Psychobiological Evaluation of the Army Resilience Training (OpPHX)

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).

Study Overview

• Status: Completed
• Conditions: Psychological Stress; Psychological Adaptation
• Intervention / Treatment: Behavioral: Army Resilience Training; Other: 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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Land
    • Liestal, Basel-Land, Switzerland, 4410
      • Swiss Military Caserne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Army Resilience Training; 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; 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 Names: Resilience Training
Active Comparator: Diversity Management Training; 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; Diversity Management Training consists four training sessions of 90 minutes each. Participants learn about diversity and social awareness reflecting different situations and settings.; Other Names: Diversity Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of acute psychological stress	Perceived stress intensity measured by Visual Analogue Scale	Weeks 2, 9 and 12 of the military training
Affect of acute psychological stress	Perceived stress measured by Positive Negative Affect	Weeks 2, 9 and 12 of the military training
Stress Appraisal	Perceived stress appraisal measured by Primary and Secondary Appraisal	Weeks 2, 9 and 12 of the military training

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resilience	Resilience measured by following questionnaire: Brief Resilience Scale	Weeks 1 and 15 of the military training and follow-up (+7 months)
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)
Perceived Stress	Stress management measured by following questionnaire: Perceived Stress Questionnaire	BWeeks 1 and 15 of the military training and follow-up (+7 months)
Stress Reactivity	Stress management measured by following questionnaire: Stress Reactivity Scale	BWeeks 1 and 15 of the military training and follow-up (+7 months)
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)
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)
Personality	Personality measured by following questionnaire: NEO-Five Factor Inventory	Weeks 1 and 15 of the military training and follow-up (+7 months)
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)
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)
Optimism	Optimism measured by following questionnaire: Life Orientation Test	Weeks 1 and 15 of the military training and follow-up (+7 months)
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)
Health	Health measured by following questionnaire: Maastricht Vital Exhaustion Questionnaire	Weeks 1 and 15 of the military training and follow-up (+7 months)
Sleep	Sleep measured by following questionnaire: Pittsburgh Sleep Quality Index	Weeks 1 and 15 of the military training and follow-up (+7 months)
Leadership	Leadership measured by following questionnaire: Leader Member Exchange	Follow-up (+7 months)

Collaborators and Investigators

• Sponsor: Military Academy at ETH Zurich
• Collaborators: Swiss Armed Forces
• Investigators: Principal Investigator: Hubert Annen, PhD, Military Academy at ETH Zurich

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): August 17, 2018

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: Project ID 2017-00841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No