NCT04124380

Understanding and Testing Recovery Processes for PTSD and Alcohol Use Following Sexual Assault

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Sexual assault can lead to devastating consequences including the development of chronic conditions including posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD). Interventions delivered soon after exposure to assault can decrease the long-term negative consequences of sexual assault but existing interventions are limited in their ability to target concurrent PTSD symptoms and alcohol use and little is known about how to make best practice treatment decisions in the early period following sexual assault. A greater emphasis on transdiagnostic processes that are related to both PTSD and alcohol use, such as fear and reward systems, can elucidate mechanisms of recovery, lead to the development of more effective intervention approaches, and guide clinical decision making for patients recently exposed to sexual assault.

Detailed 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. 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.

Conditions

• Alcohol; Use, Problem
• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Imaginal Exposure	Six 50 min, twice weekly video telehealth sessions will be provided based on prolonged exposure therapy for PTSD. This brief intervention includes psycho-education and focuses on imaginal exposure only based on Zoellner et al., (2016).
BEHAVIORAL	Alcohol Skills Training	Six 50 min, twice weekly video telehealth sessions will be provided based on content from the alcohol skills training program and CBT protocols. Each session includes teaching skills and practice, focusing on mitigating rewarding aspects of alcohol, addressing cravings, and increasing other natural rewards.
BEHAVIORAL	Supportive Telehealth	The supportive counseling intervention, modeled after Litz et al. (2007), will ask participants to self-monitor their experience of weekly symptoms and complete weekly online writing about daily non-trauma related concerns and hassles. Participants will talk with a therapist on the telephone twice per week.

Timeline

• Start date: 2021-06-02
• Primary completion: 2026-06-01
• Completion: 2026-08-31
• First posted: 2019-10-11
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States