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

NCT04124380 | Active Not Recruiting DMC

• 3 other identifiers: STUDY00008021R01AA0274991F32AA029865-01A1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol; Use, Problem; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (4)

• Alcohol Use Interview

  Alcohol use will be measured using the Timeline Followback Interview (TLFB) to measure frequency and quantity of drinking behavior over the past month. The TLFB is a count of total drinks per day over the last month. Higher number of drinks on the TLFB represents higher alcohol use and worse outcomes.

  Past month

• Alcohol Use Self-Report

  Alcohol use will be measured using the Daily Drinking Questionnaire (DDQ) to assess for self report of typical weekly drinking (quantity, frequency). The DDQ asks for an estimated number of drinks consumed on each day in a typical week over the last month. Higher estimates for number of typical drinks each day on the DDQ represents higher alcohol use and worse outcomes.

  Past month

• Posttraumatic Stress Disorder Severity (PTSD) Interview

  PTSD symptom severity will be measured using the Posttraumatic Stress Symptoms Scale- Interview Version for DSM-5 (PSS-I-5). The PSS-I-5 is a 20 item scale, with a minimum score of 0 and a maximum score of 80; higher values represent increased PTSD symptom severity and worse outcomes.

  Past two weeks

• Posttraumatic Stress Disorder Severity (PTSD) Self-Report

  PTSD symptom severity will be measured using the Posttraumatic Stress Symptoms Scale- Self-report Version for DSM-5 (PSS-SR-5). The PSS-SR-5 is a 20 item scale, with a minimum score of 0 and a maximum score of 80; higher values represent increased PTSD symptom severity and worse outcomes.

  Past two weeks

Secondary Outcomes (8)

• Psychosocial Functioning

  Past two weeks

• Quality of Life Functioning

  Past two weeks

• Alcohol Cravings

  Past week

• Alcohol Consequences

  Past week

• Depression Self-Report

  Past week

Study Arms (5)

Imaginal Exposure First, then Alcohol Skills

EXPERIMENTAL

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

Behavioral: Imaginal Exposure; Behavioral: Alcohol Skills Training

Alcohol Skills First, then Imaginal Exposure

EXPERIMENTAL

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.

Behavioral: Imaginal Exposure; Behavioral: Alcohol Skills Training

Supportive Counseling/Telehealth

ACTIVE COMPARATOR

Internet-based intervention focusing on providing support.

Behavioral: Supportive Telehealth

Alcohol Skills First, no additional treatment

EXPERIMENTAL

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

Behavioral: Alcohol Skills Training

Imaginal Exposure First, no additional treatment

EXPERIMENTAL

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

Behavioral: Imaginal Exposure

Interventions

Imaginal Exposure 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 First, then Imaginal Exposure; Imaginal Exposure First, no additional treatment; Imaginal Exposure First, then Alcohol Skills

Alcohol Skills Training 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, no additional treatment; Alcohol Skills First, then Imaginal Exposure; Imaginal Exposure First, then Alcohol Skills

Supportive Telehealth 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.

Supportive Counseling/Telehealth

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Individuals who identify as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identifies as female.
• Between the age of 18 and 65.
• Reports a sexual assault in the last 4 weeks to 1 year.
• Current PTSD severity of 23+ on the PSS-I-5.
• Current heavy alcohol use (2+ heavy episodic drinking occasions \[4+ drinks on one occasion\] in past month).
• Access to the internet and a device with a webcam.

You may not qualify if:

• Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-5.
• 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).
• Unwilling or unable to discontinue current trauma-focused psychotherapy or current substance use psychotherapy.
• Unstable dose of psychotropic medications in the prior 3 months.
• Ongoing intimate relationship with the perpetrator of most recent assault.
• Current diagnosis of a severe substance use disorder according to DSM-5, other than alcohol in the last month.
• No clear trauma memory.
• 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).

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 37795783 DERIVED

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

Implosive Therapy; Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Alcohols; Organic Chemicals

Study Officials

• Michele Bedard-Gilligan, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Psychiatry

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 11, 2019
• Study Start: June 2, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)