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Psychobiological Evaluation of the Army Resilience Training (OpPHX)

Primary Purpose

Psychological Stress, Psychological Adaptation

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Army Resilience Training
Diversity Management Training
Sponsored by
Military Academy at ETH Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychological Stress

Eligibility Criteria

18 Years - 28 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • no

Sites / Locations

  • Swiss Military Caserne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Army Resilience Training

Diversity Management Training

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in heart rate variability (HRV)
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
During stress exposure; six saliva samples will be taken and analyzed for cortisol reactivity.
Change of Testosterone Levels
During stress exposure; four saliva samples will be taken and analyzed for testosterone levels.

Secondary Outcome Measures

Intensity of acute psychological stress
Perceived stress intensity measured by Visual Analogue Scale
Affect of acute psychological stress
Perceived stress measured by Positive Negative Affect
Stress Appraisal
Perceived stress appraisal measured by Primary and Secondary Appraisal

Full Information

First Posted
July 26, 2017
Last Updated
January 10, 2019
Sponsor
Military Academy at ETH Zurich
Collaborators
Swiss Armed Forces
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1. Study Identification

Unique Protocol Identification Number
NCT03242837
Brief Title
Psychobiological Evaluation of the Army Resilience Training
Acronym
OpPHX
Official Title
Psychobiological Evaluation of the Army Resilience Training
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
August 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Military Academy at ETH Zurich
Collaborators
Swiss Armed Forces

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Psychological Adaptation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Army Resilience Training
Arm Type
Experimental
Arm Description
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
Arm Title
Diversity Management Training
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Army Resilience Training
Other Intervention Name(s)
Resilience Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Diversity Management Training
Other Intervention Name(s)
Diversity Management
Intervention Description
Diversity Management Training consists four training sessions of 90 minutes each. Participants learn about diversity and social awareness reflecting different situations and settings.
Primary Outcome Measure Information:
Title
Change in heart rate variability (HRV)
Description
Change is the difference from HRV at baseline (week 2) and after resilience training (intervention) in week 9
Time Frame
Weeks 2 (baseline) and 9 of the military training
Title
Area under the curve (AUC) with respect to changes of salivary cortisol titer
Description
During stress exposure; six saliva samples will be taken and analyzed for cortisol reactivity.
Time Frame
Weeks 2 and 9 of the military training
Title
Change of Testosterone Levels
Description
During stress exposure; four saliva samples will be taken and analyzed for testosterone levels.
Time Frame
Weeks 2 and 9 of the military training
Secondary Outcome Measure Information:
Title
Intensity of acute psychological stress
Description
Perceived stress intensity measured by Visual Analogue Scale
Time Frame
Weeks 2, 9 and 12 of the military training
Title
Affect of acute psychological stress
Description
Perceived stress measured by Positive Negative Affect
Time Frame
Weeks 2, 9 and 12 of the military training
Title
Stress Appraisal
Description
Perceived stress appraisal measured by Primary and Secondary Appraisal
Time Frame
Weeks 2, 9 and 12 of the military training
Other Pre-specified Outcome Measures:
Title
Resilience
Description
Resilience measured by following questionnaire: Brief Resilience Scale
Time Frame
Weeks 1 and 15 of the military training and follow-up (+7 months)
Title
Psychological Resistance
Description
Psychological Resistance measured by following questionnaire: Resilience Scale RS-11
Time Frame
Weeks 1 and 15 of the military training and follow-up (+7 months)
Title
Perceived Stress
Description
Stress management measured by following questionnaire: Perceived Stress Questionnaire
Time Frame
BWeeks 1 and 15 of the military training and follow-up (+7 months)
Title
Stress Reactivity
Description
Stress management measured by following questionnaire: Stress Reactivity Scale
Time Frame
BWeeks 1 and 15 of the military training and follow-up (+7 months)
Title
Coping Strategies
Description
Stress management measured by following questionnaire: Coping Inventory for Stressful Situations
Time Frame
Weeks 1 and 15 of the military training and follow-up (+7 months)
Title
Cognitive Emotion Regulation
Description
Stress management measured by following questionnaire: Cognitive Emotion Regulation Questionnaire
Time Frame
Weeks 1 and 15 of the military training and follow-up (+7 months)
Title
Personality
Description
Personality measured by following questionnaire: NEO-Five Factor Inventory
Time Frame
Weeks 1 and 15 of the military training and follow-up (+7 months)
Title
Dark Triad
Description
Dark Triad measured by following questionnaire: Dark Triad / Dirty Dozen
Time Frame
Weeks 1 and 15 of the military training and follow-up (+7 months)
Title
Self-Esteem
Description
Self-Esteem measured by following questionnaire: Rosenberg Self Esteem Scale
Time Frame
Weeks 1 and 15 of the military training and follow-up (+7 months)
Title
Optimism
Description
Optimism measured by following questionnaire: Life Orientation Test
Time Frame
Weeks 1 and 15 of the military training and follow-up (+7 months)
Title
Social Support
Description
Social Support measured by following questionnaire: Berlin Social Support Scales
Time Frame
Weeks 1 and 15 of the military training and follow-up (+7 months)
Title
Health
Description
Health measured by following questionnaire: Maastricht Vital Exhaustion Questionnaire
Time Frame
Weeks 1 and 15 of the military training and follow-up (+7 months)
Title
Sleep
Description
Sleep measured by following questionnaire: Pittsburgh Sleep Quality Index
Time Frame
Weeks 1 and 15 of the military training and follow-up (+7 months)
Title
Leadership
Description
Leadership measured by following questionnaire: Leader Member Exchange
Time Frame
Follow-up (+7 months)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: military cadets of the Swiss Army Infantry Officers School Inf OS 10-1/17 Exclusion Criteria: no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert Annen, PhD
Organizational Affiliation
Military Academy at ETH Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Military Caserne
City
Liestal
State/Province
Basel-Land
ZIP/Postal Code
4410
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Psychobiological Evaluation of the Army Resilience Training

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