NCT06571513

Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post-traumatic Stress Disorder

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-09-23
• Primary completion: 2026-03-07
• Completion: 2026-03-07
• First posted: 2024-08-26
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States