Clinical trial NCT01599624: Stress Resilience Training System
Official title: Stress Resilience Training System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Depression
PTSD
Keywords: Resilience
Perceived stress
PTSD symptoms
Depression
Anxiety
Sleep quality
United States Navy service members
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: Office of Naval Research (ONR)
name: Perceptronics Solutions
First posted: 2012-05-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Stress Resilience Training System (SRTS) program is a stress reduction and resilience building system that blends cognitive training to anticipate the effects of stress with advanced biofeedback to mitigate stress effects and aftereffects, using a game-based learning framework on an iPad platform.

The proposed study will evaluate the effectiveness of the SRTS program at reducing perceived stress, PTSD symptoms, depression, anxiety, sleep quality, coping, attrition and class/operational performance among United States Navy service members.

Detailed description: 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.

In an increasing number of military personnel, the adverse effects of service and particularly of stressful combat exposure are significant, long lasting and possibly fatal. Most stress research is focused on treatment, but because stress effects are liable to appear years after exposure, it is imperative that methodologies be developed to mitigate the adverse effects of military-related stress and prevent its post-exposure effects.

It has long been accepted that warfighters adapt to combat stress after the first few experiences and that training can help duplicate this process, with recent studies showing that experienced military personnel are able to control and even utilize stress productively. A key part of what experienced personnel learn is self-awareness of their stress state and self-regulation of stress energy in order to maintain or even improve performance. These skills can be greatly enhanced by combining cognitive learning methodologies grounded in learning theory and biofeedback techniques based on Heart Rate Variability (HRV) with innovative simulation and game-based training tools.

The Stress Resilience Training System (SRTS) program is a stress reduction and resilience building system that blends cognitive training to anticipate the effects of stress with advanced biofeedback to mitigate stress effects and aftereffects, using a game-based learning framework on an iPad platform.

The proposed study will evaluate the effectiveness of the SRTS program at reducing perceived stress, PTSD symptoms, depression, anxiety, sleep quality, coping, attrition and class/operational performance among United States Navy service members.

Eligibility criteria: Inclusion Criteria:

* Subjects must be Sailors attached to the Training Support Center San Diego (USN).
* All genders and ethnic groups are to be included in the study.

Exclusion Criteria:

* Subjects will be excluded from participation if they will not be at the command for a minimum of 4 months from the start date.

Primary outcomes:
measure: Perceived Stress Scale-10
timeFrame: baseline, 2 months, 4 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, 2 months, 4 months
measure: Generalized Anxiety Disorder Measure (GAD-7)
timeFrame: baseline, 2 months, 4 months
Secondary outcomes:
measure: PTSD Checklist -Civilian Version (PCL-C)
timeFrame: baseline, 2 months, 4 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, 2 months, 4 months
measure: Response to Stressful Experiences Scale (RSES)
timeFrame: baseline, 2 months, 4 months
measure: Brief COPE
timeFrame: baseline, 2 months, 4 months
measure: Unit Support
timeFrame: baseline, 2 months, 4 months
measure: Quality of Life Scale (QOLS)
timeFrame: baseline, 2 months, 4 months
measure: Performance Indicator
timeFrame: 4 months
measure: Attrition Rate
timeFrame: 4 months
Other outcomes:
measure: Compliance
timeFrame: end of program (2 or 4 months)
Locations:
Study officials:
affiliation: U.S. Navy, Medical Service Corps, Naval Center for Combat & Operational Stress Control (NCCOSC)
name: Scott L Johnston, PhD
role: PRINCIPAL_INVESTIGATOR
References: