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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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
933 Previous Clinical Trials
7,394,551 Total Patients Enrolled
46 Trials studying Alcoholism
5,041 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,365,333 Total Patients Enrolled
423 Trials studying Alcoholism
985,644 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Up to what capacity are patients enrolled in this research project?

"Affirmative. According to the clinicaltrials.gov database, this scientific experiment is actively searching for 64 participants across 1 site since its initial post on December 15th 2020 and most recent edit on July 22nd 2022."

Answered by AI

Does this research include participants aged 70 and above?

"Patients that meet the age requirements of 18-65 are eligible to apply for this trial. In addition, there are 34 clinical trials available exclusively for individuals below 18 years old and 257 additional studies open to those above 65."

Answered by AI

Are any participants still able to join this research endeavor?

"Affirmative. Clinicaltrials.gov shows that the trial was initially posted on December 15th 2020 and edited most recently in July 22nd 2022, with an aim to recruit 64 participants from a single site."

Answered by AI

Am I able to join this experiment?

"This medical study seeks 64 individuals with an alcohol abuse disorder, aged 18 to 65. The applicants must meet the specific criteria listed which includes a score of 31 or higher on the DSM-5's PTSD Checklist (PCL-5), a minimum 3 on AUDIT-C screen, and have experienced sexual assault within the past 6 weeks. Moreover, all candidates need to be able to comprehend English fluently."

Answered by AI

What is the aim of this medical examination?

"The primary objective of the trial, which is to evaluate the change in percent drinking days on the Time Line Follow-Back over a six week period, will be supplemented by analyses of anxiety and depression levels via The Beck Anxiety Inventory (BAI) and Patient Health Questionnaire-9. Additionally, participants' substance use in the past 30 days will be assessed through The Time Line Follow-Back survey instrument."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~17 spots leftby Jun 2025