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Clinical Trials/NCT01685294
NCT01685294
Completed
Phase 3

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

Brown University5 sites in 1 country181 target enrollmentDecember 2011

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Brown University
Enrollment
181
Locations
5
Primary Endpoint
Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 3 Months
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
October 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Jennifer Johnson

Associate Professor (Research), Department of Psychiatry and Human Behavior

Brown University

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

Outcomes

Primary Outcomes

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

Time Frame: 3 Months from Baseline

Secondary Outcomes

  • Change from Baseline in Suicidality at 6 Months(6 Months from Baseline)
  • Cost-effectiveness(6 months post-baseline)
  • Change from Baseline in Hamilton Rating Scale for Depression (HRSD) at 6 Months(6 Months from Baseline)
  • 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 In-Prison Functioning at 6 Months(6 Months from Baseline)

Study Sites (5)

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