A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
2 other identifiers
interventional
100
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2025
CompletedFirst Submitted
Initial submission to the registry
April 7, 2025
CompletedFirst Posted
Study publicly available on registry
April 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 14, 2028
February 3, 2026
February 1, 2026
3.1 years
April 7, 2025
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
6 months after treatment completion
Secondary Outcomes (17)
PTSD Symptom Severity (Clinician Rated)
1 month after treatment completion
PTSD Symptom Severity (Clinician Rated)
3 months after treatment completion
PTSD Symptom Severity (Clinician Rated)
6 months after treatment completion
Hyperarousal Symptom Severity (Self Rated)
1 month after treatment completion
Hyperarousal Symptom Severity (Self Rated)
3 months after treatment completion
- +12 more secondary outcomes
Study Arms (2)
Frequency Filtered Music
EXPERIMENTALParticipants 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 COMPARATORParticipants 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- Wright-Patterson Air Force Basecollaborator
Study Sites (2)
The Ohio State University
Columbus, Ohio, 43210, United States
Wright Patterson Air Force Base Mental Health Center
Dayton, Ohio, 45433, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
April 7, 2025
First Posted
April 13, 2025
Study Start
January 10, 2025
Primary Completion (Estimated)
February 14, 2028
Study Completion (Estimated)
February 14, 2028
Last Updated
February 3, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
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.