Frequency Filtered Music for PTSD

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Heart condition, Tinnitus, Severe TBI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

100 Participants Needed

Trial Summary

What is the purpose of 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

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Frequency Filtered Music for PTSD?

Research shows that music therapy, which includes methods like Trauma-focused Music and Imagery, can help reduce PTSD symptoms and improve well-being. Studies have found that music therapy is as effective as standard talk therapies for trauma and can be more culturally adaptable, leading to better treatment compliance. ^{1 2 3 4 5}

Is Frequency Filtered Music safe for humans?

Music therapy, including methods like trauma-focused music and imagery, has been used safely in various studies for conditions like PTSD, showing no significant safety concerns. ^{1 5 6 7 8}

How does frequency filtered music treatment for PTSD differ from other treatments?

Frequency filtered music for PTSD is unique because it uses music therapy to help regulate emotions and reduce trauma symptoms, unlike traditional talk therapies. This approach can be more culturally adaptable and may have lower dropout rates, making it a promising alternative for those who struggle with standard psychological treatments. ^{1 3 5 7 9}

Eligibility Criteria

This trial is for individuals with PTSD who will undergo cognitive processing therapy. Participants must be willing to listen to music before therapy sessions, complete interviews and questionnaires, have their arousal monitored, and use a Fitbit device with smartphone surveys for 4 weeks.

Inclusion Criteria

I can attend daily therapy sessions for two weeks at specified locations.

I have been diagnosed with PTSD or have symptoms close to PTSD, including feeling extremely alert or easily startled.

I can stand up from a chair without help.

Exclusion Criteria

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)

Use of hearing aids

An allergy that would prevent wearing adhesive for durations of 2 hours or less

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 10 daily sessions of cognitive processing therapy and listen to 15 minutes of music before each session

2 weeks

10 visits (in-person)

Monitoring

Participants wear a Fitbit device and complete smartphone surveys

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical interviews and questionnaires

6 months

Treatment Details

Interventions

• Frequency Filtered Music

Trial Overview The study tests if frequency filtered music enhances the effectiveness of cognitive processing therapy in reducing PTSD symptoms. It compares two groups: one listens to filtered classical music and the other unfiltered music before daily therapy sessions over ten days.

Participant Groups

Group I: Frequency Filtered Music Experimental Treatment 2 Interventions

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).

Group II: Unfiltered Music Active Control 2 Interventions

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).

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Wright-Patterson Air Force Base

Collaborator

Trials

1

Recruited

500+

Findings from Research

In a randomized controlled trial involving 170 emergency department patients, listening to purpose-designed music or sound compositions significantly reduced self-rated anxiety levels by 10%-15% compared to control groups that received no soundtrack or simulated ambient noise.

The most effective interventions included electroacoustic musical compositions and audio field recordings, both of which led to significant decreases in anxiety, highlighting the potential of sound therapy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Original sound compositions reduce anxiety in emergency department patients: a randomised controlled trial. Weiland, TJ., Jelinek, GA., Macarow, KE., et al.[2019]

In a study involving 126 mechanically ventilated patients in intensive care units, preferred music playlists were analyzed to understand their impact on managing anxiety through patient-directed music listening interventions.

The findings highlight the importance of music selection in therapeutic interventions, suggesting that involving a board-certified music therapist can enhance the effectiveness of music listening protocols in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. Heiderscheit, A., Johnson, K., Chlan, LL.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Music therapy versus treatment as usual for refugees diagnosed with posttraumatic stress disorder (PTSD): study protocol for a randomized controlled trial. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

Original sound compositions reduce anxiety in emergency department patients: a randomised controlled trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Music Therapy for Posttraumatic Stress in Adults: A Theoretical Review. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Amelioration of psychiatric symptoms through exposure to music individually adapted to brain rhythm disorders - a randomised clinical trial on the basis of fundamental research. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Music therapy was noninferior to verbal standard treatment of traumatized refugees in mental health care: Results from a randomized clinical trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Baseline and modulated acoustic startle responses in adolescent girls with posttraumatic stress disorder. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Audiological evaluation of nonalcoholic, drug-free posttraumatic stress disorder patients. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Customized Versus Noncustomized Sound Therapy for Treatment of Tinnitus: A Randomized Crossover Clinical Trial. [2017]