A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD

Recruiting now · Not applicable

Conditions studied: PTSD - Post Traumatic Stress Disorder

In brief

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

Key facts

Study ID: NCT06925867
Run by: Ohio State University
People needed: 100
Starts: 2025-01-10
Expected to finish: 2028-02-14
Last updated by the study team: 2026-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

The Ohio State University — Columbus, Ohio, United States (enrolling)
Wright Patterson Air Force Base Mental Health Center — Dayton, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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