Group Therapy for Women Prisoners With Comorbid Substance Use and Depression

Depressive Disorder Clinical Trial

Official title:

Group IPT for Women Prisoners With Comorbid Substance Use and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606996
• Other study ID #: 1K23DA021159-01
• Status: Completed
• Phase: Phase 2
• First received: January 22, 2008
• Last updated: April 17, 2013
• Start date: July 2006
• Est. completion date: December 2009

Study information

• Verified date: April 2013
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Other known NCT identifiers

• NCT01831349

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Substance Abuse
• Substance Dependence
• Substance-Related Disorders

Intervention

Behavioral:
• Group interpersonal psychotherapy (IPT-G)

• Psychoeducation on co-occurring disorders (PSYCHOED)

Locations

Country	Name	City	State
United States	Adult Correctional Institution	Cranston	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance-free days after release from prison, measured by the Timeline Followback method		3 months post-release	No
Primary	Severity of substance use after release from prison, measured by the Addiction Severity Index		3 months post-release	No
Primary	Verification of substance-free status using breath alcohol tests and urine drug screens		3 months post-release	No
Primary	Depression symptom severity measured by the Modified Hamilton Rating Scale for Depression		Pre-release	No
Primary	Depression symptom severity measured by the Beck Depression Inventory		Pre-release	No
Secondary	Severity of legal problems after release, measured by the Legal Composite of the Addiction Severity Index		3 months post-release	No
Secondary	Interpersonal problems, measured by the Inventory of Interpersonal Problems		3 months post-release	No
Secondary	Peer support and social support, measured by the Criminal Justice client Evaluation of Self and Treatment		3 months post-release	No
Secondary	Perceived social support measured by the Multidimensional Scale of Perceived Social Support		3 months post-release	No
Secondary	Social support for recovery, measured by the Important People and Activities scale		3 months post-release	No
Secondary	Social functioning, measured by the Social Adjustment Scale		3 months post-release	No