Cognitive Behavioral Interventions/Approach

Cognitive Behavioral Interventions/Approach

PEP Topic 
Anxiety
Description 

Cognitive behavioral interventions are designed to reflect concepts from cognitive behavioral therapy (CBT), which examines the association among throughts, feelings, and behaviors. Cognitive behavioral interventions do not involve full CBT psychotherapy; however, they do assist patients in identifying negative or unhelpful thoughts and beliefs in order to change these. Cognitive behavioral intervention approaches also help individuals to identify helpful and unhelpful behaviors, establish goals, and develop skills to solve problems and implement new behaviors to facilitate effective coping. Structured programs based on cognitive behavioral approaches may include activities such as education or relaxation training, may be provided in individual or group settings, and may be delivered in person, telephonically, or by other methods.

Likely to Be Effective

Research Evidence Summaries

Ames, S.C., Tan, W.W., Ames, G.E., Stone, R.L., Rizzo, T.D., Jr., Crook, J.E., . . . Rummans, T.A. (2011). A pilot investigation of a multidisciplinary quality of life intervention for men with biochemical recurrence of prostate cancer. Psycho-Oncology, 20, 435–440.

doi: 10.1002/pon.1769
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Study Purpose:

To evaluate the acceptability and estimate the effect size of a multidisciplinary quality-of-life intervention for men with biochemical recurrence of prostate cancer

Intervention Characteristics/Basic Study Process:

The intervention involved eight multidisciplinary group sessions consisting of education, goal setting, relaxation training, problem solving, social support, physical activity, and mood management.

Sample Characteristics:

  • The sample was comprised of 57 men diagnosed with prostate cancer with biochemical recurrence.
  • Median age of sample was 76 years.
  • Men had prostate-specific antigen only recurrence post surgery or radiation without clinical or x-ray evidence of metastases.
  • The sample was 89% white, 10% black, and 1% other.
  • Thirty-nine percent had graduated college.

Setting:

  • Outpatient clinic
  • Florida

Phase of Care and Clinical Applications:

Biochemical relapse phase

Study Design:

A randomized controlled trial design was used.

Measurement Instruments/Methods:

  • Functional Assessment of Cancer Therapy–Prostate (47-item measure of prostate-specific quality of life)
  • Memorial Anxiety Scale for Prostate Cancer (18 items)
  • Perceived Stress Scale–10 (10 items)
  • Profile of Mood States–Brief (30 items)

Results:

  • No difference was reported between groups.
  • Intervention effect size was 0.45 at the end of treatment.

Conclusions:

The results did not provide strong support for a meaningful effect of the intervention provided here on anxiety or quality of life in patients with biochemical recurrence of prostate cancer. Findings suggest that this type of intervention is acceptable to the patient population, since there was a high rate of attendance.

Limitations:

  • No data or statistical analysis were reported to determine between group differences.
  • The study had no appropriate attentional control.

Nursing Implications:

Given the lack of durability, the intense, multidisciplinary nature of this intervention may not be the best use of limited resources. Further, such a multidisciplinary intervention may be difficult to replicate in the community setting.

Arving, C., Sjödén, P.-O., Bergh, J., Hellbom, M., Johansson, B., Glimelius, B., et al. (2007). Individual psychosocial support for breast cancer patients: A randomized study of nurse versus psychologist interventions and standard care. Cancer Nursing, 30, E10–E19.

doi: 10.1097/01.NCC.0000270709.64790.05
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Study Purpose:

To compare individual psychosocial support (cognitive behavioral therapy [CBT]) for patients with breast cancer provided by oncology nurses specially trained in psychologic techniques (INS), or the same support given by psychologists (IPS), versus standard care provided in Sweden.

Intervention Characteristics/Basic Study Process:

Measures were done at one, three, and six months after inclusion in study.

Sample Characteristics:

The sample was comprised of 179 patients with breast cancer who were about to start adjuvant therapy.

Study Design:

A prospective, randomized study design was used.

