RecruitingNot ApplicableNCT06925867

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

Sponsor

Ohio State University

Enrollment

100 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

PTSD - Post Traumatic Stress Disorder

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a special music therapy using frequency-modulated sound (delivered through a vest and headphones that vibrate the body) can improve the results of Cognitive Processing Therapy (CPT), a well-established talking therapy for PTSD. **You may be eligible if...** - You are 18 or older - You have been diagnosed with PTSD, or have most PTSD symptoms including heightened anxiety or startle response (hyperarousal) - You can move from sitting to standing without help - You can attend two weeks of daily in-person therapy sessions in Ohio or at Wright-Patterson Air Force Base **You may NOT be eligible if...** - You have a heart condition (such as irregular heartbeat) or a pacemaker - You use hearing aids or have tinnitus (ringing in the ears) - You have an allergy to adhesives used with sensors - You are not sufficiently fluent in English to participate in psychotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERFrequency Filtered Music

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.

OTHERUnfiltered Music

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

BEHAVIORALCognitive Processing Therapy for PTSD

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.