Clinical trial NCT06925867: A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
Official title: A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD - Post Traumatic Stress Disorder
Keywords: music
hyperarousal
cognitive processing therapy
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Wright-Patterson Air Force Base
First posted: 2025-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: PTSD Symptom Severity (Self Rated)
timeFrame: 1 month after treatment completion
measure: PTSD Symptom Severity (Self Rated)
timeFrame: 3 months after treatment completion
measure: PTSD Symptom Severity (Self Rated)
timeFrame: 6 months after treatment completion
Secondary outcomes:
measure: PTSD Symptom Severity (Clinician Rated)
timeFrame: 1 month after treatment completion
measure: PTSD Symptom Severity (Clinician Rated)
timeFrame: 3 months after treatment completion
measure: PTSD Symptom Severity (Clinician Rated)
timeFrame: 6 months after treatment completion
measure: Hyperarousal Symptom Severity (Self Rated)
timeFrame: 1 month after treatment completion
measure: Hyperarousal Symptom Severity (Self Rated)
timeFrame: 3 months after treatment completion
measure: Hyperarousal Symptom Severity (Self Rated)
timeFrame: 6 months after treatment completion
measure: Hyperarousal Symptom Severity (Clinician Rated)
timeFrame: 1 month after treatment completion
measure: Hyperarousal Symptom Severity (Clinician Rated)
timeFrame: 3 months after treatment completion
measure: Hyperarousal Symptom Severity (Clinician Rated)
timeFrame: 6 months after treatment completion
measure: PTSD Diagnosis (Clinician Rated)
timeFrame: 1 month after treatment completion
measure: PTSD Diagnosis (Clinician Rated)
timeFrame: 3 months after treatment completion
measure: PTSD Diagnosis (Clinician Rated)
timeFrame: 6 months after treatment completion
measure: Change in resting parasympathetic activity
timeFrame: Change from 1 week before treatment start to 1 week after treatment completion
measure: Change in resting physiological arousal
timeFrame: Change from 1 week before treatment start to 1 week after treatment completion
measure: Change in parasympathetic activity during cognitive stress test
timeFrame: Change from 1 week before treatment start to 1 week after treatment completion
measure: Change in sympathetic activity during cognitive stress test
timeFrame: Change from 1 week before treatment start to 1 week after treatment completion
measure: Change in cardiac physiological arousal during cognitive stress test
timeFrame: Change from 1 week before treatment start to 1 week after treatment completion
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Dayton
country: United States
facility: Wright Patterson Air Force Base Mental Health Center
state: Ohio
Study officials:
References: