Anxiety Clinical Trial - The Sound Mind Warrior Study

Status Completed

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02328690
Study type	Interventional
Source	Fort Belvoir Community Hospital
Contact
Status	Completed
Phase	N/A
Start date	June 2012
Completion date	July 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.