<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/NCT03819426</url>
  </required_header>
  <id_info>
    <org_study_id>18-01277</org_study_id>
    <nct_id>NCT03819426</nct_id>
  </id_info>
  <brief_title>Walking or High Intensity Exercise for Anxiety</brief_title>
  <official_title>Walking or High Intensity Exercise for Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
      After an initial phone screen process, approximately 50 participants will be enrolled and&#xD;
      evaluated/screened in person after consenting to achieve 30 eligible participants with a&#xD;
      principal diagnosis of GAD, panic disorder, or social anxiety disorder and high anxiety&#xD;
      sensitivity (Anxiety Sensitivity Index score =20). Participants will be given a choice of&#xD;
      either high intensity interval training (HIIT) or walking interventions, which will be&#xD;
      completed over the course of 8 weeks. The goal of the study is to 1) obtain pilot data&#xD;
      comparing the efficacy of HIIT vs. walking for effects on psychiatric, functioning and immune&#xD;
      outcomes, 2) to identify adherence levels given the choice of exercise intensity, and 3) to&#xD;
      identify proportion of individuals opting for each intervention. Results from this pilot&#xD;
      study will be used to inform future grant applications including a K award.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Actual">July 29, 2020</completion_date>
  <primary_completion_date type="Actual">July 29, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of HIIT measured by Quality of Life Enjoyment &amp; Satisfaction Questionnaire (Q-LES-Q-SF)</measure>
    <time_frame>Week 1</time_frame>
    <description>Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of HIIT measured by Quality of Life Enjoyment &amp; Satisfaction Questionnaire (Q-LES-Q-SF)</measure>
    <time_frame>Week 10</time_frame>
    <description>Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Generalized Anxiety Disorder</condition>
  <condition>Panic Disorder</condition>
  <condition>Social Anxiety</condition>
  <arm_group>
    <arm_group_label>High Intensity Interval Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be shown the appropriate techniques and intensity (high intensity; i.e., 70-90% of maximum heart rate (220-age) with a verified online youtube video. Participants will be provided with this video and other options that can be followed to complete 15 minute HIIT interventions at home. Interventionist will observe participant engaging in HIIT for 15 minutes. HIIT intervention (for 15 minutes) will also be observed during Session 4 and 8.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This intervention will be demonstrated during Session 1. Participants will be shown the appropriate walking intensity (low intensity; i.e., approximately 50% of maximum heart rate (220-age) or lower) by interventionist. Interventionist will observe participant engaging in walking at appropriate intensity level for 15 minutes. Walking intervention (for 15 minutes) will also be observed during Session 4 and 8.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low Intensity Exercise Intervention</intervention_name>
    <description>Those in the walking intervention will be instructed to take walks below a brisk pace (low intensity) to improve mood</description>
    <arm_group_label>Walking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High Intensity Intervention</intervention_name>
    <description>Instructed in high intensity interval training techniques and will be provided videos to follow for implementation of intervention at home that will include short bursts of high energy</description>
    <arm_group_label>High Intensity Interval Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anxiety Sensitivity Index score of ≥20 (i.e., high anxiety sensitivity)&#xD;
&#xD;
          -  Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety&#xD;
             disorder, or panic disorder&#xD;
&#xD;
          -  Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past&#xD;
             3 months)&#xD;
&#xD;
          -  Able and willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lifetime history of Bipolar I or II or any psychotic disorder&#xD;
&#xD;
          -  Meets criteria for bulimia or anorexia in the past 6 months&#xD;
&#xD;
          -  Meets criteria for substance use disorder in the past 3 months&#xD;
&#xD;
          -  High current suicide risk as indicated by a score of ≥4 on the C-SSRS&#xD;
&#xD;
          -  Risk for exercise according to Physical Activity Readiness Questionnaire with excluded&#xD;
             medical conditions including heart conditions, lung disease, bone/joint problems, or&#xD;
             seizures&#xD;
&#xD;
          -  Women who are currently pregnant or plan to become pregnant during the duration of the&#xD;
             study&#xD;
&#xD;
          -  Participation in concurrent evidence-based therapy (e.g., cognitive behavioral&#xD;
