<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/NCT03228745</url>
  </required_header>
  <id_info>
    <org_study_id>H2017:299</org_study_id>
    <nct_id>NCT03228745</nct_id>
  </id_info>
  <brief_title>The Health Impact of Mindfulness Based Stress Reduction on Total Knee Arthroplasty</brief_title>
  <official_title>The Health Impact of Mindfulness Based Stress Reduction on Total Knee Arthroplasty: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite surgical success of total knee arthroplasty (TKA), reports of dissatisfaction and&#xD;
      poor outcomes including increased pain, reduced function for daily activities, and&#xD;
      compromised psychological health are common. Interventions to improve TKA outcomes are&#xD;
      primarily education-focused, however there is little support for efficacy. Evidence suggests&#xD;
      that mindfulness based stress reduction (MBSR) is effective for improving both physical and&#xD;
      mental health, which are factors implicated in negative post-operative TKA outcomes. The&#xD;
      efficacy of this empirically supported intervention on TKA outcomes has not been assessed.&#xD;
      The proposed pilot study will conduct a randomized controlled trial to evaluate the&#xD;
      feasibility and efficacy of pre-surgical MBSR on post-surgical outcomes. Post-operative pain&#xD;
      (severity and catastrophizing), functioning (interference and illness impact), quality of&#xD;
      life, emotional distress (anxiety and depression) and sleep will be assessed in pre-surgical&#xD;
      MBSR and compared to treatment as usual. This pilot will provide an opportunity for TKA&#xD;
      patients to receive an intervention that may improve outcomes. Further, it will provide&#xD;
      insight into the relationship between pre-surgical MBSR and post-operative TKA outcomes,&#xD;
      which will assist in the development of MBSR adaptations to less time intensive, and&#xD;
      potentially more accessible, future offerings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty-five participants on the waitlist for a TKA will be recruited from Concordia Hospital&#xD;
      Hip and Knee Institute - a facility that performs 800 TKA's per year. Participants will be&#xD;
      divided into two groups: the pre-operative MBSR group (30 participants, divided into two MBSR&#xD;
      groups), and the treatment-as-usual (TAU;15 participants). The individuals in the&#xD;
      pre-operative MBSR group will receive a pre-operative 8-week community-based MBSR course&#xD;
      taught by a certified instructor, which includes group classes lasting 2.5 hours a week,&#xD;
      45-minutes of home practice 6 days per week, a 1-hour orientation session at the beginning,&#xD;
      and a full-day silent retreat at the end. During the orientation, participants will complete&#xD;
      the study measures for this study. Two weeks prior to the surgery at the pre-anesthesia&#xD;
      clinic, all patients will receive another set of short self-reported questionnaires. All&#xD;
      patients will subsequently receive post-operative questionnaires at the following regularly&#xD;
      scheduled post-operative appointments: 6-8 weeks after surgery, and at 6 month and 1 year&#xD;
      follow-ups. Clinic personnel, who are blinded to assignment, will administer these measures&#xD;
      with all other regularly distributed clinical measures. Clinic personnel will also review the&#xD;
      chart to inform researchers as to what physical condition contributed to the need for a TKA.&#xD;
      The TAU group will have the opportunity to enroll in an MBSR course following the completion&#xD;
      of the study (after approximately 1 year), at no cost.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">October 20, 2020</completion_date>
  <primary_completion_date type="Actual">March 10, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants undergoing total knee arthroplasty who complete the mindfulness course MBSR to determine feasibility of this intervention</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Feasibility of MBSR intervention for TKA patients by determining the proportion of individuals who consent, are recruited, and complete the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive function Patient- Reported Outcomes Measurements Information System (PROMIS) scales</measure>
    <time_frame>Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program</time_frame>
    <description>Brief self-report questionnaire with questions surrounding cognitive function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue PROMIS scale</measure>
    <time_frame>Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program</time_frame>
    <description>Brief self-report questionnaire with questions surrounding fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain interference PROMIS scale</measure>
    <time_frame>Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program</time_frame>
    <description>Brief self-report questionnaire with questions surrounding pain interference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain behaviour PROMIS scale</measure>
    <time_frame>Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program</time_frame>
    <description>Brief self-report questionnaire with questions surrounding pain behaviour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep disturbance PROMIS scale</measure>
    <time_frame>Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program</time_frame>
    <description>Brief self-report questionnaire with questions surrounding sleep disturbance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Illness Impact PROMIS scale</measure>
    <time_frame>Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program</time_frame>
