NCT03242837

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

August 14, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2018

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

July 26, 2017

Last Update Submit

January 10, 2019

Conditions

Psychological StressPsychological Adaptation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Intensity of acute psychological stress

    Weeks 2, 9 and 12 of the military training

  • Affect of acute psychological stress

    Weeks 2, 9 and 12 of the military training

  • Stress Appraisal

    Weeks 2, 9 and 12 of the military training

Other Outcomes (14)

  • Resilience

    Weeks 1 and 15 of the military training and follow-up (+7 months)

  • Psychological Resistance

    Weeks 1 and 15 of the military training and follow-up (+7 months)

  • Perceived Stress

    BWeeks 1 and 15 of the military training and follow-up (+7 months)

  • +11 more other outcomes

Study Arms (2)

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

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

Other: Diversity Management Training

Interventions

Army Resilience TrainingBEHAVIORAL

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.

Also known as: Resilience Training
Army Resilience Training
Diversity Management TrainingOTHER

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

Also known as: Diversity Management
Diversity Management Training

Eligibility Criteria

Age18 Years - 28 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Military Caserne

Liestal, Basel-Landschaft, 4410, Switzerland

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Hubert Annen, PhD

    Military Academy at ETH Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 8, 2017

Study Start

August 14, 2017

Primary Completion

July 31, 2018

Study Completion

August 17, 2018

Last Updated

January 11, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)