Interpersonal Therapy for Depression in Breast Cancer

NCT01191580 | Completed Phase 4

• 1 other identifier: #5996/7033R
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Scale (HAMD-17)

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

  week 12

Study Arms (3)

Interpersonal Psychotherapy

EXPERIMENTAL

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 IPT for depressed breast cancer patients of diverse ethnic background, socioeconomic status, and cancer progression stage.

Behavioral: Interpersonal Psychotherapy

Problem-Solving Therapy

EXPERIMENTAL

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.

Behavioral: Problem-Solving Therapy

Brief Supportive Psychotherapy

ACTIVE COMPARATOR

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.

Behavioral: Brief Supportive Psychotherapy

Interventions

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.

Also known as: IPT

Interpersonal Psychotherapy

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.

Also known as: PST

Problem-Solving Therapy

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.

Also known as: BSP

Brief Supportive Psychotherapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10033, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• John C. Markowitz, M.D.

  NYSPI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: August 31, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

US (1)