<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/NCT04413006</url>
  </required_header>
  <id_info>
    <org_study_id>sccpvgtbsas2020</org_study_id>
    <nct_id>NCT04413006</nct_id>
  </id_info>
  <brief_title>Self-compassion for Chronic Pain Virtual Group Treatment Program</brief_title>
  <official_title>A Self-compassion Group-based Treatment for Chronic Pain Via Video Conferencing During the COVID-19 Pandemic: Feasibility Study for a Potential New Mode of Treatment Delivery</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>
    <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>
      As a result of COVID-19 and measures taken by the Canadian Government to reduce the&#xD;
      transmission of the virus, in-person psychology services have been suspended. Psychology&#xD;
      services are now being conducted via video conferencing. The purpose of the current project&#xD;
      is to pilot-test a 6-week Self Compassion Treatment for Chronic Pain delivered virtually, in&#xD;
      order to understand its utility in the current environment. The treatment is to be delivered&#xD;
      through a secure professional ZOOM licence. Objective 1 of the project is to assess the&#xD;
      feasibility and acceptability of attending the treatment group through virtual participation.&#xD;
      Objective 2 is to assess the effectiveness of the group treatment in improving&#xD;
      self-compassion, mental health, relationship with pain, and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be adult psychology outpatients of one of the two tertiary care pain&#xD;
      clinics in Winnipeg, or patients of one of the psychologists working in the Clinical Health&#xD;
      Psychology Program, and who would normally have been invited to attend an in-person&#xD;
      group-based intervention at the Health Sciences Centre.&#xD;
&#xD;
      Participants will complete a set of questionnaires that are standard in our clinic, and that&#xD;
      will be accessed via the online survey platform, Survey Gizmo.&#xD;
&#xD;
      Participants will complete 6-weeks of the virtual Self-Compassion for Chronic Pain Treatment&#xD;
      Group. Session 1: Participant introductions. Introduction of concepts: Self-Compassion (and&#xD;
      how it differs from Self-Esteem, Self-Pity, or Self-Indulgence), rationale of self-compassion&#xD;
      for chronic pain. Introductory experiential self-compassion exercises. Assignment of&#xD;
      homework. Session 2: Check-in and homework review. Introduction to mindfulness and its&#xD;
      applicability in self-compassion. Brief body scan and mindfulness of the breath exercises.&#xD;
      ACT Matrix exercise. Additional experiential self-compassion exercises. Discussion of&#xD;
      awareness of pleasant experiences. Assignment of homework (including awareness of pleasant&#xD;
      experiences throughout the week). Session 3: Check-in and homework review. Self-Compassion in&#xD;
      relationships and being present and compassionate in our relationships. Loving-kindness&#xD;
      meditation. Additional experiential self-compassion exercises Assignment of homework. Session&#xD;
      4: Check-in and homework review. Self-Compassion in the face of difficulties. Working with&#xD;
      difficult emotions (e.g., shame, guilt, anger, self-criticism) with self-compassion.&#xD;
      Additional experiential self-compassion exercises. Assignment of homework. Session 5:&#xD;
      Check-in and homework review. Self-care in chronic pain management. Cultivating gratitude,&#xD;
      self-appreciation and savouring attitudes. Additional experiential self-compassion exercises.&#xD;
      Assignment of homework. Session 6: Check-in and homework review. Compassionate body scan.&#xD;
      Review of program. A look forward (strategies to maintain practices, prepare for setbacks and&#xD;
      get back on track). Wrap-up.&#xD;
&#xD;
      Procedure. All participants who were scheduled to attend an in-person group-based therapy&#xD;
      program will be contacted to invite them to participate in this new virtual group. They will&#xD;
      be assured that their decision to participate (or to not participate) in this study will not&#xD;
      impact their eligibility for participation in the next in-person group, when in-person groups&#xD;
      resume. Additionally, current patients of pain psychologists in the Clinical Health&#xD;
      Psychology Program will be invited to the new program at the discretion of the treating&#xD;
      psychologist (this is in line with current practices). They will be informed that because&#xD;
      they are participating in a new group, a novel delivery format, and a unique environment, the&#xD;
      group program will be evaluated as part of a research study. If they agree to be part of the&#xD;
      study verbally, they will be sent a link to the Consent form and baseline questionnaires&#xD;
      through Survey Gizmo. Baseline questionnaires will be reviewed prior to beginning of the&#xD;
      group, and all participants who score in the &quot;severe&quot; range on the PHQ-9 (i.e. a score of 20&#xD;
