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Group Therapy for Women Prisoners With Comorbid Substance Use and Depression

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ClinicalTrials.gov Identifier: NCT00606996
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : April 18, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Jennifer Johnson, Brown University

Tracking Information
First Submitted Date  ICMJE January 22, 2008
First Posted Date  ICMJE February 5, 2008
Last Update Posted Date April 18, 2013
Study Start Date  ICMJE July 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
  • Substance-free days after release from prison, measured by the Timeline Followback method [ Time Frame: 3 months post-release ]
  • Severity of substance use after release from prison, measured by the Addiction Severity Index [ Time Frame: 3 months post-release ]
  • Verification of substance-free status using breath alcohol tests and urine drug screens [ Time Frame: 3 months post-release ]
  • Depression symptom severity measured by the Modified Hamilton Rating Scale for Depression [ Time Frame: Pre-release ]
  • Depression symptom severity measured by the Beck Depression Inventory [ Time Frame: Pre-release ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
  • 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 diagnosis measured by the Structured Clinical Interview for DSM-IV Axis I Disorders
  • Depression symptom severity measured by the Modified Hamilton Rating Scale for Depression
  • Depression symptom severity measured by the Beck Depression Inventory
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
  • Severity of legal problems after release, measured by the Legal Composite of the Addiction Severity Index [ Time Frame: 3 months post-release ]
  • Interpersonal problems, measured by the Inventory of Interpersonal Problems [ Time Frame: 3 months post-release ]
  • Peer support and social support, measured by the Criminal Justice client Evaluation of Self and Treatment [ Time Frame: 3 months post-release ]
  • Perceived social support measured by the Multidimensional Scale of Perceived Social Support [ Time Frame: 3 months post-release ]
  • Social support for recovery, measured by the Important People and Activities scale [ Time Frame: 3 months post-release ]
  • Social functioning, measured by the Social Adjustment Scale [ Time Frame: 3 months post-release ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Group Therapy for Women Prisoners With Comorbid Substance Use and Depression
Official Title  ICMJE Group IPT for Women Prisoners With Comorbid Substance Use and Depression
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Substance Abuse
  • Substance Dependence
  • Depressive Disorder
Intervention  ICMJE
  • Behavioral: Group interpersonal psychotherapy (IPT-G)
  • Behavioral: Psychoeducation on co-occurring disorders (PSYCHOED)
Study Arms  ICMJE
  • Experimental: IPT-G
    Group Interpersonal Psychotherapy
    Intervention: Behavioral: Group interpersonal psychotherapy (IPT-G)
  • Active Comparator: PSYCHOED
    Psychoeducation
    Intervention: Behavioral: Psychoeducation on co-occurring disorders (PSYCHOED)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2013)
38
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2008)
80
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606996
Other Study ID Numbers  ICMJE 1K23DA021159-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Jennifer Johnson, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer E. Johnson, Ph.D. Department of Psychiatry and Human Behavior, Brown University
PRS Account Brown University
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP