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

NCT01685294 | Completed Phase 3 DMC

• 2 other identifiers: 1R01MH095230-01R01MH095230
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 5

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder (MDD); Suicidality; Incarcerated Populations; Prisons; Interpersonal Psychotherapy (IPT)

Outcome Measures

Primary Outcomes (1)

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

  3 Months from Baseline

Secondary Outcomes (6)

• Change from Baseline in Suicidality at 3 Months

  3 Months from Baseline

• Change from Baseline in In-Prison Functioning at 3 Months

  3 Months from Baseline

• Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months

  6 Months from Baseline

• Change from Baseline in Suicidality at 6 Months

  6 Months from Baseline

• Change from Baseline in In-Prison Functioning at 6 Months

  6 Months from Baseline

Study Arms (2)

Treatment as Usual (TAU)

NO INTERVENTION

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

Group Interpersonal Psychotherapy (IPT) for Depression + TAU

EXPERIMENTAL

Participants will receive Group IPT for Depression + TAU.

Behavioral: Group IPT for Depression + TAU

Interventions

Group IPT for Depression + TAU BEHAVIORAL

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.

Group Interpersonal Psychotherapy (IPT) for Depression + TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

Massachusetts Correctional Institute - Old Colony Correctional Center

Bridgewater, Massachusetts, 02324, United States

Location

Massachusetts Correctional Institution - Framingham

Framingham, Massachusetts, 01702, United States

Location

South Middlesex Correctional Center

Framingham, Massachusetts, 01702, United States

Location

Massachusetts Correctional Institution - Norfolk

Norfolk, Massachusetts, 02056, United States

Location

Adult Correctional Institution - Men's & Women's Medium & Minimum Security Facilities

Cranston, Rhode Island, 02920, United States

Location

Related Publications (3)

• Johnson JE, Hailemariam M, Zlotnick C, Richie F, Wiltsey-Stirman S. Analysis of implementation processes in a hybrid effectiveness-implementation trial of interpersonal psychotherapy (IPT) for major depressive disorder in prisons: Training, supervision, and recommendations. PLoS One. 2024 May 14;19(5):e0288182. doi: 10.1371/journal.pone.0288182. eCollection 2024.

  PMID: 38743716 DERIVED

• 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.

  PMID: 30857489 DERIVED

• 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.

  PMID: 30714749 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Suicidal Ideation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Jennifer E. Johnson, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research), Department of Psychiatry and Human Behavior

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: September 14, 2012
• Study Start: December 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

US (5)