Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors

Not Applicable

Recruiting

• Conditions: Post-traumatic Stress Disorder
• Interventions: Behavioral: Written Exposure Therapy; Behavioral: Unemotional Writing

• Registration Number: NCT06571513
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Study Start: 2024-09-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Written Exposure Therapy	Written Exposure Therapy	Five sessions of remotely-delivered written exposure therapy.
Unemotional Writing	Unemotional Writing	Five sessions of remotely-delivered non-emotional writing.

Primary Outcome Measures

Name	Time	Method
Retention Rates	Month 5	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.
Recruitment Rates	Baseline	To assess feasibility of the study recruitment protocol, the proportion of eligible participants who enroll in the study and are randomized will be calculated.
Changes in PTSD Symptom Severity Over Time	Baseline, Week 4, Week 8, Month 3, Month 5	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.
Treatment Completion Rates	Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Change in Pain Symptom Severity and Extent Over Time	Baseline, Week 4, Week 8, Month 3, Month 5	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.
Change in Somatic Symptom Score Over Time	Baseline, Week 4, Week 8, Month 3, Month 5	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.
Change in Depressive Symptom Score Over Time	Baseline, Week 4, Week 8, Month 3, Month 5	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States