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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Group IPT for Depression + TAU
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder (MDD), Suicidality, Incarcerated Populations, Prisons, Interpersonal Psychotherapy (IPT)

Eligibility Criteria

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

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

Sites / Locations

  • Massachusetts Correctional Institute - Old Colony Correctional Center
  • Massachusetts Correctional Institution - Framingham
  • South Middlesex Correctional Center
  • Massachusetts Correctional Institution - Norfolk
  • Adult Correctional Institution - Men's & Women's Medium & Minimum Security Facilities

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual (TAU)

Group Interpersonal Psychotherapy (IPT) for Depression + TAU

Arm Description

Standard prison mental health treatment instead of the research groups, including individual therapy, medication, etc.

Participants will receive Group IPT for Depression + TAU.

Outcomes

Primary Outcome Measures

Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months

Secondary Outcome Measures

Change from Baseline in Suicidality at 3 Months
Suicidality as measured by the Beck Scale for Suicide Ideation.
Change from Baseline in In-Prison Functioning at 3 Months
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
Change from Baseline in Suicidality at 6 Months
Suicidality as measured by the Beck Scale for Suicide Ideation.
Change from Baseline in In-Prison Functioning at 6 Months
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
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."

Full Information

First Posted
August 29, 2012
Last Updated
January 12, 2016
Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01685294
Brief Title
Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression
Official Title
Effectiveness of Interpersonal Psychotherapy (IPT) for Men and Women Prisoners With Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder (MDD), Suicidality, Incarcerated Populations, Prisons, Interpersonal Psychotherapy (IPT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
Standard prison mental health treatment instead of the research groups, including individual therapy, medication, etc.
Arm Title
Group Interpersonal Psychotherapy (IPT) for Depression + TAU
Arm Type
Experimental
Arm Description
Participants will receive Group IPT for Depression + TAU.
Intervention Type
Behavioral
Intervention Name(s)
Group IPT for Depression + TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months
Time Frame
3 Months from Baseline
Secondary Outcome Measure Information:
Title
Change from Baseline in Suicidality at 3 Months
Description
Suicidality as measured by the Beck Scale for Suicide Ideation.
Time Frame
3 Months from Baseline
Title
Change from Baseline in In-Prison Functioning at 3 Months
Description
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)
Time Frame
3 Months from Baseline
Title
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months
Time Frame
6 Months from Baseline
Title
Change from Baseline in Suicidality at 6 Months
Description
Suicidality as measured by the Beck Scale for Suicide Ideation.
Time Frame
6 Months from Baseline
Title
Change from Baseline in In-Prison Functioning at 6 Months
Description
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)
Time Frame
6 Months from Baseline
Title
Cost-effectiveness
Description
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."
Time Frame
6 months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer E. Johnson, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Correctional Institute - Old Colony Correctional Center
City
Bridgewater
State/Province
Massachusetts
ZIP/Postal Code
02324
Country
United States
Facility Name
Massachusetts Correctional Institution - Framingham
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
South Middlesex Correctional Center
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
Massachusetts Correctional Institution - Norfolk
City
Norfolk
State/Province
Massachusetts
ZIP/Postal Code
02056
Country
United States
Facility Name
Adult Correctional Institution - Men's & Women's Medium & Minimum Security Facilities
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30857489
Citation
Felton JW, Hailemariam M, Richie F, Reddy MK, Edukere S, Zlotnick C, Johnson JE. Preliminary efficacy and mediators of interpersonal psychotherapy for reducing posttraumatic stress symptoms in an incarcerated population. Psychother Res. 2020 Feb;30(2):239-250. doi: 10.1080/10503307.2019.1587192. Epub 2019 Mar 11.
Results Reference
derived
PubMed Identifier
30714749
Citation
Johnson JE, Stout RL, Miller TR, Zlotnick C, Cerbo LA, Andrade JT, Nargiso J, Bonner J, Wiltsey-Stirman S. Randomized cost-effectiveness trial of group interpersonal psychotherapy (IPT) for prisoners with major depression. J Consult Clin Psychol. 2019 Apr;87(4):392-406. doi: 10.1037/ccp0000379. Epub 2019 Feb 4.
Results Reference
derived

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

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