<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/NCT02251028</url>
  </required_header>
  <id_info>
    <org_study_id>S-20130103</org_study_id>
    <nct_id>NCT02251028</nct_id>
  </id_info>
  <brief_title>Value-based Cognitive Behavioral Therapy for Prevention of Chronic Whiplash-associated Disorders</brief_title>
  <official_title>Value-based Cognitive Behavioural Therapy for the Prevention of Chronic Whiplash Associated Disorders: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a specifically tailored value-based&#xD;
      cognitive behavioural therapy program (V-CBT) is able to prevent the development of&#xD;
      persistent disability, pain, and psychological distress if delivered within the first three&#xD;
      months after a whiplash injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the present study is to test whether a specifically tailored&#xD;
      value-based cognitive-behavioural therapy program (V-CBT) is able to prevent the development&#xD;
      of persistent disability, pain, and psychological distress if delivered within the first&#xD;
      three months after a whiplash injury. Methods. The current study is a two-armed randomized&#xD;
      controlled study with a crossover design. Group A is scheduled for V-CBT within one week of&#xD;
      randomization and group B with a delayed onset 3 months after randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disability as measured by Pain Disability Index</measure>
    <time_frame>Change scores at 12- and 24-weeks after randomization</time_frame>
    <description>The PDI measures how pain interferes with daily life activities within 7 different domains. The 7 domains are rated from 0 (no disability) to 10 (worst disability). The scale shows good reliability and validity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain by NDI</measure>
    <time_frame>Change scores at 12- and 24-weeks after randomization</time_frame>
    <description>Neck pain intensity and disability is measured with the Neck Disability Index (NDI; Vernon &amp; Mior, 1991). The NDI measures within 10 domains pain and how neck pain affects the ability to handle daily life activities such as personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration, and headache. The total score range from 0 (no disability) to 100 (total disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain by NRS</measure>
    <time_frame>Change scores at 12- and 24-weeks after randomization</time_frame>
    <description>Pain is also measured on four numerical pain rating scales (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Patients mark their answers on each scale corresponding to their pain now, highest level of pain, lowest level of pain, and finally average pain over the past week (NRS: Turk &amp; Melzack, 2001).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of re-injury by TSK</measure>
    <time_frame>Change scores at 12- and 24-weeks after randomization</time_frame>
    <description>Fear of re-injury due to movement is measured with Tampa Scale for Kinesiophobia (TSK; Kori, Miller, &amp; Todd, 1990). TSK is a 17-item scale assessing fear of movement on a 4-point likert scale ranging from 17 to 68 with higher scores indicating higher levels of kinesiophobia. The scale is commonly used in various chronic pain samples and has good construct and predictive validity (Roelofs, Goubert, Peters, Vlayen, &amp; Crombes, 2004). The clinical cut-off score is set to ≥ 37.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain-related catastrophizing by PCS</measure>
    <time_frame>Change scores at 12- and 24-weeks after randomization</time_frame>
    <description>Catastrophic thinking related to pain is measured with the Pain Catastrophizing Scale (PCS; Sullivan, Bishop, Pivik, 1995). The PCS-instructions ask participants to reflect on past painful experiences and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain on a five-point Likert scale with (0 = not at all, 4 = all the time).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression by HADS</measure>
    <time_frame>Change scores at 12- and 24-weeks after randomization</time_frame>
    <description>To assess the level of anxiety and depressive symptoms, the Hospital Anxiety and Depression Scale is used (HADS; Zigmond &amp; Snaith, 1983). The scale consists of 14 items, 7 relating to anxiety (HADS-A) and 7 to depression (HADS-D) with responses ranging from 0 (no symptoms) to 3 (maximum impairment). A cut-off score of ≥ 8 on each subscale is used in order to include all possible cases of depression and anxiety as suggested by (Zigmond &amp; Snaith, 1983).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD-symptomatology</measure>
    <time_frame>Change scores at 12- and 24-weeks after randomization</time_frame>
    <description>PTSD-symptomatology is measured with the PTSD-8 (Hansen, Andersen, Armour, Elklit, Palic, &amp; Mackrill, 2010). The scale is a brief version of The Harvard Trauma Questionnaire part IV (HTQ-IV; Molicca, Caspi-Yavin, Bollini, &amp; Truong, 1992) and consists of 8 items on a four-point Likert scale (1 = not at all, 4 = very often). The items relate to the three core clusters in PTSD in DSM-IV: avoidance (2 items), intrusion (4 items), and hyperarousal (2 items). The scale has proven good psychometric properties in various trauma samples including whiplash injured (Hansen et al., 2010).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Musculoskeletal Disorders</condition>
  <condition>Whiplash</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group A receives value-based cognitive behavior therapy after randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group B receives value-based cognitive behavior therapy after 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Value-based cognitive-behavioral therapy</intervention_name>
    <description>The intervention is a manualized program specifically tailored for prevention of disability and psychological distress after whiplash injuries. The intervention is delivered by two trained clinical psychologists og consists of 10 weekly one-hour individual sessions.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  18 and 65-years-old&#xD;
&#xD;
          -  WAD level I-II.&#xD;
&#xD;
          -  3-months post-injury&#xD;
&#xD;
          -  Disability in at least one important life domain (≥ 5 on the pain disability index)&#xD;
             and moderate levels of pain (average pain intensity ≥ 4 on the NRS scale).&#xD;
&#xD;
          -  Meet at least one of the psychological risk criteria:&#xD;
&#xD;
          -  Elevated levels of pain catastrophizing, fear-avoidance-beliefs, symptoms of anxiety&#xD;
             and/or depression, and posttraumatic stress symptoms.&#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>Tonny Elmose Andersen, MSc,Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Psychology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ask Elklit, professor</last_name>
    <role>Study Director</role>
    <affiliation>Department of Psychology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern Denmark</name>
      <address>
        <city>Odense</city>
        <state>Syddanmark</state>
        <zip>5230</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Tonny Elmose Andersen, phd.</investigator_full_name>
    <investigator_title>MSc., Ph.D</investigator_title>
  </responsible_party>
  <keyword>whiplash, prevention, pain, cognitive-behavioural therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Whiplash Injuries</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/NCT02251028
org study id: S-20130103
nct id: NCT02251028
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether a specifically tailored value-based
      cognitive behavioural therapy program (V-CBT) is able to prevent the development of
      persistent disability, pain, and psychological distress if delivered within the first three
      months after a whiplash injury.
