Interpersonal Therapy for Depression in Breast Cancer

Major Depression Clinical Trial

Official title:

Interpersonal Therapy for Depression in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191580
• Other study ID #: #5996/7033R
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2010
• Last updated: July 13, 2017
• Start date: October 2009
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose a randomized clinical trial to compare the efficacy of Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), and Brief Supportive Psychotherapy (BSP), in improving depressive symptoms, psychosocial functioning, and quality of life among patients with breast cancer and major depressive disorder (MDD).

Description:

Depressive symptoms and disorders are common in cancer patients: up to 58% have depressive symptoms, and 38% meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for major depressive disorder (MDD). Depression worsens over the course of cancer treatment, persists long after cancer therapy, recurs with recurrence of cancer, and negatively affects patients' adherence to cancer treatment, survival, symptom management, psychosocial functioning, and quality of life. As surviving cancer becomes increasingly common, there is an urgent need to establish an empirical basis for the provision of evidence-based treatments to depressed cancer patients.We propose a randomized clinical trial to compare the efficacy of Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), and Brief Supportive Psychotherapy (BSP), in improving depressive symptoms, psychosocial functioning, and quality of life among patients with breast cancer and major depressive disorder. The study is based on several complementary observations from recent studies. First, 30-60% of cancer patients experience clinically significant depressive symptoms. Second, depression is associated with poorer cancer outcomes. Third, over the course of the illness, depression recurs or persists for a significant number of cancer patients. Fourth, several recent reviews have indicated that, despite decades of research and hundreds of studies, the available evidence is insufficient to empirically guide the treatment of major depressive disorder in cancer patients. This has led the national institute of health, the Institute of Medicine, and other experts to call for well-designed, controlled trials of the treatment of depression in cancer patients.

Interpersonal Psychotherapy is a brief, manualized therapy that has shown efficacy in treating major depression in several controlled trials including a large trial for depressed HIV-infected individuals and other randomized trials in depressed individuals with other comorbid medical illnesses. Research shows that Interpersonal Psychotherapy improves social skills and functioning. Interpersonal Psychotherapy has shown remarkable flexibility and efficacy across age ranges, cultures, formats, and modes of delivery. We recently obtained promising pilot data in a small open trial on the acceptability and efficacy of individual Interpersonal Psychotherapy for depressed breast cancer patients of diverse ethnic background, socioeconomic status, and cancer progression stage. Problem-Solving Therapy is a brief, manualized form of cognitive-behavioral therapy (CBT) that has been adapted to treat depression in cancer patients, and has shown highly promising results. Brief Supportive Psychotherapy, a relatively unstructured psychotherapy commonly used in clinical practice, focuses on the patient's affect. It builds a strong therapeutic alliance through careful, empathic listening and validating and encouraging toleration of the patient's emotions. It has shown promising results in depressed individuals with cancer and other medical illnesses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• A primary psychiatric diagnosis of Major Depressive Disorder as defined by: a score of 18 or above in the 17-item Hamilton Depression Scale; Male or female ages 18+;

• Ability to give consent

• Diagnosis of Breast Cancer

• Patients may be either English or Spanish speaking

Exclusion Criteria:

• Lifetime history of psychosis or bipolar disorder

• Patients meeting diagnostic statistic manual for mental disorder criteria for alcohol or substance use disorders who require acute detoxification.

• Current suicide risk.

• Advanced cancer or other condition that limits remaining life expectancy to less than 6 months.

• Patients who are receiving effective medication for Depression

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• Interpersonal Psychotherapy
Interpersonal Psychotherapy will consist of twelve 50-minute sessions delivered within a period of 16 weeks. IPT is divided into three phases.
• Problem-Solving Therapy
Problem-Solving Therapy will also consist of 12 50-minute sessions. The goals of the PST are: 1) to assist patients to identify and link life situations related to the depression; 2) to increase the effectiveness of the patient's problem-solving attempts at coping with current problems based on an intervention carried out in a concrete, structured and, unambiguous manner.
• Brief Supportive Psychotherapy
The treatment approach will follow the standard supportive therapy approaches used in depression and medical illness, as noted below. Brief Supportive Psychotherapy has a biopsychosocial perspective, recognizing contributions of genetic predisposition and neuroendocrine factors (Novalis et al., 1993, p. 257-277). Its goals are to maximize patient function during crisis, to support the patient's judgment with the therapist's reasoning skills, and to engender hope for recovery. Primary techniques and practices include reality testing; being relatively accepting of existing defenses but attempting to restructure them when appropriate; and, using self-esteem enhancing measures.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale (HAMD-17)	Change in HAMD-17 following acute treatment is the primary outcome measure	week 12