proportion of the initial sample was lost to follow-up.
• Risks of bias were due to no attentional control and an unblended design.

In-person or by-telephone cognitive behavioral intervention delivered by nurses trained in intervention delivery could help to reduce the prevalence of depression and anxiety in newly diagnosed cancer patients. Initial determination of risk for development of clinical depression and anxiety can be useful to identify those patients who may benefit most from such an intervention.

Evaluate the effects of group cognitive behavioral therapy (CBT) among women with breast cancer and major depression

The intervention was a protocol-driven group intervention, delivered in group meetings weekly for 10 weeks. The content included cognitive restructuring dealing with existential concerns, behavioral activation, focusing on the importance of behavior in improving depressive symptoms, coping with side effects of treatment and pursuing healthy behaviors, and interpersonal communication examining the impact of relationships on mood. The intervention group also received progressive muscle relaxation training. Patients were randomized to the CBT or usual care wait list control group. The control group received an educational booklet. Sessions were audio taped and reviewed by supervisors to ensure treatment fidelity. All interventions were done by the same person. Patients were assessed at baseline, at the end of treatment, and at six months after the intervention.

• N = 54
• MEAN AGE = 50.63 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer—most were stage 0–1. More than 94% had received chemotherapy. More than two-thirds had a psychiatric history and family history of mental illness. All were diagnosed with major depressive disorder. All had completed initial cancer treatment.
• OTHER KEY SAMPLE CHARACTERISTICS: 22.6% had completed at least some college education. About half were currently employed, and approximately 90% were married.

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: China

PHASE OF CARE: Transition phase after active treatment

Single-blind randomized controlled trial

• Hamilton Rating Scale for Depression (HRSD)
• Self-Rating Anxiety Scale (SAS)
• Functional Assessment of Cancer Therapy-Breast Self Esteem Scale (SES)

At the end of treatment, a significant improvement was seen in HRSD results in the intervention group compared to controls (p = .00), with a between-groups effect size (ES) of 2.19. At six months, the difference between groups remained significant (p = .00) with an ES of 1.51. HRSD scores declined in all subjects over time. SAS scores declined in all subjects over time. At the end of treatment and at six months, scores were significantly lower in the intervention group (p < .05) with between-groups ES of 0.5 and 0.66, respectively. SES scores were higher in the intervention group but only were significantly different between groups at six months.

Group CBT reduced symptoms of depression and anxiety and increased self-esteem in patients with breast cancer who had major depressive disorder. These effects were maintained to some extent over a six-month period. The greatest effect was seen in reducing depressive symptoms

• Small sample (< 100)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Though they state intent to treat analysis using the last measure carried forward, the sample size used for six months was less than the number who completed the intervention phase of the study. No attentional control condition existed. The sample was limited to Chinese women with mostly early-stage breast cancer who had completed treatment and had a depression diagnosis. No information is provided regarding whether any patients were receiving antidepressants or other relevant medications. Interventions all were provided by a single experienced individual, so findings may not be similar in other situations.

Findings demonstrate that group CBT was effective in reducing symptoms of anxiety and depression among patients with major depressive disorder. Patients with clinically significant depression need to be identified and treated for depression. CBT is one option for management of major depression among patients with cancer.

To test the short-term efficacy of a video-based delivery of cognitive behavioral therapy for insomnia compared to a professionally administered method and a no-treatment group

Patients with breast cancer postradiation therapy who were 18 months post-treatment with insomnia were randomized into one of three groups: a video-based cognitive behavioral therapy intervention (VB-CBTI) (60 minute video with six booklets), a professionally delivered CBTI (six weekly, 50-minute, in-person sessions), or a no-treatment group.

