Stress Resilience Training System

NCT01599624 | Completed DMC

• 1 other identifier: NMCSD.2012.0032
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress; Anxiety; Depression; PTSD

Keywords

Resilience; Perceived stress; PTSD symptoms; Depression; Anxiety; Sleep quality; United States Navy service members

Outcome Measures

Primary Outcomes (3)

• Perceived Stress Scale-10

  This is a 10-item scale designed to measure the degree to which a person perceives aspects of their life as uncontrollable, unpredictable and overwhelming. Participants are asked to indicate how often they have felt a certain way in the last month. The scale utilizes a 5-point likert format with responses ranging from never to very often.

  baseline, 2 months, 4 months

• Pittsburgh Sleep Quality Index (PSQI)

  The scale consists of seven different components of sleep quality that sum to an overall sleep quality score. A global score of 0-5 indicates good sleep quality while a global score greater than 5 indicates poor sleep quality. The global score as well as the sleep latency and habitual sleep efficiency scores will be used as continuous variables (Buysse, 1989).

  baseline, 2 months, 4 months

• Generalized Anxiety Disorder Measure (GAD-7)

  The scale was initially developed to screen for generalized anxiety disorder, but has sensitivity and specificity to panic, social anxiety, and PTSD. The instructions ask respondents to indicate how often they have been bothered by problems over the past two weeks. Scores are obtained from likert responses that range from 0 "Not at all" to 4 "Nearly every day". The total score can range from 0 to 21, with scores of 5, 10, and 15 being cutpoints for mild, moderate, and severe anxiety, respectively. The measure will be utilized to gain anxiety symptom severity scores (Spitzer et al., 2006).

  baseline, 2 months, 4 months

Secondary Outcomes (8)

• PTSD Checklist -Civilian Version (PCL-C)

  baseline, 2 months, 4 months

• Patient Health Questionnaire (PHQ-9)

  baseline, 2 months, 4 months

• Response to Stressful Experiences Scale (RSES)

  baseline, 2 months, 4 months

• Brief COPE

  baseline, 2 months, 4 months

• Unit Support

  baseline, 2 months, 4 months

Other Outcomes (1)

• Compliance

  end of program (2 or 4 months)

Study Arms (2)

iPad-based SRTS

EXPERIMENTAL

Behavioral: Stress Resilience Training System (SRTS)

iPad-based PMR program

EXPERIMENTAL

Behavioral: Progressive Muscle Relaxation (PMR)

Interventions

Stress Resilience Training System (SRTS) 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 SRTS

Progressive Muscle Relaxation (PMR) 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.

iPad-based PMR program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• Office of Naval Research (ONR): collaborator
• Perceptronics Solutions: collaborator

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral 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: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 16, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 19, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share