Participant reactions to a pretreatment research assessment during a treatment outcome study for PTSD

Abstract

Participants' reactions to pretreatment assessments have not been studied as part of a randomized clinical trial (RCT) for posttraumatic stress disorder (PTSD). The current study examined participants' reactions in women with PTSD who completed pretreatment assessments during an RCT. We assessed participant reactions (N = 100) to a pretreatment assessment that included selfreport questionnaires, interviews, and psychophysiological assessment. Results indicated that participation in pretreatment assessment was well tolerated as measured by participants' reports of distress, interest level, perceptions of the appropriateness of assessment length, and willingness to participate in a similar assessment in the future. Participating in lengthy pretreatment assessments did not adversely impact treatment participation or outcome.Participation in trauma-focused research is typically well tolerated as evidenced by modest levels of distress, willingness to participate in similar research in the future, and positive perceptions about the research experience (e.g., Becker-Blease & Freyd, 2006;Griffin, Resick, Waldrop, & Mechanic, 2003;Newman & Kaloupek, 2004). However, some research suggests that posttraumatic stress disorder (PTSD) symptoms may be associated with greater distress during trauma-focused research (Newman & Kaloupek, 2004). Additionally, participants' pretreatment assessment reactions have yet to be studied as part of a randomized clinical trial (RCT) for PTSD. The extant research typically involves a single assessment session that includes a single self-report questionnaire or interview (Newman & Kaloupek, 2004). Pretreatment RCT assessments differ from nontrial trauma-focused research because they are lengthy and include numerous forms of research assessment, including multimethod assessments of traumatic events, which could induce participant distress or exhaustion and adversely impact treatment participation and outcome. To garner information that can enhance PTSD treatment outcome research, it is imperative to investigate potentially adverse effects of research participation among individuals with PTSD who are participating in a lengthy pretreatment assessment as part of an RCT for PTSD. This study examined participants' reactions to a three-session pretreatment assessment that included self-report questionnaires, interviews, and psychophysiological assessment that were administered as part of a larger RCT for PTSD (Resick et al., 2008). All participants met diagnostic criteria for PTSD and were seeking psychotherapy. Participants completed a selfreport questionnaire to assess their reactions to pretreatment assessments. Assessment reactions were examined descriptively and comparisons were made to examine which assessment procedures were associated with the highest levels of distress. Assessment reactions were also examined in relationship to whether participants began and completed treatment and PTSD treatment outcome. NIH Public Access Method ParticipantsParticipants included 100 female survivor...

The Burden of Research on Trauma for Respondents: A Prospective and Comparative Study on Respondents Evaluations and Predictors

“…Somewhat more recently, Resick and colleagues [9] assessed evaluations of the pre-treatment assessments among female survivors of childhood and/or adult interpersonal violence with PTSD (N = 100) who were seeking psychotherapy (3 days of assessment (3–4 h/d.). Findings showed that a small group evaluated the questionnaires as (very) distressing (8%) compared to the clinical interview (19%) and talking about the trauma (53%).…”

Acute effects of trauma-focused research procedures on participant safety and distress

“…For example, in a nonclinical sample of college students, Cromer and colleagues (2006) found that participants did not perceive greater distress from trauma-related questions than from other personal questions about topics such as weight and academic achievement. Participants with PTSD rated questionnaires about trauma as less stressful, and diagnostic interviews more stressful, than a psychophysiological task with trauma-unrelated stressors (Resick et al, 2009). One the other hand, participants with PTSD also report greater distress after completing trauma-related vs. unrelated questionnaires (Ferrier-Auerbach et al, 2009).…”

“…Prior studies have examined distress (e.g., dislike of study procedures or regret about participation) and perceived benefits directly related to participation (Walker, 1997; Parslow et al, 2000; Cromer et al, 2006; Deprince and Chu, 2008; Resick et al, 2009) but have not examined participants’ potential for harm to self or others. In their study, Cromer et al (2006) found that undergraduates rated trauma-related questionnaires no more distressing, compared to everyday events, than other questionnaires about academic achievement, body image, parents’ income, race, and sexuality.…”

“…In a military veteran sample, Parslow et al (Parslow et al, 2000) found frequent reports of distress among people with a history of PTSD, which were unrelated to willingness to participate in future studies or an increased utilization of medical services. Resick and colleagues (2009) found that participants with PTSD rated study procedures with trauma-related material to be distressing but more interesting. Greater perceived burden of assessments at pretreatment predicted greater chance of treatment completion.…”

Overview of Bioethical Issues in Contemporary PTSD Treatment and Research: Considering Priorities for Future Empirical Ethics Investigation

“…A handful of empirical studies have measured PTSD status in participants and subsequently evaluated participants' reaction to their research participation (e.g., Carlson et al 2003;Edwards et al 2009;Parslow et al 2000;Resick, Iverson, and Artz 2009;Weitlauf et al 2007). Uniformly, such studies have reported that a majority of participants with PTSD report minimal distress in response to questions about their traumatic experiences or about their PTSD symptoms, and findings are robust across diverse measures of reactions to research participation and study modalities (e.g., mailed surveys, psychophysiological evaluation of distress, and interviews that included direct inquiry about prior trauma exposure; Griffin et al 2003;Walker et al 1997).…”