Stress Resilience Training System

NCT ID: NCT01599624

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-05-31

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.

Conditions

Stress; Anxiety; Depression; PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

iPad-based SRTS

Group Type: EXPERIMENTAL

Stress Resilience Training System (SRTS)

Intervention Type: BEHAVIORAL

SRTS training provides both cognitive learning and training in a scientifically-designed stress resilience training approach designed to minimize the adverse effects of stress and also enhance its positive effects. In summary, the SRTS training comprises: (1) Cognitive rules and mental exercises based on expert knowledge and research; (2) Biofeedback stress control exercises based on proven HRV (Heart Rate Variability) algorithms developed by the Institute of HeartMath; and (3) E-Learning presentation of games and simulations to motivate younger trainees. The training is designed to familiarize participants with the iPad and the SRTS program. Participants will be told how to use the system and how often to use the system. SRTS program participants will each be assigned an iPad to take home with them and practice the techniques for a period of two months.

iPad-based PMR program

Group Type: EXPERIMENTAL

Progressive Muscle Relaxation (PMR)

Intervention Type: BEHAVIORAL

Progressive muscle relaxation is the systematic tensing and relaxing of 16 different muscle groups, starting with one's toes and ending with one's head (Jacobson, 1938; Conrad \& Roth, 2007). PMR users are instructed to inhale as they tense the muscles and exhale as they release the tension. Participants will participate in a two-hour PMR training. PMR participants will be given iPADs with a video recording that guides the user through working each muscle group while instructing them to focus on positive thoughts and feelings and breathing techniques. PMR program participants will each be assigned an iPad to take home with them and practice the techniques for a period of two months.

Interventions

Stress Resilience Training System (SRTS)

SRTS training provides both cognitive learning and training in a scientifically-designed stress resilience training approach designed to minimize the adverse effects of stress and also enhance its positive effects. In summary, the SRTS training comprises: (1) Cognitive rules and mental exercises based on expert knowledge and research; (2) Biofeedback stress control exercises based on proven HRV (Heart Rate Variability) algorithms developed by the Institute of HeartMath; and (3) E-Learning presentation of games and simulations to motivate younger trainees. The training is designed to familiarize participants with the iPad and the SRTS program. Participants will be told how to use the system and how often to use the system. SRTS program participants will each be assigned an iPad to take home with them and practice the techniques for a period of two months.

Intervention Type: BEHAVIORAL

Progressive Muscle Relaxation (PMR)

Progressive muscle relaxation is the systematic tensing and relaxing of 16 different muscle groups, starting with one's toes and ending with one's head (Jacobson, 1938; Conrad \& Roth, 2007). PMR users are instructed to inhale as they tense the muscles and exhale as they release the tension. Participants will participate in a two-hour PMR training. PMR participants will be given iPADs with a video recording that guides the user through working each muscle group while instructing them to focus on positive thoughts and feelings and breathing techniques. PMR program participants will each be assigned an iPad to take home with them and practice the techniques for a period of two months.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Office of Naval Research (ONR)

FED

Sponsor Role: collaborator

Perceptronics Solutions

UNKNOWN

Sponsor Role: collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott L Johnston, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

NMCSD.2012.0032

Identifier Type: -

Identifier Source: org_study_id