StressNCT01599598
Coherence Training for Military Personnel
A study testing Progressive Muscle Relaxation and Coherence Advantage in people with Stress, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress
- What is being tested?
- Progressive Muscle Relaxation and Coherence Advantage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Sep 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sailors
- Enrolled as students in the Surface Warfare Medicine Institute's Independent Duty Corpsman School
Who cannot join
- Administratively rolled over into another class
- Dropped out of the school (due to academic or medical reasons)
Trial locations and contacts
1 site in 1 country.
United States1 site
Surface Warfare Medicine Institute
San Diego, California, 92134
About this study
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.
- Conditions
- Stress
- Being tested
- Progressive Muscle Relaxation, Coherence Advantage
- Keywords
- 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
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle RelaxationBehavioural
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.
Coherence AdvantageBehavioural
Also called emWave2
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.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation | Active comparator | 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. Receives: Behavioral: Progressive Muscle Relaxation |
| Coherence Advantage | Active comparator | 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. Receives: Behavioral: Coherence Advantage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress symptomatology
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.
Measured: 12 months
Secondary outcomes (2)
School performance
The effectiveness of the two stress intervention trainings will be evaluated on final grades.
Measured: 12 months
Attrition
The effectiveness of the two stress intervention trainings will be evaluated on rates of attrition.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott L Johnston, PhD, Principal investigator, U.S. Navy, Medical Service Corps, Naval Center for Combat & Operational Stress Control (NCCOSC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599598
- Sponsor's protocol ID
- NMCSD.2011.0130
- Status last verified
- Aug 2016
- First submitted
- 7 May 2012
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coherence Training for Military Personnel
- ClinicalTrials.gov ID
- NCT01599598
- Acronym / sponsor ID
- NMCSD.2011.0130
- Conditions
- Stress
- Keywords
- perceived stress, depression, anxiety, posttraumatic stress disorder, military, school, training environment, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Apr 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 May 2012 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation | Active comparator | Behavioral: Progressive Muscle RelaxationA 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. |
| Coherence Advantage | Active comparator | Behavioral: Coherence AdvantageA 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Sailors
- Enrolled as students in the Surface Warfare Medicine Institute's Independent Duty Corpsman School
Key exclusion criteria (2 listed)
- Administratively rolled over into another class
- Dropped out of the school (due to academic or medical reasons)
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 |
|---|---|---|
| Progressive Muscle RelaxationParticipants 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. | Behavioural | Progressive Muscle Relaxation |
| Coherence AdvantageAlso: emWave2Participants 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. | Behavioural | Coherence Advantage |
Primary outcome
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.
2 secondary outcomes
School performance
Time frame: 12 months
Attrition
Time frame: 12 months
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 19 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Scott L Johnston, PhD principal investigator
U.S. Navy, Medical Service Corps, Naval Center for Combat & Operational Stress Control (NCCOSC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation and Coherence Advantage in people with Stress, run by United States Naval Medical Center, San Diego at 1 site 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 2 inclusion and 2 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 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Stress symptomatology (time frame: 12 months). 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 19 Aug 2016.