Interpersonal Therapy for Depression in Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by New York State Psychiatric Institute
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01191580
First received: June 24, 2010
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Major Depression
Behavioral: Interpersonal Psychotherapy
Behavioral: Problem-Solving Therapy
Behavioral: Brief Supportive Psychotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interpersonal Therapy for Depression in Breast Cancer

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Hamilton Depression Scale (HAMD-17) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Hamilton Depression Scale [ Time Frame: Week -1 ] [ Designated as safety issue: No ]
  • Hamilton Depression Scale [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • Hamilton Depression Scale [ Time Frame: week 8 ] [ Designated as safety issue: No ]
  • Hamilton Depression Scale [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Hamilton Depression Scale [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Hamilton Depression Scale [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Hamilton Depression Scale [ Time Frame: week 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life (QlesQ) [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interpersonal Psychotherapy
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
Interpersonal Psychotherapy will consist of twelve 50-minute sessions delivered within a period of 16 weeks. IPT is divided into three phases.
Other Name: IPT
Experimental: Problem-Solving Therapy
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
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 Name: PST
Active Comparator: Brief Supportive Psychotherapy
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

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 Name: BSP

Detailed Description:

Depressive symptoms and disorders are common in cancer patients: up to 58% have depressive symptoms, and 38% meet 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191580

Contacts
Contact: Carlos Blanco, M.D., Ph.D (646) 774-8111 CB255@columbia.edu
Contact: Jorge Mario Rodríguez-Fernández (646) 774-5409 FernanJ@nyspi.columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10033
Contact: Carlos Blanco, M.D.    646-774-8111    CB255@columbia.edu   
Principal Investigator: Carlos Blanco, M.D.,Ph.D         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Carlos Blanco, M.D., Ph.D NYSPI
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01191580     History of Changes
Other Study ID Numbers: #5996
Study First Received: June 24, 2010
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Depressive Disorder
Depressive Disorder, Major
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014