Study Summary
This trial will test a new cognitive-behavioral intervention for reducing symptoms of addiction and PTSD in women who have recently experienced sexual assault. If successful, the intervention could be used to help women recover from these traumatic events.
Eligible Conditions
- Substance Use Disorder
- Sexual Assault
- Post Traumatic Stress Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 3 Secondary · Reporting Duration: : Baseline and after completion of study visits, approximately six weeks.
: Baseline and after completion of study visits, approximately six weeks.
Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist
Baseline and after completion of study visits, approximately six weeks.
Change in Alcohol Use Disorder symptoms on the Alcohol Use Disorders Identification Test
Change in Anxiety Symptoms on The Beck Anxiety Inventory
Change in Depression Symptoms on The Beck Depression Inventory-II
Change in Depression Symptoms on The PHQ-9
Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders
Day 30
Change in number of standard drinks per drinking day on The Time Line Follow-Back
Day 30
Change in Percent Drinking Days on The Time Line Follow-Back
Day 30
Change in Percent Substance Use Days on The Time Line Follow-Back
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Written Exposure and Cognitive Behavioral Therapy
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: Written Exposure and Cognitive Behavioral Therapy · No Placebo Group · N/A
Written Exposure and Cognitive Behavioral Therapy
Behavioral
Experimental Group · 1 Intervention: Written Exposure and Cognitive Behavioral Therapy · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: : baseline and after completion of study visits, approximately six weeks.
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,250 Previous Clinical Trials
2,029,342 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
838 Previous Clinical Trials
5,378,558 Total Patients Enrolled
1 Trials studying Sexual Assault
165 Patients Enrolled for Sexual Assault
Eligibility Criteria
Age 18 - 65 · Female Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The victim was sexually assaulted within the past six weeks.
Subjects with a mood disorder or another anxiety disorder (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder) may be included in the study
A female between the ages of 18 and 65 years old, of any race or ethnicity.
When you're reporting a problem to your doctor, be sure to report a minimum of two substance use disorder symptoms
All subjects must be able to understand English in order to take this class.
You have a minimum of one symptom of each cluster of Posttraumatic Stress Disorder.
The person must agree to complete all the treatment and follow-up visits.
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Conditions
Cancer Related
Treatments