<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/NCT02214264</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0572</org_study_id>
    <secondary_id>MLK2014</secondary_id>
    <nct_id>NCT02214264</nct_id>
  </id_info>
  <brief_title>Brief Trainings to Buffer Against Acute Stress Effects</brief_title>
  <official_title>Brief Trainings to Buffer Against Acute Stress Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate and compare the effectiveness of several brief&#xD;
      trainings based on contemplative practices and positive psychology to buffer against the&#xD;
      negative effects that acute stress has on behavior and cognitive abilities. The investigators&#xD;
      hypothesize that training will buffer against negative effects of acute stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be taught a stress reducing training (breath awareness, loving kindness&#xD;
      practice, gratitude exercise) and will practice using this technique for 10-15 minutes.&#xD;
      Following this, all participants will undergo the Cold Pressor Task (CPT) for up to 3&#xD;
      minutes.&#xD;
&#xD;
      Before and after these tasks, participant data related to attention, working memory, self&#xD;
      regulation, affect, and prosociality will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline performance on Operational Span task</measure>
    <time_frame>Baseline and 10 minutes following post stress induction</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in time spent on hand grip self regulation task</measure>
    <time_frame>Baseline and 30 minutes post stress induction</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline on likeability ratings of neutral stimuli</measure>
    <time_frame>Baseline and 1 minute post stress induction</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of trials completed in optional Generosity task</measure>
    <time_frame>40 minutes post stress induction</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Affect Schedule ratings at baseline</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Affect Schedule ratings after pre-test measures</measure>
    <time_frame>2 minutes before training</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Affect Schedule ratings after training</measure>
    <time_frame>1 minute after training</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Affect Schedule ratings after stress induction</measure>
    <time_frame>1 minute after stress induction</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Affect Schedule ratings after post-test</measure>
    <time_frame>1 minute after post-test measures</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Implicit Positive and Negative Affect Test at baseline</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Implicit Positive and Negative Affect Test after pre-test measures</measure>
    <time_frame>2 minutes before training</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Implicit Positive and Negative Affect Test after training</measure>
    <time_frame>1 minute after training</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Implicit Positive and Negative Affect Test after stress induction</measure>
    <time_frame>1 minute after stress induction</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Implicit Positive and Negative Affect Test after post-test</measure>
    <time_frame>1 minute after post-test</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant interest in participating in future training</measure>
    <time_frame>40 minutes post stress induction</time_frame>
    <description>Interest will be rated using a visual analog scale.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">172</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Loving-Kindness training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive Loving-Kindness meditation training for approximately 12 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breath Awareness training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive Breath Awareness meditation training for approximately 12 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gratitude training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Gratitude training for approximately 12 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants write and then think about the physical space in which they live (i.e., their home) for approximately 12 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Loving-Kindness meditation training</intervention_name>
    <description>Participants undergo training for approximately 12 minutes. Training involves guided reflections and intentions related to feeling loving-kindness towards the self and others.</description>
    <arm_group_label>Loving-Kindness training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breath Awareness meditation training</intervention_name>
    <description>Participants undergo training for approximately 12 minutes. Training involves guided awareness focused on sensations of breathing.</description>
    <arm_group_label>Breath Awareness training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Gratitude</intervention_name>
    <description>Participants undergo training for approximately 12 minutes. Training involves reflections of gratitude for people, events, and things in one's life.</description>
    <arm_group_label>Gratitude training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Participants will write and then think about the physical space in which they live (i.e., their home) for approximately 12 minutes.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergraduate psychology recruitment pool&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-native English speakers, pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stacey Schaefer</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin-Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>May 21, 2019</last_update_submitted>
  <last_update_submitted_qc>May 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02214264
org study id: 2014-0572
secondary id: MLK2014
nct id: NCT02214264
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate and compare the effectiveness of several brief
      trainings based on contemplative practices and positive psychology to buffer against the
      negative effects that acute stress has on behavior and cognitive abilities. The investigators
      hypothesize that training will buffer against negative effects of acute stress.
Participants will be taught a stress reducing training (breath awareness, loving kindness
      practice, gratitude exercise) and will practice using this technique for 10-15 minutes.
      Following this, all participants will undergo the Cold Pressor Task (CPT) for up to 3
      minutes.

      Before and after these tasks, participant data related to attention, working memory, self
      regulation, affect, and prosociality will be collected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change from baseline performance on Operational Span task
time frame: Baseline and 10 minutes following post stress induction
measure: Change from baseline in time spent on hand grip self regulation task
time frame: Baseline and 30 minutes post stress induction
measure: Change from baseline on likeability ratings of neutral stimuli
time frame: Baseline and 1 minute post stress induction
measure: Number of trials completed in optional Generosity task
time frame: 40 minutes post stress induction
measure: Positive and Negative Affect Schedule ratings at baseline
time frame: Baseline
measure: Positive and Negative Affect Schedule ratings after pre-test measures
time frame: 2 minutes before training
measure: Positive and Negative Affect Schedule ratings after training
time frame: 1 minute after training
measure: Positive and Negative Affect Schedule ratings after stress induction
time frame: 1 minute after stress induction
measure: Positive and Negative Affect Schedule ratings after post-test
time frame: 1 minute after post-test measures
measure: Implicit Positive and Negative Affect Test at baseline
time frame: Baseline
measure: Implicit Positive and Negative Affect Test after pre-test measures
time frame: 2 minutes before training
measure: Implicit Positive and Negative Affect Test after training
time frame: 1 minute after training
measure: Implicit Positive and Negative Affect Test after stress induction
time frame: 1 minute after stress induction
measure: Implicit Positive and Negative Affect Test after post-test
time frame: 1 minute after post-test
measure: Participant interest in participating in future training
time frame: 40 minutes post stress induction
description: Interest will be rated using a visual analog scale.
arm group label: Loving-Kindness training
arm group type: Experimental
description: Participants receive Loving-Kindness meditation training for approximately 12 minutes.
arm group label: Breath Awareness training
arm group type: Experimental
description: Participants receive Breath Awareness meditation training for approximately 12 minutes.
arm group label: Gratitude training
arm group type: Experimental
description: Participants will receive Gratitude training for approximately 12 minutes.
arm group label: Control
arm group type: Other
description: Participants write and then think about the physical space in which they live (i.e., their home) for approximately 12 minutes.
intervention type: Behavioral
intervention name: Loving-Kindness meditation training
description: Participants undergo training for approximately 12 minutes. Training involves guided reflections and intentions related to feeling loving-kindness towards the self and others.
arm group label: Loving-Kindness training
intervention type: Behavioral
intervention name: Breath Awareness meditation training
description: Participants undergo training for approximately 12 minutes. Training involves guided awareness focused on sensations of breathing.
arm group label: Breath Awareness training
intervention type: Behavioral
intervention name: Gratitude
description: Participants undergo training for approximately 12 minutes. Training involves reflections of gratitude for people, events, and things in one's life.
arm group label: Gratitude training
intervention type: Behavioral
intervention name: Control
description: Participants will write and then think about the physical space in which they live (i.e., their home) for approximately 12 minutes.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stacey Schaefer
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor