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Group Therapy for Women Prisoners With Comorbid Substance Use and Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00606996
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : April 18, 2013
Information provided by (Responsible Party):
Dr. Jennifer Johnson, Brown University

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.

Condition or disease Intervention/treatment Phase
Substance Abuse Substance Dependence Depressive Disorder Behavioral: Group interpersonal psychotherapy (IPT-G) Behavioral: Psychoeducation on co-occurring disorders (PSYCHOED) Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group IPT for Women Prisoners With Comorbid Substance Use and Depression
Study Start Date : July 2006
Primary Completion Date : December 2009
Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: IPT-G
Group Interpersonal Psychotherapy
Behavioral: Group interpersonal psychotherapy (IPT-G)
Active Comparator: PSYCHOED
Behavioral: Psychoeducation on co-occurring disorders (PSYCHOED)

Primary Outcome Measures :
  1. Substance-free days after release from prison, measured by the Timeline Followback method [ Time Frame: 3 months post-release ]
  2. Severity of substance use after release from prison, measured by the Addiction Severity Index [ Time Frame: 3 months post-release ]
  3. Verification of substance-free status using breath alcohol tests and urine drug screens [ Time Frame: 3 months post-release ]
  4. Depression symptom severity measured by the Modified Hamilton Rating Scale for Depression [ Time Frame: Pre-release ]
  5. Depression symptom severity measured by the Beck Depression Inventory [ Time Frame: Pre-release ]

Secondary Outcome Measures :
  1. Severity of legal problems after release, measured by the Legal Composite of the Addiction Severity Index [ Time Frame: 3 months post-release ]
  2. Interpersonal problems, measured by the Inventory of Interpersonal Problems [ Time Frame: 3 months post-release ]
  3. Peer support and social support, measured by the Criminal Justice client Evaluation of Self and Treatment [ Time Frame: 3 months post-release ]
  4. Perceived social support measured by the Multidimensional Scale of Perceived Social Support [ Time Frame: 3 months post-release ]
  5. Social support for recovery, measured by the Important People and Activities scale [ Time Frame: 3 months post-release ]
  6. Social functioning, measured by the Social Adjustment Scale [ Time Frame: 3 months post-release ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606996

United States, Rhode Island
Adult Correctional Institution
Cranston, Rhode Island, United States, 02920
Sponsors and Collaborators
Brown University
Principal Investigator: Jennifer E. Johnson, Ph.D. Department of Psychiatry and Human Behavior, Brown University

Responsible Party: Dr. Jennifer Johnson, Associate Professor, Brown University
ClinicalTrials.gov Identifier: NCT00606996     History of Changes
Obsolete Identifiers: NCT01831349
Other Study ID Numbers: 1K23DA021159-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: April 18, 2013
Last Verified: April 2013

Keywords provided by Dr. Jennifer Johnson, Brown University:
Drug Abuse
Drug Dependence
Alcohol Abuse
Alcohol Dependence
Major Depressive Disorder
Dysthymic Disorder

Additional relevant MeSH terms:
Depressive Disorder
Substance-Related Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Chemically-Induced Disorders