<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/NCT04496258</url>
  </required_header>
  <id_info>
    <org_study_id>1606445</org_study_id>
    <nct_id>NCT04496258</nct_id>
  </id_info>
  <brief_title>Investigating the Neural Systems That Support the Beneficial Effects of Positive Emotion on Stress Regulation</brief_title>
  <official_title>Investigating the Neural Systems That Support the Beneficial Effects of Positive Emotion on Stress Regulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wake Forest University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Denver</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>
      For this study, community participants will visit the PI's psychophysiology lab for a single&#xD;
      experimental session. In this study, participants will complete pre-task questionnaires&#xD;
      (trait measures), and a brief mood measure, followed by a task training in which a research&#xD;
      assistant describes and gives examples of cognitive reappraisal in response to negative&#xD;
      images. Participants are then randomly assigned to positive or neutral emotion induction&#xD;
      conditions, to be delivered by virtual reality. Then, participants complete an event-related,&#xD;
      picture-based cognitive reappraisal task for 30-45 minutes, during which skin conductance&#xD;
      level will be collected. Following the task, participants will once again respond to a mood&#xD;
      measure, and answer a series of questions regarding the task they have completed, including&#xD;
      difficulty of regulation, or any images that were personally relevant.&#xD;
&#xD;
      The investigators predict that the positive emotion induction will result in powerful effects&#xD;
      on self-reported emotion and skin conductance, which may or may not interact with the&#xD;
      cognitive reappraisal condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For the studies, participants will be recruited via paper and electronic flyers on campus and&#xD;
      in the surrounding communities. Interested participants will be screened via phone, email&#xD;
      and/or web form to assess eligibility according to criteria listed elsewhere. Should&#xD;
      participants qualify, they will be invited to complete a single laboratory session in the&#xD;
      PI's psychophysiology lab.&#xD;
&#xD;
      Once arriving at the laboratory, participants will complete the consent process, in which a&#xD;
      research assistant trained in ethical principles regarding human subjects research will&#xD;
      answer any questions about the consent form and verbally reinforce the key rights of the&#xD;
      participants outlined there. Once both parties are satisfied, consent forms will be signed.&#xD;
&#xD;
      Participants will sit with a trained research assistant/experimenter who will give an&#xD;
      overview of the entire session, and then begin training for the cognitive reappraisal task.&#xD;
      This training takes 10-15 minutes. During the training, the experimenter will offer several&#xD;
      possible reappraisals of negative images and allow the participants to offer their own as&#xD;
      well, providing encouragement and feedback. During this training, the experimenter will also&#xD;
      go over the method of encouragement and feedback. During this training, the experimenter will&#xD;
      also go over the method of responding (using the VR equipment). Participants will be reminded&#xD;
      during training that they may stop the experiment at any point if the pictures are too&#xD;
      upsetting.&#xD;
&#xD;
      Immediately following task training, participants will make a general mood rating using the&#xD;
      PANAS. Then, they will be randomly assigned to a positive or neutral mood induction, to be&#xD;
      delivered by 10 minutes exploring a positive (beach scene) or neutral (office scene) VR&#xD;
      environment using a headset with integrated audio. After the VR exploration, participants&#xD;
      will complete the reappraisal task. The task will take just under 20 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2021</start_date>
  <completion_date type="Actual">April 14, 2022</completion_date>
  <primary_completion_date type="Actual">April 14, 2022</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported emotion ratings</measure>
    <time_frame>During the task intervention which will last 18 minutes</time_frame>
    <description>Participants will be rating their negative and positive emotions during the intervention. They will be asked &quot;How positive do you feel?&quot; and &quot;How negative do you feel?&quot; after each image and will answer on a scale of 1-9 with 1 being low (&quot;I don't feel positive at all&quot; or &quot;I don't feel negative at all&quot;) to 9 (&quot;I feel very positive&quot; or &quot;I feel very negative&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Means of self-reported emotion ratings</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>The mean of each negative and positive emotion score will be calculated post-intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin conductance level</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>The researchers will place electrodes on the palm and will measure changes in conductance in response to negative/neutral images.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mood ratings</measure>
