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

Last updated: April 7, 2025
Sponsor: Ohio State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

Frequency Filtered Music

Cognitive Processing Therapy for PTSD

Unfiltered Music

Clinical Study ID

NCT06925867
2024H0212
HT94252410126
  • Ages > 18
  • All Genders

Study 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

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 OhioState University or at the Wright-Patterson Air Force Base (WPAFB) Medical Center

Exclusion

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 byan external sound)

  • Severe traumatic brain injury

  • An ongoing stressor or condition deemed by the investigators to place theparticipant at risk for injury or a poor outcome (e.g., undergoing disabilityevaluation, undergoing a medical board evaluation to be medically discharged fromthe military, pending negative administrative or legal actions).

  • Inability to complete the informed consent process due to the acute effects of amedical or psychiatric condition (e.g., intoxication, mania, psychosis)

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Frequency Filtered Music
Phase:
Study Start date:
January 10, 2025
Estimated Completion Date:
February 14, 2028

Connect with a study center

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Wright Patterson Air Force Base Mental Health Center

    Dayton, Ohio 45433
    United States

    Site Not Available

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