Psychobiological Evaluation of the Army Resilience Training (OpPHX)

January 10, 2019 updated by: Military Academy at ETH Zurich
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Weeks 2 (baseline) and 9 of the military training
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.
Weeks 2 and 9 of the military training
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.
Weeks 2 and 9 of the military training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intensity of acute psychological stress
Time Frame: Weeks 2, 9 and 12 of the military training
Perceived stress intensity measured by Visual Analogue Scale
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
Perceived stress measured by Positive Negative Affect
Weeks 2, 9 and 12 of the military training
Stress Appraisal
Time Frame: Weeks 2, 9 and 12 of the military training
Perceived stress appraisal measured by Primary and Secondary Appraisal
Weeks 2, 9 and 12 of the military training

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resilience
Time Frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
Resilience measured by following questionnaire: Brief Resilience Scale
Weeks 1 and 15 of the military training and follow-up (+7 months)
Psychological Resistance
Time Frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
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
Time Frame: BWeeks 1 and 15 of the military training and follow-up (+7 months)
Stress management measured by following questionnaire: Perceived Stress Questionnaire
BWeeks 1 and 15 of the military training and follow-up (+7 months)
Stress Reactivity
Time Frame: BWeeks 1 and 15 of the military training and follow-up (+7 months)
Stress management measured by following questionnaire: Stress Reactivity Scale
BWeeks 1 and 15 of the military training and follow-up (+7 months)
Coping Strategies
Time Frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
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
Time Frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
Stress management measured by following questionnaire: Cognitive Emotion Regulation Questionnaire
Weeks 1 and 15 of the military training and follow-up (+7 months)
Personality
Time Frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
Personality measured by following questionnaire: NEO-Five Factor Inventory
Weeks 1 and 15 of the military training and follow-up (+7 months)
Dark Triad
Time Frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
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
Time Frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
Self-Esteem measured by following questionnaire: Rosenberg Self Esteem Scale
Weeks 1 and 15 of the military training and follow-up (+7 months)
Optimism
Time Frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
Optimism measured by following questionnaire: Life Orientation Test
Weeks 1 and 15 of the military training and follow-up (+7 months)
Social Support
Time Frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
Social Support measured by following questionnaire: Berlin Social Support Scales
Weeks 1 and 15 of the military training and follow-up (+7 months)
Health
Time Frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
Health measured by following questionnaire: Maastricht Vital Exhaustion Questionnaire
Weeks 1 and 15 of the military training and follow-up (+7 months)
Sleep
Time Frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
Sleep measured by following questionnaire: Pittsburgh Sleep Quality Index
Weeks 1 and 15 of the military training and follow-up (+7 months)
Leadership
Time Frame: Follow-up (+7 months)
Leadership measured by following questionnaire: Leader Member Exchange
Follow-up (+7 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Military Academy at ETH Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss Armed Forces

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hubert Annen, PhD, Military Academy at ETH Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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