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Written Exposure Therapy for Post-Traumatic Stress Disorder
N/A
Waitlist Available
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
* Cisgender woman
* Writes and speaks English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 8, month 3, month 5
Awards & highlights
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.
Eligible Conditions
- Post-Traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4, week 8, month 3, month 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 8, month 3, month 5
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 moreSecondary 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
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
552 Total Patients Enrolled
US Department of Veterans AffairsFED
872 Previous Clinical Trials
497,947 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,528 Previous Clinical Trials
4,197,292 Total Patients Enrolled
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