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NCT Number: NCT06925867

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

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

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Key information

Conditions

PTSD - Post Traumatic Stress Disorder Combat Disorders Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University, Columbus, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Frequency Filtered Music

Other

The frequency filtered music intervention is 2.5 hours of classical music that has been filtered by applying an algorithm to alternate narrowing and expanding the range of acoustic frequencies over time, with the alternations intensifying in frequency range over the course of administration. The filtering is optimized for the frequency response of adult human hearing and intended to mimic the expression of the human voice around a central set of frequencies of 800-1200 Hz, the approximate resonant frequency of the human ear. The filtering method is similar to adjusting the treble and bass settings on a stereo system while music is playing; the melody and instruments can still be heard, but the highest and lowest pitches are modulated over time.

Other names: Safe and Sound Protocol

Unfiltered Music

Other

The unfiltered music intervention is 2.5 hours of classical music with. The playlist of pieces is identical to the filtered music condition.

Cognitive Processing Therapy for PTSD

Behavioral

Cognitive processing therapy (CPT) is a cognitive therapy that focuses on why patients believe the traumatic event occurred, how that event affected their beliefs about self and others, and how to evaluate their beliefs. Patients then learn to label events, thoughts, and subsequent emotions while the therapist helps them examine the facts and context of the trauma through Socratic questioning. Using progressive worksheets, patients are taught to examine their own thoughts and emotions and develop new, more balanced thinking about traumatic events.

Primary outcomes

  1. PTSD Symptom Severity (Self Rated)

    Time frame: 1 month after treatment completion

    PTSD symptom severity will be assessed using the PTSD Checklist for DSM 5 (PCL-5). The scale includes 20 items that rate the severity of each symptom using a 5-point scale, with items summed to provide an overall metric of PTSD symptom severity.

  2. PTSD Symptom Severity (Self Rated)

    Time frame: 3 months after treatment completion

    PTSD symptom severity will be assessed using the PTSD Checklist for DSM 5 (PCL-5). The scale includes 20 items that rate the severity of each symptom using a 5-point scale, with items summed to provide an overall metric of PTSD symptom severity.

  3. PTSD Symptom Severity (Self Rated)

    Time frame: 6 months after treatment completion

    PTSD symptom severity will be assessed using the PTSD Checklist for DSM 5 (PCL-5). The scale includes 20 items that rate the severity of each symptom using a 5-point scale, with items summed to provide an overall metric of PTSD symptom severity.

Secondary outcomes

  1. PTSD Symptom Severity (Clinician Rated)

    Time frame: 1 month after treatment completion

    PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)

  2. PTSD Symptom Severity (Clinician Rated)

    Time frame: 3 months after treatment completion

    PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)

  3. PTSD Symptom Severity (Clinician Rated)

    Time frame: 6 months after treatment completion

    PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)

  4. Hyperarousal Symptom Severity (Self Rated)

    Time frame: 1 month after treatment completion

    Hyperarousal symptoms will also be measured using items from the PCL-5. Hyperarousal symptom severity is calculated by summing the 6 Criterion E items of each scale (i.e., items 15-20), such that higher scores indicate more severe hyperarousal.

  5. Hyperarousal Symptom Severity (Self Rated)

    Time frame: 3 months after treatment completion

    Hyperarousal symptoms will also be measured using items from the PCL-5. Hyperarousal symptom severity is calculated by summing the 6 Criterion E items of each scale (i.e., items 15-20), such that higher scores indicate more severe hyperarousal.

  6. Hyperarousal Symptom Severity (Self Rated)

    Time frame: 6 months after treatment completion

    Hyperarousal symptoms will also be measured using items from the PCL-5. Hyperarousal symptom severity is calculated by summing the 6 Criterion E items of each scale (i.e., items 15-20), such that higher scores indicate more severe hyperarousal.

  7. Hyperarousal Symptom Severity (Clinician Rated)

    Time frame: 1 month after treatment completion

    PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion E

  8. Hyperarousal Symptom Severity (Clinician Rated)

    Time frame: 3 months after treatment completion

    PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion E

  9. Hyperarousal Symptom Severity (Clinician Rated)

    Time frame: 6 months after treatment completion

    PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion E

  10. PTSD Diagnosis (Clinician Rated)

    Time frame: 1 month after treatment completion

    PTSD diagnosis as assessed by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)

  11. PTSD Diagnosis (Clinician Rated)

    Time frame: 3 months after treatment completion

    PTSD diagnosis as assessed by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)

  12. PTSD Diagnosis (Clinician Rated)

    Time frame: 6 months after treatment completion

    PTSD diagnosis as assessed by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)

  13. Change in resting parasympathetic activity

    Time frame: Change from 1 week before treatment start to 1 week after treatment completion

    High-frequency heart rate variability during seated rest will be calculated from electrocardigram data using CardioBatch Plus software. Range: 0 - 15 ln(msec). Greater variability indicates greater parasympathetic vagal activity

  14. Change in resting physiological arousal

    Time frame: Change from 1 week before treatment start to 1 week after treatment completion

    Mean heart period during seated rest will be calculated from electrocardigram data. Range: 200-1500 msec. Longer heart period indicates lower physiological arousal.

  15. Change in parasympathetic activity during cognitive stress test

    Time frame: Change from 1 week before treatment start to 1 week after treatment completion

    High-frequency heart rate variability response to a cognitive stress test from resting baseline will be calculated from electrocardigram data using CardioBatch Plus software.

  16. Change in sympathetic activity during cognitive stress test

    Time frame: Change from 1 week before treatment start to 1 week after treatment completion

    Change in rate of skin conductance response firing per minute to a cognitive stress test from resting baseline will be calculated. Faster rate indicates more sympathetic activation.

  17. Change in cardiac physiological arousal during cognitive stress test

    Time frame: Change from 1 week before treatment start to 1 week after treatment completion

    Change in mean heart period to a cognitive stress test from resting baseline will be calculated. Shorter mean heart period indicates greater arousal.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Wright-Patterson Air Force Base

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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