<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/NCT02194036</url>
  </required_header>
  <id_info>
    <org_study_id>2014/393 (REK)</org_study_id>
    <nct_id>NCT02194036</nct_id>
  </id_info>
  <brief_title>Learning Oriented Physiotherapy - a New Approach</brief_title>
  <acronym>LOF</acronym>
  <official_title>The Effect of Learning Oriented Physiotherapy on Health-Related Functioning and Quality of Life in Patients With Various Anxiety Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Nord-Trøndelag HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health North Trøndelag</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Møre and Romsdal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>South Coast Hospital Hf Dps Aust-Agder Units Arendal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helse Nord-Trøndelag HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Outpatients that suffer from different anxiety disorders may have physical ailments that&#xD;
      negatively affect daily life functioning and quality of life. LOF is a physical therapy&#xD;
      approach focusing on the link between bodily and mental balance and through defined, but&#xD;
      simple movements, patients are expected to learn how to cope and reduce health complaints.&#xD;
&#xD;
      This study aims to investigate the short- and longterm effect of LOF compared to other&#xD;
      standardized psychiatric treatments given in the clinic on levels of anxiety and depression,&#xD;
      health related function and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Health Related Quality of Life (HRoQL)</measure>
    <time_frame>From baseline to 6, 12 and 18 months of follow-up</time_frame>
    <description>In this study HRoQL will be measured by the validated EQ5D questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Levels of Anxiety and Depression</measure>
    <time_frame>From baseline to 6, 12 and 18 months of follow-up</time_frame>
    <description>Hospital Anxiety and Depression Scale (HAD) will be used as instrument to assess levels and changes in anxiety and depression over time&#xD;
.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Agitation</condition>
  <condition>Anxiety</condition>
  <condition>Dizziness</condition>
  <condition>Pain</condition>
  <condition>Numbness</condition>
  <condition>Depression</condition>
  <condition>Fatigue</condition>
  <condition>Sleep Disturbances</condition>
  <arm_group>
    <arm_group_label>Learning oriented physiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Learning oriented physiotherapy is a treatment approach based on knowledge from neuroscience and particularly aimed to curb physical symptoms and ailments, but also to regain a sense of better physical balance and mental control. Therapy sessions are normally given every 2 weeks with individual homework lessons between. The therapy will last between 6 to 12 months depending on learning process and individual needs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Widely Recognized Psychiatric Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Outpatient Treatment within the Psychiatric clinic</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Learning Oriented Physiotherapy</intervention_name>
    <description>Clinical practice based on a new understanding of the neurobiological basis for the interaction between body and mind, the foundation of learning and what is needed to bring about change of behavior.</description>
    <arm_group_label>Learning oriented physiotherapy</arm_group_label>
    <other_name>LOF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Widely Recognized Psychiatric Treatment</intervention_name>
    <description>Standard recognized psychiatric treatment tailored to individual needs.</description>
    <arm_group_label>Widely Recognized Psychiatric Treatment</arm_group_label>
    <other_name>CBT</other_name>
    <other_name>Speech Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The study population will be recruited among patients referred to three Norwegian&#xD;
        psychiatric outpatient clinics for anxiety-like conditions. The same criteria for inclusion&#xD;
        and exclusion will be applied for the experimental and active comparator group.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Participants should be&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  able to read, write and speak Norwegian&#xD;
&#xD;
          -  understand the project information and consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants should not&#xD;
&#xD;
          -  have ongoing substance abuse or addiction.&#xD;
&#xD;
          -  be psychotic.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars-Petter Granan, phD</last_name>
    <role>Study Director</role>
    <affiliation>Oslo University Hospital, Department of Pain Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regional Psychiatric Centre Aust-Agder</name>
      <address>
        <city>Arendal</city>
        <state>Aust-Agder</state>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychiatric Clinic</name>
      <address>
        <city>Molde</city>
        <state>Møre And Romsdal</state>
        <zip>7401</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychiatric Clinic</name>
      <address>
        <city>Levanger</city>
        <state>North Trøndelag</state>
        <zip>7601</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>http://www.balansekoden.no</url>
    <description>A website with information about the learning-oriented therapy as a new approach, based on new knowledge in neuroscience</description>
  </link>
  <reference>
    <citation>Britt Fadnes, Kirsti Leira and Per Brodal. Learning-oriented physiotherapy. Theory and practice. University Press, 2013.</citation>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>January 26, 2018</last_update_submitted>
  <last_update_submitted_qc>January 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ownership of body</keyword>
  <keyword>Bodily and mental balance</keyword>
  <keyword>Learning</keyword>
  <keyword>Body image</keyword>
  <keyword>Sensations</keyword>
  <keyword>Expectations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Dizziness</mesh_term>
  </condition_browse>
  <!-- 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/NCT02194036
org study id: 2014/393 (REK)
nct id: NCT02194036
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Outpatients that suffer from different anxiety disorders may have physical ailments that
      negatively affect daily life functioning and quality of life. LOF is a physical therapy
      approach focusing on the link between bodily and mental balance and through defined, but
      simple movements, patients are expected to learn how to cope and reduce health complaints.

      This study aims to investigate the short- and longterm effect of LOF compared to other
      standardized psychiatric treatments given in the clinic on levels of anxiety and depression,
      health related function and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes in Health Related Quality of Life (HRoQL)
time frame: From baseline to 6, 12 and 18 months of follow-up
description: In this study HRoQL will be measured by the validated EQ5D questionnaire
measure: Changes in Levels of Anxiety and Depression
time frame: From baseline to 6, 12 and 18 months of follow-up
description: Hospital Anxiety and Depression Scale (HAD) will be used as instrument to assess levels and changes in anxiety and depression over time
.
arm group label: Learning oriented physiotherapy
arm group type: Experimental
description: Learning oriented physiotherapy is a treatment approach based on knowledge from neuroscience and particularly aimed to curb physical symptoms and ailments, but also to regain a sense of better physical balance and mental control. Therapy sessions are normally given every 2 weeks with individual homework lessons between. The therapy will last between 6 to 12 months depending on learning process and individual needs.
arm group label: Widely Recognized Psychiatric Treatment
arm group type: Active Comparator
description: Standard Outpatient Treatment within the Psychiatric clinic
intervention type: Behavioral
intervention name: Learning Oriented Physiotherapy
description: Clinical practice based on a new understanding of the neurobiological basis for the interaction between body and mind, the foundation of learning and what is needed to bring about change of behavior.
arm group label: Learning oriented physiotherapy
other name: LOF
intervention type: Behavioral
intervention name: Widely Recognized Psychiatric Treatment
description: Standard recognized psychiatric treatment tailored to individual needs.
arm group label: Widely Recognized Psychiatric Treatment
other name: CBT
other name: Speech Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars-Petter Granan, phD
role: Study Director
affiliation: Oslo University Hospital, Department of Pain Medicine
facility: 
facility: 
facility: 
country: Norway
url: http://www.balansekoden.no
description: A website with information about the learning-oriented therapy as a new approach, based on new knowledge in neuroscience
citation: Britt Fadnes, Kirsti Leira and Per Brodal. Learning-oriented physiotherapy. Theory and practice. University Press, 2013.
responsible party type: Sponsor
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Dizziness