Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Alcohol; Use, Problem
  • Posttraumatic Stress Disorder
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Only males

Description

Following sexual assault, many individuals will develop chronic problems including posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD). Intervention provided soon after assault can decrease the risk of developing chronic psychopathology and associated negative consequences. Interven...

Following sexual assault, many individuals will develop chronic problems including posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD). Intervention provided soon after assault can decrease the risk of developing chronic psychopathology and associated negative consequences. Interventions that address common underlying mechanisms of PTSD and alcohol use, such as fear and reward systems, have strong potential utility as efficacious and accessible interventions for clinicians treating patients recently exposed to sexual assault. This proposal is designed to test fear and reward as crucial processes underlying recovery following sexual assault and elucidate the most efficacious treatment targets. Employing experimental tasks (safety-signal learning paradigm and probabilistic reward task) to capture baseline underlying vulnerabilities in fear and reward systems respectively will allow for exploration of how these processes impact recovery. A randomized clinical trial (N = 180) will be conducted to test efficacy of intervention approaches that target PTSD or alcohol use compared to supportive telehealth. In addition, a phased study design will allow for exploration of efficacy of primary and secondary intervention approaches to test the questions of 1) whether it is more efficacious to target PTSD or alcohol use first; and 2) whether it is necessary to target both PTSD and alcohol use to facilitate recovery or if one is sufficient. This proposal is significant in exploring transdiagnostic mechanisms implicated in recovery following sexual assault, fear and reward, and using a novel design to compare efficacy, ordering, and necessity of two distinct intervention approaches.

Tracking Information

NCT #
NCT04124380
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Michele Bedard-Gilligan, PhD University of Washington