Five studies claimed to demonstrate efficacy of psychotherapy for depression in cancer patients

demand evidence and thinkAt my primary blog site, PLOS Mind the Brain I am critically discussing an article for which this post provides some resources helpful for readers in forming their own opinions.

Hart, S. L., Hoyt, M. A., Diefenbach, M., Anderson, D. R., Kilbourn, K. M., Craft, L. L., … & Stanton, A. L. (2012). Meta-analysis of efficacy of interventions for elevated depressive symptoms in adults diagnosed with cancer. Journal of the National Cancer Institute, 104(13), 990-1004.

The authors declare psychotherapy to be superior to control contentions in relieving the depressive symptoms of cancer patients and that they are ready to be rolled out into routine care.

I hope that is the case, but I depend on evidence for my judgment. I withhold judgment when the evidence is insufficient. Indeed, if we decide to soon that we have enough evidence, were discouraged from doing the research necessary to produce more evidence.

The the meta-analysis is seriously flawed and the authors’ evaluation of the literature is premature. Their conclusion serves to promote the services of the sponsoring organization’s membership with the claim of being evidence-based without the interventions having earned this status.

These authors claim to found only five relevant studies reported in six papers after an exhaustive review of the literature. Three of the studies ( 1-3 below )are quite inappropriate for addressing whether it is psychotherapy is effective with cancer patients. They involve substantial reorganizations of care and provision of medication. Any effects of psychotherapy cannot be as separate out.

In two of the three collaborative care studies, patients in the intervention group, but not the control group got free treatment. Differences in whether patients had to pay for treatment probably explained the very low utilization by the control group. The remaining two studies are pitifully too small for making firm recommendations.

In the PLOS Mind the Brain post, I referred to these studies by their numbers below.

1. Strong, V., Waters, R., Hibberd, C., Murray, G., Wall, L., Walker, J., … & Sharpe, M. (2008). Management of depression for people with cancer (SMaRT oncology 1): a randomised trial. The Lancet, 372(9632), 40-48.

http://www.lancet.com/journals/lancet/article/PIIS0140-6736(08)60991-5

This is one of the articles that should not have been counted has psychotherapy. I do not find other articles in the literature where the study is counted as psychotherapy. I am sure that the authors would agree with me they did a lot more than provide psychotherapy.

The study aimed to assess the efficacy and cost of Depression Care for People with Cancer, a nurse-delivered complex intervention that was designed to treat major depressive disorder in patients who have cancer.

The intervention is described as

In addition to usual care, patients in the intervention group were offered a maximum of 10 one-to-one sessions over 3 months, preferably at the cancer centre but by telephone or at patients’ homes if they were unable to attend the centre.

The intervention Depression Care for People with Cancer, included education about depression and its treatment (including antidepressant medication); problem-solving treatment to teach the patients coping strategies designed to overcome feelings of helplessness; and communication about management of major depressive disorder with each patient’s oncologist and primary-care doctor. For 3 months after the treatment sessions progress was monitored by monthly telephone calls. This monitoring used the nine-item Patient HealthQuestionnaire (PHQ-9)16 to assess the severity of depression.

The intervention produced an overall modest reduction in depressive symptoms. This treatment effect was sustained at 6 and 12 months. The intervention also improved anxiety and fatigue but not pain or physical functioning.

The authors conclude that the intervention offers a model for the management of major depressive disorder in patients with cancer and other medical disorders who are attending specialist medical services that is feasible, acceptable, and potentially cost effective.

2a. Ell, K., Xie, B., Quon, B., Quinn, D. I., Dwight-Johnson, M., & Lee, P. J. (2008). Randomized controlled trial of collaborative care management of depression among low-income patients with cancer. Journal of Clinical Oncology, 26(27), 4488-4496.

http://jco.ascopubs.org/content/26/27/4488.full.pdf

This is another collaborative care study that should not have been counted has psychotherapy. It is reported in two articles, the second being longer term follow-up.

It examined the effectiveness of the Alleviating Depression Among Patients With Cancer (ADAPt-C) collaborative care management for major depression or dysthymia.

Intervention patients had access for up to 12 months to a depression clinical specialist (supervised by a psychiatrist) who offered education, structured psychotherapy, and maintenance/relapse prevention support. The psychiatrist prescribed antidepressant medications for patients preferring or assessed to require medication.

Study patients were 472 low-income, predominantly female Hispanic patients with cancer age ≥ 18 years with major depression (49%), dysthymia (5%), or both (46%). Patients were randomly assigned to intervention (n = 242) or enhanced usual care (EUC; n = 230).

At 12 months, 63% of intervention patients had a 50% or greater reduction in depressive symptoms from baseline as assessed by the Patient Health Questionnaire-9 (PHQ-9) depression scale compared with 50% of EUC patients (odds ratio [OR] = 1.98; 95% CI, 1.16 to 3.38; P = .01).

The study concludes that ADAPt-C collaborative care is feasible and results in significant reduction in depressive symptoms, improvement in quality of life, and lower pain levels compared with EUC for patients with depressive disorders in a low-income, predominantly Hispanic population in public sector oncology clinics.

