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Interpersonal Therapy for Depression in Breast Cancer

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy
Problem-Solving Therapy
Brief Supportive Psychotherapy
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Interpersonal Psychotherapy

Problem-Solving Therapy

Brief Supportive Psychotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hamilton Depression Scale (HAMD-17)
Change in HAMD-17 following acute treatment is the primary outcome measure

Secondary Outcome Measures

Full Information

First Posted
June 24, 2010
Last Updated
July 13, 2017
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01191580
Brief Title
Interpersonal Therapy for Depression in Breast Cancer
Official Title
Interpersonal Therapy for Depression in Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal Psychotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Problem-Solving Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Brief Supportive Psychotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Other Intervention Name(s)
IPT
Intervention Description
Interpersonal Psychotherapy will consist of twelve 50-minute sessions delivered within a period of 16 weeks. IPT is divided into three phases.
Intervention Type
Behavioral
Intervention Name(s)
Problem-Solving Therapy
Other Intervention Name(s)
PST
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Supportive Psychotherapy
Other Intervention Name(s)
BSP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Depression Scale (HAMD-17)
Description
Change in HAMD-17 following acute treatment is the primary outcome measure
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C. Markowitz, M.D.
Organizational Affiliation
NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Interpersonal Therapy for Depression in Breast Cancer

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