Combined Written Exposure and Cognitive Behavioral Therapy for Sexual Assault Survivors
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Must not be taking: Psychotropics
Disqualifiers: Psychotic, Bipolar, Dissociative, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on psychotropic medications, you must be stabilized on them for at least two weeks before starting the study.
What data supports the effectiveness of the treatment Written Exposure Therapy (WET) and its integration with Cognitive Behavioral Therapy for Sexual Assault Survivors?
Research shows that Written Exposure Therapy (WET) is effective for treating post-traumatic stress disorder (PTSD), with outcomes similar to other established therapies like Cognitive Processing Therapy. Additionally, integrating cognitive behavioral therapy (CBT) with exposure therapy has been beneficial for individuals with both PTSD and alcohol use disorders, suggesting potential effectiveness for sexual assault survivors.
12345Is Written Exposure Therapy (WET) safe for humans?
Written Exposure Therapy (WET) has been studied for posttraumatic stress disorder (PTSD) and is generally considered safe, with studies showing it is well-tolerated by participants, including veterans and pregnant women with PTSD.
12356How is the treatment for sexual assault survivors different from other treatments?
This treatment combines Written Exposure Therapy (WET), which is a brief, 5-session therapy focusing on writing about traumatic experiences, with Cognitive Behavioral Therapy for Alcohol Use Disorder, making it unique in addressing both trauma and alcohol use in a concise and integrated manner.
12367Eligibility Criteria
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.Inclusion Criteria
I am a woman aged between 18 and 65.
Subjects must be able to comprehend English
A score of 3 or greater on the Alcohol Use Disorders Identification Test (AUDIT-C) screen
+3 more
Exclusion Criteria
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
Individuals who attempted suicide in the past month. These individuals will be referred directly for treatment
You are currently having thoughts of hurting yourself or ending your life.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants complete a five-week behavioral treatment for stress and alcohol use, including surveys and daily assessments
5-6 weeks
Weekly visits (in-person), daily assessments (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment with standardized repeated measures
4 weeks
Participant Groups
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.
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
Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Written Exposure Therapy for:
- Post-Traumatic Stress Disorder (PTSD)
- Alcohol Use Disorder
🇪🇺 Approved in European Union as Written Exposure Therapy for:
- PTSD
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
Loading ...
Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Long-term treatment gains of a brief exposure-based treatment for PTSD. [2022]Written exposure therapy (WET) is a 5-session PTSD treatment that may address barriers in treatment for posttraumatic stress disorder (PTSD) given its brevity and tolerability. A recent study found outcomes for WET were non-inferior to outcomes from Cognitive Processing Therapy (CPT) through 36 weeks from first treatment session (Sloan, Marx, Lee, & Resick, 2018); the current study examined whether treatment gains were maintained through 60 weeks from first session, and also evaluated both treatments' effect on depressive symptoms.
Brief novel therapies for PTSD: Written Exposure Therapy. [2022]Written Exposure Therapy (WET) is a 5-session exposure-based intervention for the treatment of posttraumatic stress disorder (PTSD). WET was developed through a series of systematic evaluations of the expressive writing procedure. It is an efficient intervention, requiring limited patient and therapist time and no between-session assignments. The treatment results in statistically and clinically significant symptom change among individuals, including veterans, with PTSD.
An Open Pilot Trial of Written Exposure Therapy for Patients With Post-Traumatic Stress Disorder in Korea. [2021]Written exposure therapy (WET) is exposure therapy for post-traumatic stress disorder (PTSD). Compared to evidencebased treatments for PTSD, WET requires only five sessions, has a shorter session time, and no between-session assignments. The current study examined the efficacy of WET among Korean patients with PTSD due to various traumatic events on PTSD symptoms, depressive symptoms, and global functioning levels.
Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders. [2019]Aims This study aimed to test the efficacy of integrated cognitive behaviour therapy (CBT) for coexisting post traumatic stress disorder (PTSD) and alcohol use disorders (AUD). Setting Clinics across Sydney, Australia.Design Randomized controlled trial of 12 once-weekly individual sessions of either integrated CBT for PTSD and AUD(integrated therapy, IT; n = 33) or CBT for AUD plus supportive counselling (alcohol-support, AS; n = 29). Blind assessments were conducted at baseline and post-treatment and at 5 [standard deviation (SD) = 2.25] and 9.16(SD = 3.45) months post-treatment. Participants Sixty-two adults with concurrent PTSD and AUD. Measurements Outcomes included changes in alcohol consumption (time-line follow-back), PTSD severity [clinician-administered PTSD scale (CAPS)], alcohol dependence and problems, and depression and anxiety. Findings Reductions in PTSD severity were evident in both groups. IT participants who had received one or more sessions of exposure therapy exhibited a twofold greater rate of clinically significant change in CAPS severity at follow-up than AS participants [IT60%, AS 39%, odds ratio (OR): 2.31, 95% confidence interval (CI): 1.06, 5.01]. AS participants exhibited larger reductions than IT participants in alcohol consumption, dependence and problems within the context of greater treatment from other services during follow-up. Results lend support to a mutually maintaining effect between AUD and PTSD. Conclusions Individuals with severe and complex presentations of coexisting post-traumatic stress disorder(PTSD) and alcohol use disorders (AUD) can derive substantial benefit from cognitive behaviour therapy targeting AUD, with greater benefits associated with exposure for PTSD. Among individuals with dual disorders, these therapies can generate significant, well-maintained treatment effects on PTSD, AUD and psychopathology.
Effectiveness of written exposure therapy for posttraumatic stress disorder in the Department of Veterans Affairs Healthcare System. [2023]Written Exposure Therapy (WET) for posttraumatic stress disorder (PTSD) has been shown to be efficacious in clinical trials; however, research is needed to determine WET's effectiveness in clinical practice settings. Additionally, research is needed to understand whether patient characteristics or treatment delivery format moderate outcomes.
Written exposure therapy for treatment of perinatal PTSD among women with comorbid PTSD and SUD: A pilot study examining feasibility, acceptability, and preliminary effectiveness. [2023]This pilot open trial examined the feasibility, acceptability, and preliminary effectiveness of Written Exposure Therapy (WET), a 5-session evidence-based intervention for posttraumatic stress disorder (PTSD) during pregnancy. Participants were pregnant women with comorbid PTSD and substance use disorder (SUD) receiving prenatal care in a high risk obstetrics-addictions clinic.
A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial. [2022]Written exposure therapy (WET), a 5-session intervention, has been shown to efficaciously treat posttraumatic stress disorder (PTSD). However, this treatment has not yet been directly compared with a first-line PTSD treatment such as cognitive processing therapy (CPT).