Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression

January 12, 2016 updated by: Dr. Jennifer Johnson, Brown University
This study will examine the effects of a first-line treatment for major depressive disorder (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this 3-year randomized trial is to promote uptake of evidence-based treatment in criminal justice settings by conducting a fully-powered randomized effectiveness study that collects pilot implementation data, including cost-effectiveness data. Group IPT will be compared to treatment as usual (TAU) in a sample of 90 male and 90 female prisoners with MDD from 4 institutions, allowing us to explore gender effects.

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Bridgewater, Massachusetts, United States, 02324
        • Massachusetts Correctional Institute - Old Colony Correctional Center
      • Framingham, Massachusetts, United States, 01702
        • Massachusetts Correctional Institution - Framingham
      • Framingham, Massachusetts, United States, 01702
        • South Middlesex Correctional Center
      • Norfolk, Massachusetts, United States, 02056
        • Massachusetts Correctional Institution - Norfolk
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Adult Correctional Institution - Men's & Women's Medium & Minimum Security Facilities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet all DSM-IV criteria for primary (non-substance induced) major depressive disorder
  • Expectation of at least 6 months of incarceration at baseline interview
  • Incarcerated for at least 4 weeks

Exclusion Criteria:

  • Lifetime:

    • Bipolar disorder
    • Psychotic disorder
  • Are imminently suicidal
  • Cannot understand English well enough to understand the consent form or assessment instruments when read aloud

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Treatment as Usual (TAU)
Standard prison mental health treatment instead of the research groups, including individual therapy, medication, etc.
EXPERIMENTAL: Group Interpersonal Psychotherapy (IPT) for Depression + TAU
Participants will receive Group IPT for Depression + TAU.
Behavioral: Group IPT for Depression + TAU
Interpersonal psychotherapy (IPT) will be administered in 20 group 90-minute sessions over 10 weeks and 4 individual sessions (before group starts, in the middle of the group, at the end of the group, and one month after the group ends). These sessions will focus on improving your relationships with others, building healthy relationships, setting goals, and increasing coping skills. Additionally, participants will receive standard prison mental health treatment, individual therapy, medication, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months
Time Frame: 3 Months from Baseline
3 Months from Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Suicidality at 3 Months
Time Frame: 3 Months from Baseline
Suicidality as measured by the Beck Scale for Suicide Ideation.
3 Months from Baseline
Change from Baseline in In-Prison Functioning at 3 Months
Time Frame: 3 Months from Baseline
In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale)
3 Months from Baseline
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months
Time Frame: 6 Months from Baseline
6 Months from Baseline
Change from Baseline in Suicidality at 6 Months
Time Frame: 6 Months from Baseline
Suicidality as measured by the Beck Scale for Suicide Ideation.
6 Months from Baseline
Change from Baseline in In-Prison Functioning at 6 Months
Time Frame: 6 Months from Baseline
In-prison functioning will be assessed by the number of correctional programs enrolled/completed and disciplinary/incident reports (measured by the Timeline Followback); aggression/victimization (measured by the Conflict Tactics Scale 2); social support (measured by the Multidimensional Scale of Perceived Social Support and the UCLA Loneliness Scale)
6 Months from Baseline
Cost-effectiveness
Time Frame: 6 months post-baseline
Cost-effectiveness based on costs of IPT and TAU, improvements in HRSD scores, LIFE scores, and cost-offsets, including medical costs, programs completed, fewer fights, fewer suicide attempts, and reduced length of incarceration due to more "good time."
6 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (ESTIMATE)

September 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH095230-01 (NIH)
  • R01MH095230 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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