• N = 242
• MEAN AGE = 54.4 years (SD = 8.8 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer; 18 months postradiation therapy for nonmetastatic cancer; poor sleep defined by Insomnia Severity Index scores; sleep medication use
• OTHER KEY SAMPLE CHARACTERISTICS: Able to read French; no cognitive impairments; no psychiatric disorders; no prior diagnoses of sleep disorders other than insomnia; no nightshift work; no psychotherapy for insomnia; no language, hearing, or visual deficits; 25.6% taking antidepressants; 31% taking anxiolytics; 73% receiving hormone therapy

• SITE: Single-site
• SETTING TYPE: Outpatient    
• LOCATION: Canadian oncology and radiology department (academic)

• PHASE OF CARE: Transition phase after active treatment

Randomized, controlled, three-arm intervention study

• Mini Mental State Exam (MMSE)
• Structured Clinical Interview for DSM Disorders (SCID)
• Insomnia Severity Index (ISI) (pretreatment)
• Sleep diary
• Multidimensional Fatigue Inventory (MFI)
• Hospital Anxiety and Depression Scale (HADS)
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (​EORTC-QLQ C30)
• Dysfunctional Beliefs and Attitudes Scale (DBAS)
• Actigraphy secondary outcomes

Group-by-time interactions were significant for sleep variables with video-based CBTI being associated with greater sleep improvements compared to the control group for sleep variables other than early-morning awakening and total sleep time (p < 0.001). There were no significant differences between in-person and video-based CBTI for sleep onset latency, wake after sleep onset, total wake time, and sleep efficiency. In-person treatment was associated with a greater reduction in ISI scores, early morning awakening, and total wake time compared to video-based CBTI. The magnitude of change over time was greater with in-person CBTI compared to video CBTI. Both interventions demonstrated a greater improvement in sleep outcomes than the control group. Actigraphy showed a significant reduction (pre/post) in the in-person group only. Secondary outcomes among the in-person group included a significant reduction in depression (p < 0.001), fatigue (p < 0.001), and dysfunctional beliefs about sleep (p < 0.001).

Both CBTIs were effective in improving sleep compared to usual care. The video format seems to be an effective treatment option, but in-person therapy continues to show better efficacy. CBTI also was associated with improvements in fatigue and depression scores.

• Subject withdrawals ≥ 10%
• Other limitations/explanation: There always is a risk for treatment contamination with randomized, controlled trials. This study was limited to patients who received radiation treatment and those willing to participate in CBTIs, which limits generalizability. There were significant baseline differences in the numbers of participants taking anxiolytics on a regular basis with the highest proportion concentrated in the control group; this could have led to an underestimation of the results of the intervention alone.

CBTIs can be challenging to implement because access to care for patients with cancer is varied. Although in-person therapy was most effective, the video-based intervention also was effective in improving sleep, fatigue, and depression outcomes. Providing options to rural populations without access to in-person care is essential for increasing efficacy in a wider population with insomnia. The findings of this study regarding the efficacy of a video-based CBTI provide nurses with another option that warrants its use as a treatment with longer effects.

To pilot a randomized trial examining the effectiveness of cognitive behavioral therapy (CBT) and aromatherapy massage (AM) in reducing emotional distress in patients with cancer and to compare the differences in effectiveness between the CBT and AM groups

Participants were randomized to one of two treatment groups: CBT or AM. The study did not explain how the CBT intervention was actually implemented, except to note that trained and accredited therapists delivered the therapy. The study listed the topics covered in the CBT sessions but did not describe the procedures, group-session format, etc. AM was described as standard massage with 20 essential oils, delivered by a trained aromatherapist, in a quiet room with minimal talking. Each group received one of these interventions along with “treatment as usual” (standard care). Both groups were offered, after study entry, up to eight one-hour sessions delivered over 10 weeks. Time interval between treatments was not delineated.

• The study reported on a sample of 36 patients (39 enrolled; 3 dropped out before postintervention assessment).
• Mean patient age was 52.5 years.
• The sample was 79% female (n = 31) and 21% male (n = 8).
• The sample was composed mostly of patients with breast and colorectal cancer but also included patients with lung or prostate cancer, lymphoma, and myeloma.
• The stage of disease and other characteristics, such as type of treatment, was unspecified. Also unspecified was whether participants were receiving pharmacologic treatment for emotional distress (anxiety or depression) or some other psychological support. Study participants were screened, by means of the Hospital Anxiety and Depression Scale (HADS), for anxiety and depression. The initial cut score was 8. (An initial cut score of 8–10 is considered borderline for anxiety or depression.) Four months after study initiation, the cut score was increased to 11. (A cut score of 11 or higher is considered clinically significant.) The demographics of the CBT and AM groups were similar except in regard to gender: The CBT group contained only one male; seven males were in the AM group. In both groups, the total sample size was too small to allow researchers to detect significance differences.

