NCT00606996

Brief Summary

The purpose of the study is to determine whether interpersonal psychotherapy is effective for treating co-occurring depression and substance use among women prisoners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

3.4 years

First QC Date

January 22, 2008

Last Update Submit

March 18, 2025

Conditions

Substance AbuseSubstance DependenceDepressive Disorder

Keywords

Drug AbuseDrug DependenceAlcohol AbuseAlcohol DependenceMajor Depressive DisorderDysthymic DisorderPrisonersWomen

Outcome Measures

Primary Outcomes (5)

  • Substance-free days after release from prison, measured by the Timeline Followback method

    3 months post-release

  • Severity of substance use after release from prison, measured by the Addiction Severity Index

    3 months post-release

  • Verification of substance-free status using breath alcohol tests and urine drug screens

    3 months post-release

  • Depression symptom severity measured by the Modified Hamilton Rating Scale for Depression

    Pre-release

  • Depression symptom severity measured by the Beck Depression Inventory

    Pre-release

Secondary Outcomes (6)

  • Severity of legal problems after release, measured by the Legal Composite of the Addiction Severity Index

    3 months post-release

  • Interpersonal problems, measured by the Inventory of Interpersonal Problems

    3 months post-release

  • Peer support and social support, measured by the Criminal Justice client Evaluation of Self and Treatment

    3 months post-release

  • Perceived social support measured by the Multidimensional Scale of Perceived Social Support

    3 months post-release

  • Social support for recovery, measured by the Important People and Activities scale

    3 months post-release

  • +1 more secondary outcomes

Study Arms (2)

IPT-G

EXPERIMENTAL

Group Interpersonal Psychotherapy

Behavioral: Group interpersonal psychotherapy (IPT-G)

PSYCHOED

ACTIVE COMPARATOR

Psychoeducation

Behavioral: Psychoeducation on co-occurring disorders (PSYCHOED)

Interventions

Group interpersonal psychotherapy (IPT-G)BEHAVIORAL
IPT-G
Psychoeducation on co-occurring disorders (PSYCHOED)BEHAVIORAL
PSYCHOED

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants are recruited from prison substance use treatment programs.
  • Current primary (non-substance-induced, as defined by the SCID) depressive disorder (major depressive or dysthymic disorder) after at least 4 weeks of prison SUD treatment and abstinence.
  • A minimum Hamilton Depression score of 18 or higher, indicating moderate to severe depression.
  • Depressive disorder at any time while not incarcerated.
  • Substance use disorder one month prior to incarceration.
  • Between 10 and 18 weeks away from release from prison.

You may not qualify if:

  • Lifetime criteria for bipolar disorder
  • Lifetime criteria for a psychotic disorder
  • Actively suicidal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adult Correctional Institution

Cranston, Rhode Island, 02920, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersDepressive DisorderAlcoholismDepressive Disorder, MajorDysthymic Disorder

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersMood DisordersAlcohol-Related Disorders

Study Officials

  • Jennifer E. Johnson, Ph.D.

    Department of Psychiatry and Human Behavior, Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

July 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations

US(1)