xml: <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/NCT06027944</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-71791</org_study_id>
      <nct_id>NCT06027944</nct_id>
    </id_info>
    <brief_title>Impact of Light on Mood</brief_title>
    <official_title>More Than Meets the Eye? The Impact of Light on Mood Regulation in Humans</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Palo Alto Health Care System</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>VA Palo Alto Health Care System</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 investigators are examining whether the content of a visual scene impacts the&#xD;
        antidepressant effects of light or if this impact is solely mediated by the intensity of the&#xD;
        light.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>Crossover Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in mood</measure>
      <time_frame>15 minutes</time_frame>
      <description>Change in subjective mood as recored by the Positive and Negative Affect Schedule (PANAS). The PANAS ranges 10-50 on a positive mood scale (higher = more positive) and 10-50 on a negative mood scale (higher = more negative)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in fast brain electrical activity</measure>
      <time_frame>15 minutes</time_frame>
      <description>Change in the beta power spectrum (12.5-30 Hz) of the electroencephalogram (brain waves, measured in microvolts)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in systolic blood pressure (SBP)</measure>
      <time_frame>15 minutes</time_frame>
      <description>Change in SBP (mm Hg) as measured by finger plethysmography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in heart rate variability (HRV)</measure>
      <time_frame>15 minutes</time_frame>
      <description>Shift in the ratio of the power of low frequency to high frequency components in heart rate variability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sympathetic activity</measure>
      <time_frame>15 minutes</time_frame>
      <description>Sympathetic activity will be imputed through the galvanic skin response (GSR). Change in skin conductance (the electrical activity on the skin) will be measured in microsiemens</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>Scene</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>High fidelity scene of nature emitted from a monitor</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Scrambled scene</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The same pixels that are used to create the scene in the alternate arm will be randomly scrambled on the monitor</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Light exposure</intervention_name>
      <description>Participants will be exposed to 15 minutes of each arm. They will be exposed twice and a randomized order (1/2/1/2 or 2/1/2/1)</description>
      <arm_group_label>Scene</arm_group_label>
      <arm_group_label>Scrambled scene</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 18-60&#xD;
  &#xD;
            -  Mild depressive symptomatology&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No depressive symptomatology&#xD;
  &#xD;
            -  Severe depressive symptomatology&#xD;
  &#xD;
            -  Active or unstable medical condition&#xD;
  &#xD;
            -  Diabetes&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>VA Palo Alto Health Care System</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94304</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>VA Palo Alto Health Care System</investigator_affiliation>
      <investigator_full_name>Jamie M. Zeitzer, Ph.D.</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>After completion of data collection, cleaning, and publication, all experimental data will be made available via Dryad</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>within three months of publication, no time limit</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027944
  org study id: IRB-71791
  nct id: NCT06027944
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators are examining whether the content of a visual scene impacts the
        antidepressant effects of light or if this impact is solely mediated by the intensity of the
        light.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Outcomes Assessor)
  measure: Change in mood
  time frame: 15 minutes
  description: Change in subjective mood as recored by the Positive and Negative Affect Schedule (PANAS). The PANAS ranges 10-50 on a positive mood scale (higher = more positive) and 10-50 on a negative mood scale (higher = more negative)
  measure: Change in fast brain electrical activity
  time frame: 15 minutes
  description: Change in the beta power spectrum (12.5-30 Hz) of the electroencephalogram (brain waves, measured in microvolts)
  measure: Change in systolic blood pressure (SBP)
  time frame: 15 minutes
  description: Change in SBP (mm Hg) as measured by finger plethysmography
  measure: Change in heart rate variability (HRV)
  time frame: 15 minutes
  description: Shift in the ratio of the power of low frequency to high frequency components in heart rate variability
  measure: Change in sympathetic activity
  time frame: 15 minutes
  description: Sympathetic activity will be imputed through the galvanic skin response (GSR). Change in skin conductance (the electrical activity on the skin) will be measured in microsiemens
  arm group label: Scene
  arm group type: Experimental
  description: High fidelity scene of nature emitted from a monitor
  arm group label: Scrambled scene
  arm group type: Active Comparator
  description: The same pixels that are used to create the scene in the alternate arm will be randomly scrambled on the monitor
  intervention type: Other
  intervention name: Light exposure
  description: Participants will be exposed to 15 minutes of each arm. They will be exposed twice and a randomized order (1/2/1/2 or 2/1/2/1)
  arm group label: Scene
  arm group label: Scrambled scene
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: VA Palo Alto Health Care System
  investigator full name: Jamie M. Zeitzer, Ph.D.
  investigator title: Professor
  mesh term: Depression
  sharing ipd: Yes
  ipd description: After completion of data collection, cleaning, and publication, all experimental data will be made available via Dryad
  ipd info type: Study Protocol
  ipd info type: Analytic Code
  ipd time frame: within three months of publication, no time limit