This Stage II trial is responsive to the National Institute on Drug Abuse Program Announcement, Behavioral &Integrative Treatment Development Program (PA 07-111). Although many investigators have written about the need for single-gender treatment for women with substance use disorders (SUDs), there are very few specific therapies developed for this population, and even fewer empirical studies to determine the relative effectiveness of these therapies versus standard treatments in a mixed-gender setting. The primary aim of our current competing continuation proposal is to extend the work accomplished under the previous award (DA015434) by conducting at two sites a randomized controlled Stage II trial of the newly developed Women's Recovery Group (WRG) in a larger, more diverse sample of women than characterized that of our Stage I trial. We will randomly assign women with substance dependence to the twelve-session, single-gender, manual-based, women-focused Women's Recovery Group (WRG), or to an equivalent amount of the active comparison treatment, mixed-gender Group Drug Counseling (GDC), which focuses on recovery from SUDs without attention to women-specific antecedents to, and predictors of recovery from, SUDs. We will assess patients monthly and compare treatment outcomes at three months (i.e., end of treatment), six months (3-month post-treatment follow-up), and nine months (6-month post-treatment follow-up). We hypothesize that women randomized to the women focused, single-gender WRG will have better outcomes than will patients who receive mixed-gender GDC, as measured by (a) days of any substance use, (b) improvement in ASI drug and alcohol composite scores. In addition to testing the efficacy of the WRG, our second aim will be to investigate a priori hypotheses regarding potential moderators and mediators of treatment outcome. We will explore psychiatric severity and self efficacy as potential moderators of outcome as well as engagement in ancillary treatment and community support as potential mediators of treatment outcome. Finally, we 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.

Public Health Relevance

This study will further investigate the efficacy of a new manual-based, 12-session Women's Recovery Group (WRG) that combines an all-women group composition and women-focused content for women with substance use disorders, compared with a standard, effective mixed-gender group therapy condition. Even though nonstandardized women's substance abuse treatment groups are offered routinely in community-based substance abuse treatment programs, there are few previous empirical studies of the efficacy of such all-women's interventions and almost no randomized controlled trials of the effectiveness of all-women's treatment compared with delivering such treatment in a mixed-gender setting. The current study will enhance our knowledge of the efficacy of providing substance abuse treatment in a manual-based, all-women's recovery group compared with delivering such treatment in a standard mixed-gender format.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA015434-05
Application #
7675481
Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Kahana, Shoshana Y
Project Start
2002-09-30
Project End
2012-06-30
Budget Start
2009-07-01
Budget End
2010-06-30
Support Year
5
Fiscal Year
2009
Total Cost
$613,731
Indirect Cost
Name
Mclean Hospital
Department
Type
DUNS #
046514535
City
Belmont
State
MA
Country
United States
Zip Code
02478
Sugarman, Dawn E; Wigderson, Sara B; Iles, Brittany R et al. (2016) 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 25:573-80
Greenfield, Shelly F; Crisafulli, Michele A; Kaufman, Julia S et al. (2014) 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 23:197-204
Greenfield, Shelly F; Sugarman, Dawn E; Freid, Cathryn M et al. (2014) Group therapy for women with substance use disorders: results from the Women's Recovery Group Study. Drug Alcohol Depend 142:245-53
Greenfield, Shelly F; Cummings, Amanda M; Kuper, Laura E et al. (2013) A qualitative analysis of women's experiences in single-gender versus mixed-gender substance abuse group therapy. Subst Use Misuse 48:750-60
Greenfield, Shelly F; Kuper, Laura E; Cummings, Amanda M et al. (2013) Group Process in the single-gender Women's Recovery Group compared with mixed-gender Group Drug Counseling. J Groups Addict Recover 8:
McHugh, R Kathryn; Greenfield, Shelly F (2010) Psychiatric Symptom Improvement in Women Following Group Substance Abuse Treatment: Results from the Women's Recovery Group Study. J Cogn Psychother 24:26-36
Cummings, Amanda M; Gallop, Robert J; Greenfield, Shelly F (2010) Self-efficacy and substance use outcomes for women in single gender versus mixed-gender group treatment. J Groups Addict Recover 5:4-16
Kuper, Laura E; Gallop, Robert; Greenfield, Shelly F (2010) Changes in coping moderate substance abuse outcomes differentially across behavioral treatment modality. Am J Addict 19:543-9
Greenfield, Shelly F; Grella, Christine E (2009) What is ""women-focused"" treatment for substance use disorders? Psychiatr Serv 60:880-2
Greenfield, Shelly F; Potter, Jennifer Sharpe; Lincoln, Melissa F et al. (2008) High psychiatric symptom severity is a moderator of substance abuse treatment outcomes among women in single vs. mixed gender group treatment. Am J Drug Alcohol Abuse 34:594-602

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