StressSRTSNCT01599624
Stress Resilience Training System
A study testing Stress Resilience Training System (SRTS) and Progressive Muscle Relaxation (PMR) in people with Stress and Anxiety, run by United States Naval Medical Center, San Diego.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- Stress Resilience Training System (SRTS) and Progressive Muscle Relaxation (PMR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to May 2015
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects will be excluded from participation if they will not be at the command for a minimum of 4 months from the start date.
About this study
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.
Read the 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
- Being tested
- Stress Resilience Training System (SRTS), Progressive Muscle Relaxation (PMR)
- Keywords
- Resilience, Perceived stress, PTSD symptoms, Depression, Anxiety, Sleep quality, United States Navy service members
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Resilience Training System (SRTS)Behavioural
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.
Progressive Muscle Relaxation (PMR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| iPad-based SRTS | Experimental | Not described Receives: Behavioral: Stress Resilience Training System (SRTS) |
| iPad-based PMR program | Experimental | Not described Receives: Behavioral: Progressive Muscle Relaxation (PMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: baseline, 2 months, 4 months
Secondary outcomes (8)
PTSD Checklist -Civilian Version (PCL-C)
The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD and monitoring symptom change during and after treatment. We will use the PCL-C (civilian) version for this study. The PCL-C (civilian) asks about symptoms in relation to "stressful experiences." The PCL-C is useful because it can be used with any population. The symptoms endorsed may not be specific to just one event, which can be helpful when assessing survivors who have symptoms due to multiple events. Typically, it is optimal to assess traumatic event exposure to ensure that a respondent has experienced at least one Criterion A event.
Measured: baseline, 2 months, 4 months
Patient Health Questionnaire (PHQ-9)
The scale measures the severity of depressive symptoms an individual endorses; the range of scores is 0 to 27, with scores of 5, 10, 15, and 20 indicating mild, moderate, moderately severe and severe depression, respectively. The criteria for major depressive disorder (MDD) can be met when a respondent checks "nearly every day" on the first item and checks four of the following items at equal or greater than "more than half the days." The ninth item reflects one's degree of suicidal ideation (SI). We will have a licensed independent practitioner available to whom those with any SI endorsed will be referred for a risk assessment. The PHQ-9 score will be used as a continuous dependent variable (Kroenke et al., 2001).
Measured: baseline, 2 months, 4 months
Response to Stressful Experiences Scale (RSES)
The RSES is a 22-item assessment designed to measure how individuals respond to stress, adversity and trauma. It includes six factors: positive appraisal, spirituality, active coping, self-efficacy, learning and meaning-making and acceptance of limits. Responses for individual questions will be reviewed in addition to the overall score which reflects the strength of the trait (Johnson, 2008).
Measured: baseline, 2 months, 4 months
Brief COPE
The Brief COPE is a 28-item scale designed to measure how people cope with stressful situations. Factor analysis revealed 10 distinct subscales: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, and planning (Carver, 1997).
Measured: baseline, 2 months, 4 months
Unit Support
The scale measures an individual's perceived degree of cohesion and quality of relationships with other military personnel during a given period of time spent together. Respondents are asked to describe how much they agree or disagree to a number of statements. Scores are obtained on a 5 point likert scale with responses ranging from 1 Strongly disagree to 5 Strongly agree. Higher scores reflect a better quality of relationships and a more unified group (King et al., 2003).
Measured: baseline, 2 months, 4 months
Quality of Life Scale (QOLS)
The QOLS is a 16 item scale assessing quality of life in areas such as physical health, social connections, recreation, etc. (Burckhardt 193).
Measured: baseline, 2 months, 4 months
Performance Indicator
Command-determined performance data will be collected from Training Support Center San Diego.
Measured: 4 months
Attrition Rate
This will be measured as the percentage of service members who drop out of each respective training program. This information will be collected from the command.
Measured: 4 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 startOct 2012
- Primary completionMay 2015
- Study completionMay 2015
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- Office of Naval Research (ONR), Perceptronics Solutions
- 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
- NCT01599624
- Sponsor's protocol ID
- NMCSD.2012.0032
- Acronym
- SRTS
- Status last verified
- Aug 2016
- First submitted
- 7 May 2012
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Stress Resilience Training System
- ClinicalTrials.gov ID
- NCT01599624
- Acronym / sponsor ID
- SRTS / NMCSD.2012.0032
- Conditions
- Stress, Anxiety, Depression, PTSD
- Keywords
- Resilience, Perceived stress, PTSD symptoms, Depression, Anxiety, Sleep quality, United States Navy service members
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- Office of Naval Research (ONR), Perceptronics Solutions
- Study start
- Oct 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iPad-based SRTS | Experimental | Behavioral: Stress Resilience Training System (SRTS) |
| iPad-based PMR program | Experimental | Behavioral: Progressive Muscle Relaxation (PMR) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects will be excluded from participation if they will not be at the command for a minimum of 4 months from the start date.
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 |
|---|---|---|
| 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. | Behavioural | iPad-based SRTS |
| 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. | Behavioural | iPad-based PMR program |
Primary outcome
Perceived Stress Scale-10
Time frame: baseline, 2 months, 4 months
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.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline, 2 months, 4 months
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).
Generalized Anxiety Disorder Measure (GAD-7)
Time frame: baseline, 2 months, 4 months
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).
8 secondary outcomes
PTSD Checklist -Civilian Version (PCL-C)
Time frame: baseline, 2 months, 4 months
Patient Health Questionnaire (PHQ-9)
Time frame: baseline, 2 months, 4 months
Response to Stressful Experiences Scale (RSES)
Time frame: baseline, 2 months, 4 months
Brief COPE
Time frame: baseline, 2 months, 4 months
Unit Support
Time frame: baseline, 2 months, 4 months
Quality of Life Scale (QOLS)
Time frame: baseline, 2 months, 4 months
Performance Indicator
Time frame: 4 months
Attrition Rate
Time frame: 4 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)
Questions about this trial
What is this clinical trial studying?
A study testing Stress Resilience Training System (SRTS) and Progressive Muscle Relaxation (PMR) in people with Stress and Anxiety, run by United States Naval Medical Center, San Diego.
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 1 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.
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?
Perceived Stress Scale-10 (time frame: baseline, 2 months, 4 months). The study lists 3 primary outcomes in all. 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.