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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Jennifer Johnson, Brown University
ClinicalTrials.gov Identifier:
NCT01685294
First received: August 29, 2012
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

This study will examine the effects of a first-line treatment for major depressive disorder (MDD), interpersonal psychotherapy (IPT), among men and women prisoners.


Condition Intervention Phase
Major Depressive Disorder
Behavioral: Group IPT for Depression + TAU
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression

Further study details as provided by Brown University:

Primary Outcome Measures:
  • Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months [ Time Frame: 3 Months from Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Suicidality at 3 Months [ Time Frame: 3 Months from Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Suicidality at 6 Months [ Time Frame: 6 Months from Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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."


Estimated Enrollment: 180
Study Start Date: December 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01685294

Locations
United States, Massachusetts
Massachusetts Correctional Institute - Old Colony Correctional Center
Bridgewater, Massachusetts, United States, 02324
Massachusetts Correctional Institution - Framingham
Framingham, Massachusetts, United States, 01702
South Middlesex Correctional Center
Framingham, Massachusetts, United States, 01702
Massachusetts Correctional Institution - Norfolk
Norfolk, Massachusetts, United States, 02056
United States, Rhode Island
Adult Correctional Institution - Men's & Women's Medium & Minimum Security Facilities
Cranston, Rhode Island, United States, 02920
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Jennifer E. Johnson, Ph.D. Brown University
  More Information

No publications provided

Responsible Party: Dr. Jennifer Johnson, Associate Professor (Research), Department of Psychiatry and Human Behavior, Brown University
ClinicalTrials.gov Identifier: NCT01685294     History of Changes
Other Study ID Numbers: 1 R01 MH095230-01, R01MH095230
Study First Received: August 29, 2012
Last Updated: June 3, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Brown University:
Major Depressive Disorder (MDD)
Suicidality
Incarcerated Populations
Prisons
Interpersonal Psychotherapy (IPT)

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014