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

NCT ID: NCT06925867

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2028-02-14

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

Conditions

PTSD - Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Frequency Filtered Music

Participants will receive 10 daily sessions of cognitive processing therapy (2 weeks total) and listen to 15 minutes of frequency filtered classical music before each therapy session (2.5 hours music listening total).

Group Type: EXPERIMENTAL

Frequency Filtered Music

Intervention Type: 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.

Cognitive Processing Therapy for PTSD

Intervention Type: 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.

Unfiltered Music

Participants will receive 10 daily sessions of cognitive processing therapy (2 weeks total) and listen to 15 minutes of classical music with no frequency filtering before each therapy session (2.5 hours music listening total).

Group Type: ACTIVE_COMPARATOR

Unfiltered Music

Intervention Type: 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

Intervention Type: 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.

Interventions

Frequency 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.

Intervention Type: OTHER

Unfiltered Music

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

Intervention Type: OTHER

Cognitive 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Safe and Sound Protocol

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wright-Patterson Air Force Base

UNKNOWN

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Jacek Kolacz

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University

Columbus, Ohio, United States

Site Status: RECRUITING

Wright Patterson Air Force Base Mental Health Center

Dayton, Ohio, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Olivia Roath

Role: primary

olivia.roath@osumc.edu

614-814-1287

Olivia Roath

Role: primary

olivia.roath@osumc.edu

614-814-1287

Other Identifiers

HT94252410126

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024H0212

Identifier Type: -

Identifier Source: org_study_id