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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women who have experienced sexual assault in the past year and use alcohol. It combines writing exercises with therapy to address stress and alcohol use over five weeks. Known as Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder, this approach supports recovery. Participants will complete surveys during visits and may also perform short assessments on their smartphones. Women who remember the assault and struggle with alcohol use may be well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new therapeutic approaches.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Written Exposure Therapy (WET) is generally well-tolerated. This therapy aids individuals who have experienced traumatic events, such as sexual assault. Research indicates that WET can effectively reduce symptoms of posttraumatic stress disorder (PTSD). In these studies, no major harmful side effects have been reported.

For the combined therapy using WET with Cognitive Behavioral Therapy (CBT) for Alcohol Use Disorder, early results suggest benefits for individuals facing both trauma and alcohol issues. A preliminary study showed that participants managed the therapy sessions without serious negative effects.

These findings suggest both therapy approaches are safe. However, as with any treatment, individual experiences can vary. It's important to discuss any concerns or questions about joining with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combined Written Exposure Therapy and Cognitive Behavioral Therapy for Alcohol Use Disorder because it integrates mental health and substance use treatment in a unique way. Unlike traditional therapies that often address these issues separately, this approach simultaneously tackles trauma from sexual assault and alcohol use disorder. This integrated method aims to provide more comprehensive care, potentially leading to more effective and quicker recovery for survivors by addressing both the psychological and behavioral aspects of their condition.

What evidence suggests that this trial's treatments could be effective for stress and alcohol use?

Research has shown that Written Exposure Therapy, one of the treatments in this trial, can reduce symptoms of posttraumatic stress disorder (PTSD) in sexual assault survivors. This therapy involves writing about the traumatic experience in a structured way, which has proven effective in aiding recovery. Another treatment arm in this trial integrates Written Exposure Therapy with Cognitive Behavioral Therapy for Alcohol Use Disorder. This combination addresses both PTSD and alcohol misuse, which often occur together after trauma. Early evidence suggests that these therapies together can lower stress and help manage alcohol use more effectively. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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) 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]

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) 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]

Citations

1. rainn.org rainn.org/help-and-healing/hotline/

RAINN's National Sexual Assault Hotline RAINN's National Sexual Assault Hotline. Have you or someone you love been sexually assaulted or abused? You are not alone. Connect with a RAINN support ...

2. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/written_exposure_therapy.asp

Written Exposure Therapy for PTSD - PTSD: National ... What is PTSD? PTSD Basics · More PTSD Topics. Closed Arrow Types of Trauma. War and Combat · Violence and Abuse · Disaster Events. Closed Arrow Is it PTSD? How ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06571513

Written Exposure Therapy to Improve Recovery Among ... ... data necessary to design and support a large-scale trial. Official Title. Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/9989773

Early intervention using written exposure therapy for PTSD ... National Institute on Alcohol Abuse and Alcoholism. STEPS. Substance Use Skills Training and Exposure Post-Sexual Assault. Footnotes. Declaration of interests.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789424000297

State of the Science: Written Exposure Therapy for ... ... survivors of child sexual abuse and gender-based violence in Australia. 2025, BMJ Open. Online expressive writing intervention for the psychosexual well-being ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003287

Early intervention using written exposure therapy for PTSD ... Integrated interventions aimed at reducing PTSD and AUD symptoms following recent sexual assault are needed and should address barriers to care and early ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12272704/

Painful, but necessary: a qualitative process evaluation on ... KEYWORDS: Early intervention, rape, PTSD, prolonged exposure therapy, qualitative, sexual assault center. HIGHLIGHTS. Modified Prolonged ...