Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors

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.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Written Exposure Therapy; Behavioral: Unemotional Writing

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 30 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Written Exposure Therapy; Five sessions of remotely-delivered written exposure therapy.	Behavioral: Written Exposure Therapy; During session one of the written exposure therapy intervention, the therapist will provide psychoeducation about PTSD and the rationale for the proposed intervention. Psychoeducation and treatment rationale are scripted to ensure consistency. The therapist will provide the participant with instructions for writing about the same trauma memory (their recent sexual assault) during each session. They will be asked to look back at the event and write for 30 minutes about the details of the event including what they saw, heard, felt, smelled, etc. without regard for spelling or grammar. The participant will self-report Subjective Units of Distress Scale (SUDS) levels to the therapist at the beginning and end of each session. After 30 minutes, the therapist will ask the participant to stop writing, review the experience of writing and discuss as needed, and conclude the session.
Placebo Comparator: Unemotional Writing; Five sessions of remotely-delivered non-emotional writing.	Behavioral: Unemotional Writing; During the unemotional writing sessions, the therapist will read instructions for writing about non-emotional topics. The participant will be instructed to describe what they did the day before the session from the time they woke up until the time they went to bed, as objectively as possible, without regard for spelling or grammar. The therapist will then leave the participant with a written version of the instructions for 30 minutes while the participant writes. The participant will self report Subjective Units of Distress Scale (SUDS) levels to the therapist at the beginning and end of each session. After 30 minutes, the therapist will ask the participant to stop writing, review the experience of writing and discuss as needed, and conclude the session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in PTSD Symptom Severity Over Time	The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5). Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80), with higher scores indicating greater symptom severity. PTSD symptom severity will be compared between treatment groups over time.	Baseline, Week 4, Week 8, Month 3, Month 5
Recruitment Rates	To assess feasibility of the study recruitment protocol, the proportion of eligible participants who enroll in the study and are randomized will be calculated.	Baseline
Retention Rates	To assess feasibility of the study protocol, the proportion of participants who complete the study protocol, according to study arm and in total, will be calculated.	Month 5
Treatment Completion Rates	To assess feasibility of the treatment protocol, treatment completion rates will be calculated according to study arm and in total. Treatment completers will be defined as participants who complete at least 4 out of 5 written exposure therapy or control sessions.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Symptom Severity and Extent Over Time	Pain severity and extent will be evaluated using a modified version of the Regional Pain Scale, where each item is scored on a 0-10 numeric rating with 0 indicating no pain and 10 indicating severe pain. Pain symptom severity and extent will be compared between treatment groups over time.	Baseline, Week 4, Week 8, Month 3, Month 5
Change in Somatic Symptom Score Over Time	Somatic symptoms will be assessed using a modified version of the Pennebaker Inventory of Limbic Languidness (PILL), which assesses the frequency of common physical symptoms and sensations. Each item is scored on a 0-10 scale where 0 indicates no problems. Number of moderate to severe somatic symptoms (scores ≥ 4) will be compared between groups.	Baseline, Week 4, Week 8, Month 3, Month 5
Change in Depressive Symptom Score Over Time	The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8b is an 8-item scale developed to assess depression in individuals 18 and older. Each item is rated on a five-point scale. For this study, response options are slightly altered for greater consistency across measures and precision in response levels (i.e., 1 = "never" is changed to none of the time and 5 = "always" is changed to "all or almost all of the time."). Items are summed to provide a total severity score (range = 8-40), with higher scores indicating greater severity of depression. Depressive symptom severity will be compared between treatment groups over time.	Baseline, Week 4, Week 8, Month 3, Month 5

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: US Department of Veterans Affairs; Foundation of Hope, North Carolina
• Investigators: Principal Investigator: Samuel A McLean, MD, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): March 7, 2026
• Study Completion (Actual): March 7, 2026

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Mental Disorders; Sexual Assault; Stress Disorders, Post-traumatic; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 22-1437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared on request provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
• IPD Sharing Time Frame: Beginning 12 months following publication and continuing for 36 months
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No