← Back to Search

Recovery Processes for PTSD and Alcohol Use After Sexual Assault

N/A
Recruiting
Led By Michele Bedard-Gilligan, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the age of 18 and 65.
Identifies as female.
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up past month
Awards & highlights

Summary

This trial will focus on understanding how to better treat people who have recently experienced sexual assault, in order to mitigate any long-term effects.

Who is the study for?
This trial is for women aged 18-65 who have experienced a sexual assault within the last year and are dealing with heavy alcohol use and PTSD. Participants must have internet access, a webcam, and a certain level of PTSD severity. Those on high doses of benzodiazepines or with severe mental health conditions like schizophrenia or bipolar disorder cannot join.Check my eligibility
What is being tested?
The study tests how supportive telehealth, alcohol skills training, and imaginal exposure can help recovery from PTSD and reduce alcohol use after sexual assault. It aims to understand early treatment decisions that affect both fear and reward systems related to these conditions.See study design
What are the potential side effects?
While specific side effects are not listed for this psychological intervention trial, participants may experience discomfort discussing traumatic events or changes in their drinking habits during the course of therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I identify as female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently diagnosed with severe depression or bipolar disorder.
Select...
I cannot or will not stop my current therapy for trauma or substance use.
Select...
My mental health medication dose has been stable for the last 3 months.
Select...
I am taking a high dose of benzodiazepines.
Select...
I have been diagnosed with schizophrenia, delusional disorder, or another serious mental health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~past month
This trial's timeline: 3 weeks for screening, Varies for treatment, and past month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol Use Interview
Alcohol Use Self-Report
Posttraumatic Stress Disorder Severity (PTSD) Interview
+1 more
Secondary outcome measures
Alcohol Consequences
Alcohol Cravings
Depression Interview
+5 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Imaginal Exposure First, then Alcohol SkillsExperimental Treatment2 Interventions
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 II: Imaginal Exposure First, no additional treatmentExperimental Treatment1 Intervention
Imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. No additional treatment.
Group III: Alcohol Skills First, then Imaginal ExposureExperimental Treatment2 Interventions
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 IV: Alcohol Skills First, no additional treatmentExperimental Treatment1 Intervention
Alcohol skills targeting alcohol misuse after sexual assault only. No additional treatment.
Group V: Supportive Counseling/TelehealthActive Control1 Intervention
Internet-based intervention focusing on providing support.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imaginal Exposure
2017
N/A
~40

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,762 Previous Clinical Trials
1,876,302 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
815 Previous Clinical Trials
1,159,691 Total Patients Enrolled
Michele Bedard-Gilligan, PhDPrincipal Investigator - University of Washington
University of Washington
1 Previous Clinical Trials
63 Total Patients Enrolled

Media Library

Alcohol Skills Training Clinical Trial Eligibility Overview. Trial Name: NCT04124380 — N/A
Alcohol Use Disorder Research Study Groups: Imaginal Exposure First, then Alcohol Skills, Alcohol Skills First, then Imaginal Exposure, Supportive Counseling/Telehealth, Alcohol Skills First, no additional treatment, Imaginal Exposure First, no additional treatment
Alcohol Use Disorder Clinical Trial 2023: Alcohol Skills Training Highlights & Side Effects. Trial Name: NCT04124380 — N/A
Alcohol Skills Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04124380 — N/A
~38 spots leftby Jun 2025