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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 weeks3 visits
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.
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.
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 moreSecondary 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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged between 18 and 65.You are currently having thoughts of hurting yourself or ending your life.You have other health or mental conditions that the researchers think might make it unsafe for you to take part in the study.You have experienced a traumatic event and may have symptoms of posttraumatic stress disorder (PTSD). You may also have a history of alcohol use disorder, mood disorders (except bipolar disorder), or other anxiety disorders. It's important to include participants with these conditions because they often occur together. You may also have another substance use disorder, but alcohol use disorder should be your primary concern.I have been on stable doses of my mental health medications for at least two weeks.I am experiencing severe withdrawal symptoms and need detox.You have experienced sexual assault in the last six weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Written Exposure Therapy
- Group 2: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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