PTSD - Post Traumatic Stress DisorderNCT06925867
A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
A study testing Frequency Filtered Music, Unfiltered Music and Cognitive Processing Therapy for PTSD in people with PTSD - Post Traumatic Stress Disorder, run by Ohio State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Frequency Filtered Music, Unfiltered Music and Cognitive Processing Therapy for PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2025to 14 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Olivia Roath, 614-814-1287, olivia.roath@osumc.edu
Jacek Kolacz
- Recruiting
Wright Patterson Air Force Base Mental Health Center
Dayton, Ohio, 45433
Olivia Roath, 614-814-1287, olivia.roath@osumc.edu
About this study
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.
Read more
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
- Being tested
- Frequency Filtered Music, Unfiltered Music, Cognitive Processing Therapy for PTSD
- Keywords
- music, hyperarousal, cognitive processing therapy
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency Filtered MusicOther
Also called Safe and Sound Protocol
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.
Unfiltered MusicOther
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 PTSDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Frequency Filtered Music | Experimental | 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). Receives: Other: Frequency Filtered Music; Behavioral: Cognitive Processing Therapy for PTSD |
| Unfiltered Music | Active comparator | 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). Receives: Other: Unfiltered Music; Behavioral: Cognitive Processing Therapy for PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptom Severity (Self Rated)
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.
Measured: 1 month after treatment completion
PTSD Symptom Severity (Self Rated)
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.
Measured: 3 months after treatment completion
PTSD Symptom Severity (Self Rated)
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.
Measured: 6 months after treatment completion
Secondary outcomes (17)
PTSD Symptom Severity (Clinician Rated)
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Measured: 1 month after treatment completion
PTSD Symptom Severity (Clinician Rated)
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Measured: 3 months after treatment completion
PTSD Symptom Severity (Clinician Rated)
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Measured: 6 months after treatment completion
Hyperarousal Symptom Severity (Self Rated)
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.
Measured: 1 month after treatment completion
Hyperarousal Symptom Severity (Self Rated)
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.
Measured: 3 months after treatment completion
Hyperarousal Symptom Severity (Self Rated)
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.
Measured: 6 months after treatment completion
Hyperarousal Symptom Severity (Clinician Rated)
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion E
Measured: 1 month after treatment completion
Hyperarousal Symptom Severity (Clinician Rated)
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion E
Measured: 3 months after treatment completion
Hyperarousal Symptom Severity (Clinician Rated)
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R) Criterion E
Measured: 6 months after treatment completion
PTSD Diagnosis (Clinician Rated)
PTSD diagnosis as assessed by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Measured: 1 month after treatment completion
PTSD Diagnosis (Clinician Rated)
PTSD diagnosis as assessed by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Measured: 3 months after treatment completion
PTSD Diagnosis (Clinician Rated)
PTSD diagnosis as assessed by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Measured: 6 months after treatment completion
Change in resting parasympathetic activity
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
Measured: Change from 1 week before treatment start to 1 week after treatment completion
Change in resting physiological arousal
Mean heart period during seated rest will be calculated from electrocardigram data. Range: 200-1500 msec. Longer heart period indicates lower physiological arousal.
Measured: Change from 1 week before treatment start to 1 week after treatment completion
Change in parasympathetic activity during cognitive stress test
High-frequency heart rate variability response to a cognitive stress test from resting baseline will be calculated from electrocardigram data using CardioBatch Plus software.
Measured: Change from 1 week before treatment start to 1 week after treatment completion
Change in sympathetic activity during cognitive stress test
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.
Measured: Change from 1 week before treatment start to 1 week after treatment completion
Change in cardiac physiological arousal during cognitive stress test
Change in mean heart period to a cognitive stress test from resting baseline will be calculated. Shorter mean heart period indicates greater arousal.
Measured: Change from 1 week before treatment start to 1 week after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start10 Jan 2025
- Primary completion14 Feb 2028 (estimated)
- Study completion14 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Wright-Patterson Air Force Base
- Responsible party
- Principal investigator, Jacek Kolacz, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925867
- Sponsor's protocol ID
- 2024H0212
- Other IDs
- HT94252410126
- Status last verified
- Feb 2026
- First submitted
- 7 Apr 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
- ClinicalTrials.gov ID
- NCT06925867
- Acronym / sponsor ID
- 2024H0212
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- music, hyperarousal, cognitive processing therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Wright-Patterson Air Force Base
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 14 Feb 2028 (estimated)
- Study completion
- 14 Feb 2028 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frequency Filtered Music | Experimental | Other: Frequency Filtered Music, Behavioral: Cognitive Processing Therapy for PTSDParticipants 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). |
| Unfiltered Music | Active comparator | Other: Unfiltered Music, Behavioral: Cognitive Processing Therapy for PTSDParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequency Filtered MusicAlso: Safe and Sound ProtocolThe 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 | Frequency Filtered Music |
| Unfiltered MusicThe unfiltered music intervention is 2.5 hours of classical music with. The playlist of pieces is identical to the filtered music condition. | Other | Unfiltered Music |
| Cognitive Processing Therapy for PTSDCognitive 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. | Behavioural | Frequency Filtered Music, Unfiltered Music |
Primary outcome
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.
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.
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.
17 secondary outcomes
PTSD Symptom Severity (Clinician Rated)
Time frame: 1 month after treatment completion
PTSD Symptom Severity (Clinician Rated)
Time frame: 3 months after treatment completion
PTSD Symptom Severity (Clinician Rated)
Time frame: 6 months after treatment completion
Hyperarousal Symptom Severity (Self Rated)
Time frame: 1 month after treatment completion
Hyperarousal Symptom Severity (Self Rated)
Time frame: 3 months after treatment completion
Hyperarousal Symptom Severity (Self Rated)
Time frame: 6 months after treatment completion
Hyperarousal Symptom Severity (Clinician Rated)
Time frame: 1 month after treatment completion
Hyperarousal Symptom Severity (Clinician Rated)
Time frame: 3 months after treatment completion
Hyperarousal Symptom Severity (Clinician Rated)
Time frame: 6 months after treatment completion
PTSD Diagnosis (Clinician Rated)
Time frame: 1 month after treatment completion
PTSD Diagnosis (Clinician Rated)
Time frame: 3 months after treatment completion
PTSD Diagnosis (Clinician Rated)
Time frame: 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
Change in resting physiological arousal
Time frame: 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
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 cardiac physiological arousal during cognitive stress test
Time frame: Change from 1 week before treatment start to 1 week after treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wright Patterson Air Force Base Mental Health Center
Dayton, United States
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequency Filtered Music, Unfiltered Music and Cognitive Processing Therapy for PTSD in people with PTSD - Post Traumatic Stress Disorder, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptom Severity (Self Rated) (time frame: 1 month after treatment completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.