<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/NCT03289156</url>
  </required_header>
  <id_info>
    <org_study_id>2017-05-0011</org_study_id>
    <nct_id>NCT03289156</nct_id>
  </id_info>
  <brief_title>Strategies for Responding to Stress</brief_title>
  <official_title>Strategies for Responding to Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas at Austin</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to examine whether changes in psychological and physiological&#xD;
      responses differ based on different strategies for responding to stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine whether changes in psychological and physiological&#xD;
      responses differ based on different strategies for responding to stress. Different strategies&#xD;
      being examined in this study include exercise and arousal reappraisal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</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>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stress Reappraisal</measure>
    <time_frame>One day</time_frame>
    <description>Self-report ratings of appraisal of a lab based stressor as threatening or challenging.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychological Response to Stress</measure>
    <time_frame>One day</time_frame>
    <description>Self-report ratings of perceived stress, anxiety, and fear in response to a lab based psychosocial stressor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological Response to Stress</measure>
    <time_frame>One day</time_frame>
    <description>Heart rate in response to a lab based psychosocial stressor as threatening or challenging.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Arousal Reappraisal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brief educational intervention about the stress response and arousal reappraisal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three 5-minute bouts of aerobic exercise at increasing intensities</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arousal Reappraisal + Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brief educational intervention about the stress response and arousal reappraisal followed by three 5-minute bouts of aerobic exercise at increasing intensities with practice applying the arousal reappraisal learned earlier.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Time-matched rest</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Arousal Reappraisal</intervention_name>
    <description>Brief readings educating about the stress response and usefulness of arousal reappraisal.</description>
    <arm_group_label>Arousal Reappraisal</arm_group_label>
    <arm_group_label>Arousal Reappraisal + Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Three 5-minute bouts of exercise at increasing intensities (65%, 75%, and 85%) with 5-15 minute breaks in-between for recovery.</description>
    <arm_group_label>Arousal Reappraisal + Exercise</arm_group_label>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females ages 18 to 35&#xD;
&#xD;
          -  Speaks English fluently&#xD;
&#xD;
          -  Passes the Physical Activity Readiness Questionnaire-Plus&#xD;
&#xD;
          -  Mild to Moderate depression symptoms as measured by the Beck Depression Inventory-II&#xD;
             (a score ≥14 but ≤25)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hearing or visually impaired such that it will interfere with ability to participate&#xD;
             effectively&#xD;
&#xD;
          -  Currently exercising regularly, defined as exercising at a moderate-intensity more&#xD;
             than 2 times a week, for at least 20 minutes each time.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jolene Jacquart, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas at Austin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas at Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
    <investigator_full_name>Jolene Jacquart</investigator_full_name>
    <investigator_title>Graduate Student</investigator_title>
  </responsible_party>
  <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/NCT03289156
org study id: 2017-05-0011
nct id: NCT03289156
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine whether changes in psychological and physiological
      responses differ based on different strategies for responding to stress.
The purpose of this study is to examine whether changes in psychological and physiological
      responses differ based on different strategies for responding to stress. Different strategies
      being examined in this study include exercise and arousal reappraisal.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: None (Open Label)
measure: Stress Reappraisal
time frame: One day
description: Self-report ratings of appraisal of a lab based stressor as threatening or challenging.
measure: Psychological Response to Stress
time frame: One day
description: Self-report ratings of perceived stress, anxiety, and fear in response to a lab based psychosocial stressor.
measure: Physiological Response to Stress
time frame: One day
description: Heart rate in response to a lab based psychosocial stressor as threatening or challenging.
arm group label: Arousal Reappraisal
arm group type: Active Comparator
description: Brief educational intervention about the stress response and arousal reappraisal
arm group label: Exercise
arm group type: Active Comparator
description: Three 5-minute bouts of aerobic exercise at increasing intensities
arm group label: Arousal Reappraisal + Exercise
arm group type: Experimental
description: Brief educational intervention about the stress response and arousal reappraisal followed by three 5-minute bouts of aerobic exercise at increasing intensities with practice applying the arousal reappraisal learned earlier.
arm group label: Control
arm group type: No Intervention
description: Time-matched rest
intervention type: Behavioral
intervention name: Arousal Reappraisal
description: Brief readings educating about the stress response and usefulness of arousal reappraisal.
arm group label: Arousal Reappraisal
arm group label: Arousal Reappraisal + Exercise
intervention type: Behavioral
intervention name: Exercise
description: Three 5-minute bouts of exercise at increasing intensities (65%, 75%, and 85%) with 5-15 minute breaks in-between for recovery.
arm group label: Arousal Reappraisal + Exercise
arm group label: Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jolene Jacquart, MA
role: Principal Investigator
affiliation: University of Texas at Austin
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas at Austin
investigator full name: Jolene Jacquart
investigator title: Graduate Student
sharing ipd: No