Early Intervention Following Sexual Assault

NCT04582695 | Active Not Recruiting DMC

• 2 other identifiers: 000991141K23AA028055
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ptsd; Alcohol Use Disorder; Sexual Assault and Rape

Outcome Measures

Primary Outcomes (4)

• Change in Percent Drinking Days on The Time Line Follow-Back

  The Time Line Follow Back (TLFB) will be used to assess heavy drinking in the past 30-days. This calendar-assisted interview yielded estimates in terms of the number of standard drinks consumed daily in the past 30 days used to obtain retrospective self-report of alcohol use by using a calendar and other memory prompts to stimulate recall.

  Participants will report on drinking during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.

• Change in number of standard drinks per drinking day on The Time Line Follow-Back

  The Time Line Follow Back (TLFB) will be used to assess heavy drinking in the past 30-days and use. This calendar-assisted interview yielded estimates in terms of the number of standard drinks consumed daily in the past 30 days used to obtain retrospective self-report of alcohol use by using a calendar and other memory prompts to stimulate recall.

  Participants will report on drinking during the 30 days prior to initiation of the study, and ever day until completion of study visits, approximately six weeks.

• Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5)

  Participants will be asked to complete the 20-item Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5) to measure traumatic stress symptoms corresponding with the Diagnostic and Statistical Manual of Mental Disorders -5 PTSD criteria. Items are rated on a five-point Likert scale ranging from 0 (Not at all) to 4 (Extremely) with higher scores indicating greater traumatic stress symptoms. Total scores will be used.

  Baseline and after completion of study visits, approximately six weeks.

• Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders

  The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders (CAPS-5) is the gold standard in Posttraumatic Stress Disorder (PTSD) assessment. It is a structured 30-minute interview that can be used to diagnosis PTSD. Items focus on symptom presence, onset and duration of symptoms, subjective distress, impact on functioning, and symptom improvement.

  Baseline and after completion of study visits, approximately six weeks.

Secondary Outcomes (3)

• Change in Depression Symptoms on The Patient Health Questionnaire-9.

  Baseline and after completion of study visits, approximately six weeks.

• Change in Anxiety Symptoms on The Beck Anxiety Inventory

  Baseline and after completion of study visits, approximately six weeks.

• Change in Percent Days Using Substances on The Time Line Follow-Back

  Participants will report on substance use during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.

Study Arms (2)

Written Exposure Therapy

ACTIVE COMPARATOR

Behavioral: Written Exposure Therapy

Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder

EXPERIMENTAL

Behavioral: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder

Interventions

Written Exposure Therapy BEHAVIORAL

Participants will receive 5 to 6 weeks of written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes.

Written Exposure Therapy

Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder BEHAVIORAL

Participants will receive 5 to 6 weeks of an integrated behavioral therapy that address posttraumatic stress disorder and alcohol use disorder. Sessions will be 60 minutes in length. It will include written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes. In addition, they will receive 20 minutes of intervention focused on cognitive behavioral therapy for alcohol use disorder which involves learning skills to cope with alcohol cravings and behavior (e.g., challenging thoughts, problem solving).

Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

  PMID: 37795783 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism

Interventions

Cognitive Behavioral Therapy; Ethanol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 9, 2020
• Study Start: December 15, 2020
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)