Clinical trial NCT06571513: Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors
Official title: Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: Trauma and Stressor Related Disorders
Mental Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-traumatic
Sexual Assault
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Foundation of Hope, North Carolina
name: US Department of Veterans Affairs
First posted: 2024-08-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this pilot trial is to determine the feasibility and initial efficacy of telehealth-delivered written exposure therapy to reduce the development of posttraumatic stress disorder after sexual assault. This pilot trial will provide the data necessary to design and support a large-scale trial.

Detailed description: Each year, approximately 100,000 women in the United States present to sexual assault nurse examiner (SANE) programs for evaluation after experiencing sexual assault. A wealth of data demonstrates that the development of adverse posttraumatic neuropsychiatric sequelae such as posttraumatic stress disorder (PTSD) is common in this population and that individuals with a history of traumatic stress exposure and/or posttraumatic stress symptoms are at increased risk. Unfortunately, no secondary preventive interventions are currently widely available that can prevent PTSD among those at high risk. Moreover, the 10% of sexual assault survivors in the United States who live in rural communities face even greater barriers to obtaining care. Written exposure therapy is an evidence-based, low-cost intervention that has demonstrated efficacy in treating chronic PTSD symptoms after a variety of traumatic stress exposures, including sexual assault. In addition, telehealth delivery of written exposure therapy for PTSD has yielded similar treatment outcomes and lower attrition compared to in-person delivery. The present protocol will assess the feasibility and preliminary efficacy of telehealth-delivered written exposure therapy as a secondary preventive intervention for sexual assault survivors in the acute aftermath of trauma exposure. This pilot trial will randomize N=80 women who received SANE care following sexual assault to five sessions of either virtual written exposure therapy (n=40) or virtual unemotional writing control (n=40). The same experienced therapists will deliver both interventions via telehealth/video sessions. Participant follow-ups will be performed remotely via REDCap self-report surveys by trained assessors and research associates. Results of this trial will demonstrate the feasibility and potential efficacy of written exposure therapy to reduce the development of PTSD after sexual assault and will provide the data necessary to design and support a large-scale trial.

Eligibility 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

Primary outcomes:
measure: Changes in PTSD Symptom Severity Over Time
timeFrame: Baseline, Week 4, Week 8, Month 3, Month 5
measure: Recruitment Rates
timeFrame: Baseline
measure: Retention Rates
timeFrame: Month 5
measure: Treatment Completion Rates
timeFrame: Week 8
Secondary outcomes:
measure: Change in Pain Symptom Severity and Extent Over Time
timeFrame: Baseline, Week 4, Week 8, Month 3, Month 5
measure: Change in Somatic Symptom Score Over Time
timeFrame: Baseline, Week 4, Week 8, Month 3, Month 5
measure: Change in Depressive Symptom Score Over Time
timeFrame: Baseline, Week 4, Week 8, Month 3, Month 5
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Samuel A McLean, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: