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Group Therapy for Women Prisoners With Comorbid Substance Use and Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Jennifer Johnson, Brown University
ClinicalTrials.gov Identifier:
NCT00606996
First received: January 22, 2008
Last updated: April 17, 2013
Last verified: April 2013

January 22, 2008
April 17, 2013
July 2006
December 2009   (final data collection date for primary outcome measure)
  • Substance-free days after release from prison, measured by the Timeline Followback method [ Time Frame: 3 months post-release ] [ Designated as safety issue: No ]
  • Severity of substance use after release from prison, measured by the Addiction Severity Index [ Time Frame: 3 months post-release ] [ Designated as safety issue: No ]
  • Verification of substance-free status using breath alcohol tests and urine drug screens [ Time Frame: 3 months post-release ] [ Designated as safety issue: No ]
  • Depression symptom severity measured by the Modified Hamilton Rating Scale for Depression [ Time Frame: Pre-release ] [ Designated as safety issue: No ]
  • Depression symptom severity measured by the Beck Depression Inventory [ Time Frame: Pre-release ] [ Designated as safety issue: No ]
  • 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
  • Depression diagnosis measured by the Structured Clinical Interview for DSM-IV Axis I Disorders
Complete list of historical versions of study NCT00606996 on ClinicalTrials.gov Archive Site
  • Severity of legal problems after release, measured by the Legal Composite of the Addiction Severity Index [ Time Frame: 3 months post-release ] [ Designated as safety issue: No ]
  • Interpersonal problems, measured by the Inventory of Interpersonal Problems [ Time Frame: 3 months post-release ] [ Designated as safety issue: No ]
  • Peer support and social support, measured by the Criminal Justice client Evaluation of Self and Treatment [ Time Frame: 3 months post-release ] [ Designated as safety issue: No ]
  • Perceived social support measured by the Multidimensional Scale of Perceived Social Support [ Time Frame: 3 months post-release ] [ Designated as safety issue: No ]
  • Social support for recovery, measured by the Important People and Activities scale [ Time Frame: 3 months post-release ] [ Designated as safety issue: No ]
  • Social functioning, measured by the Social Adjustment Scale [ Time Frame: 3 months post-release ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Group Therapy for Women Prisoners With Comorbid Substance Use and Depression
Group IPT for Women Prisoners With Comorbid Substance Use and Depression

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

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Substance Abuse
  • Substance Dependence
  • Depressive Disorder
  • Behavioral: Group interpersonal psychotherapy (IPT-G)
  • Behavioral: Psychoeducation on co-occurring disorders (PSYCHOED)
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606996
1 K23 DA021159-01
Not Provided
Dr. Jennifer Johnson, Brown University
Brown University
Not Provided
Principal Investigator: Jennifer E. Johnson, Ph.D. Department of Psychiatry and Human Behavior, Brown University
Brown University
April 2013

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