Clinical trial NCT00606996: 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
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Substance Dependence
Depressive Disorder
Keywords: Drug Abuse
Drug Dependence
Alcohol Abuse
Alcohol Dependence
Major Depressive Disorder
Dysthymic Disorder
Prisoners
Women
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Substance-free days after release from prison, measured by the Timeline Followback method
timeFrame: 3 months post-release
measure: Severity of substance use after release from prison, measured by the Addiction Severity Index
timeFrame: 3 months post-release
measure: Verification of substance-free status using breath alcohol tests and urine drug screens
timeFrame: 3 months post-release
measure: Depression symptom severity measured by the Modified Hamilton Rating Scale for Depression
timeFrame: Pre-release
measure: Depression symptom severity measured by the Beck Depression Inventory
timeFrame: Pre-release
Secondary outcomes:
measure: Severity of legal problems after release, measured by the Legal Composite of the Addiction Severity Index
timeFrame: 3 months post-release
measure: Interpersonal problems, measured by the Inventory of Interpersonal Problems
timeFrame: 3 months post-release
measure: Peer support and social support, measured by the Criminal Justice client Evaluation of Self and Treatment
timeFrame: 3 months post-release
measure: Perceived social support measured by the Multidimensional Scale of Perceived Social Support
timeFrame: 3 months post-release
measure: Social support for recovery, measured by the Important People and Activities scale
timeFrame: 3 months post-release
measure: Social functioning, measured by the Social Adjustment Scale
timeFrame: 3 months post-release
Other outcomes:
Locations:
city: Cranston
country: United States
facility: Adult Correctional Institution
state: Rhode Island
Study officials:
affiliation: Department of Psychiatry and Human Behavior, Brown University
name: Jennifer E. Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: