ACTIVE_NOT_RECRUITING

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

Conditions

Alcohol; Use, Problem Posttraumatic Stress Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-06-02

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04124380

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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).

Contacts and Locations

Principal Investigator

Michele Bedard-Gilligan, PhD

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

University of Washington

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: University of Washington

Michele Bedard-Gilligan, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-02

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2021-06-02

Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

Alcohol; Use, Problem
Posttraumatic Stress Disorder