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Behavioral Intervention

Written Exposure Therapy for PTSD

N/A
Recruiting
Led By Samuel A McLean, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18+ years of age
Presents for SANE care within 7 days of sexual assault
Must not have
Age <18
Currently receiving cognitive-behavioral therapy or exposure-based psychological treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 8, month 3, month 5

Summary

"This trial aims to test if therapy delivered through telehealth can help reduce the likelihood of developing PTSD after a sexual assault. The goal is to gather data to plan a larger trial in the future."

Who is the study for?
This trial is for individuals who have experienced a sexual assault and are at risk of developing post-traumatic stress disorder (PTSD). The details on specific inclusion and exclusion criteria are not provided, but typically these would involve age limits, the timeframe since the assault, mental health history, and other factors relevant to PTSD.
What is being tested?
The study is testing two different types of writing therapies delivered via telehealth: Unemotional Writing and Written Exposure Therapy. It aims to see if they can help prevent PTSD in those who've recently survived a sexual assault.
What are the potential side effects?
While side effects are not detailed here, psychological interventions like these may sometimes cause temporary increases in distress due to recalling traumatic events. Participants will likely be monitored closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I sought care within a week after experiencing a sexual assault.
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I was sent home after receiving care from a sexual assault nurse examiner.
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I am a cisgender woman.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I am currently undergoing cognitive-behavioral or exposure-based therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 8, month 3, month 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 8, month 3, month 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in PTSD Symptom Severity Over Time
Recruitment Rates
Retention Rates
+1 more
Secondary study objectives
Change in Depressive Symptom Score Over Time
Change in Pain Symptom Severity and Extent Over Time
Change in Somatic Symptom Score Over Time

Side effects data

From 2023 Phase 2 trial • 16 Patients • NCT04889664
85%
Fatigue
69%
Other
38%
Dizziness
38%
Headache
23%
Blurred Vision
15%
Difficulty Sleeping
15%
Frequent Urination
15%
Menstrual Irregularity
15%
Nausea/vomiting
8%
Increased Perspiration
8%
Decreased energy
8%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and Written Exposure Therapy

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Written Exposure TherapyExperimental Treatment1 Intervention
Five sessions of remotely-delivered written exposure therapy.
Group II: Unemotional WritingPlacebo Group1 Intervention
Five sessions of remotely-delivered non-emotional writing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Written Exposure Therapy
2021
Completed Phase 2
~370

Find a Location

Who is running the clinical trial?

Foundation of Hope, North CarolinaOTHER
16 Previous Clinical Trials
540 Total Patients Enrolled
US Department of Veterans AffairsFED
873 Previous Clinical Trials
497,761 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,554 Previous Clinical Trials
4,293,053 Total Patients Enrolled
~53 spots leftby Jul 2026
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