ACTIVE_NOT_RECRUITING

Early Intervention Following Sexual Assault

Conditions

Ptsd Alcohol Use Disorder Sexual Assault and Rape

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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

This study is for women who have experienced a sexual assault in the past six weeks and use alcohol. The research involves completing a five week behavioral treatment for stress and alcohol use. Participants will complete surveys during visits. Participants may also be asked to complete brief daily assessments on their smart phones.

Official Title

Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault

Quick Facts

Study Start:2020-12-15

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04582695

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
* Female; any race or ethnicity; age 18 to 65 years old. * Sexual assault that occurred within the past 12 months. * Subjects must be able to comprehend English. * A score of 3 or greater on the Alcohol Use Disorders Identification Test (AUDIT-C) screen. * A score of 31 or greater on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5). Subjects may also meet criteria for an alcohol use disorder, previous history of posttraumatic stress disorder, mood disorder (except bipolar affective disorder, see Exclusion Criteria) or other anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive-compulsive disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD and PTSD (Norman et al., 2018; Zinzow et al., 2012). Subjects may meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for another substance use disorder if AUD is the primary substance of choice. * Must consent to complete all treatment and follow-up visits.	* Lack of any memory of the sexual assault * Subjects meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a history of or current psychotic, bipolar, dissociative identify disorder, or a current eating disorder, as the study protocol may be therapeutically insufficient. * Subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA). These subjects will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed. * Individuals considered an immediate suicide risk, with current suicidal ideation and intent. * Individuals who attempted suicide in the past month. These individuals will be referred directly for treatment. * Individuals on psychotropic medications must be stabilized on it for at least two weeks prior to beginning the study. * Any other medical or psychiatric conditions that the investigators believe may compromise the individual's ability to safely participate in the study.

Inclusion Criteria

Exclusion Criteria

* Female; any race or ethnicity; age 18 to 65 years old.
* Sexual assault that occurred within the past 12 months.
* Subjects must be able to comprehend English.
* A score of 3 or greater on the Alcohol Use Disorders Identification Test (AUDIT-C) screen.
* A score of 31 or greater on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5). Subjects may also meet criteria for an alcohol use disorder, previous history of posttraumatic stress disorder, mood disorder (except bipolar affective disorder, see Exclusion Criteria) or other anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive-compulsive disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD and PTSD (Norman et al., 2018; Zinzow et al., 2012). Subjects may meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for another substance use disorder if AUD is the primary substance of choice.
* Must consent to complete all treatment and follow-up visits.

* Lack of any memory of the sexual assault
* Subjects meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a history of or current psychotic, bipolar, dissociative identify disorder, or a current eating disorder, as the study protocol may be therapeutically insufficient.
* Subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA). These subjects will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed.
* Individuals considered an immediate suicide risk, with current suicidal ideation and intent.
* Individuals who attempted suicide in the past month. These individuals will be referred directly for treatment.
* Individuals on psychotropic medications must be stabilized on it for at least two weeks prior to beginning the study.
* Any other medical or psychiatric conditions that the investigators believe may compromise the individual's ability to safely participate in the study.

Contacts and Locations

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

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 Date2020-12-15

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2020-12-15

Study Completion Date2026-01-31

Terms related to this study

Additional Relevant MeSH Terms

Ptsd
Alcohol Use Disorder
Sexual Assault and Rape