Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors

NCT06571513 | Completed

• 1 other identifier: 22-1437
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder

Keywords

Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-traumatic; Sexual Assault

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Change in Pain Symptom Severity and Extent Over Time

  Baseline, Week 4, Week 8, Month 3, Month 5

• Change in Somatic Symptom Score Over Time

  Baseline, Week 4, Week 8, Month 3, Month 5

• Change in Depressive Symptom Score Over Time

  Baseline, Week 4, Week 8, Month 3, Month 5

Study Arms (2)

Written Exposure Therapy

EXPERIMENTAL

Five sessions of remotely-delivered written exposure therapy.

Behavioral: Written Exposure Therapy

Unemotional Writing

PLACEBO COMPARATOR

Five sessions of remotely-delivered non-emotional writing.

Behavioral: Unemotional Writing

Interventions

Written Exposure Therapy BEHAVIORAL

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.

Written Exposure Therapy

Unemotional Writing BEHAVIORAL

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.

Unemotional Writing

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identifies as a woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cisgender woman
• Writes and speaks English
• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation of Hope, North Carolina: collaborator
• US Department of Veterans Affairs: collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic

Study Officials

• Samuel A McLean, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: September 23, 2024
• Primary Completion: March 7, 2026
• Study Completion: March 7, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 12 months following publication and continuing for 36 months
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)