    <time_frame>Pre-intervention and immediately after the intervention</time_frame>
    <description>Pre- and post-task mood as measured by the Positive and Negative Affect Schedule (PANAS) will be taken before and after the intervention. The PANAS is a 20-question questionnaire rated on a scale of 1 to 5 (with 1 being &quot;very slight or not at all&quot; and 5 being &quot;extremely&quot;). Questions 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19 represent the positive affect scale with scores ranging between 10 and 50 (the higher the score, the higher the levels of positive affect). Questions 2, 4, 6, 7, 8, 11, 13, 15,18, and 20 represent the negative affect scale with scores falling between 10 and 50 (lower scores represent lower levels of negative affect).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Debriefing of instructions</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>Following the VR task, participants will be asked to report the task instructions in their own words. The first questions will ask participants to reiterate the instructions they were given for the cognitive reappraisal task (for example: &quot;What were you instructed to do during the 'LOOK' trials?&quot;) This is a fill in the blank question and there are no right or wrong answers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Task difficulty</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>The next batch of questions will ask the participant questions about the difficulty of the task. An example question is &quot;How difficult was it to follow the 'LOOK' instruction?&quot; Participants will be rating the level of difficulty on a scale of 1 to 7 with 1 being &quot;not difficult at all&quot; to 7 being &quot;very difficult&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Task compliance</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>Participants will be asked about self-reported task compliance. For example, one question will ask &quot;What percentage of the time were you able to follow the &quot;LOOK&quot; instruction?&quot; The participants will be rating their self-compliance for each task from 0% (non-compliant) to 100% (fully compliant).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experience with task images</measure>
    <time_frame>Immediately after the intervention</time_frame>
    <description>Participants will be asked whether they have any experience with reappraisal or the specific images presented in the task. The first question will ask &quot;Have you ever been trained to change your emotions by changing the way you think (in therapy, or in another experiment, or anywhere else)?&quot; Participants can choose &quot;Yes&quot; or &quot;No&quot; for this question. The participant will have to extrapolate if they have changed their emotions before using a fill in the blank. The next question will ask &quot;Have you ever seen any of these exact emotional images before?&quot; The participant then once again will be asked to extrapolate which images they have seen and what emotional response was generated by these images using a fill in the blank option.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Depression trait differences</measure>
    <time_frame>Baseline</time_frame>
    <description>The participants will be given the Beck's Depression Inventory(BDI-II) which measures symptoms of depression and will be used to examine any between-subjects trait differences. The BDI-II is a 21 self-report measure looking at symptoms of depression with ratings falling between 0 and 3 (0 being &quot;not at all&quot; and 3 would indicate experiencing these symptoms on a constant basis).</description>
  </other_outcome>
  <other_outcome>
    <measure>Emotional regulation trait differences</measure>
    <time_frame>Baseline</time_frame>
    <description>The Emotion Regulation Questionnaire (ERQ) looks at methods of regulating emotions and will be used to examine any between-subjects trait differences. The ERQ is a 10-item self-report questionnaire assessing the use of two strategies to alter emotions: cognitive reappraisal and expressive suppression. The scale is rated on a 7-point Likert scale with 1 being &quot;strongly disagree&quot; and 7 being &quot;strongly agree&quot;. Six items are categorized as using cognitive reappraisal while four of the items assess expressive suppression.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Behavior</condition>
  <arm_group>
    <arm_group_label>Positive VR Scene</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will explore a virtual reality (VR) environment of a beach scene. Participants will be randomly assigned (between subjects) to beach or office scene. VR will be presented on an Occulus Rift device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neutral VR Scene</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will explore a virtual reality (VR) environment of a neutral office scene. Participants will be randomly assigned (between subjects) to beach or office scene. VR will be presented on an Occulus Rift device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive Emotion Induction</intervention_name>
    <description>Participants are expected to have a positive emotional response to the more positive beach scene.</description>