    <description>Brief self-report questionnaire with questions surrounding psychosocial illness impact</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global health PROMIS scale</measure>
    <time_frame>Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program</time_frame>
    <description>Brief self-report questionnaire with questions surrounding global health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety PROMIS scale</measure>
    <time_frame>Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program</time_frame>
    <description>Brief self-report questionnaire with questions surrounding anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression PROMIS scale</measure>
    <time_frame>Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program</time_frame>
    <description>Brief self-report questionnaire with questions surrounding anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing scale</measure>
    <time_frame>Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program</time_frame>
    <description>Brief self-report questionnaire surrounding pain catastrophizing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The benefit from mindfulness intervention assessed by the Five Facet Mindfulness Questionnaire</measure>
    <time_frame>Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program</time_frame>
    <description>Use a brief self-report questionnaire to determine if the participant's level of mindfulness increased as a result of the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>pre-operative MBSR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-operative MBSR is a condition where individuals will receive a pre-operative 8-week community-based MBSR course, which includes group classes lasting 2.5 hours a week, 45-minutes of home practice 6 days per week, a 1-hour orientation session at the beginning, and a full-day silent retreat at the end. During the orientation, participants will complete the study measures for this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treatment-as-usual (TAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The individuals in the TAU group will receive their treatment as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pre-operative MBSR</intervention_name>
    <description>A MBSR program typically consists of 8 weekly 2.5 hour sessions, home practice (typically 45 minutes per day, 6 days per week), and one day retreat. During the program, participants engage in a number of mindfulness practices (e.g., body scan, mindful movement, meditation) and discussions of their experiences, with the aim enhancing awareness to moment-to-moment experiences in a non-judging and accepting manner.</description>
    <arm_group_label>pre-operative MBSR</arm_group_label>
    <other_name>mindfulness based stress reduction</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  on waitlist for first TKA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  on waitlist for revision TKA&#xD;
&#xD;
          -  taken a mindfulness course in the past 2 years&#xD;
&#xD;
          -  not able to read or understand English&#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>Renee El-Gabalawy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Kornelsen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric Bohm, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Corey Mackenzie, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Heather Macdonald, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gordon Asmundson, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Regina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 10, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>May 13, 2021</last_update_submitted>
  <last_update_submitted_qc>May 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Renée El-Gabalawy</investigator_full_name>
    <investigator_title>Dr., Assistant Professor, Staff Psychologist</investigator_title>
  </responsible_party>
  <keyword>mindfulness based stress reduction</keyword>
  <keyword>total knee arthroplasty</keyword>
  <keyword>pre-operative</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03228745/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03228745/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03228745/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03228745
org study id: H2017:299
nct id: NCT03228745
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Despite surgical success of total knee arthroplasty (TKA), reports of dissatisfaction and
      poor outcomes including increased pain, reduced function for daily activities, and
      compromised psychological health are common. Interventions to improve TKA outcomes are
      primarily education-focused, however there is little support for efficacy. Evidence suggests
      that mindfulness based stress reduction (MBSR) is effective for improving both physical and
      mental health, which are factors implicated in negative post-operative TKA outcomes. The
      efficacy of this empirically supported intervention on TKA outcomes has not been assessed.
      The proposed pilot study will conduct a randomized controlled trial to evaluate the
      feasibility and efficacy of pre-surgical MBSR on post-surgical outcomes. Post-operative pain
      (severity and catastrophizing), functioning (interference and illness impact), quality of
      life, emotional distress (anxiety and depression) and sleep will be assessed in pre-surgical
      MBSR and compared to treatment as usual. This pilot will provide an opportunity for TKA
      patients to receive an intervention that may improve outcomes. Further, it will provide
      insight into the relationship between pre-surgical MBSR and post-operative TKA outcomes,
      which will assist in the development of MBSR adaptations to less time intensive, and
      potentially more accessible, future offerings.
