Combined Written Exposure and Cognitive Behavioral Therapy for Sexual Assault Survivors

Overseen By Sudie Back, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Psychotropics

Disqualifiers: Psychotic, Bipolar, Dissociative, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5-6 weeks

64 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 5 6}

How 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. ^{1 2 3 6 7}

Eligibility 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

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.

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

Treatment Details

Interventions

• Written Exposure Therapy
• Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder

Trial Overview 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.

Participant Groups

Group I: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder Experimental Treatment 1 Intervention

Group II: Written Exposure Therapy Active Control 1 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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

Written Exposure Therapy (WET) is as effective as Cognitive Processing Therapy (CPT) for treating PTSD, maintaining similar outcomes even 60 weeks after treatment, with large effects on PTSD symptoms for both therapies.

Both WET and CPT significantly reduced depressive symptoms over the study period, although CPT showed a quicker reduction; however, the overall difference in effectiveness for depression was small.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term treatment gains of a brief exposure-based treatment for PTSD. Thompson-Hollands, J., Marx, BP., Lee, DJ., et al.[2022]

Written Exposure Therapy (WET) is an effective 5-session treatment for PTSD that shows significant symptom improvement and requires less time from both patients and therapists compared to traditional therapies.

WET has similar efficacy to Cognitive Processing Therapy (CPT) but with a much lower dropout rate (6% for WET vs. 39% for CPT), making it a promising option for diverse populations, including veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief novel therapies for PTSD: Written Exposure Therapy. Thompson-Hollands, J., Marx, BP., Sloan, DM.[2022]

Written exposure therapy (WET) significantly reduced PTSD symptoms in Korean patients, with 60.9% of participants no longer meeting PTSD criteria at 6 weeks, increasing to 77.8% at 24 weeks, demonstrating its efficacy.

The therapy also improved depressive symptoms and global functioning, with a low dropout rate of 8%, indicating that WET is a feasible and effective treatment option for PTSD in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open Pilot Trial of Written Exposure Therapy for Patients With Post-Traumatic Stress Disorder in Korea. Park, JE., Choi, KS., Han, YR., et al.[2021]

Integrated cognitive behaviour therapy (CBT) for PTSD and alcohol use disorders (AUD) showed that participants receiving exposure therapy had a significantly higher rate of clinically meaningful improvement in PTSD severity compared to those receiving standard alcohol-support therapy (60% vs 39%).

While both therapies reduced PTSD severity, participants in the alcohol-support group reported greater reductions in alcohol consumption and dependence, suggesting that tailored approaches may be necessary for optimal outcomes in individuals with coexisting PTSD and AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders. Sannibale, C., Teesson, M., Creamer, M., et al.[2019]

Written Exposure Therapy (WET) significantly reduced PTSD symptoms (effect size d = .84), depression symptoms (d = .47), and functional impairment (d = .36) in a study involving 277 veterans, demonstrating its effectiveness in a clinical setting.

The treatment was effective regardless of whether it was delivered in-person or via telehealth, with telehealth showing a lower dropout rate, suggesting it may be a more accessible option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of written exposure therapy for posttraumatic stress disorder in the Department of Veterans Affairs Healthcare System. LoSavio, ST., Worley, CB., Aajmain, ST., et al.[2023]

Written Exposure Therapy (WET) significantly reduced PTSD symptoms in pregnant women, with improvements lasting up to 6 months postpartum, indicating its potential effectiveness for this population.

The intervention was found to be feasible and acceptable, with high participant satisfaction and strong therapist adherence to the treatment protocol, suggesting it could be a viable option for managing PTSD during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written exposure therapy for treatment of perinatal PTSD among women with comorbid PTSD and SUD: A pilot study examining feasibility, acceptability, and preliminary effectiveness. Nillni, YI., Baul, TD., Paul, E., et al.[2023]

Written exposure therapy (WET) is as effective as cognitive processing therapy (CPT) in treating PTSD, showing noninferior symptom reduction over time in a study of 126 participants.

WET requires significantly fewer sessions (5 sessions) compared to CPT (12 sessions) and resulted in lower dropout rates, suggesting it may be a more efficient treatment option for patients with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial. Sloan, DM., Marx, BP., Lee, DJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term treatment gains of a brief exposure-based treatment for PTSD. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Brief novel therapies for PTSD: Written Exposure Therapy. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

An Open Pilot Trial of Written Exposure Therapy for Patients With Post-Traumatic Stress Disorder in Korea. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of written exposure therapy for posttraumatic stress disorder in the Department of Veterans Affairs Healthcare System. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial. [2022]