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

NCT ID: NCT04124380

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-02
• Study Completion Date: 2026-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Imaginal Exposure First, then Alcohol Skills

Imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. After imaginal exposure, alcohol skills targeting alcohol misuse after sexual assault.

Group Type: EXPERIMENTAL

Imaginal Exposure

Intervention Type: BEHAVIORAL

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).

Alcohol Skills Training

Intervention Type: BEHAVIORAL

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.

Alcohol Skills First, then Imaginal Exposure

Alcohol skills targeting alcohol misuse after sexual assault. After alcohol skills training, imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault.

Group Type: EXPERIMENTAL

Imaginal Exposure

Intervention Type: BEHAVIORAL

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).

Alcohol Skills Training

Intervention Type: BEHAVIORAL

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.

Supportive Counseling/Telehealth

Internet-based intervention focusing on providing support.

Group Type: ACTIVE_COMPARATOR

Supportive Telehealth

Intervention Type: BEHAVIORAL

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.

Alcohol Skills First, no additional treatment

Alcohol skills targeting alcohol misuse after sexual assault only. No additional treatment.

Group Type: EXPERIMENTAL

Alcohol Skills Training

Intervention Type: BEHAVIORAL

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.

Imaginal Exposure First, no additional treatment

Imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. No additional treatment.

Group Type: EXPERIMENTAL

Imaginal Exposure

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Identifies as female.

2. Between the age of 18 and 65.

3. Reports a sexual assault in the last 4 weeks to 1 year.

4. Current PTSD severity of 23+ on the PSS-I-5.

5. Current heavy alcohol use (2+ heavy episodic drinking occasions [4+ drinks on one occasion] in past month).

6. Access to the internet and a device with a webcam.

Exclusion Criteria

1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-5.

2. Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).

3. Unwilling or unable to discontinue current trauma-focused psychotherapy or current substance use psychotherapy.

4. Unstable dose of psychotropic medications in the prior 3 months.

5. Ongoing intimate relationship with the perpetrator of most recent assault.

6. Current diagnosis of a severe substance use disorder according to DSM-5, other than alcohol in the last month.

7. No clear trauma memory.

8. Current higher dose use of benzodiazepines (greater than the equivalent of 4 mg of lorazepam, 2 mg alprazolam, 1.5 mg clonazepam, or 20 mg of diazepam).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Michele Bedard-Gilligan

Professor, School of Medicine: Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Bedard-Gilligan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

Reference Type: DERIVED

PMID: 37795783 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01AA027499

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1F32AA029865-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008021

Identifier Type: -

Identifier Source: org_study_id