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

Abstract

Background and Objectives Open-enrollment group therapy research is challenged by the participant recruitment necessary to ensure continuous group enrollment. We present successful strategies to overcome the following barriers during the Women’s Recovery Group (WRG) two-site clinical trial (N = 158): maintenance of sample size and balanced gender randomization during continuous enrollment, maintenance of group attendance, and training and retention of therapists over the 24-month continuous group enrollment. Methods To increase recruitment, we targeted referral sources yielding the highest enrollment conversion at each site. Group sessions were consistently held regardless of group size. Therapists were trained in two teams allowing for coverage and uninterrupted treatment over 24 months. Results At both sites recruitment and enrollment increased with each successive quarter. Sample size and end date targets were met without disruptions in treatment. Group therapists reported high satisfaction with their training and treatment experiences. Discussion and Conclusions Strategies implemented supported targeted enrollment and study duration, stability of open enrollment group therapy frame, and therapist retention and satisfaction.

Group therapy for women with substance use disorders: Results from the Women's Recovery Group Study

“…Our qualitative studies of the Stage I WRG (Greenfield et al, 2013a, 2013b) demonstrated that women participants in WRG found the support of other women in the group to be an essential component of the WRG (Greenfield et al, 2013a), and we documented a greater number of supportive statements made in WRG than GDC (Greenfield et al, 2013b). Although in this Stage II trial there were no differences between WRG and GDC in average number of participants per group session, treatment attendance, and turn-over, similar to other open enrollment group therapy studies, the Stage II trial of WRG was challenged to provide a robust and stable group attendance (average group ≤ 3 participants for both WRG and GDC; Greenfield et al, 2014). It is possible that differences between the Stage I and Stage II trial results may in part be due to fewer average participants per group and lower stability of attendance in the Stage II trial.…”

“…The Stage II trial demonstrates that the WRG was comparable to mixed-gender GDC in an open-enrollment format delivered in two community-based clinical settings (Greenfield et al, 2014). Our sample differs in certain demographic characteristics typical of some women seeking treatment in the community (SAMHSA, 2012), insofar as our participants were predominately white, attained higher educational status, and were more affluent.…”

“…Participants were recruited through treatment programs and private practices, websites, and advertisements (for detailed recruitment information see Greenfield et al, 2014). Inclusion criteria were: 1) current DSM-IV diagnosis of substance dependence for at least one substance besides nicotine; 2) age 18 years or older; 3) use of substances within the past 60 days; 4) available during the follow-up period; 5) interested in group treatment; 6) gave consent for study personnel to communicate with their treatment providers; 7) providing two individuals who could assist in locating the participant; 8) ability to attend group weekly; and 9) signed informed consent.…”

“…However, most group treatment is delivered in open enrollment (or “rolling”) group format in which patients can enter at any time in the group sequence and exit the group after 12 weeks are completed (Morgan-Lopez and Fals-Stewart, 2006; Washton, 2005) rather than starting and ending with a cohort of other participants. Because the WRG is intended to be a manual-based treatment ready for dissemination into clinical practice if demonstrated to be effective (Greenfield et al, 2014), the Stage II trial was designed to be implemented in an open group format at two clinical sites. The aim of this clinical trial was to investigate the effectiveness of the WRG relative to GDC in reducing days of use of any substance from baseline in a sample of women heterogeneous with regard to drugs of abuse, co-occurring disorders, trauma histories, and age and stage of life, as well as to demonstrate the feasibility of implementing the WRG in open-enrollment group format.…”

Restrictions for reimbursement of direct-acting antiviral treatment for hepatitis C virus infection in Canada: a descriptive study

“…We also reviewed the criteria for Aboriginal people and federal prisoners as these populations are disproportionately affected by HCV infection [25][26][27][28] and receive drug coverage from national plans.…”