Clinical trial NCT01318538: Women's Recovery Group (WRG) Study - A Randomized Controlled Stage II Trial
Official title: Recovery Group for Women With Substance Use Disorders - Stage II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Alcohol-Related Disorders
Keywords: Substance use disorders, Gender differences, women, treatment outcomes, group therapy
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-03-18
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this Stage II randomized controlled behavioral treatment development trial was to test the effectiveness of the Women's Recovery Group (WRG) relative to mixed-gender Group Drug Counseling (GDC) and demonstrate the feasibility of implementing the WRG in an open-enrollment (i.e., rolling admission) group format at two clinical sites. The Stage II trial aims were to (1) investigate effectiveness of the WRG relative to GDC in a sample of women heterogeneous with respect to substance use and co-occurring psychiatric disorders, and (2) demonstrate the feasibility of implementing WRG in an open enrollment group format characteristic of community treatment programs at two sites.

Detailed description: This Stage II trial builds on the Stage I trial that compared the single-gender WRG to mixed-gender GDC and demonstrated preliminary support for the WRG in treating women with substance use disorders (SUDs). It was hypothesized that women in the WRG would decrease their substance use more so than women in the GDC. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community. The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session structured relapse prevention group therapy that utilizes a cognitive-behavioral approach and includes gender-specific content and single-gender group composition. There are 14 specific session topics that can be flexibly implemented in any order for a 12-week sequence of groups. In the Stage I trial, women were randomized to WRG (n=16) or mixed-gender GDC (n =7). No significant differences in outcomes emerged between WRG and GDC during the 12 week group sequence. However, in the 6 months post-treatment, WRG participants showed a pattern of continued reductions in substance use while GDC participants did not. While the design of the Stage I trial was essential for treatment development and testing, the Stage I trial had a small sample size and used a semi-closed enrollment format. However, most treatment is delivered in an open enrollment format (i.e., rolling admission) in which patients enter at any time in the group sequence and exit the group after 12 weeks are completed. Because WRG is intended to be a manual-based treatment ready for dissemination into clinical practice if demonstrated to be effective, the Stage II trial was designed to be implemented in an open group format and to enroll a larger, more diverse sample at two clinical sites. The study was designed to investigate the effectiveness of the WRG relative to the GDC in (1) reducing days of use of any substance from baseline in a sample of women with heterogeneity with regard to their substance dependence, co-occurring psychiatric disorders, and other demographic characteristics, and (2) to demonstrate the feasibility of implementing the WRG in an open-enrollment group format.

Eligibility criteria: Inclusion Criteria:

* Subjects were included in the study if they:

  * were 18 years or older
  * used substances within the past 60 days
  * met current Diagnostic and Statistical Manual (DSM)-IV criteria (American Psychiatric Association, 2000; World Health Organization, 1997) of substance dependence (in addition to any nicotine dependence)
  * planned to stay within the area during the study period
  * consented for study personnel to communicate with other mental health professionals from whom they are receiving care
  * furnished the names of two locators who can assist study personnel in locating them during the study period
  * were interested in group treatment
  * lived close enough either to McLean Hospital or SSTAR to come to group weekly
  * were able to sign informed consent.

Exclusion Criteria:

* Patients were excluded if they:

  * had a current medical condition that would prevent regular group attendance
  * had mental retardation or organic mental disorder
  * had certain other major Axis I psychiatric disorders according to the Composite International Diagnostic Interview (CIDI), such as psychotic disorders or bipolar I disorder
  * would be in a residential treatment setting throughout the treatment period in which substance use is monitored and restricted (e.g., a therapeutic community)
  * required medical detoxification (these patients could enter the study after being detoxified)
  * were current intravenous drug users
  * engaged in 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)

Primary outcomes:
measure: Percent Change in Mean Days of Any Substance Use for Women
timeFrame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
measure: Change in Mean ASI Alcohol Composite Score for Women
timeFrame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
measure: Change in Mean ASI Drug Composite Score for Women
timeFrame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
Secondary outcomes:
measure: Percent Change in Mean Alcohol Use Days for Women
timeFrame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
measure: Percent Change in Mean Drug Use Days for Women
timeFrame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
measure: Percent Change in Mean Heavy Drinking Days for Women
timeFrame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
measure: Change in Mean Drinks Per Drinking Day for Women
timeFrame: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)
Other outcomes:
measure: Therapist Adherence
timeFrame: In treatment (weeks 1-12)
measure: Group Attendance
timeFrame: In treatment (weeks 1-12)
measure: Group Stability
timeFrame: In treatment (weeks 1-12)
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Fall River
country: United States
facility: Stanley Street Treatment and Resources (SSTAR)
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Shelly F Greenfield, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenfield SF, Crisafulli MA, Kaufman JS, Freid CM, Bailey GL, Connery HS, Rapoza M, Rodolico J. Implementing substance abuse group therapy clinical trials in real-world settings: challenges and strategies for participant recruitment and therapist training in the Women's Recovery Group Study. Am J Addict. 2014 May-Jun;23(3):197-204. doi: 10.1111/j.1521-0391.2014.12099.x.
citation: Greenfield SF. Treating Women with Substance Use Disorders: The Women's Recovery Group Manual. New York: Guilford Press; 2016.
citation: Greenfield SF, Sugarman DE, Freid CM, Bailey GL, Crisafulli MA, Kaufman JS, Wigderson S, Connery HS, Rodolico J, Morgan-Lopez AA, Fitzmaurice GM. Group therapy for women with substance use disorders: results from the Women's Recovery Group Study. Drug Alcohol Depend. 2014 Sep 1;142:245-53. doi: 10.1016/j.drugalcdep.2014.06.035. Epub 2014 Jul 4.
citation: Sugarman DE, Wigderson SB, Iles BR, Kaufman JS, Fitzmaurice GM, Hilario EY, Robbins MS, Greenfield SF. Measuring affiliation in group therapy for substance use disorders in the Women's Recovery Group study: Does it matter whether the group is all-women or mixed-gender? Am J Addict. 2016 Oct;25(7):573-80. doi: 10.1111/ajad.12443. Epub 2016 Sep 20.