title: Acute effects of trauma-focused research procedures on participant safety and distress.
abstract: The ethical conduct of research on posttraumatic stress disorder (PTSD) requires assessing the risks to study participants. Some previous findings suggest that patients with PTSD report higher distress compared to non-PTSD participants after trauma-focused research. However, the impact of study participation on participant risk, such as suicidal/homicidal ideation and increased desire to use drugs or alcohol, has not been adequately investigated. Furthermore, systematic evaluation of distress using pre- and post-study assessments, and the effects of study procedures involving exposure to aversive stimuli, are lacking. Individuals with a history of PTSD (n=68) and trauma-exposed non-PTSD controls (n=68) responded to five questions about risk and distress before and after participating in research procedures including a PTSD diagnostic interview and a behavioral task with aversive stimuli consisting of mild electrical shock. The desire to use alcohol or drugs increased modestly with study participation among the subgroup (n=48) of participants with current PTSD. Participation in these research procedures was not associated with increased distress or participant risk, nor did study participation interact with lifetime PTSD diagnosis. These results suggest some increase in distress with active PTSD but a participant risk profile that supports a favorable risk-benefit ratio for conducting research in individuals with PTSD.
authors.affiliation: Mental Illness Research Education and Clinical Center for Post Deployment Mental Health, Durham VA Medical Center, Durham, NC, USA; Duke-UNC Brain Imaging and Analysis Center, Duke University, Durham, NC, USA.
authors.forename: Vanessa M
authors.initials: VM
authors.lastname: Brown
authors.affiliation: Mental Illness Research Education and Clinical Center for Post Deployment Mental Health, Durham VA Medical Center, Durham, NC, USA; Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA; Center for Health Services Research in Primary Care, Durham, NC, USA.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Strauss
authors.affiliation: Duke-UNC Brain Imaging and Analysis Center, Duke University, Durham, NC, USA; Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.
authors.forename: Kevin S
authors.initials: KS
authors.lastname: LaBar
authors.affiliation: Department of Psychology, Yale University, New Haven, CT, USA.
authors.forename: Andrea L
authors.initials: AL
authors.lastname: Gold
authors.affiliation: Department of Psychology, Yale University, New Haven, CT, USA.
authors.forename: Gregory
authors.initials: G
authors.lastname: McCarthy
authors.affiliation: Mental Illness Research Education and Clinical Center for Post Deployment Mental Health, Durham VA Medical Center, Durham, NC, USA; Duke-UNC Brain Imaging and Analysis Center, Duke University, Durham, NC, USA; Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA. Electronic address: rajendra.morey@gmail.com.
authors.forename: Rajendra A
authors.initials: RA
authors.lastname: Morey
mesh_terms: D000328:Adult; D032984:Ethics, Research; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D035842:Research Subjects / Q000523:psychology*; D018570:Risk Assessment; D012307:Risk Factors; D013313:Stress Disorders, Post-Traumatic / Q000523:psychology*; D013315:Stress, Psychological / Q000523:psychology*; D059020:Suicidal Ideation
keywords: Distress; Homicidal ideation; PTSD; Research risks; Risk assessment; Suicidal ideation; Trauma