• Single site
• Outpatient setting
• An urban teaching hospital, recruited from outpatient oncology clinics, in London, England

Patients were undergoing multiple phases of care.

The study, a pilot, was a randomized, single-blind, prospective, repeated-measure clinical trial with no control group. Measures were collected at baseline and at three and six months postintervention.

• Hospital Anxiety and Depression Scale (HADS): For screening and participant eligibility
• At baseline: Treatment preferences and beliefs about effectiveness and satisfaction with either CBT or AM
• Profile of Mood States Short Form (POMS-SF): Total mood disturbance score (TMS), summed from six subscales
• Psychological Outcomes Profiles (PSYCHLOPS): Six-point Likert scale to assess distress, duration, and impact of two patient-derived problem areas
• EuroQol: A health-related quality-of-life measure
• Client event recall: Asking patients about their experience with the therapy
• Consultation and Relational Empathy (CARE) measure: To quantify each patient’s perception of relational empathy with the therapist

The study was drastically underpowered, with too small a sample to allow researchers to draw meaningful conclusions. The study produced no statistically significant findings.

• With low recruitment (8%), a protracted period (two years, but still called a pilot?), and an underpowered design that lacked a strong conceptual grounding and rationale, this study produced no meaningful conclusions and suggested no direct application to practice.
• Both therapies, AM and CBT, were well received and posed no risk of harm.
• To treat the \"whole patient,\" nonpharmacologic interventions should be offered, when possible, to patients with cancer.

• The study had a small sample size, with less than 100 participants.
• The study had risks of bias due to no control group and as the result of sample characteristics.
• Findings are not generalizable.
• The study used nonrandom (convenience) sampling with a low accrual rate.
• Screening criteria changed four months into the trial, but data do not differentiate participants (defined only as patients with HADS greater than 8).
• Rationale for sampling time points is unclear (e.g., why should researchers expect an effect three to six months after AM?).
• Time between last treatment (AM or CBT) and three-month sampling is not noted, so relating outcomes to intervention is difficult.
• Participants were allowed to select the  number of therapy sessions to attend, which is certainly a weakness.
• Whether CBT was delivered in a group format cannot be ascertained.

AM may be beneficial as a treatment for short-term anxiety. This poorly designed and controlled pilot study offers no other immediate nursing implication.

To determine if group-based cognitive behavioral therapy (CBT) following surgery for breast cancer had long-term benefits for depressive symptoms

Women who previously participated in a single-blind RCT of 10 weeks of a group-based cognitive behavioral intervention versus a one-day psychoeducational control condition were contacted five years later for follow-up assessment. Patients were mailed a questionnaire to complete.

• N = 130
• MEAN AGE: 62.5 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: 88.4% were disease free at follow-up.

• SITE: Single site  
• SETTING TYPE: Home  
• LOCATION: Miami, FL

• PHASE OF CARE: Late effects and survivorship

• Follow up post-RCT

• Center for Epidemiological Studies Depression Scale (CES-D)

Women who had participated in the CBT intervention reported fewer depressive symptoms (d = 0.32, p = 0.03). The power to detect this difference was 0.93.

Findings suggest that CBT-approach interventions had long-term benefit in reducing depressive symptoms among women with breast cancer.

• The measure for depression was different from what was used in the initial study, and it is unclear whether patients had clinically relevant depression to begin with.

Cognitive behavioral interventions have been shown to be effective interventions for depression. This study suggests that CBT benefits can be long lasting. Alhough most nurses do not provide full CBT, principles of the CBT approach can be readily incorporated into nursing care and psychoeducational interventions. This approach can be recommended for use.

To report on health-related quality of life (HRQOL) and depressive outcomes from an earlier trial using nurse counseling after intervention (NUCAI)

Nurses delivered as many as six 45–60 minutes sessions every two months. The sessions consisted of six components: completing a Hospital Anxiety and Depression Scale before each session to lead a discussion of current mental state, having a discussion of current physical problems, having a discussion of life functioning, providing the AFTER (Adjustment to Fear, Threat, or Expectation of Recurrence) intervention, providing general medical assistance, and referring patients to psychological care. The AFTER intervention had four components: expressing fear of recurrence, identifying beliefs about recurrence, evaluating self-examinations, reducing excessive checking behavior, and relaxation. Usual care was provided twice monthly in sessions about complications and monitoring for recurrence. Patients were referred for psychological aftercare if psychosocial problems were assessed.

