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Behavioral Intervention

Combined Written Exposure and Cognitive Behavioral Therapy for Sexual Assault Survivors

N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after completion of study visits, approximately six weeks.
Awards & highlights
No Placebo-Only Group

Summary

This trial 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, with surveys and daily assessments.

Who is the study for?
This trial is for women aged 18-65 who've experienced sexual assault within the last six weeks, use alcohol, and may have PTSD or other mood disorders. They must understand English, consent to all treatments and surveys, score above certain thresholds on alcohol use and PTSD severity scales but not be at immediate suicide risk or undergoing severe withdrawal.
What is being tested?
The study tests a five-week treatment combining Written Exposure Therapy with Cognitive Behavioral Therapy specifically tailored for stress related to sexual assault and alcohol use. Participants will complete surveys during visits and possibly daily assessments via smartphones.
What are the potential side effects?
While specific side effects are not listed, behavioral therapies like those being tested can sometimes lead to increased emotional distress due to confronting traumatic memories or changes in drinking habits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Percent Drinking Days on The Time Line Follow-Back
Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders
Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5)
+1 more
Secondary study objectives
Change in Anxiety Symptoms on The Beck Anxiety Inventory
Change in Depression Symptoms on The Patient Health Questionnaire-9.
Change in Percent Days Using Substances on The Time Line Follow-Back

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use DisorderExperimental Treatment1 Intervention
Group II: Written Exposure TherapyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
973 Previous Clinical Trials
7,399,320 Total Patients Enrolled
46 Trials studying Alcoholism
5,027 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,706 Total Patients Enrolled
456 Trials studying Alcoholism
823,722 Patients Enrolled for Alcoholism

Media Library

Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04582695 — N/A
Alcoholism Research Study Groups: Written Exposure Therapy, Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder
Alcoholism Clinical Trial 2023: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder Highlights & Side Effects. Trial Name: NCT04582695 — N/A
Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04582695 — N/A
~8 spots leftby Jun 2025