- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01599598
Coherence Training for Military Personnel
August 17, 2016 updated by: United States Naval Medical Center, San Diego
Military operations and training situations present many physical and psychological challenges for service members to adapt to and overcome.
The challenges of these changing conditions necessitate having to cope with stress, which is seen as the negative perceptions, feelings, and emotions that manifest from the subjective physical and/or mental strain on life processes.
In addition, service members are returning from deployments having gone through traumatic experiences that can develop into posttraumatic stress disorder (PTSD), depression or other serious conditions.
The Surface Warfare Independent Duty Corpsman (IDC) School is an example of a training environment where some students may be entering the program with symptoms of PTSD, which may preclude or make it more difficult for them to perform well.
Autonomic nervous system (ANS) dysregulation has been observed in patients with PTSD and those experiencing chronic stress, such that there is more arousing, sympathetic input to the heart than calming, parasympathetic input, which is usually the dominant division of the ANS involved in controlling one's heart rate.
The IDC training program is an example of an environment where the service member is expected to excel while being subjected to multiple sources of stress.
The fast tempo coupled with performance expectations may induce stress and actually inhibit learning.
The Institute of HeartMath has developed the Coherence Advantage program which teaches one to self-regulate their emotions while focusing on breathing to compliment the active process of self-regulation.
In conjunction, the emWave Personal Stress Reliever allows the user to receive heart rate variability (HRV) biofeedback, hence giving the user the opportunity to self-regulate their ANS through breathing and self-regulation techniques.
The proposed study will test the effectiveness of the Coherence Advantage program versus progressive muscle relaxation (PMR) in reducing stress symptomatology among Surface Warfare IDC students.
The effectiveness of these two different interventions will be compared on outcomes of PTSD, depression, anxiety, sleep quality, perceived stress, attrition, and class performance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
192
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92134
- Surface Warfare Medicine Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Sailors
- Enrolled as students in the Surface Warfare Medicine Institute's Independent Duty Corpsman School
Exclusion Criteria:
- Administratively rolled over into another class
- Dropped out of the school (due to academic or medical reasons)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Progressive Muscle Relaxation
A stress intervention where subjects will learn to regulate stress based on the tensing and releasing of the major muscle groups in the body, accompanied with relaxed breathing techniques.
|
Participants will be instructed to practice the techniques twice daily for 5-15 minutes per session, and subsequently use the techniques when confronted with a stressful event such as a project deadline, exam, skill evaluation, etc. Participants in this condition will listen to PMR instruction by way of a mp3 player.
|
|
Active Comparator: Coherence Advantage
A stress intervention where subjects will learn to regulate stress by focusing on breathing and mindfulness techniques while recognizing physiological coherence by way of a portable biofeedback device.
|
Participants will be instructed to practice the techniques twice daily for 5-15 minutes per session, and subsequently use the techniques when confronted with a stressful event such as a project deadline, exam, skill evaluation, etc. Participants in this condition will practice the techniques while using a biofeedback device to recognize when they enter psychophysiological coherence.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress symptomatology
Time Frame: 12 months
|
The effectiveness of the two stress intervention trainings will be evaluated on symptoms of depression, posttraumatic stress disorder, generalized anxiety, perceived stress, and sleep quality.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
School performance
Time Frame: 12 months
|
The effectiveness of the two stress intervention trainings will be evaluated on final grades.
|
12 months
|
|
Attrition
Time Frame: 12 months
|
The effectiveness of the two stress intervention trainings will be evaluated on rates of attrition.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
May 7, 2012
First Submitted That Met QC Criteria
May 14, 2012
First Posted (Estimate)
May 16, 2012
Study Record Updates
Last Update Posted (Estimate)
August 19, 2016
Last Update Submitted That Met QC Criteria
August 17, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMCSD.2011.0130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.