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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2014

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change from Baseline in Suicidality at 3 Months
    • Time Frame: 3 Months from Baseline
    • Suicidality as measured by the Beck Scale for Suicide Ideation.
  • 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)
  • Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months
    • Time Frame: 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.
  • 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)
  • 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.”

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brown University
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Jennifer Johnson, Associate Professor (Research), Department of Psychiatry and Human Behavior – Brown University
  • Overall Official(s)
    • Jennifer E. Johnson, Ph.D., Principal Investigator, Brown University

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