An interventional study of Frequency Filtered Music and Unfiltered Music in PTSD - Post Traumatic Stress Disorder, sponsored by Ohio State University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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:
Participants will:
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This study's planned enrollment of 100 is above the median of 72 across 167 interventional studies indexed under Combat Disorders.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: Cognitive Processing Therapy for PTSD
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).
Other: Unfiltered Music · Behavioral: Cognitive Processing Therapy for PTSD
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.
Also known as: Safe and Sound Protocol
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 (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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from 1 week before treatment start to 1 week after treatment completion
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Starting 6 months after publication of primary results
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.
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