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Group Therapy for Women Prisoners With Comorbid Substance Use and Depression

Primary Purpose

Substance Abuse, Substance Dependence, Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Group interpersonal psychotherapy (IPT-G)
Psychoeducation on co-occurring disorders (PSYCHOED)
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Drug Abuse, Drug Dependence, Alcohol Abuse, Alcohol Dependence, Major Depressive Disorder, Dysthymic Disorder, Prisoners, Women

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Adult Correctional Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPT-G

PSYCHOED

Arm Description

Group Interpersonal Psychotherapy

Psychoeducation

Outcomes

Primary Outcome Measures

Substance-free days after release from prison, measured by the Timeline Followback method
Severity of substance use after release from prison, measured by the Addiction Severity Index
Verification of substance-free status using breath alcohol tests and urine drug screens
Depression symptom severity measured by the Modified Hamilton Rating Scale for Depression
Depression symptom severity measured by the Beck Depression Inventory

Secondary Outcome Measures

Severity of legal problems after release, measured by the Legal Composite of the Addiction Severity Index
Interpersonal problems, measured by the Inventory of Interpersonal Problems
Peer support and social support, measured by the Criminal Justice client Evaluation of Self and Treatment
Perceived social support measured by the Multidimensional Scale of Perceived Social Support
Social support for recovery, measured by the Important People and Activities scale
Social functioning, measured by the Social Adjustment Scale

Full Information

First Posted
January 22, 2008
Last Updated
April 17, 2013
Sponsor
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT00606996
Brief Title
Group Therapy for Women Prisoners With Comorbid Substance Use and Depression
Official Title
Group IPT for Women Prisoners With Comorbid Substance Use and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University

4. Oversight

5. Study Description

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.
Detailed Description
Incarcerated women are a vulnerable and rapidly expanding population with high lifetime rates of both substance use disorder (SUD; abuse or dependence on alcohol, illegal drugs, or prescription drugs; 70%) and depressive disorder (DD; major depressive disorder and dysthymic disorder; 20-27%). DDs tend to worsen the course of SUDs for incarcerated women by increasing their risk for suicide attempts, contributing to the persistence of substance abuse, and reducing the likelihood of a successful transition to an independent, sober life in the community. Recent evidence indicates that DDs are common in persons with SUDs, often do not remit with SUD treatment, and should be treated. Despite growing recognition that co-occurring disorders, such as DDs, among substance abusing incarcerated women present an important public health concern, integrated treatments for SUD-DD have not been well-developed for or systematically tested in this population. Group Interpersonal Psychotherapy (IPT-G) has been shown to be efficacious in treating DD in other populations and may be especially pertinent to the needs of incarcerated women with SUD-DD because interpersonal difficulties not only affect severity of depression, but are also strong predictors of drinking to cope, SUD relapse, and prison recidivism in women. This study tests the hypotheses that as adjuncts to prison SUD treatment, IPT-G, relative to psychoeducation on co-occurring disorders, will produce at least moderate effect sizes for: Reduction in the risk and severity of substance use relapse after release from prison Recovery from depressive disorder and reduction in depressive symptoms Improvement in social support and interpersonal functioning Reduction in the severity of legal problems during the 3 month follow-up period

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Substance Dependence, Depressive Disorder
Keywords
Drug Abuse, Drug Dependence, Alcohol Abuse, Alcohol Dependence, Major Depressive Disorder, Dysthymic Disorder, Prisoners, Women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPT-G
Arm Type
Experimental
Arm Description
Group Interpersonal Psychotherapy
Arm Title
PSYCHOED
Arm Type
Active Comparator
Arm Description
Psychoeducation
Intervention Type
Behavioral
Intervention Name(s)
Group interpersonal psychotherapy (IPT-G)
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation on co-occurring disorders (PSYCHOED)
Primary Outcome Measure Information:
Title
Substance-free days after release from prison, measured by the Timeline Followback method
Time Frame
3 months post-release
Title
Severity of substance use after release from prison, measured by the Addiction Severity Index
Time Frame
3 months post-release
Title
Verification of substance-free status using breath alcohol tests and urine drug screens
Time Frame
3 months post-release
Title
Depression symptom severity measured by the Modified Hamilton Rating Scale for Depression
Time Frame
Pre-release
Title
Depression symptom severity measured by the Beck Depression Inventory
Time Frame
Pre-release
Secondary Outcome Measure Information:
Title
Severity of legal problems after release, measured by the Legal Composite of the Addiction Severity Index
Time Frame
3 months post-release
Title
Interpersonal problems, measured by the Inventory of Interpersonal Problems
Time Frame
3 months post-release
Title
Peer support and social support, measured by the Criminal Justice client Evaluation of Self and Treatment
Time Frame
3 months post-release
Title
Perceived social support measured by the Multidimensional Scale of Perceived Social Support
Time Frame
3 months post-release
Title
Social support for recovery, measured by the Important People and Activities scale
Time Frame
3 months post-release
Title
Social functioning, measured by the Social Adjustment Scale
Time Frame
3 months post-release

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Lifetime criteria for bipolar disorder Lifetime criteria for a psychotic disorder Actively suicidal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer E. Johnson, Ph.D.
Organizational Affiliation
Department of Psychiatry and Human Behavior, Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adult Correctional Institution
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States

12. IPD Sharing Statement

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Group Therapy for Women Prisoners With Comorbid Substance Use and Depression

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