Status:
RECRUITING
A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Wright-Patterson Air Force Base
Conditions:
PTSD - Post Traumatic Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if the addition of frequency filtered music (Safe and Sound Protocol) to daily cognitive processing therapy improves effectiveness for reducing PTSD symptom...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Meets diagnostic criteria for a) PTSD or b) subthreshold PTSD with hyperarousal (i.e., meets diagnostic threshold for 3 of 4 symptoms, one of which is hyperarousal)
- Ability to move between sitting to standing without assistance
- Ability to attend two weeks of daily in-person therapy sessions at either the Ohio State University or at the Wright-Patterson Air Force Base (WPAFB) Medical Center
Exclusion
- Heart condition (such as cardiac arrhythmia) or pacemaker
- An allergy that would prevent wearing adhesive for durations of 2 hours or less
- Insufficient English fluency to fully engage in psychotherapy
- Use of hearing aids
- Current or prior tinnitus (persistent ringing or other noises in ears not caused by an external sound)
- Severe traumatic brain injury
- An ongoing stressor or condition deemed by the investigators to place the participant at risk for injury or a poor outcome (e.g., undergoing disability evaluation, undergoing a medical board evaluation to be medically discharged from the military, pending negative administrative or legal actions).
- Inability to complete the informed consent process due to the acute effects of a medical or psychiatric condition (e.g., intoxication, mania, psychosis)
Key Trial Info
Start Date :
January 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 14 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06925867
Start Date
January 10 2025
End Date
February 14 2028
Last Update
April 13 2025
Active Locations (2)
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1
The Ohio State University
Columbus, Ohio, United States, 43210
2
Wright Patterson Air Force Base Mental Health Center
Dayton, Ohio, United States, 45433