Measurement Instruments/Methods:

  • Hospital Anxiety and Depression Scale
  • State-Trait Anxiety Inventory
  • Impact of Event Scale (intrusion and avoidance subscales)

Results:

Results indicated that CBT offered by specially trained nurses is just as effective as CBT offered by psychologists. Statistically significant improvements in anxiety over time (p < 0.01) were shown between the INS and IPS groups versus the standard care group.

Limitations:

  • No screening for psychological problems or treatment before inclusion into the study may flaw the results.
  • Insufficient power of study may limit results.

Boesen, E.H., Karlsen, R., Christensen, J., Paaschburg, B., Nielsen, D., Bloch, I.S., . . . Johansen, C. (2011). Psychosocial group intervention for patients with primary breast cancer: A randomised trial. European Journal of Cancer, 47, 1363–1372.

doi: 10.1016/j.ejca.2011.01.002
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

  • Single site
  • Outpatient setting
  • Denmark

Study Design:

 Randomized controlled trial

Measurement Instruments/Methods:

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

Results:

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

Conclusions:

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

Limitations:

  • 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.

Nursing Implications:

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

Dolbeault, S., Cayrou, S., Bredart, A., Viala, A.L., Desclaux, B., Saltel, P., . . . Dickes, P. (2009). The effectiveness of a psycho-educational group after early-stage breast cancer treatment: Results of a randomized French study. Psycho-Oncology, 18, 647–656.

doi:10.1002/pon.1440
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Study Purpose:

To determine effect of a cognitive behavioral type of intervention on anxiety

Intervention Characteristics/Basic Study Process:

The intervention involved eight weeks of group-based cognitive behavioral training that included cognitive restructuring techniques, relaxation, peer exchange, communication, and general medical information.

Sample Characteristics:

  • The final sample was comprised of 167 French women with early-stage breast cancer.
  • Mean age in the treatment group was 54.5 +/- 9.3; mean age in the control group was 51.6 +/- 9.6.

Setting:

  • Multisite
  • Outpatient setting
  • France

Phase of Care and Clinical Applications:

  • Transition phase after initial treatment
  • Late effects and survivorship

Study Design:

A randomized controlled trial design was used.

Measurement Instruments/Methods:

  • Spielberger State-Trait Anxiety Inventory (STAI)
  • Profile of Mood States (POMS)
  • Mental Adjustment to Cancer (MAC) Scale
  • EORTC Quality of Life Questionnaire

Results:

The treatment group showed a greater reduction in anxiety over time compared to the control group (p = 0.001).

Conclusions:

Structured psychoeducational group interventions in patients with early-stage breast cancer in remission can have a positive effect on emotional states, especially in reducing anxiety.

Limitations:

  • The study had no attentional control.
  • Age and chemotherapy treatment were found to be significant confounding variables, and there were significant differences in the control and intervention groups on these variables.
  • The intervention was provided in a group setting, making it difficult to determine how much of the effect seen was due to the specific structured intervention as opposed to the peer support aspects of the intervention.

Nursing Implications:

The practicality of conducting two-hour group sessions weekly for eight weeks may be questionable. Furthermore, the study was funded and the intervention was provided free of charge—this may not be routinely possible.

Fleming, L., Randell, K., Harvey, C.J., & Espie, C.A. (2014). Does cognitive behaviour therapy for insomnia reduce clinical levels of fatigue, anxiety and depression in cancer patients? Psycho-Oncology.

doi: 10.1002/pon.3468
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

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

Phase of Care and Clinical Applications:

PHASE OF CARE: Transition phase after active treatment

Study Design:

Secondary analysis of a randomized controlled trial

Measurement Instruments/Methods:

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

Results:

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.

Conclusions:

The CBTI reduced prevalence of insomnia and clinically relevant fatigue.

Limitations:

  • 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.

Nursing Implications:

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.

Greer, J.A., Traeger, L., Bemis, H., Solis, J., Hendriksen, E.S., Park, E.R., . . . Safren, S.A. (2012). A pilot randomized controlled trial of brief cognitive-behavioral therapy for anxiety in patients with terminal cancer. Oncologist, 17, 1337–1345.

doi: 10.1634/theoncologist.2012-0041
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

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

Phase of Care and Clinical Applications:

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

Study Design:

A pilot feasibility and randomized controlled trial design was used.

