<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/NCT03256617</url>
  </required_header>
  <id_info>
    <org_study_id>00100188</org_study_id>
    <nct_id>NCT03256617</nct_id>
  </id_info>
  <brief_title>The Development of a Cognitive Reassurance Training Program</brief_title>
  <official_title>The Development of a Cognitive Reassurance Training Program and Its Impact on Physical Therapist and Patient Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</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>
      The focus of this proposal is to evaluate the feasibility of a cognitive reassurance training&#xD;
      program by examining changes in physical therapist low back pain beliefs and skills with&#xD;
      training and evaluating the quality with which physical therapists apply cognitive&#xD;
      reassurance to patients. The secondary focus is to examine the association between physical&#xD;
      therapist application of cognitive reassurance and short-term changes in patients' low back&#xD;
      pain beliefs and expectations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Identifying strategies to favorably alter unhelpful cognitions of patients with recent onset&#xD;
      low back pain is a research priority and could help curb the transition from acute to chronic&#xD;
      low back pain; lessening the need for prolonged and costly management. Current evidence&#xD;
      suggests that psychological factors, including maladaptive pain beliefs and avoidant&#xD;
      behaviors and expectations for recovery, are associated with poor outcomes in patients with&#xD;
      low back pain. Recently, considerable attention has been given to training non-psychologists&#xD;
      to provide psychologically based interventions for patients with low back pian. A recent&#xD;
      review of interventions that included psychological approaches noted that all of the trials&#xD;
      that failed to show beneﬁt included delivery of the intervention by non-psychologists.&#xD;
      Authors suggest that increasing the effort in selecting, training, supervising and assessing&#xD;
      the competence of the practitioners delivering the treatment could improve results.&#xD;
&#xD;
      Low back pain comprises approximately 50% of the caseload of outpatient physical therapists&#xD;
      physical therapists making physical therapists ideally positioned to manage the unhelpful&#xD;
      cognitions of patients with low back pain. However, physical therapists often feel unprepared&#xD;
      when managing the cognitive factors associated with low back pain. The purpose of this&#xD;
      project is to develop and assess the effectiveness of a training program for physical&#xD;
      therapists that focuses on cognitive reassurance; a novel cognitive intervention for patients&#xD;
      with low back pain.&#xD;
&#xD;
      Cognitive reassurance is a communication approach in which maladaptive beliefs and&#xD;
      expectations are identified. Tailored explanations for the patient's conditions are then&#xD;
      provided, possible prognosis and treatment are discussed, and clariﬁcations are offered. With&#xD;
      adequate training, physical therapists could utilize cognitive reassurance to promote&#xD;
      patients' understanding of his/her condition and modify maladaptive low back pain-related&#xD;
      beliefs and expectations.&#xD;
&#xD;
      The proposed pilot study will use a pre-post design to examine the impact of cognitive&#xD;
      reassurance training on the low back pain beliefs and skills in physical therapists and&#xD;
      physical therapist assistants. Following the training the investigators will recruit patients&#xD;
      who have scheduled an evaluation for low back pain with the physical therapists who attended&#xD;
      the training. Patient data will be collected at baseline before the evaluation and follow up&#xD;
      data at 2, 4 and 8 weeks.&#xD;
&#xD;
      The specific aims are: 1) Evaluate the feasibility of a cognitive reassurance training&#xD;
      program for physical therapists that focuses on modifying physical therapists' beliefs and&#xD;
      improving physical therapists' skill in the application of cognitive reassurance for patients&#xD;
      with acute/subacute low back pain. 2) Evaluate the application of cognitive reassurance by&#xD;
      physical therapists to patients with acute/sub-acute low back pain. 3) Examine the&#xD;
      association between physical therapist application of cognitive reassurance and short-term&#xD;
      changes in the patient's low back pain beliefs and expectations (low back pain beliefs,&#xD;
      self-efficacy, pain catastrophizing, fear-avoidance).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruiting beyond September 10, 2018 would mean that the training occurred more than a year in&#xD;
    the past. For this reason, we terminated recruitment.&#xD;
  </why_stopped>
  <start_date type="Actual">May 19, 2017</start_date>
  <completion_date type="Actual">November 8, 2018</completion_date>
  <primary_completion_date type="Actual">August 25, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pre-post test design for the therapists followed by a prospective cohort of patients.&#xD;
We anticipate 50 physical therapy providers and 150 patients for a total of 200 participants.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in back beliefs questionnaire for health care providers</measure>
    <time_frame>Baseline, 5 days</time_frame>
    <description>Measures providers' beliefs about back pain pre and post training</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Low back pain vignettes</measure>
    <time_frame>End of 2nd day of therapist training</time_frame>
    <description>Measures provider decision making related to cognitive reassurance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skills assessment</measure>
    <time_frame>End of 2nd day of therapist training</time_frame>
