<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03242837</url>
  </required_header>
  <id_info>
    <org_study_id>Project ID 2017-00841</org_study_id>
    <nct_id>NCT03242837</nct_id>
  </id_info>
  <brief_title>Psychobiological Evaluation of the Army Resilience Training</brief_title>
  <acronym>OpPHX</acronym>
  <official_title>Psychobiological Evaluation of the Army Resilience Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Military Academy at ETH Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss Armed Forces</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Military Academy at ETH Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the influence of a resilience training on psychobiological factors which&#xD;
      are related to stress and resilience in young healthy male cadets. Half of participants will&#xD;
      join in the resilience training, while the other half take part in a control-training&#xD;
      (diversity management training).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The resilience training (Army Resilience Training / ART) is a stress prevention program based&#xD;
      on well established methods from Cognitive Behavioral Therapy (CBT) and Positive Psychology&#xD;
      adapted for the needs of Swiss Armed Forces. ART is designed for healthy subjects to learn&#xD;
      how to get over strain.&#xD;
&#xD;
      Diversity management training (DMT) aims to promote social skills and acts as control&#xD;
      condition. DMT is part of the military training but not mandatory for the study population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">August 17, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in heart rate variability (HRV)</measure>
    <time_frame>Weeks 2 (baseline) and 9 of the military training</time_frame>
    <description>Change is the difference from HRV at baseline (week 2) and after resilience training (intervention) in week 9</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve (AUC) with respect to changes of salivary cortisol titer</measure>
    <time_frame>Weeks 2 and 9 of the military training</time_frame>
    <description>During stress exposure; six saliva samples will be taken and analyzed for cortisol reactivity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Testosterone Levels</measure>
    <time_frame>Weeks 2 and 9 of the military training</time_frame>
    <description>During stress exposure; four saliva samples will be taken and analyzed for testosterone levels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensity of acute psychological stress</measure>
    <time_frame>Weeks 2, 9 and 12 of the military training</time_frame>
    <description>Perceived stress intensity measured by Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Affect of acute psychological stress</measure>
    <time_frame>Weeks 2, 9 and 12 of the military training</time_frame>
    <description>Perceived stress measured by Positive Negative Affect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress Appraisal</measure>
    <time_frame>Weeks 2, 9 and 12 of the military training</time_frame>
    <description>Perceived stress appraisal measured by Primary and Secondary Appraisal</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Resilience</measure>
    <time_frame>Weeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Resilience measured by following questionnaire: Brief Resilience Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Psychological Resistance</measure>
    <time_frame>Weeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Psychological Resistance measured by following questionnaire: Resilience Scale RS-11</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived Stress</measure>
    <time_frame>BWeeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Stress management measured by following questionnaire: Perceived Stress Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Stress Reactivity</measure>
    <time_frame>BWeeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Stress management measured by following questionnaire: Stress Reactivity Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Coping Strategies</measure>
    <time_frame>Weeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Stress management measured by following questionnaire: Coping Inventory for Stressful Situations</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive Emotion Regulation</measure>
    <time_frame>Weeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Stress management measured by following questionnaire: Cognitive Emotion Regulation Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Personality</measure>
    <time_frame>Weeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Personality measured by following questionnaire: NEO-Five Factor Inventory</description>
  </other_outcome>
  <other_outcome>
    <measure>Dark Triad</measure>
    <time_frame>Weeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Dark Triad measured by following questionnaire: Dark Triad / Dirty Dozen</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-Esteem</measure>
    <time_frame>Weeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Self-Esteem measured by following questionnaire: Rosenberg Self Esteem Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Optimism</measure>
    <time_frame>Weeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Optimism measured by following questionnaire: Life Orientation Test</description>
  </other_outcome>
  <other_outcome>
    <measure>Social Support</measure>
    <time_frame>Weeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Social Support measured by following questionnaire: Berlin Social Support Scales</description>
  </other_outcome>
  <other_outcome>
    <measure>Health</measure>
    <time_frame>Weeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Health measured by following questionnaire: Maastricht Vital Exhaustion Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep</measure>
    <time_frame>Weeks 1 and 15 of the military training and follow-up (+7 months)</time_frame>
    <description>Sleep measured by following questionnaire: Pittsburgh Sleep Quality Index</description>
  </other_outcome>
  <other_outcome>
    <measure>Leadership</measure>
    <time_frame>Follow-up (+7 months)</time_frame>
    <description>Leadership measured by following questionnaire: Leader Member Exchange</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Psychological Stress</condition>
  <condition>Psychological Adaptation</condition>
  <arm_group>
    <arm_group_label>Army Resilience Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diversity Management Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Army Resilience Training</intervention_name>
    <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.</description>
    <arm_group_label>Army Resilience Training</arm_group_label>
    <other_name>Resilience Training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diversity Management Training</intervention_name>
    <description>Diversity Management Training consists four training sessions of 90 minutes each. Participants learn about diversity and social awareness reflecting different situations and settings.</description>
    <arm_group_label>Diversity Management Training</arm_group_label>
    <other_name>Diversity Management</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  military cadets of the Swiss Army Infantry Officers School Inf OS 10-1/17&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>28 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hubert Annen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Military Academy at ETH Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Swiss Military Caserne</name>
      <address>
        <city>Liestal</city>
        <state>Basel-Land</state>
        <zip>4410</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03242837
org study id: Project ID 2017-00841
nct id: NCT03242837
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in heart rate variability (HRV)
time frame: Weeks 2 (baseline) and 9 of the military training
description: Change is the difference from HRV at baseline (week 2) and after resilience training (intervention) in week 9
measure: Area under the curve (AUC) with respect to changes of salivary cortisol titer
time frame: Weeks 2 and 9 of the military training
description: During stress exposure; six saliva samples will be taken and analyzed for cortisol reactivity.
