Recovery Group for Women With Substance Use Disorders

Substance-Related Disorders Clinical Trial

Official title:

Recovery Group for Women With Substance Use Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01318538
• Other study ID #: NIDA - 5R01DA015434-05
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 22, 2011
• Last updated: May 11, 2011
• Start date: August 2008
• Est. completion date: June 2012

Study information

• Verified date: May 2011
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to conduct a randomized controlled Stage II trial of the Women's Recovery Group (WRG) in a larger, more diverse sample of women than characterized that of the investigators' Stage I trial. The current study is being conducted at two sites. The investigators will compare 12 weekly sessions in an open-enrollment format of the women-focused, single-gender WRG versus an equivalent amount of the active comparison treatment, mixed-gender Group Drug Counseling (GDC). In addition to testing the efficacy of the WRG, the investigators' second aim will be to investigate a priori hypotheses regarding potential moderators (e.g., psychiatric severity, self-efficacy) and mediators (e.g., engagement in ancillary treatment and community support) of treatment outcome. Finally, the investigators will conduct exploratory analyses of group process characteristics of the WRG identified during the Stage I trial and explore differences in group process between single-gender WRG and mixed-gender GDC groups.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 135
• Est. completion date: June 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects will be included in the study if they are

• age 18 years or older

• meet current DSM-IV criteria (American Psychiatric Association, 2000; World Health Organization, 1997) of substance dependence

• plan to stay within the area during the study period

• consent for study personnel to communicate with other mental health professionals from whom they are receiving care

• furnish the names of two locators who can assist study personnel in locating them during the study period

• are interested in group treatment

• live close enough either to McLean Hospital or SSTAR to come to group weekly

• are able to sign informed consent.

Exclusion Criteria:

• Patients will be excluded if they

• have a current medical condition that would prevent regular group attendance *have mental retardation or organic mental disorder

• have certain other major Axis I psychiatric disorders according to the CIDI (World Health Organization, 1997) such as psychotic disorders or bipolar I disorder that are more likely to respond to another form of treatment (Mueser, Noordsy, Drake, Fox, & Barlow, 2003; Weiss RD et al., 2007)

• will be in residential treatment setting throughout the treatment period in which substance use is monitored and restricted (e.g., a therapeutic community), since the intensive treatment in that setting and the restricted access to drugs could represent an important confounding variable

• currently require medical detoxification (these patients may enter the study after being detoxified)

• are current intravenous drug users

• manifest self-destructive behaviors (e.g., life-threatening bulimia or anorexia, suicide attempts and chronic suicidality) or other behaviors (e.g., violence toward others, assault behaviors) that would interfere with group participation and would best be treated by other therapeutic modalities (e.g., DBT for parasuicidal behaviors).

Study Design

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

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Behavior Therapy
• Disease
• Substance-Related Disorders

Intervention

Behavioral:
• group treatment for substance use disorders
This two-site clinical trial compares single-gender Women's Recovery Group (WRG) and an effective control condition, mixed-gender Group Drug Counseling (GDC). WRG is a new 12-session women-focused, manual-based relapse-prevention group therapy that uses a cognitive-behavioral approach. It is a 90-minute structured relapse prevention weekly group therapy with both women-focused content as well as an all-women group composition. The control condition, Group Drug Counseling (GDC), consists of 12 weekly 90-minute structured sessions and is conducted in a mixed-gender group composition and has no women-focused content. Both groups stress abstinence. Women are randomly assigned to one of the two conditions and the groups are conducted in a rolling group, open format at two sites, McLean Hospital in Belmont, MA and SSTAR in Fall River, MA.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts
United States	Stanley Street Treatment and Resources (SSTAR)	Fall River	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in substance use		Change from baseline at end of treatment and 6 months post-treatment	No
Secondary	Psychiatric Severity		Duration of the study (9 months)	No
Secondary	Self-efficacy		Duration of the study (9 months)	No