Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-01 @ 8:00 AM
Study NCT ID:
NCT06925867
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
Sponsor:
Ohio State University
Organization:
Study Overview
Official Title:
A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HT94252410126 | OTHER_GRANT | Department of Defense | View |