NCT01599598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

May 7, 2012

Last Update Submit

August 17, 2016

Conditions

Keywords

perceived stressdepressionanxietyposttraumatic stress disordermilitaryschooltraining environmentheart rate variabilityprogressive muscle relaxationpsychophysiological coherencecoherence advantagestress reductionstress regulationindependent duty corpsmen

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (2)

  • School performance

    12 months

  • Attrition

    12 months

Study Arms (2)

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.

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.

Behavioral: Coherence Advantage

Interventions

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.

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 practice the techniques while using a biofeedback device to recognize when they enter psychophysiological coherence.

Also known as: emWave2
Coherence Advantage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Sailors
  • Enrolled as students in the Surface Warfare Medicine Institute's Independent Duty Corpsman School

You may not qualify if:

  • Administratively rolled over into another class
  • Dropped out of the school (due to academic or medical reasons)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surface Warfare Medicine Institute

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersStress Disorders, Post-Traumatic

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Scott L Johnston, PhD

    U.S. Navy, Medical Service Corps, Naval Center for Combat & Operational Stress Control (NCCOSC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2012

First Posted

May 16, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 19, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations