The Sound Mind Warrior Study

NCT02328690 | Completed

• 1 other identifier: 361395
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety; Stress

Keywords

binaural beat technology; sound technology; cardiovascular stress response; military; music; anxiety; stress

Outcome Measures

Primary Outcomes (5)

• C-Reactive Protein

  C-reactive protein is a biomarker of the inflammatory process.

  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.

  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.

  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.

  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.

  At 5 weeks

Study Arms (2)

Music with BBT

EXPERIMENTAL

Music embedded with special tones.

Other: Binaural Beat Technology

Music without BBT

PLACEBO COMPARATOR

Music not embedded with special tones.

Other: Binaural Beat Technology

Interventions

Binaural Beat Technology OTHER

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.

Also known as: Hemi-Sync

Music with BBT; Music without BBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fort Belvoir Community Hospital: lead
• Walter Reed National Military Medical Center: collaborator
• TriService Nursing Research Program: collaborator

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, 22060, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• MeLisa Gantt, PhD

  Gantt Clinical Research Institute LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: (former) Chief, Research Program

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 31, 2014
• Study Start: June 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (2)