NCT06925867 A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
| NCT ID | NCT06925867 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | PTSD - Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2028-02-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-01-10 with a primary completion date of 2028-02-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 symptoms. The main questions it aims to answer are: * Does the addition of frequency filtered music reduce PTSD symptoms for patients receiving cognitive processing therapy for PTSD? * Does the addition of frequency filtered music to cognitive processing therapy improve stress physiology (arousal)? * Does improvement in physiological stress regulation help explain improvements in hyperarousal and PTSD symptoms? Researchers will compare the effects of a frequency filtered classical music playlist to an identical playlist without added filtering. Participants will be randomized to a music playlist. Participants will: * Receive 10 daily sessions of cognitive processing therapy * Listen to 15 minutes of music before their therapy sessions (2.5 hours music listening total). * Complete clinical interviews and questionnaires before, during, and up to 6 months after therapy. * Have their physiological arousal monitored during listening and therapy sessions * Wear a Fitbit device and complete smartphone surveys for 4 weeks
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Frequently Asked Questions
Who can join the NCT06925867 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PTSD - Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06925867 currently recruiting?
Yes, NCT06925867 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ohio State University to inquire about joining.
Where is the NCT06925867 trial being conducted?
This trial is being conducted at Columbus, United States, Dayton, United States.
Who is sponsoring the NCT06925867 clinical trial?
NCT06925867 is sponsored by Ohio State University. The trial plans to enroll 100 participants.
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