Clinical trial NCT02328690: The Sound Mind Warrior Study
Official title: Binaural Beat Technology: A Complementary Path to Post Deployment Wellness (The Sound Mind Warrior Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Keywords: binaural beat technology
sound technology
cardiovascular stress response
military
music
anxiety
stress
Lead sponsor: Fort Belvoir Community Hospital
Sponsor class: FED
Collaborators: name: Walter Reed National Military Medical Center
name: TriService Nursing Research Program
First posted: 2014-12-31
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: C-Reactive Protein
timeFrame: Before the intervention and again at 5 weeks
measure: State-Trait Anxiety (STAI)
timeFrame: Before the intervention and again at 5 weeks
measure: Morning Blood Pressure/Evening Blood Pressure Decline
timeFrame: Before the intervention, at 2 weeks and again at 4 weeks
measure: Cardiovascular Reactivity
timeFrame: Before the intervention and again at 5 weeks
measure: Post Intervention Questionnaire
timeFrame: At 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
Study officials:
affiliation: Gantt Clinical Research Institute LLC
name: MeLisa Gantt, PhD
role: PRINCIPAL_INVESTIGATOR
References: