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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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)

Study details
    PTSD - Post Traumatic Stress Disorder

NCT06925867

Ohio State University

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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