measure: Change of Testosterone Levels
time frame: Weeks 2 and 9 of the military training
description: During stress exposure; four saliva samples will be taken and analyzed for testosterone levels.
measure: Intensity of acute psychological stress
time frame: Weeks 2, 9 and 12 of the military training
description: Perceived stress intensity measured by Visual Analogue Scale
measure: Affect of acute psychological stress
time frame: Weeks 2, 9 and 12 of the military training
description: Perceived stress measured by Positive Negative Affect
measure: Stress Appraisal
time frame: Weeks 2, 9 and 12 of the military training
description: Perceived stress appraisal measured by Primary and Secondary Appraisal
measure: Resilience
time frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
description: Resilience measured by following questionnaire: Brief Resilience Scale
measure: Psychological Resistance
time frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
description: Psychological Resistance measured by following questionnaire: Resilience Scale RS-11
measure: Perceived Stress
time frame: BWeeks 1 and 15 of the military training and follow-up (+7 months)
description: Stress management measured by following questionnaire: Perceived Stress Questionnaire
measure: Stress Reactivity
time frame: BWeeks 1 and 15 of the military training and follow-up (+7 months)
description: Stress management measured by following questionnaire: Stress Reactivity Scale
measure: Coping Strategies
time frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
description: Stress management measured by following questionnaire: Coping Inventory for Stressful Situations
measure: Cognitive Emotion Regulation
time frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
description: Stress management measured by following questionnaire: Cognitive Emotion Regulation Questionnaire
measure: Personality
time frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
description: Personality measured by following questionnaire: NEO-Five Factor Inventory
measure: Dark Triad
time frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
description: Dark Triad measured by following questionnaire: Dark Triad / Dirty Dozen
measure: Self-Esteem
time frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
description: Self-Esteem measured by following questionnaire: Rosenberg Self Esteem Scale
measure: Optimism
time frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
description: Optimism measured by following questionnaire: Life Orientation Test
measure: Social Support
time frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
description: Social Support measured by following questionnaire: Berlin Social Support Scales
measure: Health
time frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
description: Health measured by following questionnaire: Maastricht Vital Exhaustion Questionnaire
measure: Sleep
time frame: Weeks 1 and 15 of the military training and follow-up (+7 months)
description: Sleep measured by following questionnaire: Pittsburgh Sleep Quality Index
measure: Leadership
time frame: Follow-up (+7 months)
description: Leadership measured by following questionnaire: Leader Member Exchange
arm group label: Army Resilience Training
arm group type: Experimental
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 group label: Diversity Management Training
arm group type: Active Comparator
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: Army Resilience Training
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.
arm group label: Army Resilience Training
other name: Resilience Training
intervention type: Other
intervention name: Diversity Management Training
description: Diversity Management Training consists four training sessions of 90 minutes each. Participants learn about diversity and social awareness reflecting different situations and settings.
arm group label: Diversity Management Training
other name: Diversity Management
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 28 Years
healthy volunteers: No
last name: Hubert Annen, PhD
role: Principal Investigator
affiliation: Military Academy at ETH Zurich
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Stress, Psychological
sharing ipd: No