The Sound Mind Warrior Study



Status:Completed
Conditions:Anxiety, Anxiety
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:7/16/2016
Start Date:June 2012
End Date:July 2015

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

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.

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

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
We found this trial at
2
sites
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Bethesda, MD
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Fort Belvoir, Virginia 22060
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Fort Belvoir, VA
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