Depression

ONS PEP Weight-of-Evidence Category: Recommended for Practice

Nonpharmacologic Interventions

Psychoeducational Interventions

Given et al., 2004³

Patients were provided with a focused assessment that corresponded with a specific symptom management treatment intervention. The interventions recommended were based on a cognitive-behavioral approach.

A total of 237 patients and their family caregivers participated in the study of 609 eligible patients in this randomized control trial. Patients were diagnosed with a solid tumor and were within two months of the first cycle of chemotherapy. Patients who were receiving radiation or had previous chemotherapy were not eligible.

Men and women were included in the study who were diagnosed with a variety of tumor types in various cancer stages. The underlying concept used is that self-management strategies are learned. A cognitive-behavioral approach would then assist patients in controlling symptoms. 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 that have been identified with depression were placed in a subindex and included fatigue, insomnia, anorexia, and poor concentration.

Data analysis included two-sample t tests, a chi-square test, and a general linear model.

The Center for Epidemiological Studies Depression Scale was used.

The use of cognitive-behavioral interventions helped to lower depression at 10 weeks over those receiving usual care among those with higher levels of baseline symptoms. In patients with a higher level of depression at baseline, the cognitive-behavioral interventions were less effective. Thus, cognitive-behavioral interventions may indirectly lower depression by managing symptoms with less of an affective component. Symptoms with a physiologic and psychological component may be more difficult to modify and require longer term intervention.

Limitations: Medications used to treat depression were not standardized. A variety of medications were used at various doses. The article did not describe in detail how the intervention sessions were completed, only that phone interviews and in-person sessions were conducted varying in time from 30–60 minutes. The background and training for the nurses who provided interventions were not identified. The specific symptom management interventions were not provided. It would have been helpful to know the symptom management strategies that were utilized and if specific guidelines were established.

ONS level: I (2)

Sharpe et al., 2004²⁵

Patients with major depressive disorder were recruited from consecutive attendees at cancer clinics and provided an intervention (problem-solving therapy) to evaluate whether the outcome of major depression was affected.

This study was nonrandomized and compared the outcomes of two sequentially recruited cohorts. All of the participants were female (N = 30 per group).

Patients were evaluated for the presence of major depression using the Structured Clinical Interview for DSM-IV, the Hospital Anxiety and Depression Scale (HADS), and the Manchester Concerns Checklist.

The authors concluded that patients who received the intervention had less depression than those receiving usual care.

Major flaws:

1. No standard number of problem-solving sessions was used. Patients were provided 1–13 weeks of interventional sessions.

2. All patients were female.

3. No control was provided for the use of medications. More patients in the interventional group were on antidepressants compared to those receiving usual care.

4. The study was not randomized.

Limitations:

Only one nurse provided the intervention, making it difficult to reproduce.

ONS level: II (6)

Pharmacologic Interventions

Antidepressant Medications

Musselman et al., 2001¹²

Patients with malignant melanoma received paroxetine or placebo two weeks prior to initiation of interferon alfa, continuing for the first 12 weeks of therapy.

Study tablets contained 10 mg of paroxetine; both groups took one tablet daily for a week, followed by 2 tablets daily for a week. Two weeks after the initiation of interferon alfa (four weeks after beginning paroxetine or placebo), the dosage of the study medication could be increased up to four tablets per day at the discretion of the study psychiatrist. The average number of tablets at the maximal dose for each group was 3.1.

40 adult patients with malignant melanoma that had been resected but was estimated to have a greater than 50% chance of recurrence

Randomized, double-blind study

Single site

Patients were evaluated at baseline and at regularly scheduled intervals for the first 12 weeks of therapy.

Tools included the Hamilton Depression and Carroll Depression rating scales, the Hamilton Anxiety Scale, and the Neurotoxicity Rating Scale.

Major depression symptoms developed in 2 of 18 patients in the paroxetine group (11%) and 9 of 20 (45%) in the placebo group.

Paroxetine treatment also significantly decreased the likelihood that interferon alfa therapy would have to be discontinued because of severe depression.

The sample size was small.

One disease group and one site were involved in the study.

Likely to be effective

ONS level: II (6)

ONS PEP Weight-of-Evidence Category: Likely to Be Effective

Pharmacologic Interventions

Methylphenidate

Homsi et al., 2001¹⁷

A phase II study of methylphenidate for depression in patients with advanced cancer. Patients who were identified as being depressed by a palliative medicine attending physician were treated with methylphenidate twice daily. Doses were titrated per regimen until response was obtained. Patients were assessed during a telephone call or bedside interview.

15 women and 15 men with the following primary cancer sites: breast (5), esophagus (4), head and neck (4), lung (4), pancreas (4), colorectal (2), and other (7) [N = 30]. One center was included, and inpatients and outpatients were enrolled in the palliative care program.

Inclusion criterion was the answer of “yes” to the question, “Are you depressed?” with no current or previous antidepressant use.

The study timeframe was seven days.

Question, “Are you depressed?”