Measurement Instruments/Methods:

  • 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)

Results:

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).

Conclusions:

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.

Limitations:

  • 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.

Nursing Implications:

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.

Groarke, A., Curtis, R., & Kerin, M. (2013). Cognitive-behavioural stress management enhances adjustment in women with breast cancer. British Journal of Health Psychology, 18, 623-641. 

doi: 10.1111/bjhp.12009
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

  • SITE:  Single site  
  • SETTING TYPE:  Outpatient

Phase of Care and Clinical Applications:

PHASE OF CARE: Transition phase after active treatment

Study Design:

Randomized controlled trial

Measurement Instruments/Methods:

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

Results:

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.

Conclusions:

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.

Limitations:

  • 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.

Nursing Implications:

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.

Guo, Z., Tang, H.Y., Li, H., Tan, S.K., Feng, K.H., Huang, Y.C., . . . Jiang, W. (2013). The benefits of psychosocial interventions for cancer patients undergoing radiotherapy. Health and Quality of Life Outcomes, 11, 121.

doi: 10.1186/1477-7525-11-121
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Study Purpose:

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.

Intervention Characteristics/Basic Study Process:

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

Sample Characteristics:

  • 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.

Setting:

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

Phase of Care and Clinical Applications:

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

Study Design:

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.

Measurement Instruments/Methods:

  • 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.

Results:

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.

Conclusions:

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.

Limitations:

Chinese study (possible cultural implications)

Nursing 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.

Hopko, D.R., Bell, J.L., Armento, M., Robertson, S., Mullane, C., Wolf, N., & Lejuez, C.W. (2008). Cognitive-behavior therapy for depressed cancer patients in a medical care setting. Behavior Therapy, 39,126–136.

doi: 10.1016/j.beth.2007.05.007
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

  • 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.

Sample Characteristics:

  • 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.

Setting:

  • Single site
  • Outpatient setting
  • Cancer institute in Tennessee

Phase of Care and Clinical Applications:

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

Study Design:

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

Measurement Instruments/Methods:

  • 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

Results:

  • 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%).

Conclusions:

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.

Limitations:

  • 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.

Nursing Implications:

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.

Hunter, M.S., Coventry, S., Hamed, H., Fentiman, I., & Grunfeld, E. A. (2009). Evaluation of a group cognitive behavioural intervention for women suffering from menopausal symptoms following breast cancer treatment. Psycho-Oncology, 18, 560–563.

doi:10.1002/pon.1414
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Study Purpose:

Primary aim: To evaluate the effectiveness of group cognitive behavioral therapy (CBT) on hot flashes and night sweats in women who have had breast cancer

Secondary aim: To evaluate the effect of group CBT on depressed mood, anxiety, sleep, and quality of life

Intervention Characteristics/Basic Study Process:

The intervention consisted of six group sessions using a psychoeducational approach with education regarding hot flushes, relaxation, stress management, and sleep strategies.

The intervention was delivered by a psychologist plus a trainee/intern.

Relaxation and paced breathing were demonstrated and practiced in each session, and participants were given a CD for ongoing use.

Sample Characteristics:

  • The sample was comprised of 17 women with breast cancer.
  • Mean age of participants was 53.7 years, with a range of 46–65 years.
  • Average time since diagnosis was 23.2 months; 82% had received chemotherapy and radiation therapy, and 71% were receiving adjuvant hormonal therapies.
  • Mean duration of hot flashes was 2.1 years.
  • Of the sample, 70% were employed and 53% had more than 16 years of education.

Setting:

  • Single site (two breast units)
  • Other setting
  • London, England, United Kingdom

Phase of Care and Clinical Applications:

  • Transition phase after initial treatment
  • Late effects and survivorship

Study Design:

A pre/post-test design was used.

Measurement Instruments/Methods:

  • Hot Flush Frequency and Problem Rating Scale (HFRS): Three 10-point Likert-type scales
  • Daily hot flush diaries completed during a two-week assessment and at the end of treatment
  • Women’s Health Questionnaire (WHQ): 36 items to assess mood and sleep
  • Short Form 36 (SF-36): 36 items to assess health-related quality of life
  • Hot Flush Beliefs Scale (HFBS)

Results:

Depression and anxiety decreased from baseline to post-treatment (p < 0.006; p < 0.02). Reductions maintained at the three-month follow-up.

