Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06925867

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

Led by Ohio State University · Updated on 2026-02-03

100

Participants Needed

2

Research Sites

161 weeks

Total Duration

On this page

Sponsors

O

Ohio State University

Lead Sponsor

W

Wright-Patterson Air Force Base

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • Meets diagnostic criteria for PTSD or subthreshold PTSD with hyperarousal
  • Able to move between sitting and standing without assistance
  • Able to attend two weeks of daily in-person therapy sessions at Ohio State University or Wright-Patterson Air Force Base Medical Center
Not Eligible

You will not qualify if you...

  • Heart condition such as cardiac arrhythmia or pacemaker
  • Allergy preventing wearing adhesive for up to 2 hours
  • Insufficient English fluency to fully participate in psychotherapy
  • Use of hearing aids
  • Current or prior tinnitus (persistent ringing or noises in ears not caused by external sound)
  • Severe traumatic brain injury
  • Ongoing stressor or condition placing participant at risk for injury or poor outcome
  • Inability to complete informed consent due to acute medical or psychiatric conditions such as intoxication, mania, or psychosis

AI-Screening

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Trial Site Locations

Total: 2 locations

1

The Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

2

Wright Patterson Air Force Base Mental Health Center

Dayton, Ohio, United States, 45433

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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