NCT06925867 · Ohio State University
A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
What this study is about
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.
View original scientific description
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.
Interventions
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
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.
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Columbus, Ohio
- Dayton, Ohio
Collaborators
Wright-Patterson Air Force Base
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 3, 2026 · Source of record for eligibility and locations