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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

No Placebo-Only Group

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.

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.

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

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I am between 18 and 65 years old.

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I identify as female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently diagnosed with severe depression or bipolar disorder.

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I cannot or will not stop my current therapy for trauma or substance use.

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My mental health medication dose has been stable for the last 3 months.

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I am taking a high dose of benzodiazepines.

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I have been diagnosed with schizophrenia, delusional disorder, or another serious mental health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ past month

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alcohol Use Interview

Alcohol Use Self-Report

Posttraumatic Stress Disorder Severity (PTSD) Interview

+1 more

Secondary study objectives

Alcohol Consequences

Alcohol Cravings

Depression Interview

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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