Psychological StressOpPHXNCT03242837
Psychobiological Evaluation of the Army Resilience Training
A study testing Army Resilience Training and Diversity Management Training in people with Psychological Stress and Psychological Adaptation, run by Military Academy at ETH Zurich at 1 site in Switzerland.
Trial summary
This study evaluates the influence of a resilience training on psychobiological factors which are related to stress and resilience in young healthy male cadets. Half of participants will join in the resilience training, while the other half take part in a control-training (diversity management training). Read more about this study
- Who is it for?
- Ages 18 to 28 years, men only
- Conditions the study is for
- Psychological Stress, Psychological Adaptation
- What is being tested?
- Army Resilience Training and Diversity Management Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Aug 2017to 17 Aug 2018
- 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 28 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- military cadets of the Swiss Army Infantry Officers School Inf OS 10-1/17
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the influence of a resilience training on psychobiological factors which are related to stress and resilience in young healthy male cadets. Half of participants will join in the resilience training, while the other half take part in a control-training (diversity management training).
Read the detailed description
The resilience training (Army Resilience Training / ART) is a stress prevention program based on well established methods from Cognitive Behavioral Therapy (CBT) and Positive Psychology adapted for the needs of Swiss Armed Forces. ART is designed for healthy subjects to learn how to get over strain.
Diversity management training (DMT) aims to promote social skills and acts as control condition. DMT is part of the military training but not mandatory for the study population.
- Conditions
- Psychological Stress, Psychological Adaptation
- Being tested
- Army Resilience Training, Diversity Management Training
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Army Resilience TrainingBehavioural
Also called Resilience Training
The Army Resilience Training consists four training sessions of 90 minutes each. Participants learn to reflect their stress management (including thinking, emotions, behavioral consequences; coping strategies) and build resilience using specific strategies.
Diversity Management TrainingOther
Also called Diversity Management
Diversity Management Training consists four training sessions of 90 minutes each. Participants learn about diversity and social awareness reflecting different situations and settings.
| Study group | Role | What they receive |
|---|---|---|
| Army Resilience Training | Experimental | Resilience training: four training sessions of 90 minutes each (in week 3, 5, 6 and 7 of military training), in classroom, psychoeducational inputs on stress management and resilience related topics, cognitive behavioral interventions and moderated exercises Receives: Behavioral: Army Resilience Training |
| Diversity Management Training | Active comparator | Diversity Management: four training sessions of 90 minutes each (in week 3, 5, 6 and 7 of military training), classroom, psychoeducational inputs on social awareness and exercises Receives: Other: Diversity Management Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate variability (HRV)
Change is the difference from HRV at baseline (week 2) and after resilience training (intervention) in week 9
Measured: Weeks 2 (baseline) and 9 of the military training
Area under the curve (AUC) with respect to changes of salivary cortisol titer
During stress exposure; six saliva samples will be taken and analyzed for cortisol reactivity.
Measured: Weeks 2 and 9 of the military training
Change of Testosterone Levels
During stress exposure; four saliva samples will be taken and analyzed for testosterone levels.
Measured: Weeks 2 and 9 of the military training
Secondary outcomes (3)
Intensity of acute psychological stress
Perceived stress intensity measured by Visual Analogue Scale
Measured: Weeks 2, 9 and 12 of the military training
Affect of acute psychological stress
Perceived stress measured by Positive Negative Affect
Measured: Weeks 2, 9 and 12 of the military training
Stress Appraisal
Perceived stress appraisal measured by Primary and Secondary Appraisal
Measured: Weeks 2, 9 and 12 of the military training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start14 Aug 2017
- Primary completion31 Jul 2018
- Study completion17 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Academy at ETH Zurich
- Sponsor type
- Other government
- Collaborators
- Swiss Armed Forces
- Responsible party
- Sponsor
- Investigators
- Hubert Annen, PhD, Principal investigator, Military Academy at ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242837
- Sponsor's protocol ID
- Project ID 2017-00841
- Acronym
- OpPHX
- Status last verified
- Jan 2019
- First submitted
- 26 Jul 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychobiological Evaluation of the Army Resilience Training
- ClinicalTrials.gov ID
- NCT03242837
- Acronym / sponsor ID
- OpPHX / Project ID 2017-00841
- Conditions
- Psychological Stress, Psychological Adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Military Academy at ETH ZurichOther government
- Collaborators
- Swiss Armed Forces
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 8 Aug 2017 (actual)
- 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.
This study evaluates the influence of a resilience training on psychobiological factors which are related to stress and resilience in young healthy male cadets. Half of participants will join in the resilience training, while the other half take part in a control-training (diversity management training).
Detailed description
The resilience training (Army Resilience Training / ART) is a stress prevention program based on well established methods from Cognitive Behavioral Therapy (CBT) and Positive Psychology adapted for the needs of Swiss Armed Forces. ART is designed for healthy subjects to learn how to get over strain.
Diversity management training (DMT) aims to promote social skills and acts as control condition. DMT is part of the military training but not mandatory for the study population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Army Resilience Training | Experimental | Behavioral: Army Resilience TrainingResilience training: four training sessions of 90 minutes each (in week 3, 5, 6 and 7 of military training), in classroom, psychoeducational inputs on stress management and resilience related topics, cognitive behavioral interventions and moderated exercises |
| Diversity Management Training | Active comparator | Other: Diversity Management TrainingDiversity Management: four training sessions of 90 minutes each (in week 3, 5, 6 and 7 of military training), classroom, psychoeducational inputs on social awareness and exercises |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- military cadets of the Swiss Army Infantry Officers School Inf OS 10-1/17
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| Army Resilience TrainingAlso: Resilience TrainingThe Army Resilience Training consists four training sessions of 90 minutes each. Participants learn to reflect their stress management (including thinking, emotions, behavioral consequences; coping strategies) and build resilience using specific strategies. | Behavioural | Army Resilience Training |
| Diversity Management TrainingAlso: Diversity ManagementDiversity Management Training consists four training sessions of 90 minutes each. Participants learn about diversity and social awareness reflecting different situations and settings. | Other | Diversity Management Training |
Primary outcome
Change in heart rate variability (HRV)
Time frame: Weeks 2 (baseline) and 9 of the military training
Change is the difference from HRV at baseline (week 2) and after resilience training (intervention) in week 9
Area under the curve (AUC) with respect to changes of salivary cortisol titer
Time frame: Weeks 2 and 9 of the military training
During stress exposure; six saliva samples will be taken and analyzed for cortisol reactivity.
Change of Testosterone Levels
Time frame: Weeks 2 and 9 of the military training
During stress exposure; four saliva samples will be taken and analyzed for testosterone levels.
3 secondary outcomes
Intensity of acute psychological stress
Time frame: Weeks 2, 9 and 12 of the military training
Affect of acute psychological stress
Time frame: Weeks 2, 9 and 12 of the military training
Stress Appraisal
Time frame: Weeks 2, 9 and 12 of the military training
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 11 Jan 2019.
- 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.
Hubert Annen, PhD principal investigator
Military Academy at ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Army Resilience Training and Diversity Management Training in people with Psychological Stress and Psychological Adaptation, run by Military Academy at ETH Zurich at 1 site in Switzerland.
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 1 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 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in heart rate variability (HRV) (time frame: Weeks 2 (baseline) and 9 of the military training). 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 11 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.