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

Overview

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

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 resona
• 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 develo

Primary outcome measures

• PTSD Symptom Severity (Self Rated) [Time frame: 1 month after treatment completion]
• PTSD Symptom Severity (Self Rated) [Time frame: 3 months after treatment completion]
• PTSD Symptom Severity (Self Rated) [Time frame: 6 months after treatment completion]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• The Ohio State University — Columbus
• Wright Patterson Air Force Base Mental Health Center — Dayton

Identifiers

NCT: NCT06925867 · 2024H0212 · HT94252410126

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