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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685294
• Other study ID #: 1R01MH095230-01
• Secondary ID: R01MH095230
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2012
• Last updated: January 12, 2016
• Start date: December 2011
• Est. completion date: October 2014

Study information

• Verified date: January 2016
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts Correctional Institute - Old Colony Correctional Center	Bridgewater	Massachusetts
United States	Adult Correctional Institution - Men's & Women's Medium & Minimum Security Facilities	Cranston	Rhode Island
United States	Massachusetts Correctional Institution - Framingham	Framingham	Massachusetts
United States	South Middlesex Correctional Center	Framingham	Massachusetts
United States	Massachusetts Correctional Institution - Norfolk	Norfolk	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months		3 Months from Baseline	No
Secondary	Change from Baseline in Suicidality at 3 Months	Suicidality as measured by the Beck Scale for Suicide Ideation.	3 Months from Baseline	No
Secondary	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)	3 Months from Baseline	No
Secondary	Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months		6 Months from Baseline	No
Secondary	Change from Baseline in Suicidality at 6 Months	Suicidality as measured by the Beck Scale for Suicide Ideation.	6 Months from Baseline	No
Secondary	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)	6 Months from Baseline	No
Secondary	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."	6 months post-baseline	No