             therapy) targeting anxiety or depression (supportive therapy and couples therapy are&#xD;
             allowed)&#xD;
&#xD;
          -  Participants on psychiatric medication must be on a stable dose for ≥8 weeks prior to&#xD;
             participation&#xD;
&#xD;
          -  Current substance abuse or positive urine toxic screen (recreational use of marijuana&#xD;
             is permitted based on clinical assessment on the MINI that it does not meet criteria&#xD;
             for cannabis use disorder)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Szuhany, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>September 25, 2020</last_update_submitted>
  <last_update_submitted_qc>September 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2020</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>Anxiety Disorders</mesh_term>
    <mesh_term>Panic Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Any requests for data will be considered on a case by case basis given the pilot nature of this project. As this is a pilot study, there will not be sufficient data for systematic sharing. Means of participant data will be shared on clinicaltrials.gov.</ipd_description>
    <ipd_time_frame>On a case by case basis, given the pilot nature of this project.</ipd_time_frame>
    <ipd_access_criteria>Requests should be directed to Kristin.szuhany@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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/NCT03819426
org study id: 18-01277
nct id: NCT03819426
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
After an initial phone screen process, approximately 50 participants will be enrolled and
      evaluated/screened in person after consenting to achieve 30 eligible participants with a
      principal diagnosis of GAD, panic disorder, or social anxiety disorder and high anxiety
      sensitivity (Anxiety Sensitivity Index score =20). Participants will be given a choice of
      either high intensity interval training (HIIT) or walking interventions, which will be
      completed over the course of 8 weeks. The goal of the study is to 1) obtain pilot data
      comparing the efficacy of HIIT vs. walking for effects on psychiatric, functioning and immune
      outcomes, 2) to identify adherence levels given the choice of exercise intensity, and 3) to
      identify proportion of individuals opting for each intervention. Results from this pilot
      study will be used to inform future grant applications including a K award.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)
time frame: Week 1
description: Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.
measure: Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)
time frame: Week 10
description: Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.
arm group label: High Intensity Interval Training
arm group type: Experimental
description: Participants will be shown the appropriate techniques and intensity (high intensity; i.e., 70-90% of maximum heart rate (220-age) with a verified online youtube video. Participants will be provided with this video and other options that can be followed to complete 15 minute HIIT interventions at home. Interventionist will observe participant engaging in HIIT for 15 minutes. HIIT intervention (for 15 minutes) will also be observed during Session 4 and 8.
arm group label: Walking
arm group type: Experimental
description: This intervention will be demonstrated during Session 1. Participants will be shown the appropriate walking intensity (low intensity; i.e., approximately 50% of maximum heart rate (220-age) or lower) by interventionist. Interventionist will observe participant engaging in walking at appropriate intensity level for 15 minutes. Walking intervention (for 15 minutes) will also be observed during Session 4 and 8.
intervention type: Behavioral
intervention name: Low Intensity Exercise Intervention
description: Those in the walking intervention will be instructed to take walks below a brisk pace (low intensity) to improve mood
arm group label: Walking
intervention type: Behavioral
intervention name: High Intensity Intervention
description: Instructed in high intensity interval training techniques and will be provided videos to follow for implementation of intervention at home that will include short bursts of high energy
arm group label: High Intensity Interval Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kristin Szuhany, PhD
role: Principal Investigator
affiliation: NYU Langone
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anxiety Disorders
mesh term: Panic Disorder
sharing ipd: Yes
ipd description: Any requests for data will be considered on a case by case basis given the pilot nature of this project. As this is a pilot study, there will not be sufficient data for systematic sharing. Means of participant data will be shared on clinicaltrials.gov.
ipd time frame: On a case by case basis, given the pilot nature of this project.
ipd access criteria: Requests should be directed to Kristin.szuhany@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.