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

The Ohio State University

Status: Enrolling

Conditions: PTSD - Post Traumatic Stress Disorder

Treatments: Other: Frequency Filtered Music; Behavioral: Cognitive Processing Therapy for PTSD; Other: Unfiltered Music

Study type: Interventional

Funder types: Other

Identifiers

NCT06925867

HT94252410126 (Other Grant/Funding Number)

2024H0212

Details and patient eligibility

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. 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Frequency Filtered Music

Experimental group

Description:

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).

Treatment:

Behavioral: Cognitive Processing Therapy for PTSD

Other: Frequency Filtered Music

Unfiltered Music

Active Comparator group

Description:

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).

Treatment:

Other: Unfiltered Music

Behavioral: Cognitive Processing Therapy for PTSD