The primary objective of the present study is to test whether a specifically tailored
      value-based cognitive-behavioural therapy program (V-CBT) is able to prevent the development
      of persistent disability, pain, and psychological distress if delivered within the first
      three months after a whiplash injury. Methods. The current study is a two-armed randomized
      controlled study with a crossover design. Group A is scheduled for V-CBT within one week of
      randomization and group B with a delayed onset 3 months after randomization.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Disability as measured by Pain Disability Index
time frame: Change scores at 12- and 24-weeks after randomization
description: The PDI measures how pain interferes with daily life activities within 7 different domains. The 7 domains are rated from 0 (no disability) to 10 (worst disability). The scale shows good reliability and validity.
measure: Pain by NDI
time frame: Change scores at 12- and 24-weeks after randomization
description: Neck pain intensity and disability is measured with the Neck Disability Index (NDI; Vernon & Mior, 1991). The NDI measures within 10 domains pain and how neck pain affects the ability to handle daily life activities such as personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration, and headache. The total score range from 0 (no disability) to 100 (total disability).
measure: Pain by NRS
time frame: Change scores at 12- and 24-weeks after randomization
description: Pain is also measured on four numerical pain rating scales (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Patients mark their answers on each scale corresponding to their pain now, highest level of pain, lowest level of pain, and finally average pain over the past week (NRS: Turk & Melzack, 2001).
measure: Fear of re-injury by TSK
time frame: Change scores at 12- and 24-weeks after randomization
description: Fear of re-injury due to movement is measured with Tampa Scale for Kinesiophobia (TSK; Kori, Miller, & Todd, 1990). TSK is a 17-item scale assessing fear of movement on a 4-point likert scale ranging from 17 to 68 with higher scores indicating higher levels of kinesiophobia. The scale is commonly used in various chronic pain samples and has good construct and predictive validity (Roelofs, Goubert, Peters, Vlayen, & Crombes, 2004). The clinical cut-off score is set to ≥ 37.
measure: Pain-related catastrophizing by PCS
time frame: Change scores at 12- and 24-weeks after randomization
description: Catastrophic thinking related to pain is measured with the Pain Catastrophizing Scale (PCS; Sullivan, Bishop, Pivik, 1995). The PCS-instructions ask participants to reflect on past painful experiences and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain on a five-point Likert scale with (0 = not at all, 4 = all the time).
measure: Anxiety and depression by HADS
time frame: Change scores at 12- and 24-weeks after randomization
description: To assess the level of anxiety and depressive symptoms, the Hospital Anxiety and Depression Scale is used (HADS; Zigmond & Snaith, 1983). The scale consists of 14 items, 7 relating to anxiety (HADS-A) and 7 to depression (HADS-D) with responses ranging from 0 (no symptoms) to 3 (maximum impairment). A cut-off score of ≥ 8 on each subscale is used in order to include all possible cases of depression and anxiety as suggested by (Zigmond & Snaith, 1983).
measure: PTSD-symptomatology
time frame: Change scores at 12- and 24-weeks after randomization
description: PTSD-symptomatology is measured with the PTSD-8 (Hansen, Andersen, Armour, Elklit, Palic, & Mackrill, 2010). The scale is a brief version of The Harvard Trauma Questionnaire part IV (HTQ-IV; Molicca, Caspi-Yavin, Bollini, & Truong, 1992) and consists of 8 items on a four-point Likert scale (1 = not at all, 4 = very often). The items relate to the three core clusters in PTSD in DSM-IV: avoidance (2 items), intrusion (4 items), and hyperarousal (2 items). The scale has proven good psychometric properties in various trauma samples including whiplash injured (Hansen et al., 2010).
arm group label: Group A
arm group type: Active Comparator
description: Group A receives value-based cognitive behavior therapy after randomization.
arm group label: Group B
arm group type: Active Comparator
description: Group B receives value-based cognitive behavior therapy after 3 months.
intervention type: Behavioral
intervention name: Value-based cognitive-behavioral therapy
description: The intervention is a manualized program specifically tailored for prevention of disability and psychological distress after whiplash injuries. The intervention is delivered by two trained clinical psychologists og consists of 10 weekly one-hour individual sessions.
arm group label: Group A
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tonny Elmose Andersen, MSc,Ph.D.
role: Study Director
affiliation: Department of Psychology
last name: Ask Elklit, professor
role: Study Director
affiliation: Department of Psychology
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Tonny Elmose Andersen, phd.
investigator title: MSc., Ph.D
mesh term: Musculoskeletal Diseases
mesh term: Whiplash Injuries
sharing ipd: No