• N = 179  
• MEAN AGE = 60.1 years (intervention), 60.7 years (control)
• MALES: 70%, FEMALES: 30%
• KEY DISEASE CHARACTERISTICS: Intervention type of cancer: 23% larynx, 47% oral cavity, 18% OP, and 13% hypopharynx; control type of cancer: 24% larynx, 19% oral cavity, 48% OP, and 8% hypopharynx; intervention tumor stage: I–II 58% and III–IV 42%; control tumor stage: I–II 59% and III–IV 40% 
• OTHER KEY SAMPLE CHARACTERISTICS: Working status intervention: employed 35%, unemployed 33%, retired 22%, and unknown 10%; working status control: employed 37%, unemployed 37%, retired 23%, and unknown 2%

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Utrecht, Netherlands

• PHASE OF CARE: Transition phase after active treatment

Single, blinded, randomized, controlled trial

• Questionnaires were completed at baseline before cancer treatment and at three, six, nine, 12, 18, and 24 months after treatment completion.
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck (EORTC QLQ-C30 H&N 35)
• Center for Epidemiologic Studies Depression Scale (CES-D)
• Demographic and medical information collection

50% of patients were lost to follow-up, the majority of which were because of death or terminal disease. At 12 months, statistically significant differences in physical functioning, emotional functioning, pain, swallowing, social contact, opening the mouth, coughing, and depressive symptoms were present. At 18 months, statistically significant differences in global quality of life, role functioning, emotional functioning, pain, swallowing, opening mouth, and depressive symptoms were present. At 24 months, statistically significant differences in emotional functioning and fatigue were present. Appointments were difficult to complete at times because of the clinic environment.

The NUCAI showed significant improvements for patients with head and neck cancer 24 months after completing treatment.

• Risk of bias (no blinding)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: High attrition rate because of disease state; several analyses of data; fatigue measured as one aspect of multicomponent quality of life

As a nurse-led intervention, this is a feasible option for patients with head and neck cancer desiring a problem-focused intervention for symptoms.

The guideline provides an algorithm for the screening and assessment of anxiety, a care map for anxiety in adults with cancer, an algorithm for the screening and assessment of depression, a care map for depression in adults with cancer, the Patient Health Questionnaire (PHQ 9) symptom depression scale and generalized anxiety disorder (GAD) items, and selected measures for depression and anxiety (modified).

• Before the implementation of guidelines, referral systems and resources should be identified and available in each institution.
• The guidelines are designed for healthcare providers, patients, family members, and caregivers to guide in the screening, assessment, and treatment approaches of adult patients with cancer who have anxiety and depression at any stage of the cancer continuum, regardless of cancer type, disease stage, or treatment modality. 
• All patients with cancer and cancer survivors should be evaluated for the symptoms of anxiety and depression with validated instruments at periodic times during the cancer care. Treatment recommendations are based on the levels of symptoms. Follow-up care and reassessment are important in this setting to monitor for follow-through, compliance with referrals, and pharmacologic management. If compliance is poor, develop a plan. After eight weeks of treatment, if symptoms are not improved or poor compliance is noted, alter the treatment course and add a psychological or pharmacologic intervention. The guidelines recommend that individual psychological interventions be delivered by a licensed mental health professional, which may include cognitive and behavioral strategies, education and relaxation strategies, group psychosocial interventions, and physician-prescribed antidepressants. 

• A guideline that has been adapted from another country often can't lend itself to different policies or cultural influences.
• Some of the recommendations were removed from the original guideline because of references to the Edmonton Symptom Assessment Scale screening measure, which is not widely used in the United States.

Nurses play a vital role in the early screening, assessment, and treatment of patients who may have significant symptoms of anxiety and depression. By screening and making appropriate referrals, we can impact the emotional, interpersonal, and financial costs for patients and reduce the economic impact for providers and the healthcare system.