<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/NCT03818425</url>
  </required_header>
  <id_info>
    <org_study_id>256913</org_study_id>
    <nct_id>NCT03818425</nct_id>
  </id_info>
  <brief_title>Motivation and Barriers for Exercise in Patients With Anxiety or Posttraumatic Stress Disorder</brief_title>
  <official_title>Motivation and Barriers for Exercise in Patients With Anxiety or Posttraumatic Stress Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaet Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaet Innsbruck</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>
      Relevance and Aim: There has been increasing research interest in sport preferences and&#xD;
      motivational factors as well as barriers that restrain from engaging in sport activities in&#xD;
      people suffering from mental illnesses. Anxiety disorders are one of the leading mental&#xD;
      disorders worldwide. Exercise has previously shown anxiolytic effects and is discussed as an&#xD;
      adjunctive treatment option in clinical practice. This study aims to depict motivation and&#xD;
      barriers in patients with anxiety or posttraumatic stress disorders.&#xD;
&#xD;
      Design and Participants: Observational study of patients diagnosed with anxiety disorder or&#xD;
      posttraumatic stress disorder (ICD-10)&#xD;
&#xD;
      Measurements: Structured questionnaire compounded of validated scales for current physical&#xD;
      activity, sport motivation, exercise preferences, perceived barriers , self-efficacy, social&#xD;
      support for physical activity, motivation,enjoyment, quality of life as well as&#xD;
      sociodemographic data.&#xD;
&#xD;
      Duration: The questionnaire will require approximately 20 minutes, the overall duration is 3&#xD;
      months. Personal assistance for completing the questionnaire will be provided if necessary.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity</measure>
    <time_frame>5 minutes</time_frame>
    <description>self reported, actual physical activity, measured by the International Physical Activity Questionnaire Short Form, IPAQ-SF; Craig et al., 2003</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sport motivation</measure>
    <time_frame>5 minutes</time_frame>
    <description>measured by the Exercise Motivation Inventory, EMI-2; Markland &amp; Hardy,1993</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived barriers</measure>
    <time_frame>5 minutes</time_frame>
    <description>measured by 12 questions referring to Ussher, Stanbury, Cheeseman &amp; Faulkner, 2007</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-efficacy for physical activity</measure>
    <time_frame>1 minute</time_frame>
    <description>single item question according to Ussher, Stanbury, Cheeseman &amp; Faulkner, 2007</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social support for physical activity</measure>
    <time_frame>1 minute</time_frame>
    <description>single item question according to Ussher, Stanbury, Cheeseman &amp; Faulkner, 2007</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motivation for physical activity</measure>
    <time_frame>1 minute</time_frame>
    <description>single item question according to Ussher, Stanbury, Cheeseman &amp; Faulkner, 2007</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Enjoyment of physical activity</measure>
    <time_frame>1 minute</time_frame>
    <description>single item question according to Ussher, Stanbury, Cheeseman &amp; Faulkner, 2007</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">460</enrollment>
  <condition>Exercise</condition>
  <condition>Motivation</condition>
  <arm_group>
    <arm_group_label>Clinical Population</arm_group_label>
    <description>In- and Out-Patients diagnosed with depression (F32, F33), anxiety disorder (F40, F41; ICD-10) or posttraumatic stress disorder (F43.1; ICD-10)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Subjects with no previous or actual mental disorder</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of outpatient department and inpatients of the Medical Hospital Innsbruck,&#xD;
        Department of Psychiatry and Psychosomatic will be selected by clinical professionals&#xD;
        according to inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In- and out-patients with a diagnosed anxiety or posttraumatic stress disorder (F40,&#xD;
             F41, F43.1; ICD-10)&#xD;
&#xD;
          -  18 to 65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute psychosis or suicidal behaviour&#xD;
&#xD;
          -  cognitive deficits&#xD;
&#xD;
          -  problems with German language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Kopp, PhD, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Sport Science, University of Innsbruck</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Barbara Sperner-Unterweger, MD, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Psychosomatics, Medical University of Innsbruck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tyrol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 24, 2019</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>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Posttraumatic Stress Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03818425
org study id: 256913
nct id: NCT03818425
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Relevance and Aim: There has been increasing research interest in sport preferences and
      motivational factors as well as barriers that restrain from engaging in sport activities in
      people suffering from mental illnesses. Anxiety disorders are one of the leading mental
      disorders worldwide. Exercise has previously shown anxiolytic effects and is discussed as an
      adjunctive treatment option in clinical practice. This study aims to depict motivation and
      barriers in patients with anxiety or posttraumatic stress disorders.

      Design and Participants: Observational study of patients diagnosed with anxiety disorder or
      posttraumatic stress disorder (ICD-10)

      Measurements: Structured questionnaire compounded of validated scales for current physical
      activity, sport motivation, exercise preferences, perceived barriers , self-efficacy, social
      support for physical activity, motivation,enjoyment, quality of life as well as
      sociodemographic data.

      Duration: The questionnaire will require approximately 20 minutes, the overall duration is 3
      months. Personal assistance for completing the questionnaire will be provided if necessary.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Physical activity
time frame: 5 minutes
description: self reported, actual physical activity, measured by the International Physical Activity Questionnaire Short Form, IPAQ-SF; Craig et al., 2003
measure: Sport motivation
time frame: 5 minutes
description: measured by the Exercise Motivation Inventory, EMI-2; Markland & Hardy,1993
measure: Perceived barriers
time frame: 5 minutes
description: measured by 12 questions referring to Ussher, Stanbury, Cheeseman & Faulkner, 2007
measure: Self-efficacy for physical activity
time frame: 1 minute
description: single item question according to Ussher, Stanbury, Cheeseman & Faulkner, 2007
measure: Social support for physical activity
time frame: 1 minute
description: single item question according to Ussher, Stanbury, Cheeseman & Faulkner, 2007
measure: Motivation for physical activity
time frame: 1 minute
description: single item question according to Ussher, Stanbury, Cheeseman & Faulkner, 2007
measure: Enjoyment of physical activity
time frame: 1 minute
description: single item question according to Ussher, Stanbury, Cheeseman & Faulkner, 2007
arm group label: Clinical Population
description: In- and Out-Patients diagnosed with depression (F32, F33), anxiety disorder (F40, F41; ICD-10) or posttraumatic stress disorder (F43.1; ICD-10)
arm group label: Healthy Controls
description: Subjects with no previous or actual mental disorder
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Martin Kopp, PhD, Prof.
role: Study Chair
affiliation: Department of Sport Science, University of Innsbruck
last name: Barbara Sperner-Unterweger, MD, Prof.
role: Study Director
affiliation: Department of Psychosomatics, Medical University of Innsbruck
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No