A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Frequency Filtered Music
Other interventionThe 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.
Unfiltered Music
Other interventionThe unfiltered music intervention is 2.5 hours of classical music with. The playlist of pieces is identical to the filtered music condition.
Cognitive Processing Therapy for PTSD
BehavioralCognitive 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Frequency Filtered MusicExperimental treatment 2 interventions
Group B: Unfiltered MusicActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
PTSD Symptom Severity (Self Rated)
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.
Time frame
1 month after treatment completion2
PTSD Symptom Severity (Self Rated)
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.
Time frame
3 months after treatment completion3
PTSD Symptom Severity (Self Rated)
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.
Time frame
6 months after treatment completionSecondary outcomes
1
PTSD Symptom Severity (Clinician Rated)
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Time frame
1 month after treatment completion2
PTSD Symptom Severity (Clinician Rated)
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Time frame
3 months after treatment completion3
PTSD Symptom Severity (Clinician Rated)
PTSD symptom severity as measured by the Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)
Time frame
6 months after treatment completion4
Hyperarousal Symptom Severity (Self Rated)
Hyperarousal symptoms will also be measured using items from the PCL-5. Hyperarousal symptom severity is calculated by summing the 6 Criterion E items of each scale (i.e., items 15-20), such that higher scores indicate more severe hyperarousal.
Time frame
1 month after treatment completionSponsors and contacts
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Ohio State University
Lead sponsor
Wright-Patterson Air Force Base
Collaborator
Source ClinicalTrials.gov