Forty-five participants on the waitlist for a TKA will be recruited from Concordia Hospital
      Hip and Knee Institute - a facility that performs 800 TKA's per year. Participants will be
      divided into two groups: the pre-operative MBSR group (30 participants, divided into two MBSR
      groups), and the treatment-as-usual (TAU;15 participants). The individuals in the
      pre-operative MBSR group will receive a pre-operative 8-week community-based MBSR course
      taught by a certified instructor, which includes group classes lasting 2.5 hours a week,
      45-minutes of home practice 6 days per week, a 1-hour orientation session at the beginning,
      and a full-day silent retreat at the end. During the orientation, participants will complete
      the study measures for this study. Two weeks prior to the surgery at the pre-anesthesia
      clinic, all patients will receive another set of short self-reported questionnaires. All
      patients will subsequently receive post-operative questionnaires at the following regularly
      scheduled post-operative appointments: 6-8 weeks after surgery, and at 6 month and 1 year
      follow-ups. Clinic personnel, who are blinded to assignment, will administer these measures
      with all other regularly distributed clinical measures. Clinic personnel will also review the
      chart to inform researchers as to what physical condition contributed to the need for a TKA.
      The TAU group will have the opportunity to enroll in an MBSR course following the completion
      of the study (after approximately 1 year), at no cost.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants undergoing total knee arthroplasty who complete the mindfulness course MBSR to determine feasibility of this intervention
time frame: Up to 18 months
description: Feasibility of MBSR intervention for TKA patients by determining the proportion of individuals who consent, are recruited, and complete the study.
measure: Cognitive function Patient- Reported Outcomes Measurements Information System (PROMIS) scales
time frame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
description: Brief self-report questionnaire with questions surrounding cognitive function
measure: Fatigue PROMIS scale
time frame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
description: Brief self-report questionnaire with questions surrounding fatigue
measure: Pain interference PROMIS scale
time frame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
description: Brief self-report questionnaire with questions surrounding pain interference
measure: Pain behaviour PROMIS scale
time frame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
description: Brief self-report questionnaire with questions surrounding pain behaviour
measure: Sleep disturbance PROMIS scale
time frame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
description: Brief self-report questionnaire with questions surrounding sleep disturbance
measure: Psychosocial Illness Impact PROMIS scale
time frame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
description: Brief self-report questionnaire with questions surrounding psychosocial illness impact
measure: Global health PROMIS scale
time frame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
description: Brief self-report questionnaire with questions surrounding global health
measure: Anxiety PROMIS scale
time frame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
description: Brief self-report questionnaire with questions surrounding anxiety
measure: Depression PROMIS scale
time frame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
description: Brief self-report questionnaire with questions surrounding anxiety
measure: Pain Catastrophizing scale
time frame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
description: Brief self-report questionnaire surrounding pain catastrophizing
measure: The benefit from mindfulness intervention assessed by the Five Facet Mindfulness Questionnaire
time frame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
description: Use a brief self-report questionnaire to determine if the participant's level of mindfulness increased as a result of the study
arm group label: pre-operative MBSR
arm group type: Experimental
description: Pre-operative MBSR is a condition where individuals will receive a pre-operative 8-week community-based MBSR course, which includes group classes lasting 2.5 hours a week, 45-minutes of home practice 6 days per week, a 1-hour orientation session at the beginning, and a full-day silent retreat at the end. During the orientation, participants will complete the study measures for this study.
arm group label: treatment-as-usual (TAU)
arm group type: No Intervention
description: The individuals in the TAU group will receive their treatment as usual.
intervention type: Behavioral
intervention name: Pre-operative MBSR
description: A MBSR program typically consists of 8 weekly 2.5 hour sessions, home practice (typically 45 minutes per day, 6 days per week), and one day retreat. During the program, participants engage in a number of mindfulness practices (e.g., body scan, mindful movement, meditation) and discussions of their experiences, with the aim enhancing awareness to moment-to-moment experiences in a non-judging and accepting manner.
arm group label: pre-operative MBSR
other name: mindfulness based stress reduction
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Renee El-Gabalawy, PhD
role: Principal Investigator
affiliation: University of Manitoba
last name: Jennifer Kornelsen, PhD
role: Principal Investigator
affiliation: University of Manitoba
last name: Eric Bohm, MD
role: Study Director
affiliation: University of Manitoba
last name: Corey Mackenzie, PhD
role: Study Director
affiliation: University of Manitoba
last name: Heather Macdonald, MD
role: Study Director
affiliation: University of Manitoba
last name: Gordon Asmundson, PhD
role: Study Director
affiliation: University of Regina
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Renée El-Gabalawy
investigator title: Dr., Assistant Professor, Staff Psychologist
sharing ipd: No
provided document: 
provided document: 
provided document: 