Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06925867

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

Led by Ohio State University · Updated on 2026-02-03

100

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

O

Ohio State University

Lead Sponsor

W

Wright-Patterson Air Force Base

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying whether adding frequency filtered music, called the Safe and Sound Protocol, to daily cognitive processing therapy (CPT) can better reduce symptoms of Post Traumatic Stress Disorder (PTSD). This trial aims to find out if this special music helps lower PTSD symptoms, improves stress-related body responses, and whether better stress regulation explains improvements in hyperarousal and PTSD symptoms. Participants will be randomly assigned to listen to either frequency filtered classical music or the same music without filtering. Participants will receive 10 daily therapy sessions of cognitive processing therapy over two weeks. Before each session, they will listen to 15 minutes of either frequency filtered classical music or unfiltered classical music, totaling 2.5 hours of music listening. The filtered music changes certain sound frequencies over time to mimic human voice patterns, while the unfiltered music remains the same. During the study, participants will complete clinical interviews and questionnaires before, during, and up to six months after therapy. Their physiological arousal will be monitored during music listening and therapy sessions. They will also wear a Fitbit device and complete smartphone surveys for four weeks. The main outcomes measured include PTSD symptom severity at 1, 3, and 6 months after treatment, along with assessments of hyperarousal and physiological stress responses.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • Meets diagnostic criteria for PTSD or subthreshold PTSD with hyperarousal
  • Ability to move between sitting to standing without assistance
  • Ability to attend two weeks of daily in-person therapy sessions at specified medical centers
Not Eligible

You will not qualify if you...

  • Heart condition such as cardiac arrhythmia or pacemaker
  • Allergy preventing wearing adhesive for up to 2 hours
  • Insufficient English fluency for psychotherapy
  • Use of hearing aids
  • Current or prior tinnitus
  • Severe traumatic brain injury
  • Ongoing stressor or condition posing risk for injury or poor outcome
  • Inability to complete informed consent due to acute medical or psychiatric condition

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks

Participants receive 10 daily sessions of cognitive processing therapy over 2 weeks and listen to 15 minutes of either frequency filtered or unfiltered classical music before each therapy session.

10 daily visits (in-person) for therapy and music listening

Follow-up

Duration - 6 months

Participants are assessed for PTSD symptom severity and hyperarousal symptoms at 1 month, 3 months, and 6 months after treatment completion.

3 follow-up visits (in-person) at 1, 3, and 6 months post-treatment

Trial Site Locations

Total: 2 locations

1

The Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

2

Wright Patterson Air Force Base Mental Health Center

Dayton, Ohio, United States, 45433

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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