Coherence Training for Military Personnel

Sponsor

United States Naval Medical Center, San Diego (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT01599598

Collaborator

(none)

192

Enrollment

Location

Arms

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stress	Behavioral: Progressive Muscle Relaxation Behavioral: Coherence Advantage	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

192 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Coherence Training for Military Personnel

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

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.	Behavioral: Progressive Muscle Relaxation 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.	Behavioral: Coherence Advantage 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: emWave2

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.

Behavioral: Progressive Muscle Relaxation

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.

Behavioral: Coherence Advantage

Other Names:

emWave2

Outcome Measures

Primary Outcome Measures

Stress symptomatology [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.

Secondary Outcome Measures

School performance [12 months]
The effectiveness of the two stress intervention trainings will be evaluated on final grades.
Attrition [12 months]
The effectiveness of the two stress intervention trainings will be evaluated on rates of attrition.