Understanding recovery processes for PTSD and alcohol use after sexual assault

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

This study is testing new ways to help people recover from PTSD and alcohol use problems after experiencing sexual assault to see if treating both issues at the same time works better than just offering support through telehealth.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: University of Washington (other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT04124380 on ClinicalTrials.gov

What this trial studies

This study aims to explore the recovery processes for individuals who have experienced sexual assault, focusing on the development of posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD). It will test interventions that target fear and reward systems, which are believed to be crucial in recovery. A randomized clinical trial with 180 participants will compare the efficacy of interventions aimed at PTSD or alcohol use against supportive telehealth. The study will also investigate whether addressing both conditions simultaneously is necessary for effective recovery.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 65 who have reported a sexual assault within the last year and are experiencing significant PTSD symptoms and heavy alcohol use.

Not a fit: Patients with severe mental health disorders such as schizophrenia or those currently in trauma-focused psychotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment strategies for individuals recovering from sexual assault, potentially reducing the long-term impact of PTSD and alcohol use disorders.

How similar studies have performed: Other studies have shown promise in addressing concurrent PTSD and alcohol use through targeted interventions, suggesting that this approach may be effective.

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).

Where this trial is running

Seattle, Washington

• University of Washington — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Michele Bedard-Gilligan, PhD — University of Washington
• Study coordinator: Michele Bedard-Gilligan, PhD

Conditions: Alcohol, Use, Problem, Posttraumatic Stress Disorder