Coherence Training for Military Personnel

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Scott L. Johnston, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01599598
First received: May 7, 2012
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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 Intervention
Stress Symptomatology
Behavioral: Progressive Muscle Relaxation
Behavioral: Coherence Advantage

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Coherence Training for Military Personnel

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • Stress symptomatology [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The effectiveness of the two stress intervention trainings will be evaluated on final grades.

  • Attrition [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The effectiveness of the two stress intervention trainings will be evaluated on rates of attrition.


Estimated Enrollment: 106
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: emWave2

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599598

Locations
United States, California
Surface Warfare Medicine Institute
San Diego, California, United States, 92134
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: Scott L Johnston, PhD U.S. Navy, Medical Service Corps, Naval Center for Combat & Operational Stress Control (NCCOSC)
  More Information

No publications provided

Responsible Party: Scott L. Johnston, CAPT MSC USN ; Clinical Psychologist & Director of Naval Center for Combat & Operational Stress Control, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT01599598     History of Changes
Other Study ID Numbers: NMCSD.2011.0130
Study First Received: May 7, 2012
Last Updated: September 3, 2013
Health Authority: United States: Federal Government

Keywords provided by United States Naval Medical Center, San Diego:
perceived stress
depression
anxiety
posttraumatic stress disorder
military
school
training environment
heart rate variability
progressive muscle relaxation
psychophysiological coherence
coherence advantage
stress reduction
stress regulation
independent duty corpsmen

Additional relevant MeSH terms:
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014