Skip to main content
OpenTrials
Completed

NCT Number: NCT01191580

Interpersonal Therapy for Depression in Breast Cancer

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York State Psychiatric Institute

New York, 10033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interpersonal psychotherapy

Behavioral

Interpersonal Psychotherapy will consist of twelve 50-minute sessions delivered within a period of 16 weeks. IPT is divided into three phases.

Other names: IPT

Problem-Solving Therapy

Behavioral

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.

Other names: PST

Brief Supportive Psychotherapy

Behavioral

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.

Other names: BSP

Primary outcomes

  1. Hamilton Depression Scale (HAMD-17)

    Time frame: week 12

    Change in HAMD-17 following acute treatment is the primary outcome measure

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2017
First posted
Aug 31, 2010
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.