Conclusions:

Results suggest that group CBT may be an effective option for women who have menopausal symptoms following breast cancer treatment.

Limitations:

  • The sample was small.
  • Only 59% of participants completed all six sessions.

Nursing Implications:

Participants had a mean duration of hot flushes of more than two years, suggesting that symptoms may have been unrelated to their recent cancer treatment and more associated with menopause.

Kangas, M., Milross, C., Taylor, A., & Bryant, R.A. (2013). A pilot randomized controlled trial of a brief early intervention for reducing posttraumatic stress disorder, anxiety and depressive symptoms in newly diagnosed head and neck cancer patients. Psycho-Oncology, 22,1665–1673.

doi: 10.1002/pon.3208
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

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

Phase of Care and Clinical Applications:

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

Study Design:

A pilot randomized controlled trial design was used.

Measurement Instruments/Methods:

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)

Results:

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.

Conclusions:

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.

Limitations:

  • 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.

Nursing Implications:

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.

Kissane, D.W., Bloch, S., Smith, G.C., Miach, P., Clarke, D.M., Ikin, J., . . . McKenzie, D. (2003). Cognitive-existential group psychotherapy for women with primary breast cancer: A randomized controlled trial. Psycho-Oncology, 12, 532–546.

doi: 10.1002/pon.683
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Intervention Characteristics/Basic Study Process:

The intervention was cognitive-existential therapy (CEGT) provided in nine Australian hospitals. Existential themes of anxiety about death and uncertainty were incorporated into six goals of therapy: promoting a supportive environment, facilitating grief work over multiple losses, altering maladaptive cognitive patterns, enhancing problem-solving and coping skills, fostering a sense of mastery, and sorting out priorities for the future. The CEGT group had 20 weekly sessions, 90 minutes each, over six months. The control group had three 50-minute relaxation classes using progressive muscle relaxation with guided imagery. Measurements were taken at baseline, 6 months, and 12 months after the intervention. The intervention was offered by 15 therapists recruited from psychiatry, psychology, social work, occupational therapy, and oncology nursing staff. All therapists received specialized training and supervision through a series of workshops using 68-page manual.

Sample Characteristics:

  • The sample was comprised of 303 women with stage I or II breast cancer stratified by nodal status, hormone receptor status, and tumor size.
  • The intervention group (n = 154) received CEGT plus three relaxation classes.
  • The control group (n = 149) received three relaxation classes.

Setting:

Nine Australian hospitals

Study Design:

A randomized controlled trial/longitudinal study design was used.

Measurement Instruments/Methods:

  • Monash Interview for Liaison Psychiatry (structured psychiatric interview validated with DSM-IIIR)
  • Affect Balance Scale
  • Hospital Anxiety and Depression Scale (HADS)
  • Mental Adjustment to Cancer Scale (MAC)
  • Family Assessment Device
  • Satisfaction with therapy and other treatments

Results:

  • Baseline screening showed that one-third of the sample suffered from a form of depressive disorder.
  • The CEGT intervention group had reduced anxiety (p = 0.05, two-sided) compared to controls.
  • Overall effect size for group intervention was small (d = 0.25).

Conclusions:

  • The CEGT model is recommended for use in patients with early breast cancer, and the supportive-expressive treatment model is recommended for patients with advanced breast cancer.
  • The psychologist intervention group had a moderate mean effect size (d = 0.52); training and experience of the therapist make the intervention more effective.

Limitations:

  • Both groups received three relaxation classes (minor design flaw).
  • The intervention required specialized training needs for therapists.

