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

February 2, 2026 updated by: Jacek Kolacz, Ohio State University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • Jacek Kolacz
      • Dayton, Ohio, United States, 45433
        • Recruiting
        • Wright Patterson Air Force Base Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Other: 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.
Other Names:
  • Safe and Sound Protocol
Behavioral: 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.
Active Comparator: 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).
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PTSD Symptom Severity (Self Rated)
Time Frame: 1 month 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.
1 month after treatment completion
PTSD Symptom Severity (Self Rated)
Time Frame: 3 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.
3 months after treatment completion
PTSD Symptom Severity (Self Rated)
Time Frame: 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.
6 months after treatment completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PTSD Symptom Severity (Clinician Rated)
Time Frame: 1 month after treatment completion
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
1 month after treatment completion
PTSD Symptom Severity (Clinician Rated)
Time Frame: 3 months after treatment completion
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
3 months after treatment completion
PTSD Symptom Severity (Clinician Rated)
Time Frame: 6 months after treatment completion
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
6 months after treatment completion
Hyperarousal Symptom Severity (Self Rated)
Time Frame: 1 month 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.
1 month after treatment completion
Hyperarousal Symptom Severity (Self Rated)
Time Frame: 3 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.
3 months after treatment completion
Hyperarousal Symptom Severity (Self Rated)
Time Frame: 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.
6 months after treatment completion
Hyperarousal Symptom Severity (Clinician Rated)
Time Frame: 1 month after treatment completion
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion E
1 month after treatment completion
Hyperarousal Symptom Severity (Clinician Rated)
Time Frame: 3 months after treatment completion
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion E
3 months after treatment completion
Hyperarousal Symptom Severity (Clinician Rated)
Time Frame: 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
6 months after treatment completion
PTSD Diagnosis (Clinician Rated)
Time Frame: 1 month after treatment completion
PTSD diagnosis as assessed by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
1 month after treatment completion
PTSD Diagnosis (Clinician Rated)
Time Frame: 3 months after treatment completion
PTSD diagnosis as assessed by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
3 months after treatment completion
PTSD Diagnosis (Clinician Rated)
Time Frame: 6 months after treatment completion
PTSD diagnosis as assessed by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
6 months after treatment completion
Change in resting parasympathetic activity
Time Frame: 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 from 1 week before treatment start to 1 week after treatment completion
Change in resting physiological arousal
Time Frame: 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 from 1 week before treatment start to 1 week after treatment completion
Change in parasympathetic activity during cognitive stress test
Time Frame: 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 from 1 week before treatment start to 1 week after treatment completion
Change in sympathetic activity during cognitive stress test
Time Frame: 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.
Change from 1 week before treatment start to 1 week after treatment completion
Change in cardiac physiological arousal during cognitive stress test
Time Frame: 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.
Change from 1 week before treatment start to 1 week after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wright-Patterson Air Force Base

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024H0212
  • HT94252410126 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Researchers interested in using IPD and/or computer code collected or generated as part of this study may do so by contacting the study PI. Researchers will be asked to complete a Data Use Request Form, which includes contact information, description of the research project for which the data and/or code would be used, specification of which data and/or code would be needed for their proposed project, an approximate time line for their proposed project, and authorship on their proposed project.

IPD Sharing Time Frame

Starting 6 months after publication of primary results

IPD Sharing Access Criteria

All requests for data and/or code use will be reviewed by the PIs and co-Is and a majority vote will be used to determine whether the request is approved or not. If the request is approved, Dr. Kolacz will inform the requestor, return a signed copy of the completed Data Use Request Form to the requestor, and let the requestor know that written IRB approval of the requestor's proposed study from the requestor's home institution will be required before data and/or code will be shared with the requestor. If a request is approved pending revision to the Data Use Request Form, Dr. Kolacz will work with requestors to revise sections of their Data Use Request Forms in order to obtain approval. If the request is not approved, Dr. Kolacz will inform the requestor and returned a signed copy of the completed Data Use Request Form to the requestor that includes an explanation for the denial.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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