Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors
NCT Number: NCT06571513
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post-traumatic Stress Disorder
Interventions: BEHAVIORAL: Written Exposure Therapy|BEHAVIORAL: Unemotional Writing
Sponsor: University of North Carolina, Chapel Hill
Collaborators: Foundation of Hope, North Carolina|US Department of Veterans Affairs
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2026-07
Locations: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27516, United States

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.

Primary Outcome Measures: 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: 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