Komatsu, H., Hayashi, N., Suzuki, K., Yagasaki, K., Iioka, Y., Neumann, J., . . . & Ueno, N.T. (2012). Guided self-help for prevention of depression and anxiety in women with breast cancer. ISRN Nursing, 716367.

doi: 10.5402/2012/716367
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Study Purpose:

Evaluate the effects of a self-help program on depression and anxiety in women with breast cancer receiving chemotherapy

Intervention Characteristics/Basic Study Process:

Patients were assigned to intervention or treatment groups by authors (not random assignment). The intervention was a self-learning package aimed at rehearsing the chemotherapy procedure, improving beliefs in managing side effects, and helping build problem-solving skills. This group also was given a professional-led support group that met two to three times during the study. The control group received usual care including a chemotherapy education leaflet. Nurses monitored patient progress from review of patient diaries in the intervention group that documented side effects and self management performed at the beginning of each cycle of chemotherapy. Nurses involved with the intervention were educated and demonstrated increased knowledge regarding improving coping processes in daily living. Data were collected at baseline, one week, three months, and six months.

Sample Characteristics:

  • N = 65      
  • MEAN AGE: Intervention = 47.7 years (SD = 8 years), control = 49.5 years (SD = 10.9 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer at stages 1–3. All had previous surgery.
  • OTHER KEY SAMPLE CHARACTERISTICS: Most had breast-conserving surgery. The majority had less than a bachelor’s degree education level.

Setting:

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

Phase of Care and Clinical Applications:

PHASE OF CARE: Active antitumor treatment

Study Design:

Non-random, two-group comparison, quasi-experimental—historical control approach

Measurement Instruments/Methods:

  • Center for Epidemiological Studies Depression Scale (CESD)
  • State-Trait Anxiety Inventory (STAI)
  • SF-36
  • National Cancer Institute-Common Toxicity Criteria version 2.0

Results:

No significant differences were found in outcomes between study groups. Study measures improved over time in all patients.

Conclusions:

This study did not find that the intervention tested here had an effect on depression or anxiety.

Limitations:

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
  • Questionable protocol fidelity
  • No information is provided about patient compliance with diaries and symptoms experienced. No method was used for determining intervention fidelity. No information is provided as to patients' actual attendance at support group sessions. If patients in both groups were being treated in the same location, whether group contamination could have occurred is unclear. The control comparison used was actually a historic control. How the program was designed is unclear, and no apparent theoretical foundation of the program design exists. Although not statistically significant, baseline anxiety and depression scores were lower in the control group, which may have affected the ability to detect differences. Analysis was the comparison of average scores at each study time point, but changes in these scores were not analyzed. Changes in anxiety and depression scores appeared to be greater in the intervention group—analysis of differences in the size of the improvement may have shown different significance. Data reporting is questionable—confidence intervals reported with F values do not appear to be actually related to those values.

Nursing Implications:

This particular study did not demonstrate effectiveness of the intervention tested here. The study had several limitations. Anxiety and depression improved in all patients, suggesting that usual nursing education provided was just as effective as the expanded approach used here. Several study results have suggested that interventions aimed at improving anxiety and depression are most effective for patients who have clinically relevant anxiety and depression.

Korstjens, I., Mesters, I., May, A.M., van Weert, E., van den Hout, J.H., Ros, W., . . . van den Borne, B. (2011). Effects of cancer rehabilitation on problem-solving, anxiety and depression: A RCT comparing physical and cognitive-behavioural training versus physical training. Psychology and Health, 26(Suppl. 1), 63–82.

doi: 10.1080/08870441003611569
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

  • Multisite
  • Setting unspecified
  • Dutch rehabilitation centers

Phase of Care and Clinical Applications:

  • Transition phase after initial treatment
  • Late effects and survivorship

Study Design:

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

Measurement Instruments/Methods:

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

Results:

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.

Conclusions:

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.

Limitations:

  • 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.

Nursing Implications:

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.

Pitceathly, C., Maguire, P., Fletcher, I., Parle, M., Tomenson, B., & Creed, F. (2009). Can a brief psychological intervention prevent anxiety or depressive disorders in cancer patients? A randomised controlled trial. Annals of Oncology, 20, 928–934.

doi:10.1093/annonc/mdn708
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Study Purpose:

To test the hypothesis that a brief intervention would be superior to usual care to prevent anxiety or depressive disorders among newly diagnosed patients with cancer

Intervention Characteristics/Basic Study Process:

The structured intervention was based on cognitive behavioral therapy geared toward coping and exploring beliefs and thoughts about illness. The first session was 90 minutes in person with a therapist, followed by two 45-minute sessions two and six weeks later via telephone.