    <description>Assess skills in the provision of cognitive reassurance during role-playing activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Pain Catastrophizing Scale</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
    <description>Measure of patient's pain catastrophizing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fear the Avoidance Beliefs Questionnaire</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
    <description>Measure of patient's fear-avoidance beliefs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Pain Self-efficacy Questionnaire</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
    <description>Measure of patient's pain self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Back Beliefs Questionnaire</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
    <description>Measure of patient's back beliefs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient check list</measure>
    <time_frame>2 weeks following initial evaluation for low back pain by a physical therapist</time_frame>
    <description>Measure whether key messages of cognitive reassurance were perceived by the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Open-ended question</measure>
    <time_frame>2 weeks following the initial evaluation for low back pain by a physical therapist</time_frame>
    <description>Asks the patient to list the most important things they learned learned in physical therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider check list</measure>
    <time_frame>2 weeks status post initial evaluation of patient with low back pain</time_frame>
    <description>Measures whether key cognitive reassurance messages were provided to the patient by the provider</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Provider training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive reassurance training</intervention_name>
    <description>The 2-day training program includes 3 sessions that will consist of interactive didactic lectures, solving case studies and role-playing activities. The first session uses lecture and cases to present models of pain and disability, evidence based predictors of disability and delayed recovery and evidence based interventions for patients with low back pain. The second session uses role playing and case studies help the providers to 1) develop skills in identifying maladaptive beliefs about pain in patients with low back pain and 2) develop the skills to address diagnostic uncertainty and negative pain beliefs and 3) develop skills to educate patients with low back pain. The third session will use role playing and case studies to refine the provider' skills in providing cognitive reassurance to patients with low back pain.</description>
    <arm_group_label>Provider training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Therapist inclusion criteria:&#xD;
&#xD;
          -  University of Utah Health Care physical therapists and physical therapist assistants&#xD;
&#xD;
          -  Employed at least 20 hours a week&#xD;
&#xD;
          -  Licensed in the state of Utah&#xD;
&#xD;
        Therapist exclusion criteria:&#xD;
&#xD;
          -  None&#xD;
&#xD;
        Patient inclusion criteria&#xD;
&#xD;
          -  Primary reason for scheduling an evaluation with a physical therapist is low back pain&#xD;
             (defined as symptoms of pain and/or numbness between the 12th rib and buttocks with or&#xD;
             without referral in to one or both legs&#xD;
&#xD;
          -  Current episode of low back pain ≤ 12 weeks duration&#xD;
&#xD;
          -  Age 18-64&#xD;
&#xD;
          -  Ability to read and speak English&#xD;
&#xD;
        Patient exclusion criteria&#xD;
&#xD;
          -  Report being referred to physical therapy for specific low back pathology (e.g.&#xD;
             fracture)&#xD;
&#xD;
          -  Any lumbar surgery in the past 6 months&#xD;
&#xD;
          -  Current pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jake S Magel, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah Health Care Out Patient Physical Therapy Clinics</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>April 14, 2020</last_update_submitted>
  <last_update_submitted_qc>April 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Jake Magel</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>low back pain</keyword>
  <keyword>cognitive reassurance</keyword>
  <keyword>physical therapist training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT03256617
org study id: 00100188
nct id: NCT03256617
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The focus of this proposal is to evaluate the feasibility of a cognitive reassurance training
      program by examining changes in physical therapist low back pain beliefs and skills with
      training and evaluating the quality with which physical therapists apply cognitive
      reassurance to patients. The secondary focus is to examine the association between physical
      therapist application of cognitive reassurance and short-term changes in patients' low back
      pain beliefs and expectations.
Identifying strategies to favorably alter unhelpful cognitions of patients with recent onset
      low back pain is a research priority and could help curb the transition from acute to chronic
      low back pain; lessening the need for prolonged and costly management. Current evidence
      suggests that psychological factors, including maladaptive pain beliefs and avoidant
      behaviors and expectations for recovery, are associated with poor outcomes in patients with
      low back pain. Recently, considerable attention has been given to training non-psychologists
      to provide psychologically based interventions for patients with low back pian. A recent
      review of interventions that included psychological approaches noted that all of the trials
      that failed to show beneﬁt included delivery of the intervention by non-psychologists.
