Post-traumatic Stress DisorderNCT06571513
Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors
A study testing Written Exposure Therapy and Unemotional Writing in people with Post-traumatic Stress Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Written Exposure Therapy and Unemotional Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 7 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516
About this study
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.
Read the 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
- Being tested
- Written Exposure Therapy, Unemotional Writing
- Keywords
- Trauma and Stressor Related Disorders, Mental Disorders, Stress Disorders, Traumatic, Stress Disorders, Post-traumatic, Sexual Assault
- Medical subject headings
- Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Mental Disorders, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure TherapyBehavioural
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.
Unemotional WritingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy | Experimental | Five sessions of remotely-delivered written exposure therapy. Receives: Behavioral: Written Exposure Therapy |
| Unemotional Writing | Placebo comparator | Five sessions of remotely-delivered non-emotional writing. Receives: Behavioral: Unemotional Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 8
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8, Month 3, Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start23 Sep 2024
- Primary completion7 Mar 2026
- Study completion7 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Hope, North Carolina, US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Samuel A McLean, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571513
- Sponsor's protocol ID
- 22-1437
- Status last verified
- Mar 2026
- First submitted
- 22 Aug 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared on request provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors
- ClinicalTrials.gov ID
- NCT06571513
- Acronym / sponsor ID
- 22-1437
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Trauma and Stressor Related Disorders, Mental Disorders, Stress Disorders, Traumatic, Stress Disorders, Post-traumatic, Sexual Assault
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation of Hope, North Carolina, US Department of Veterans Affairs
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 7 Mar 2026 (actual)
- Study completion
- 7 Mar 2026 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written Exposure Therapy | Experimental | Behavioral: Written Exposure TherapyFive sessions of remotely-delivered written exposure therapy. |
| Unemotional Writing | Placebo comparator | Behavioral: Unemotional WritingFive sessions of remotely-delivered non-emotional writing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written Exposure TherapyDuring 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. | Behavioural | Written Exposure Therapy |
| Unemotional WritingDuring 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. | Behavioural | Unemotional Writing |
Primary outcome
Changes in PTSD Symptom Severity Over Time
Time frame: 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.
Recruitment Rates
Time frame: 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.
Retention Rates
Time frame: 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.
Treatment Completion Rates
Time frame: 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.
3 secondary outcomes
Change in Pain Symptom Severity and Extent Over Time
Time frame: Baseline, Week 4, Week 8, Month 3, Month 5
Change in Somatic Symptom Score Over Time
Time frame: Baseline, Week 4, Week 8, Month 3, Month 5
Change in Depressive Symptom Score Over Time
Time frame: Baseline, Week 4, Week 8, Month 3, Month 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared on request provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel A McLean, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy and Unemotional Writing in people with Post-traumatic Stress Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PTSD Symptom Severity Over Time (time frame: Baseline, Week 4, Week 8, Month 3, Month 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.