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

Not Applicable

Recruiting

• Conditions: PTSD - Post Traumatic Stress Disorder

• Registration Number: NCT06925867
• Lead Sponsor: Ohio State University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-10
• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13
• Primary Completion: 2028-02-14
• Study Completion: 2028-02-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PTSD Symptom Severity (Self Rated)	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 Outcome Measures

Name	Time	Method
PTSD Symptom Severity (Clinician Rated)	6 months after treatment completion	PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Hyperarousal Symptom Severity (Clinician Rated)	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
PTSD Diagnosis (Clinician Rated)	6 months after treatment completion	PTSD diagnosis as assessed by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Change in parasympathetic activity during cognitive stress test	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.
Change in sympathetic activity during cognitive stress test	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.
Hyperarousal Symptom Severity (Self Rated)	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.
Change in resting parasympathetic activity	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
Change in resting physiological arousal	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.
Change in cardiac physiological arousal during cognitive stress test	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.

Trial Locations

Locations (2)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Wright Patterson Air Force Base Mental Health Center; 🇺🇸 Dayton, Ohio, United States