The Sound Mind Warrior Study

Anxiety Clinical Trial

Official title:

Binaural Beat Technology: A Complementary Path to Post Deployment Wellness (The Sound Mind Warrior Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328690
• Other study ID #: 361395
• Status: Completed
• Phase: N/A
• First received: December 18, 2014
• Last updated: May 25, 2017
• Start date: June 2012
• Est. completion date: July 2015

Study information

• Verified date: May 2017
• Source: Fort Belvoir Community Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this prospective, double-blind, repeated measures study is to assess the efficacy of Binaural Beat Technology (BBT) on anxiety and anxiety related cardiovascular measures as well as to assess the feasibility of implementing a BBT intervention in a military population during the high risk post-deployment window.

Description:

The purpose of this prospective, double-blind, repeated measures study is to assess the efficacy of Binaural Beat Technology (BBT- a sound technology that uses special tones [embedded in music] through stereo headphones to affect your brainwaves in order to put you in a more relaxed state) on anxiety and anxiety related cardiovascular measures as well as to assess the feasibility of implementing a BBT intervention in a military population during the high risk post-deployment window.

A sample of 74 Warriors who have deployed will be randomly placed into two groups (music with BBT and music without BBT). Each group will be exposed to their respective intervention for 30 minutes at bedtime, 3 times a week, for 4 weeks. Quantitative and qualitative measures will be collected as follows…

1. Cardiovascular reactivity, c-reactive protein, and state anxiety measures will be collected at baseline and after the 4 week intervention.

2. Morning blood pressure (BP) surge and evening BP decline measures will be collected at baseline and weeks 0, 2 and 4.

3. Input from the participants will be collected via daily logs and at the completion of the 4 week intervention.

Aim 1 - To assess the feasibility of implementing a binaural beat technology intervention in a military population during the high risk post deployment window. Feasibility will be measured by assessing:

1. retention

2. number of refusal during recruitment

3. number of drop outs

4. reason for drop outs

5. reason for staying

6. number of days the technology was used

7. selection of music

8. ease of use and comfort of equipment

9. adherence to the protocol

10. evaluation of recruitment strategies

Aim 2 - To assess the impact of binaural beat technology on anxiety and relevant CV health measures. These measures included:

1. Comparison of pre and post intervention state anxiety scores

2. Observing the trend of morning blood pressure surge over time

3. Observing the trend of evening blood pressure decline over time

4. Comparison of pre and post intervention heart rate variability measures

5. Comparison of pre and post intervention c-reactive protein measures

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Military personnel who

1. Have deployed

2. Are eligible to receive healthcare at WRNMMC or FBCH

3. Are 18 years and older

4. Are able to commit to a 5-week study

Exclusion Criteria:

• Military personnel who…

1. Are taking any medication in the anti-hypertensive category

2. Are taking any medication in the anti-anxiety category

3. Have been diagnosed with moderate or severe traumatic brain injury

4. Have a history of epilepsy

5. Are taking any medication in the anti-seizure category

6. Have hearing deficit and/or wear a hearing aide

Related Conditions & MeSH terms

• Anxiety
• Stress

Intervention

Other:
• Binaural Beat Technology
A phenomenon when two nearly similar frequencies (between 30-1000 hertz [Hz]) are presented to each ear and the brain detects the difference between the two sounds. These two sounds are processed in the superior olivary nucleus of each hemisphere of the brain. This integration of brain hemispheres produces a frequency that in turn affects the reticular activating system which alters the electrical potentials of the thalamus and cerebral cortex changing brainwave frequency.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Fort Belvoir Community Hospital	Fort Belvoir	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Fort Belvoir Community Hospital	TriService Nursing Research Program, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-Reactive Protein	C-reactive protein is a biomarker of the inflammatory process.	Before the intervention and again at 5 weeks
Primary	State-Trait Anxiety (STAI)	The STAI will be used to measure overall generalized anxiety as well as current state anxiety immediately before and after the intervention. The instrument consists of 40 4-point Likert scale statements (20 related to trait anxiety and 20 related to state anxiety). Scores range from 40 to 160 with the higher score depicting a higher level of anxiety.	Before the intervention and again at 5 weeks
Primary	Morning Blood Pressure/Evening Blood Pressure Decline	Using an ambulatory blood pressure (BP) monitor, BP measures will be taken every 60 minutes starting from two hours before bedtime and ending two hours after rising. Morning BP surge will be assessed by comparing the trend of the number of millimeters of mercury (mm Hg) the BP increased during the first two hours after rising. Evening BP decline will be assessed by comparing the trend of the percentage that the BP declined while sleep when compared the mean awake BP.	Before the intervention, at 2 weeks and again at 4 weeks
Primary	Cardiovascular Reactivity	Continuous heart rate measures will be taken during five states: 1) at baseline, 2) during the training for a cognitive challenge, 3) during the cognitive challenge, 4) during recovery, and 5) when verbally coached to relax. When analyzed via the computer, a high variability response will indicate a healthy autonomic system whereas a low variability response will indicate evidence of chronic stress exposure.	Before the intervention and again at 5 weeks
Primary	Post Intervention Questionnaire	The Post Intervention Questionnaire will be used to collect qualitative data (3 questions to address efficacy and 11 questions to address feasibility). This instrument will be used in conjunction with field notes during recruitment to assess: 1) retention, 2) number of refusal during recruitment, 3) number of drop outs, 4) reason for drop out, 5) reason for staying, 6) number of day the technology was used (more or less than prescribed recommendation), 7) selection of music, 8) ease of use and comfort of equipment (e.g., sleep phone, mp3 player, etc), 9) adherence to the protocol, and 10) evaluation of recruitment strategies.	At 5 weeks