Telehealth-written exposure therapy for sexual assault survivors
Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors
This study is testing if online written therapy can help women who have recently experienced sexual assault reduce their chances of developing PTSD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06571513 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the feasibility and initial effectiveness of delivering written exposure therapy via telehealth to reduce the risk of developing post-traumatic stress disorder (PTSD) among women who have recently experienced sexual assault. The study will involve 80 women who received care from sexual assault nurse examiners and will be randomized to participate in five sessions of virtual therapy. The approach leverages evidence-based methods to provide accessible mental health support, particularly for those in rural areas who face barriers to traditional care. Data gathered from this trial will inform the design of larger-scale studies in the future.
Who should consider this trial
Good fit: Ideal candidates are cisgender women aged 18 and older who have recently experienced sexual assault and are willing to engage in remote therapy.
Not a fit: Patients who are under 18, pregnant, or currently receiving other forms of psychological treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of PTSD among sexual assault survivors.
How similar studies have performed: Previous studies have shown success with telehealth delivery of written exposure therapy, indicating promise for this novel application in sexual assault survivors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cisgender woman * Writes and speaks English * 18+ years of age * Presents for SANE care within 7 days of sexual assault * Discharged home after SANE care * Has an email address * Has an Apple (iOS) or Android-compatible smartphone with photo capability (for writing session upload), without loss of cellular connection due to inability to pay bill for \>1 year * Willing to participate in remote therapy sessions * Meets PTSD risk score criteria * Meets with research assistant (RA) for informed consent within 10 days of SANE care Exclusion Criteria: * Age \<18 * Pregnant * Incarcerated or in police custody * Presented for SANE care \>7 days after assault * Has had a change in psychiatric medication regimen 1 month prior to study enrollment * Currently receiving cognitive-behavioral therapy or exposure-based psychological treatment * Sexually assaulted at work or by a colleague * Currently lives with the person who assaulted them * History or condition that in investigator's judgment would likely make a participant non-compliant/unsuitable for participation, including deafness or blindness
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Samuel A McLean, MD, MPH — University of North Carolina, Chapel Hill
- Study coordinator: Julianna T Villarosa, MPH
- Email: dawnstudy@unc.edu
- Phone: (919) 966-8144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.