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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2024
  • participants needed
    180
  • sponsor
    University of Washington
Updated on 4 October 2022
exposure therapy
assault
sexual assault

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.

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.

Details
Condition Alcohol; Use, Problem, Posttraumatic Stress Disorder
Treatment Imaginal Exposure, Alcohol Skills Training, Supportive Telehealth
Clinical Study IdentifierNCT04124380
SponsorUniversity of Washington
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note