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

Purpose

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

Condition

  • PTSD - Post Traumatic Stress Disorder

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Frequency Filtered Music 		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).
  • 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 names:
    • Safe and Sound Protocol
  • 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.
Active Comparator
Unfiltered Music 		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).
  • 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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Ohio State University

Study Contact

If you are in crisis please dial 988 for the Suicide & Crisis Lifeline. Please note: ADAA is not a direct service organization. ADAA does not provide psychiatric, psychological, or medical advice, diagnosis, or treatment.
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