Sample Characteristics:

  • The sample was comprised of 465 patients with cancer.
  • Mean patient age was 51.4 years ± 13.04.
  • The sample was 69% female and 31% male.
  • The most common diagnoses were breast cancer, lymphoma, and gynecologic cancers.
  • Patients were excluded if they had an anxiety or depressive disorder, were taking antidepressant or anxiolytic medication, or were receiving psychological intervention.
  • At baseline, 59.6% of patients were deemed to be at high risk for development of anxiety or depressive disorders.
  • The majority of patients were receiving either chemotherapy or radiotherapy alone.
  • Most (70%–77%) patients were married or cohabitating.

Setting:

  • Single site
  • Outpatient setting
  • Manchester, England, United Kingdom

Phase of Care and Clinical Applications:

Active treatment phase

Study Design:

A randomized controlled trial design was used.

Measurement Instruments/Methods:

  • Structured clinical interview for DSM-III-R (SCII) to identify any episode of anxiety or depressive disorder
  • Hospital Anxiety and Depression Scale (HADS)
  • Concerns checklist: 14-item checklist of physical, practical, relationship, and existential concerns rated on a five-point scale

Results:

By the six-month time point, approximately 27% of participants were lost to follow-up or had dropped out of the study for various reasons. Those variables found to predict drop-out were age, gender, previous psychiatric history, and concerns score, some of which were the same variables reported to be predictive of developing an anxiety or depressive disorder.

At the 12-month follow-up, there was no difference between groups. In patients at high risk for developing an anxiety or depressive disorder, those in the intervention group were less likely to develop a disorder (p = 0.05). There was no difference in findings based on the timing of the intervention (immediate – within one week of starting treatment, versus delayed – eight weeks after starting treatment).

Conclusions:

The brief intervention studied may have potential for preventing development of anxiety or depressive disorders only in those patients who were at initial high risk for development of those disorders.

Limitations:

  • The study had no attentional control.
  • The study had increased risk of bias because patients self-selected to either the intervention or control group.

Qiu, J., Chen, W., Gao, X., Xu, Y., Tong, H., Yang, M., . . . Yang, M. (2013). A randomized controlled trial of group cognitive behavioral therapy for Chinese breast cancer patients with major depression. Journal of Psychosomatic Obstetrics and Gynaecology, 34(2), 60–67. 

doi: 10.3109/0167482X.2013.766791
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

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

Phase of Care and Clinical Applications:

PHASE OF CARE: Transition phase after active treatment

Study Design:

Single-blind randomized controlled trial

Measurement Instruments/Methods:

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

Results:

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.

Conclusions:

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

Limitations:

  • 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.

Nursing Implications:

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.

Serfaty, M., Wilkinson, S., Freeman, C., Mannix, K., & King, M. (2012). The ToT study: Helping with Touch or Talk (ToT): A pilot randomised controlled trial to examine the clinical effectiveness of aromatherapy massage versus cognitive behaviour therapy for emotional distress in patients in cancer/palliative care. Psycho-Oncology, 21, 563–569.

doi: 10.1002/pon.1921
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

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

Phase of Care and Clinical Applications:

Patients were undergoing multiple phases of care.

Study Design:

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.

Measurement Instruments/Methods:

  • 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

Results:

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

Conclusions:

  • 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.

Limitations:

  • 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.

Nursing Implications:

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

Shepherd, L., Goldstein, D., Whitford, H., Thewes, B., Brummell, V., & Hicks, M. (2006). The utility of videoconferencing to provide innovative delivery of psychological treatment for rural cancer patients: Results of a pilot study. Journal of Pain and Symptom Management, 32, 453–461.

doi: 10.1016/j.jpainsymman.2006.05.018
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Intervention Characteristics/Basic Study Process:

The intervention was cognitive behavioral therapy (CBT) offered as telepsychology. A clinical psychologist provided one-hour brief CBT to rural patients with cancer in Australia via videoconferencing. These brief CBT sessions were held weekly or biweekly for one to six sessions, depending on the patient’s Distress Thermometer rating and clinical judgment of oncology staff caring for the patient. After formal assessment, a treatment plan was individualized to include cognitive behavioral techniques, such as problem solving, activity scheduling, and controlled breathing. Each patient came to the rural clinic for the intervention. A staff member was in attendance with the patient throughout the videoconference session. Questionnaires were offered at pretreatment, post-treatment, and one month follow-up. The pretreatment questionnaire included demographic information, previous treatment by a psychologist, current use of psychotropic medications, time of initial diagnosis, and current cancer treatment prescribed.

