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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jul 20, 2026
Date Accepted: Sep 30, 2026

The final, peer-reviewed published version of this preprint can be found here:

Acute Interventions for Posttraumatic Stress Disorder and Alcohol Misuse in Women Exposed to Sexual Assault: Protocol for a Phased Randomization Trial (Project SARAH)

Bedard-Gilligan M, Lehinger EA, Joseph M, Kaysen DL, Stappenbeck CA, Cadigan JM, Fleming CB, Zoellner LA

Acute Interventions for Posttraumatic Stress Disorder and Alcohol Misuse in Women Exposed to Sexual Assault: Protocol for a Phased Randomization Trial (Project SARAH)

JMIR Res Protoc 2026;15:e107568

DOI: 10.2196/107568

PMID: 42976343

Protocol for Project SARAH: A Phased Randomization Trial of Acute Interventions for PTSD and Alcohol Misuse for Women Exposed to Sexual Assault

  • Michele Bedard-Gilligan; 
  • Elizabeth A Lehinger; 
  • Molly Joseph; 
  • Debra L Kaysen; 
  • Cynthia A Stappenbeck; 
  • Jennifer M Cadigan; 
  • Charles B Fleming; 
  • Lori A Zoellner

ABSTRACT

Background:

Sexual assault can have devastating consequences for survivors, including leading to posttraumatic stress disorder (PTSD) and alcohol misuse. Interventions provided in the initial months following a sexual assault can prevent the development of chronic problems. Early interventions that are brief, accessible, and focused on shared vulnerabilities may improve efficacy.

Objective:

Project SARAH (Sexual Assault Recovery and Hope) is designed to test fear and reward learning as processes underlying recovery following sexual assault and elucidate efficacious approaches for brief interventions to address PTSD and alcohol misuse.

Methods:

A phased, doubly randomized, and single-masked clinical trial is being conducted to test efficacy of acute intervention approaches that target (1) the fear system underlying PTSD with imaginal exposure (IE) or (2) the reward system underlying alcohol use with alcohol skills training (AST), comparing these approaches to supportive counseling (SC) via telehealth for reducing PTSD and problematic drinking.

Results:

Interventions are tested in a sample of adult female sexual assault survivors. The phased study design with two points of randomization allows for comparing IE or AST and their combination, as compared to active control, SC, as well as understanding mechanisms of recovery.

Conclusions:

This design is significant in exploring PTSD and alcohol recovery pathways acutely following sexual assault. Clinical Trial: Clinicaltrials.gov Identifier: NCT04124380; Initial registration 09/23/2019; Last updated 05/26/2026; Includes protocol and analysis plan


 Citation

Please cite as:

Bedard-Gilligan M, Lehinger EA, Joseph M, Kaysen DL, Stappenbeck CA, Cadigan JM, Fleming CB, Zoellner LA

Acute Interventions for Posttraumatic Stress Disorder and Alcohol Misuse in Women Exposed to Sexual Assault: Protocol for a Phased Randomization Trial (Project SARAH)

JMIR Res Protoc 2026;15:e107568

DOI: 10.2196/107568

PMID: 42976343

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