    <arm_group_label>Positive VR Scene</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neutral Emotion Induction</intervention_name>
    <description>Participants are expected to have a neutral emotional response to the neutral office scene.</description>
    <arm_group_label>Neutral VR Scene</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Community members ages 18-55&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  Without present psychotic symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kateri McRae, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Denver, Frontier Hall</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Denver</investigator_affiliation>
    <investigator_full_name>Kateri McRae</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>cognition</keyword>
  <keyword>reappraisal</keyword>
  <pending_results>
    <submitted>July 5, 2023</submitted>
    <submission_canceled>September 7, 2023</submission_canceled>
  </pending_results>
  <!-- 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/NCT04496258
org study id: 1606445
nct id: NCT04496258
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
For this study, community participants will visit the PI's psychophysiology lab for a single
      experimental session. In this study, participants will complete pre-task questionnaires
      (trait measures), and a brief mood measure, followed by a task training in which a research
      assistant describes and gives examples of cognitive reappraisal in response to negative
      images. Participants are then randomly assigned to positive or neutral emotion induction
      conditions, to be delivered by virtual reality. Then, participants complete an event-related,
      picture-based cognitive reappraisal task for 30-45 minutes, during which skin conductance
      level will be collected. Following the task, participants will once again respond to a mood
      measure, and answer a series of questions regarding the task they have completed, including
      difficulty of regulation, or any images that were personally relevant.

      The investigators predict that the positive emotion induction will result in powerful effects
      on self-reported emotion and skin conductance, which may or may not interact with the
      cognitive reappraisal condition.
For the studies, participants will be recruited via paper and electronic flyers on campus and
      in the surrounding communities. Interested participants will be screened via phone, email
      and/or web form to assess eligibility according to criteria listed elsewhere. Should
      participants qualify, they will be invited to complete a single laboratory session in the
      PI's psychophysiology lab.

      Once arriving at the laboratory, participants will complete the consent process, in which a
      research assistant trained in ethical principles regarding human subjects research will
      answer any questions about the consent form and verbally reinforce the key rights of the
      participants outlined there. Once both parties are satisfied, consent forms will be signed.

      Participants will sit with a trained research assistant/experimenter who will give an
      overview of the entire session, and then begin training for the cognitive reappraisal task.
      This training takes 10-15 minutes. During the training, the experimenter will offer several
      possible reappraisals of negative images and allow the participants to offer their own as
      well, providing encouragement and feedback. During this training, the experimenter will also
      go over the method of encouragement and feedback. During this training, the experimenter will
      also go over the method of responding (using the VR equipment). Participants will be reminded
      during training that they may stop the experiment at any point if the pictures are too
      upsetting.

      Immediately following task training, participants will make a general mood rating using the
      PANAS. Then, they will be randomly assigned to a positive or neutral mood induction, to be
      delivered by 10 minutes exploring a positive (beach scene) or neutral (office scene) VR
      environment using a headset with integrated audio. After the VR exploration, participants
      will complete the reappraisal task. The task will take just under 20 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Self-reported emotion ratings
time frame: During the task intervention which will last 18 minutes
description: Participants will be rating their negative and positive emotions during the intervention. They will be asked "How positive do you feel?" and "How negative do you feel?" after each image and will answer on a scale of 1-9 with 1 being low ("I don't feel positive at all" or "I don't feel negative at all") to 9 ("I feel very positive" or "I feel very negative").
measure: Means of self-reported emotion ratings
time frame: Immediately after the intervention
description: The mean of each negative and positive emotion score will be calculated post-intervention.
measure: Skin conductance level
time frame: Immediately after the intervention
description: The researchers will place electrodes on the palm and will measure changes in conductance in response to negative/neutral images.
