<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/NCT03818789</url>
  </required_header>
  <id_info>
    <org_study_id>2016-11-0091</org_study_id>
    <nct_id>NCT03818789</nct_id>
  </id_info>
  <brief_title>Acceptance and Mindfulness for Exercise in Anxiety</brief_title>
  <official_title>Mindfulness and Acceptance for Exercise in Anxiety</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>
      Anxiety is a common experience, with the U.S. lifetime prevalence of any anxiety disorder at&#xD;
      28.8%. Exercise has shown large effect sizes relative to controls in reducing mood and&#xD;
      anxiety symptoms. An anxious population generally has more difficulty when beginning or&#xD;
      increasing an exercise regimen, due to a higher level of sensitivity to discomfort.&#xD;
      Mindfulness practices may be helpful in improving adherence to an exercise program. A similar&#xD;
      study has shown that mindfulness may reduce perceived effort and make exercise more&#xD;
      enjoyable. Furthermore, mindfulness has been shown to be an effective intervention in&#xD;
      reducing anxiety and physical discomfort. The investigators intend to use a brief&#xD;
      intervention incorporating strategies of mindfulness and Acceptance and Commitment Therapy&#xD;
      (ACT) in conjunction with exercise to ease the transition into regular/increased physical&#xD;
      exercise. Measures of anxiety sensitivity and perceived stress will be included to measure&#xD;
      whether they change, and their possible effect as moderating variables on exercise adherence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID&#xD;
  </why_stopped>
  <start_date type="Actual">February 23, 2017</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 2020</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of time run in minutes</measure>
    <time_frame>During lab visit (day 1 of participation)</time_frame>
    <description>The voluntary decision when to stop exercising on the treadmill in the lab</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of time in minutes of vigorous and moderate exercise in following week</measure>
    <time_frame>One week follow-up</time_frame>
    <description>Amount exercised as assessed by International Physical Activity Questionnaire at follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms: Generalized Anxiety Disorder - 7 Scale, Beck Anxiety Inventory</measure>
    <time_frame>One week follow-up</time_frame>
    <description>These self-report questionnaires assess general anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression symptoms: Beck Depression Inventory</measure>
    <time_frame>One week follow-up</time_frame>
    <description>This self-report questionnaire assesses depression symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness during exercise: State Mindfulness Scale for Physical Activity</measure>
    <time_frame>Assessed in the lab (day 1 of participation) and at follow-ups one week later</time_frame>
    <description>This self-report questionnaire is designed to assess mindful state specifically during exercise</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A mindfulness training is applied to see if it supports exercise endurance in-lab and during follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A study skills video is shown intended to have no effect on exercise but to match for time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness and acceptance training</intervention_name>
    <description>A breathing mediation, body scan, talking about acceptance, and presence activity are used. All are low-impact and expected to cause no distress</description>
    <arm_group_label>Mindfulness</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Study skills video</intervention_name>
    <description>A YouTube video describing study skills and suggested habits is used as a control condition.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students who are enrolled in Psychology 301 at the University of Texas at Austin, as&#xD;
             well as adult and student volunteers recruited from the University of Texas at Austin&#xD;
             campus and the greater Austin community, who are 18-65 will be eligible for this&#xD;
             study.&#xD;
&#xD;
          -  Participants must exercise less than 150 minutes per week doing moderate-intensity&#xD;
             exercise consistently within the last two months.&#xD;
&#xD;
          -  They will have at least mild anxiety, as measured with either a minimum score of 8 on&#xD;
             the Beck Anxiety Inventory, or 5 on the Generalized Anxiety Disorder-7.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those that are at moderate or high risk based on the pre-participation exercise health&#xD;
             screening by the American College of Sports Medicine, or any participants that have&#xD;
             been advised to not participate in exercise or aerobic activity by a qualified medical&#xD;
             provider.&#xD;
&#xD;
          -  Those with cardiovascular or pulmonary diseases, immunological diseases, neurological&#xD;
             disorders, or have serious bone or joint problems.&#xD;
&#xD;
          -  The Beck Depression Inventory's item on suicidality will be actively checked for a&#xD;
             response of 2 or 3, with further screening given to those participants using questions&#xD;
             from the C-SSRS to screen for current suicidal ideation and past suicidal behavior.&#xD;
             Participants who endorse imminent intent or a plan to act on suicidal thoughts will be&#xD;
             immediately referred to one of the IMHR's psychologists, or 911 will be contacted if&#xD;
             they are at immediate risk of suicidal self-harm. Participants endorsing intent or a&#xD;
             specific plan will not be included in the study. Participants expressing suicidal&#xD;
             thoughts without imminent intent or a specific plan will be given resources to pursue&#xD;
             mental health treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>College of Liberal Arts</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>July 2021</verification_date>
  <study_first_submitted>October 31, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</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>Emily Carl</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03818789
org study id: 2016-11-0091
nct id: NCT03818789
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anxiety is a common experience, with the U.S. lifetime prevalence of any anxiety disorder at
      28.8%. Exercise has shown large effect sizes relative to controls in reducing mood and
      anxiety symptoms. An anxious population generally has more difficulty when beginning or
      increasing an exercise regimen, due to a higher level of sensitivity to discomfort.
      Mindfulness practices may be helpful in improving adherence to an exercise program. A similar
      study has shown that mindfulness may reduce perceived effort and make exercise more
      enjoyable. Furthermore, mindfulness has been shown to be an effective intervention in
      reducing anxiety and physical discomfort. The investigators intend to use a brief
      intervention incorporating strategies of mindfulness and Acceptance and Commitment Therapy
      (ACT) in conjunction with exercise to ease the transition into regular/increased physical
      exercise. Measures of anxiety sensitivity and perceived stress will be included to measure
      whether they change, and their possible effect as moderating variables on exercise adherence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Amount of time run in minutes
time frame: During lab visit (day 1 of participation)
description: The voluntary decision when to stop exercising on the treadmill in the lab
measure: Amount of time in minutes of vigorous and moderate exercise in following week
time frame: One week follow-up
description: Amount exercised as assessed by International Physical Activity Questionnaire at follow-up
measure: Anxiety symptoms: Generalized Anxiety Disorder - 7 Scale, Beck Anxiety Inventory
time frame: One week follow-up
description: These self-report questionnaires assess general anxiety symptoms
measure: Depression symptoms: Beck Depression Inventory
time frame: One week follow-up
description: This self-report questionnaire assesses depression symptoms
measure: Mindfulness during exercise: State Mindfulness Scale for Physical Activity
time frame: Assessed in the lab (day 1 of participation) and at follow-ups one week later
description: This self-report questionnaire is designed to assess mindful state specifically during exercise
arm group label: Mindfulness
arm group type: Experimental
description: A mindfulness training is applied to see if it supports exercise endurance in-lab and during follow-up
arm group label: Control
arm group type: Placebo Comparator
description: A study skills video is shown intended to have no effect on exercise but to match for time.
intervention type: Behavioral
intervention name: Mindfulness and acceptance training
description: A breathing mediation, body scan, talking about acceptance, and presence activity are used. All are low-impact and expected to cause no distress
arm group label: Mindfulness
intervention type: Behavioral
intervention name: Study skills video
description: A YouTube video describing study skills and suggested habits is used as a control condition.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas at Austin
investigator full name: Emily Carl
investigator title: Principal Investigator
mesh term: Anxiety Disorders
sharing ipd: Undecided