AnxietyNCT02328690
The Sound Mind Warrior Study
A study testing Binaural Beat Technology in people with Anxiety and Stress, run by Fort Belvoir Community Hospital at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Binaural Beat Technology
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Military personnel who
- Have deployed
- Are eligible to receive healthcare at WRNMMC or FBCH
- Are 18 years and older
- Are able to commit to a 5-week study
Who cannot join
- Military personnel who…
- Are taking any medication in the anti-hypertensive category
- Are taking any medication in the anti-anxiety category
- Have been diagnosed with moderate or severe traumatic brain injury
- Have a history of epilepsy
- Are taking any medication in the anti-seizure category
- Have hearing deficit and/or wear a hearing aide
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
About this study
Official title: 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.
Read the 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…
- Cardiovascular reactivity, c-reactive protein, and state anxiety measures will be collected at baseline and after the 4 week intervention.
- Morning blood pressure (BP) surge and evening BP decline measures will be collected at baseline and weeks 0, 2 and 4.
- 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:
- retention
- number of refusal during recruitment
- number of drop outs
- reason for drop outs
- reason for staying
- number of days the technology was used
- selection of music
- ease of use and comfort of equipment
- adherence to the protocol
- evaluation of recruitment strategies
Aim 2 - To assess the impact of binaural beat technology on anxiety and relevant CV health measures. These measures included:
- Comparison of pre and post intervention state anxiety scores
- Observing the trend of morning blood pressure surge over time
- Observing the trend of evening blood pressure decline over time
- Comparison of pre and post intervention heart rate variability measures
- Comparison of pre and post intervention c-reactive protein measures
- Being tested
- Binaural Beat Technology
- Keywords
- binaural beat technology, sound technology, cardiovascular stress response, military, music, anxiety, stress
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural Beat TechnologyOther
Also called Hemi-Sync
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.
| Study group | Role | What they receive |
|---|---|---|
| Music with BBT | Experimental | Music embedded with special tones. Receives: Other: Binaural Beat Technology |
| Music without BBT | Placebo comparator | Music not embedded with special tones. Receives: Other: Binaural Beat Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-Reactive Protein
C-reactive protein is a biomarker of the inflammatory process.
Measured: Before the intervention and again at 5 weeks
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.
Measured: Before the intervention and again at 5 weeks
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.
Measured: Before the intervention, at 2 weeks and again at 4 weeks
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.
Measured: Before the intervention and again at 5 weeks
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.
Measured: At 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJun 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fort Belvoir Community Hospital
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed National Military Medical Center, TriService Nursing Research Program
- Responsible party
- Principal investigator, LTC MeLisa Gantt, Fort Belvoir Community Hospital
- Investigators
- MeLisa Gantt, PhD, Principal investigator, Gantt Clinical Research Institute LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328690
- Sponsor's protocol ID
- 361395
- Status last verified
- May 2017
- First submitted
- 18 Dec 2014
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binaural Beat Technology: A Complementary Path to Post Deployment Wellness (The Sound Mind Warrior Study)
- ClinicalTrials.gov ID
- NCT02328690
- Acronym / sponsor ID
- 361395
- Keywords
- binaural beat technology, sound technology, cardiovascular stress response, military, music, anxiety, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Fort Belvoir Community HospitalUS federal agency
- Collaborators
- Walter Reed National Military Medical Center, TriService Nursing Research Program
- Study start
- Jun 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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…
- Cardiovascular reactivity, c-reactive protein, and state anxiety measures will be collected at baseline and after the 4 week intervention.
- Morning blood pressure (BP) surge and evening BP decline measures will be collected at baseline and weeks 0, 2 and 4.
- 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:
- retention
- number of refusal during recruitment
- number of drop outs
- reason for drop outs
- reason for staying
- number of days the technology was used
- selection of music
- ease of use and comfort of equipment
- adherence to the protocol
- evaluation of recruitment strategies
Aim 2 - To assess the impact of binaural beat technology on anxiety and relevant CV health measures. These measures included:
- Comparison of pre and post intervention state anxiety scores
- Observing the trend of morning blood pressure surge over time
- Observing the trend of evening blood pressure decline over time
- Comparison of pre and post intervention heart rate variability measures
- Comparison of pre and post intervention c-reactive protein measures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music with BBT | Experimental | Other: Binaural Beat TechnologyMusic embedded with special tones. |
| Music without BBT | Placebo comparator | Other: Binaural Beat TechnologyMusic not embedded with special tones. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Military personnel who
Key exclusion criteria (7 listed)
- Military personnel who…
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binaural Beat TechnologyAlso: Hemi-SyncA 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. | Other | Music with BBT, Music without BBT |
Primary outcome
C-Reactive Protein
Time frame: Before the intervention and again at 5 weeks
C-reactive protein is a biomarker of the inflammatory process.
State-Trait Anxiety (STAI)
Time frame: Before the intervention and again at 5 weeks
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.
Morning Blood Pressure/Evening Blood Pressure Decline
Time frame: Before the intervention, at 2 weeks and again at 4 weeks
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.
Cardiovascular Reactivity
Time frame: Before the intervention and again at 5 weeks
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.
Post Intervention Questionnaire
Time frame: At 5 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MeLisa Gantt, PhD principal investigator
Gantt Clinical Research Institute LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural Beat Technology in people with Anxiety and Stress, run by Fort Belvoir Community Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-Reactive Protein (time frame: Before the intervention and again at 5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.