Sample Characteristics:

  • The sample included 25 patients with cancer living in rural Australia who scored 7+/10 on a Distress Thermometer tool or who were clinically identified by staff.
  • All patients in the study received the intervention.

Setting:

Rural Australia

Study Design:

A longitudinal pilot study design was used.

Measurement Instruments/Methods:

  • Hospital Anxiety and Depression Scale (HADS): To assess anxiety and depression
  • Functional Assessment of Cancer Therapy–General (FACT-G): To assess quality of life
  • Patient satisfaction: 17 questions to assess patients’ attitudes toward their telepsychology experience postintervention

Results:

  • The study needed 165 participants to make power levels: analyses of effect size was done with reported p values (p = 0.01).
  • Patient anxiety levels over the intervention period decreased significantly, with large effect size sustained over one month.
  • Anxiety scores (part of HADS) were F = 5.55, p = 0.01, and eta² = partial squared (magnitude of association) = 0.33.

Conclusions:

The traditional “standard“ dose” of CBT is six to eight weeks (9–12 hrs) of therapy in a group setting. Even with this study’s “inadequate” dose of therapy, the individual, brief CBT made a significant decrease in patients’ anxiety levels.

Limitations:

  • Lack of control group and limited sample size were significant flaws of the study.
  • The study was a small pilot with numerous confounding variables (e.g., type of psychotropic medication taken, type and stage of cancer, time since diagnosis of cancer).
  • Presence of a staff member during videoconference, which may have inhibited patient responses to therapy, was a minor flaw.

Systematic Review/Meta-Analysis

Naaman, S.C., Radwan, K., Fergusson, D., & Johnson, S. (2009). Status of psychological trials in breast cancer patients: A report of three meta-analyses. Psychiatry, 72, 50–69.

doi: 10.1521/psyc.2009.72.1.50
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Purpose:

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

Search Strategy:

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.

Literature Evaluated:

  • 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 Characteristics:

  • 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.

Results:

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.

Conclusions:

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.

Nursing Implications:

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.

Osborn, R.L., Demoncada, A.C., & Feuerstein, M. (2006). Psychosocial interventions for depression, anxiety, and quality of life in cancer survivors: Meta-analysis. International Journal of Psychiatry in Medicine, 36, 13–34.

doi: 10.2190/EUFN-RV1K-Y3TR-FK0L
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Purpose:

To investigate the effects of cognitive behavioral therapy (CBT) and patient education (PE) on anxiety in adult cancer survivors

Search Strategy:

Databases searched were MEDLINE, PsycINFO, and the Cochrane Database (1993–2004).

Search keywords were cancer, anxiety, depression, quality of life (QOL), fatigue, stress, pain, physical function, social, self-management, evidence-based, interventions, and random/randomized.

Studies were included in the review if they

  • Reported on adult patients with cancer (all types and stages)
  • Had a control group, randomization, and measurable outcomes of interest (anxiety, depression, fatigue, QOL, physical function, and pain)
  • Had at least one follow-up assessment beyond post-treatment, which allowed for examination of duration of effects.

Studies were excluded if they were not randomized or controlled, had a score of less than four on checklist, did not report follow-up data, or did not report data on targeted outcomes.

Dissertations were excluded.

