RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-01-10
Study Completion:2028-02-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06925867

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age
  2. * 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)
  3. * Ability to move between sitting to standing without assistance
  4. * 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
  1. * Heart condition (such as cardiac arrhythmia) or pacemaker
  2. * An allergy that would prevent wearing adhesive for durations of 2 hours or less
  3. * Insufficient English fluency to fully engage in psychotherapy
  4. * Use of hearing aids
  5. * Current or prior tinnitus (persistent ringing or other noises in ears not caused by an external sound)
  6. * Severe traumatic brain injury
  7. * 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).
  8. * Inability to complete the informed consent process due to the acute effects of a medical or psychiatric condition (e.g., intoxication, mania, psychosis)

Contacts and Locations

Study Locations (Sites)

The Ohio State University
Columbus, Ohio, 43210
United States
Wright Patterson Air Force Base Mental Health Center
Dayton, Ohio, 45433
United States

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-10
Study Completion Date2028-02-14

Study Record Updates

Study Start Date2025-01-10
Study Completion Date2028-02-14

Terms related to this study

Keywords Provided by Researchers

  • music
  • hyperarousal
  • cognitive processing therapy

Additional Relevant MeSH Terms

  • PTSD - Post Traumatic Stress Disorder