2a. Ell, K., Xie, B., Kapetanovic, S., Quinn, D. I., Lee, P. J., Wells, A., & Chou, C. P. (2011). One-year follow-up of collaborative depression care for low-income, predominantly Hispanic patients with cancer. Psychiatric Services, 62(2), 162-170.

http://journals.psychiatryonline.org/article.aspx?articleid=102180

This is the follow up report for the collaborative care study that is described above. It should not be counted as providing an estimate of the effect size for psychotherapy.

The study assessed longer-term outcomes of low-income patients with cancer (predominantly female and Hispanic) after treatment in a collaborative model of depression care or in enhanced usual care.

This RCT was conducted in “safety-net oncology clinics”, recruited 472 patients with major depression symptoms. Patients were randomly assigned to a 12-month intervention (a depression care manager and psychiatrist provided problem-solving therapy, antidepressants, and symptom monitoring and relapse prevention) or enhanced usual care (control group) were interviewed at 18 and 24 months after enrollment.

At 24 months, 46% of patients in the intervention group and 32% in the control group had a ≥50% decrease in depression score over baseline (odds ratio=2.09, 95% confidence interval=1.13—3.86; p=.02); intervention patients had significantly better social (p=.03) and functional (p=.01) well-being. Treatment receipt among intervention patients declined (72%, 21%, and 18% at 12, 18, and 24 months, respectively); few control group patients reported receiving any treatment (10%, 6%, and 13%, respectively). Significant differences in receipt of counseling or antidepressants disappeared at 24 months. Depression recurrence was similar between groups (intervention, 36%; control, 39%). .

The study concludes collaborative care reduced depression symptoms and enhanced quality of life; however, results call for ongoing depression symptom monitoring and treatment for low-income cancer survivors.

3. Dwight-Johnson, M., Ell, K., & Lee, P. J. (2005). Can collaborative care address the needs of low-income Latinas with comorbid depression and cancer? Results from a randomized pilot study. Psychosomatics, 46(3), 224-232.

http://www.sciencedirect.com/science/article/pii/S0033318205700852

This is a modest pilot study that served as the basis for the large-scale study reported above.

55 low-income Latina patients with breast or cervical cancer and comorbid depression were randomly assigned to receive collaborative care as part of the Multifaceted Oncology Depression Program or usual care. Relative to patients in the usual care condition, patients receiving collaborative care were more likely to show ≥50% improvement in depressive symptoms as measured by the Personal Health Questionnaire (OR = 4.51, 95% CI=1.07–18.93). Patients in the collaborative care program were also more likely to show improvement in emotional well-being (increase of 2.15) as measured by the Functional Assessment of Cancer Therapy Scale than were those receiving usual care (decrease of 0.50) (group difference=2.65, 95% CI: 0.18–5.12). Despite health system, provider, and patient barriers to care, these initial results suggest that patients in public sector oncology clinics can benefit from onsite depression treatment.

http://www.sciencedirect.com/science/article/pii/S0033318205700852

If we exclude the three collaborative care studies above, has we should, we are left with these two modest studies.

Savard, J., Simard, S., Giguère, I., Ivers, H., Morin, C. M., Maunsell, E., … & Marceau, D. (2006). Randomized clinical trial on cognitive therapy for depression in women with metastatic breast cancer: psychological and immunological effects. Palliative & supportive care, 4(03), 219-237.

http://journals.cambridge.org/abstract_S1478951506060305

Forty-five women were randomly assigned to either individual cognitive therapy (CT) or to a waiting-list control (WLC) condition. CT was composed of eight weekly sessions of CT and three booster sessions administered at 3-week intervals following the end of treatment.

Patients treated with CT had significantly lower scores on the Hamilton Depression Rating Scale at posttreatment compared to untreated patient, as well as reduction of associated symptoms including anxiety, fatigue, and insomnia symptoms. These effects were well sustained at the 3- and 6-month follow-up evaluations. CT for depression did not appear to have a significant impact on immune functioning.

Evans, R. L., & Connis, R. T. (1995). Comparison of brief group therapies for depressed cancer patients receiving radiation treatment. Public health reports, 110(3), 306.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1382125/pdf/pubhealthrep00054-0076.pdf

A total of 72 depressed cancer patients were randomly assigned to one of three conditions–cognitive-behavioral treatment, social support, or a no-treatment control condition. Before and after intervention and at 6-month followup, study participants were individually assessed by using measures of symptom distress. Relative to the comparison group, both the cognitive-behavioral and social support therapies resulted in less depression, hostility, and somatization.

The social support intervention also resulted in fewer psychiatric symptoms and reduced maladaptive interpersonal sensitivity and anxiety. It was concluded that both group therapies can reduce symptoms of distress for depressed persons undergoing radiation treatment for cancer. Both forms of therapy resulted in improvements in psychosocial function (compared with no treatment at all), but social support groups demonstrated more changes that were evident at 6-month followup.

This article considered the support group to be an active intervention. Many studies of psychotherapy would consider such a group to be a control condition. We certainly did in a study of primary care patients. If the support group is reclassified as a comparison/control condition for cognitive-behavioral treatment, then the cognitive behavioral treatment is reduced to a negative effect size.

Yup, that’s all folks. Do you think these studies are sufficient evidence to justify sweeping conclusions and rolling out psychotherapy  into routine cancer care without further ado?that's all