measure: Mood ratings
time frame: Pre-intervention and immediately after the intervention
description: Pre- and post-task mood as measured by the Positive and Negative Affect Schedule (PANAS) will be taken before and after the intervention. The PANAS is a 20-question questionnaire rated on a scale of 1 to 5 (with 1 being "very slight or not at all" and 5 being "extremely"). Questions 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19 represent the positive affect scale with scores ranging between 10 and 50 (the higher the score, the higher the levels of positive affect). Questions 2, 4, 6, 7, 8, 11, 13, 15,18, and 20 represent the negative affect scale with scores falling between 10 and 50 (lower scores represent lower levels of negative affect).
measure: Debriefing of instructions
time frame: Immediately after the intervention
description: Following the VR task, participants will be asked to report the task instructions in their own words. The first questions will ask participants to reiterate the instructions they were given for the cognitive reappraisal task (for example: "What were you instructed to do during the 'LOOK' trials?") This is a fill in the blank question and there are no right or wrong answers.
measure: Task difficulty
time frame: Immediately after the intervention
description: The next batch of questions will ask the participant questions about the difficulty of the task. An example question is "How difficult was it to follow the 'LOOK' instruction?" Participants will be rating the level of difficulty on a scale of 1 to 7 with 1 being "not difficult at all" to 7 being "very difficult".
measure: Task compliance
time frame: Immediately after the intervention
description: Participants will be asked about self-reported task compliance. For example, one question will ask "What percentage of the time were you able to follow the "LOOK" instruction?" The participants will be rating their self-compliance for each task from 0% (non-compliant) to 100% (fully compliant).
measure: Experience with task images
time frame: Immediately after the intervention
description: Participants will be asked whether they have any experience with reappraisal or the specific images presented in the task. The first question will ask "Have you ever been trained to change your emotions by changing the way you think (in therapy, or in another experiment, or anywhere else)?" Participants can choose "Yes" or "No" for this question. The participant will have to extrapolate if they have changed their emotions before using a fill in the blank. The next question will ask "Have you ever seen any of these exact emotional images before?" The participant then once again will be asked to extrapolate which images they have seen and what emotional response was generated by these images using a fill in the blank option.
measure: Depression trait differences
time frame: Baseline
description: The participants will be given the Beck's Depression Inventory(BDI-II) which measures symptoms of depression and will be used to examine any between-subjects trait differences. The BDI-II is a 21 self-report measure looking at symptoms of depression with ratings falling between 0 and 3 (0 being "not at all" and 3 would indicate experiencing these symptoms on a constant basis).
measure: Emotional regulation trait differences
time frame: Baseline
description: The Emotion Regulation Questionnaire (ERQ) looks at methods of regulating emotions and will be used to examine any between-subjects trait differences. The ERQ is a 10-item self-report questionnaire assessing the use of two strategies to alter emotions: cognitive reappraisal and expressive suppression. The scale is rated on a 7-point Likert scale with 1 being "strongly disagree" and 7 being "strongly agree". Six items are categorized as using cognitive reappraisal while four of the items assess expressive suppression.
arm group label: Positive VR Scene
arm group type: Experimental
description: Participants will explore a virtual reality (VR) environment of a beach scene. Participants will be randomly assigned (between subjects) to beach or office scene. VR will be presented on an Occulus Rift device.
arm group label: Neutral VR Scene
arm group type: Experimental
description: Participants will explore a virtual reality (VR) environment of a neutral office scene. Participants will be randomly assigned (between subjects) to beach or office scene. VR will be presented on an Occulus Rift device.
intervention type: Behavioral
intervention name: Positive Emotion Induction
description: Participants are expected to have a positive emotional response to the more positive beach scene.
arm group label: Positive VR Scene
intervention type: Behavioral
intervention name: Neutral Emotion Induction
description: Participants are expected to have a neutral emotional response to the neutral office scene.
arm group label: Neutral VR Scene
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kateri McRae, Ph.D.
role: Principal Investigator
affiliation: University of Denver
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Denver
investigator full name: Kateri McRae
investigator title: Associate Professor
submitted: July 5, 2023
submission canceled: September 7, 2023