title: Empirically Assessing Participant Perceptions of the Research Experience in a Randomized Clinical Trial: The Women's Self-Defense Project as a Case Example.
abstract: A growing body of empirical literature has systematically documented the reactions to research participation among participants in traumafocused research. To date, the available data has generally presented an optimistic picture regarding participants' ability to tolerate and even find benefit from their participation. However, this literature has been largely limited to cross-sectional designs. No extant literature has yet examined the perceptions of participants with psychiatric illness who are participating in randomized clinical trials (RCTs) designed to evaluate the efficacy or effectiveness of novel trauma treatments. The authors posit that negative experiences of, or poor reactions to, the research experience in the context of a trauma-focused RCT may elevate the risk of participation. Indeed, negative reactions may threaten to undermine the potential therapeutic gains of participants and promoting early drop out from the trial. Empirically assessing reactions to research participation at the pilot-study phase of a clinical trial can both provide investigators and IRB members alike with empirical evidence of some likely risks of participation. In turn, this information can be used to help shape the design and recruitment methodology of the full-scale trial. Using data from the pilot study of the Women's Self-Defense Project as a case illustration, we provide readers with concrete suggestions for empirically assessing participants' perceptions of risk involved in their participation in behaviorally oriented clinical trials.
authors.affiliation: Veterans Affairs Palo Alto Health Care System, and Stanford University School of Medicine (USA).
authors.forename: Julie C
authors.initials: JC
authors.lastname: Weitlauf
authors.forename: Josef I
authors.initials: JI
authors.lastname: Ruzek
authors.forename: Darrah A
authors.initials: DA
authors.lastname: Westrup
authors.forename: Tina
authors.initials: T
authors.lastname: Lee
authors.forename: Jennifer
authors.initials: J
authors.lastname: Keller