Other symptoms (anorexia, concentration problems, fatigue, and sedation) were assessed by a categorical rating (none, mild, moderate, or severe) before starting methylphenidate and daily thereafter.

Pain was assessed using a 0-10 scale.

Known side effects of methylphenidate also were assessed.

Satisfaction question, ”Are you satisfied with the way the drug affected your mood?” was asked at the end of the study on day 7.

Depression resolved in all patients, most on day 3. Maximum daily dose needed was 20 mg. Other symptoms also improved, mean pain scores significantly decreased, and all who responded to treatment were satisfied with therapy.

Small sample, with no randomization

Long-term efficacy and side effect data are needed.

Single site data are less transferable than multisite data.

Study size and nonrandomization must be considered.

ONS level: II (6)

Nonpharmacologic Interventions

Relaxation

Sloman, 2002²⁰

Patients were assigned to one of four treatment conditions: (a) progressive muscle relaxation (PMR) training, (b) guided imagery training, (c) both a and b, and (d) control group. In the control group, the nurse spent an equal amount of time with subjects discussing general health and treatment concerns.

26 men and 30 women with advanced cancer who were being cared for at home in Sydney, Australia; all were receiving palliative care. Patients were randomly assigned to one of four groups to determine the efficacy of relaxation and imagery for control of depression and anxiety. A trained nurse taught patients the techniques in their homes, left a tape recorder and cassette, and asked subjects to practice the technique twice daily. The nurse visited twice weekly to repeat the sessions.

The HADS measured anxiety and depression, and the Functional Living Index—Cancer scale measured quality of life. Pretesting was done, and post-testing was conducted in all subjects three weeks after the initial session.

All three treatments showed significant reductions in depression over the control group. No one treatment proved to be significantly superior, and none of the three treatments produced a significant reduction in anxiety.

The sample size of 56 is small; a clear description of the PMR and guided imagery techniques was not provided, so replication would be difficult. The study occurred in one site, with one nurse conducting the interventions. Post-testing at three weeks showed a short-term benefit; long-term benefits were not addressed.

ONS level: I (2)

Randomized but small; results are promising, but more studies are needed.

ONS PEP Weight-of-Evidence Category: Effectiveness Not Established

Nonpharmacologic Interventions: Complementary Methods

Massage

Cassileth & Vickers, 2004²¹

Patients received one of three types of massage therapy and were asked to report on their symptoms post-therapy. Massages were provided by 12 licensed massage therapists.

1,290 inpatients and outpatients participated in the study. Patients were referred by physicians, nurses, or self for the therapy. Patients received Swedish massage, light touch massage, or foot massage according to their preference. Sessions lasted, on average, 20 minutes for inpatients and 60 minutes for outpatients. Conceptual model: Tactile stimulation is essential to survival and massage therapy can be used to reduce symptoms.

Patients reported the level of symptom distress (0-10) on a card prior to and following massage therapy. Comparisons were analyzed by analysis of covariance, with the baseline score as the covariate.

The effect of massage on symptom relief was demonstrated as a positive response with respect to depression.

Limitations:

1. Not randomized

2. The information about the study demographics or participants did not include enough detail.

3. There was no standard procedure for length of massage or specific type of session. Patients had a choice of three techniques.

4. Patients were referred to massage therapy, including self-referral. Self-referral may skew the post-therapy reports because patients expect a benefit.

5. No standardized assessment tool was used to measure results because symptoms were rated on a card.

6. No way to differentiate which of the massage techniques was the most beneficial

Massage therapy may have some short-term benefit in the relief of depression or depressive symptoms.

ONS level: III (8)

Hernandez-Reif et al., 2004²³

Patients were randomized to receive massage therapy or standard treatment.

The massage therapy group received 15 massages that were 3-30 minutes long per week by a trained massage therapist for four weeks. The control group received standard medical care alone.

This was a randomized study that consisted of 34 women who had stage I or II breast cancer and were at least three months post treatment.

Participants were assessed for anxiety and mood scales utilizing three standardized assessment tools: State-Trait Anxiety Inventory (STAI), Profile of Mood States (POMS), and Symptom Checklists-90-R (SCL-90-R).

Immune and neuroendocrine functions were monitored using blood levels of specific immune system markers.

Massage did show some benefit in patient mood scale assessment tools and immune system function. Specifically, reduced anxiety was found on the STAI after the first and last sessions.

Reduced depression was found on the POMS depression score after the first and last sessions and from the first to the last day of the study.

The SCL-90-R confirmed a reduction in depression from the first to the last day.

Wilcoxon’s matched pairs signed ranks tests revealed an increase in dopamine and serotonin levels in the massage group; the control group showed a significant increase in norepinephrine.

Natural killer cell cytotoxicity did not attain significance.

Limitations: The study only looked at the short-term benefit to patients. Long-term effectiveness was not demonstrated. Sample size was small; participants had early-stage breast cancer diagnoses. Patients were randomized based on a coin toss.

ONS level: II (6)