ACTIVE_NOT_RECRUITING

Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors

Quick Facts

Study Start:2024-09-23
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06571513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cisgender woman
  2. * Writes and speaks English
  3. * 18+ years of age
  4. * Presents for SANE care within 7 days of sexual assault
  5. * Discharged home after SANE care
  6. * Has an email address
  7. * 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
  8. * Willing to participate in remote therapy sessions
  9. * Meets PTSD risk score criteria
  10. * Meets with research assistant (RA) for informed consent within 30 days of SANE care
  1. * Age \<18
  2. * Pregnant
  3. * Incarcerated or in police custody
  4. * Presented for SANE care \>7 days after assault
  5. * Has had a change in psychiatric medication regimen 1 month prior to study enrollment
  6. * Currently receiving cognitive-behavioral therapy or exposure-based psychological treatment
  7. * Sexually assaulted at work or by a colleague
  8. * Currently lives with the person who assaulted them
  9. * History or condition that in investigator's judgment would likely make a participant non-compliant/unsuitable for participation, including deafness or blindness

Contacts and Locations

Principal Investigator

Samuel A McLean, MD, MPH
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Samuel A McLean, MD, MPH, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-23
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-09-23
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Post-traumatic Stress Disorder