      Authors suggest that increasing the effort in selecting, training, supervising and assessing
      the competence of the practitioners delivering the treatment could improve results.

      Low back pain comprises approximately 50% of the caseload of outpatient physical therapists
      physical therapists making physical therapists ideally positioned to manage the unhelpful
      cognitions of patients with low back pain. However, physical therapists often feel unprepared
      when managing the cognitive factors associated with low back pain. The purpose of this
      project is to develop and assess the effectiveness of a training program for physical
      therapists that focuses on cognitive reassurance; a novel cognitive intervention for patients
      with low back pain.

      Cognitive reassurance is a communication approach in which maladaptive beliefs and
      expectations are identified. Tailored explanations for the patient's conditions are then
      provided, possible prognosis and treatment are discussed, and clariﬁcations are offered. With
      adequate training, physical therapists could utilize cognitive reassurance to promote
      patients' understanding of his/her condition and modify maladaptive low back pain-related
      beliefs and expectations.

      The proposed pilot study will use a pre-post design to examine the impact of cognitive
      reassurance training on the low back pain beliefs and skills in physical therapists and
      physical therapist assistants. Following the training the investigators will recruit patients
      who have scheduled an evaluation for low back pain with the physical therapists who attended
      the training. Patient data will be collected at baseline before the evaluation and follow up
      data at 2, 4 and 8 weeks.

      The specific aims are: 1) Evaluate the feasibility of a cognitive reassurance training
      program for physical therapists that focuses on modifying physical therapists' beliefs and
      improving physical therapists' skill in the application of cognitive reassurance for patients
      with acute/subacute low back pain. 2) Evaluate the application of cognitive reassurance by
      physical therapists to patients with acute/sub-acute low back pain. 3) Examine the
      association between physical therapist application of cognitive reassurance and short-term
      changes in the patient's low back pain beliefs and expectations (low back pain beliefs,
      self-efficacy, pain catastrophizing, fear-avoidance).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pre-post test design for the therapists followed by a prospective cohort of patients.
We anticipate 50 physical therapy providers and 150 patients for a total of 200 participants.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in back beliefs questionnaire for health care providers
time frame: Baseline, 5 days
description: Measures providers' beliefs about back pain pre and post training
measure: Low back pain vignettes
time frame: End of 2nd day of therapist training
description: Measures provider decision making related to cognitive reassurance
measure: Skills assessment
time frame: End of 2nd day of therapist training
description: Assess skills in the provision of cognitive reassurance during role-playing activity
measure: Change in the Pain Catastrophizing Scale
time frame: Baseline, 4 weeks and 8 weeks
description: Measure of patient's pain catastrophizing
measure: Change in fear the Avoidance Beliefs Questionnaire
time frame: Baseline, 4 weeks and 8 weeks
description: Measure of patient's fear-avoidance beliefs.
measure: Change in the Pain Self-efficacy Questionnaire
time frame: Baseline, 4 weeks and 8 weeks
description: Measure of patient's pain self-efficacy
measure: Change in the Back Beliefs Questionnaire
time frame: Baseline, 4 weeks and 8 weeks
description: Measure of patient's back beliefs
measure: Patient check list
time frame: 2 weeks following initial evaluation for low back pain by a physical therapist
description: Measure whether key messages of cognitive reassurance were perceived by the patient.
measure: Open-ended question
time frame: 2 weeks following the initial evaluation for low back pain by a physical therapist
description: Asks the patient to list the most important things they learned learned in physical therapy
measure: Provider check list
time frame: 2 weeks status post initial evaluation of patient with low back pain
description: Measures whether key cognitive reassurance messages were provided to the patient by the provider
arm group label: Provider training
arm group type: Experimental
intervention type: Other
intervention name: Cognitive reassurance training
description: The 2-day training program includes 3 sessions that will consist of interactive didactic lectures, solving case studies and role-playing activities. The first session uses lecture and cases to present models of pain and disability, evidence based predictors of disability and delayed recovery and evidence based interventions for patients with low back pain. The second session uses role playing and case studies help the providers to 1) develop skills in identifying maladaptive beliefs about pain in patients with low back pain and 2) develop the skills to address diagnostic uncertainty and negative pain beliefs and 3) develop skills to educate patients with low back pain. The third session will use role playing and case studies to refine the provider' skills in providing cognitive reassurance to patients with low back pain.
arm group label: Provider training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jake S Magel, PT, PhD
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Jake Magel
investigator title: Research Assistant Professor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No