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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03242837
Other study ID # Project ID 2017-00841
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 14, 2017
Est. completion date August 17, 2018

Study information

Verified date January 2019
Source Military Academy at ETH Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date August 17, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 28 Years
Eligibility Inclusion Criteria:

- military cadets of the Swiss Army Infantry Officers School Inf OS 10-1/17

Exclusion Criteria:

Study Design


Intervention

Behavioral:
Army 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.
Other:
Diversity Management Training
Diversity Management Training consists four training sessions of 90 minutes each. Participants learn about diversity and social awareness reflecting different situations and settings.

Locations

Country Name City State
Switzerland Swiss Military Caserne Liestal Basel-Land

Sponsors (2)

Lead Sponsor Collaborator
Military Academy at ETH Zurich Swiss Armed Forces

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Resilience Resilience measured by following questionnaire: Brief Resilience Scale Weeks 1 and 15 of the military training and follow-up (+7 months)
Other Psychological Resistance Psychological Resistance measured by following questionnaire: Resilience Scale RS-11 Weeks 1 and 15 of the military training and follow-up (+7 months)
Other Perceived Stress Stress management measured by following questionnaire: Perceived Stress Questionnaire BWeeks 1 and 15 of the military training and follow-up (+7 months)
Other Stress Reactivity Stress management measured by following questionnaire: Stress Reactivity Scale BWeeks 1 and 15 of the military training and follow-up (+7 months)
Other Coping Strategies Stress management measured by following questionnaire: Coping Inventory for Stressful Situations Weeks 1 and 15 of the military training and follow-up (+7 months)
Other Cognitive Emotion Regulation Stress management measured by following questionnaire: Cognitive Emotion Regulation Questionnaire Weeks 1 and 15 of the military training and follow-up (+7 months)
Other Personality Personality measured by following questionnaire: NEO-Five Factor Inventory Weeks 1 and 15 of the military training and follow-up (+7 months)
Other Dark Triad Dark Triad measured by following questionnaire: Dark Triad / Dirty Dozen Weeks 1 and 15 of the military training and follow-up (+7 months)
Other Self-Esteem Self-Esteem measured by following questionnaire: Rosenberg Self Esteem Scale Weeks 1 and 15 of the military training and follow-up (+7 months)
Other Optimism Optimism measured by following questionnaire: Life Orientation Test Weeks 1 and 15 of the military training and follow-up (+7 months)
Other Social Support Social Support measured by following questionnaire: Berlin Social Support Scales Weeks 1 and 15 of the military training and follow-up (+7 months)
Other Health Health measured by following questionnaire: Maastricht Vital Exhaustion Questionnaire Weeks 1 and 15 of the military training and follow-up (+7 months)
Other Sleep Sleep measured by following questionnaire: Pittsburgh Sleep Quality Index Weeks 1 and 15 of the military training and follow-up (+7 months)
Other Leadership Leadership measured by following questionnaire: Leader Member Exchange Follow-up (+7 months)
Primary Change in heart rate variability (HRV) Change is the difference from HRV at baseline (week 2) and after resilience training (intervention) in week 9 Weeks 2 (baseline) and 9 of the military training
Primary 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. Weeks 2 and 9 of the military training
Primary Change of Testosterone Levels During stress exposure; four saliva samples will be taken and analyzed for testosterone levels. Weeks 2 and 9 of the military training
Secondary Intensity of acute psychological stress Perceived stress intensity measured by Visual Analogue Scale Weeks 2, 9 and 12 of the military training
Secondary Affect of acute psychological stress Perceived stress measured by Positive Negative Affect Weeks 2, 9 and 12 of the military training
Secondary Stress Appraisal Perceived stress appraisal measured by Primary and Secondary Appraisal Weeks 2, 9 and 12 of the military training
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