Literature Evaluated:

  • A total of 592 studies were evaluated, with only 19 studies meeting criteria. Comprehensive meta-analysis was used to determine effect size for each outcome.
  • Quality was assessed by a modified version of Jadad’s six-item checklist (randomization, double blinding, descriptions of withdrawals and dropouts, statistical analyses, inclusion and exclusion criteria, and adverse effects).
  • Longitudinal study: Times of measurement varied from one week to 14 months. Median follow-up was defined as short-term (less than eight months) and long-term (more than eight months).
  • Four studies reviewed used CBT for anxiety.
    • CBT sessions varied from four weekly one-hour sessions to 55 weekly two-hour sessions.
    • CBT included stress management and problem-solving approaches.
  • One study reviewed used PE for anxiety.
    • PE sessions varied from one 20-minute session to six weekly one-hour sessions.
    • PE included information about illness, symptom management, and discussion of treatment options using booklets, videos, and other educational materials.

Sample Characteristics:

  • The review reported on 1,492 adult cancer survivors.
  • All types and stages of cancer were represented.
  • Survivor age range was 18–84 years.
  • 790 survivors were assigned to interventions, and 702 were assigned to control (medical management only).

Results:

  • CBT interventions on anxiety (four studies):
    • Large effect was noted for individual and group CBT (g = 1.99, p < 0.01; 95% CI 0.69–3.31).
    • Of these four studies, a sensitivity analysis revealed a large effect size for individual treatment (g = 2.41, p < 0.01; 95% CI 1.2–3.55) and no effect for group interventions (d = 0.03, p+0.82; 95% CI -0.20–0.25).
    • Forest plots representing the effect sizes of CBT on anxiety favor the intervention.
  • The single trial using PE to decrease anxiety resulted in no short-term effect on anxiety and did not include long-term follow-up on anxiety (d= -0.02, p = 0.89; 95% CI -0.36–0.31).

Limitations:

  • Analysis did not consider patient adherence to pharmacologic interventions, which is known to be modest in medical patients.
  • No cost-benefit implications were noted.

Nursing Implications:

CBT is effective for short-term management (less than 8 months) of anxiety. Individually based interventions were more effective than those delivered in a group format. Various CBT approaches provided in an individual format can assist cancer survivors in reducing the emotional distress of anxiety.

Guideline/Expert Opinion

National Comprehensive Cancer Network. (2012). NCCN clinical practice guidelines in oncology: Distress management [v.2.2013]. Retrieved from http://www.nccn.org/professionals/physician_gls/pdf/distress.pdf

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Purpose & Patient Population:

To provide clinical practice guidelines for the evaluation and treatment of distress — a normal feeling of vulnerability to a feeling that leads to disabling problems, such as depression and anxiety — in adult patients with cancer

Type of Resource/Evidence-Based Process:

  • Evidence-based guidelines    
  • Consensus development involving a panel composed of physicians, psychiatrists, psychologists, and social workers

Phase of Care and Clinical Applications:

  • Phases of care: multiple phases 
  • Clinical application: palliative care

Results Provided in the Reference:

Results were not stated.

Guidelines & Recommendations:

Recommended standards of care include

  • Screening all patients for distress, at initial visits and appropriate intervals
  • Distress management according to guidelines
  • Having committees to implement standards, provide relevant education and training to healthcare professionals
  • Having mental health professionals and certified chaplains available
  • Providing a distress-thermometer screening tool
  • Identifying at-risk patients and periods of increased vulnerability, to define appropriate screening intervals

Evaluation should include measures relating to level of distress, behavior symptoms, psychiatric history and medications, pain and symptom control, body image and sexuality issues, impaired capacity, safety, potential medical causes, and psychological disorders.

Management algorithms should be provided for dementia, delirium, mood disorder, psychotic disorder, adjustment disorder, anxiety disorder, personality disorder, and substance-related disorder.

Treatments identified for use include psychotherapy, anxiolytics, antidepressants, psychoeducation, cognitive behavioral therapy, social work and counseling interventions, spiritual counseling and ethics, and palliative care consultation according to algorithms.

Limitations:

  • The evidence is mainly "lower level," and recommendations are primarily consensus-based. 
  • The panel did not include a nursing member.
  • Many recommendations tend to focus on approaches to care for patients with significant mental disorders or for those referred to a mental health team. 
  • The guidelines provide limited suggestions regarding low-level distress associated with physical symptoms.

Nursing Implications:

The guidelines provide recommended pathways regarding assessment and management of distress. They do not provide a nursing perspective or identify a role for nursing in patient management.


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