      or higher), or who score a &quot;2 or higher&quot; on item number 9 (Thoughts that you would be better&#xD;
      off dead, or thoughts of hurting yourself in some way) will be contacted by telephone for&#xD;
      further screening. They may then be offered individual distance therapy rather than the&#xD;
      group-based therapy, as per Dr. Sabourin's assessment. All consented participants will be&#xD;
      contacted by one of the two therapists (Ms. Amanda Shamblaw, Psychology Resident or Dr.&#xD;
      Brigitte Sabourin, PhD, CPsych) prior to beginning the group in order to test out the&#xD;
      connection and problem-solve any difficulties. They will also be given some preliminary&#xD;
      instructions regarding attending a video-based appointment, as per the Clinical Health&#xD;
      Psychology Program's guidelines. These include a 2-part verification of patient&#xD;
      identification (date of birth and Patient health identification number - PHIN), informing&#xD;
      participants that &quot;Despite our best efforts to ensure high level of privacy and secure&#xD;
      technology, there is always a risk that the transmission be breached and accessed by&#xD;
      unauthorized persons&quot;, &quot;no sessions are recorded&quot;, &quot;no personal information is shared with&#xD;
      Zoom&quot;. They will then verbally consent to proceed. Participants will participate in the 6&#xD;
      weekly sessions in groups of 10-12 participants. At the beginning of each session, each&#xD;
      participant will be in a virtual &quot;waiting room&quot;, and either Ms. Shamblaw or Dr. Sabourin will&#xD;
      confirm the participant's location and phone number prior to admitting them to the group. The&#xD;
      location and phone numbers are collected in order to be able to reach participants if needed.&#xD;
      They will complete measures post-treatment and at a 3-month follow-up using Survey Gizmo.&#xD;
      Finally, following treatment, participants will have the option to participate in a&#xD;
      semi-structured qualitative interview to discuss their impressions of the group, impressions&#xD;
      of attending virtually, support they felt from other group members, and general group&#xD;
      cohesion feedback. Participants will be informed that the interview is voluntary and will not&#xD;
      affect their participation in the treatment group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">May 25, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change over time in Scores on the Self-Compassion Scale (SCS)</measure>
    <time_frame>baseline, at treatment end (6-weeks after beginning treatment) and 3 months later</time_frame>
    <description>Change over time in scores on the Self-Compassion Scale (SCS) (score range is 12-60 with increases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change over time in Scores on the Pain Disability Index</measure>
    <time_frame>baseline, at treatment end (6-weeks after beginning treatment) and 3 months later</time_frame>
    <description>Change over time in scores on the Pain Disability Index (score range is 0-70 with decreases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change over time in Scores on the Chronic Pain Acceptance Questionnaire - 8</measure>
    <time_frame>baseline, at treatment end (6-weeks after beginning treatment) and 3 months later</time_frame>
    <description>Change over time in scores on the on the Chronic Pain Acceptance Questionnaire - 8 (CPAQ-8) (score range is 0-48 with increases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change over time in Scores on the Pain Catastrophizing Scale -6</measure>
    <time_frame>baseline, at treatment end (6-weeks after beginning treatment) and 3 months later</time_frame>
    <description>Change over time in scores on the on the Pain Catastrophizing Scale-6 (PCS-6) (score range is 0-24 with decreases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change over time in Scores on the Pain Self-Efficacy Questionnaire-4</measure>
    <time_frame>baseline, at treatment end (6-weeks after beginning treatment) and 3 months later</time_frame>
    <description>Change over time in Scores on the Pain Self-Efficacy Questionnaire-4 (PSEQ-4) (score range is 0-24 with increases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change over time in Pain Intensity</measure>
    <time_frame>at treatment end (6-weeks after beginning treatment) and 3 months later</time_frame>
    <description>Change over time in scores on the Numeric Rating Scale (NRS) for pain (score range is 0-10 with decreases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change over time in Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>baseline, at treatment end (6-weeks after beginning treatment) and 3 months later</time_frame>
    <description>Change over time in scores on the Patient Health Questionnaire-9 (PHQ-9) (score range is 0-27 with decreases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes over time in Anxiety Symptoms as measured by the Generalized Anxiety Scale-7</measure>
    <time_frame>baseline, at treatment end (6-weeks after beginning treatment) and 3 months later</time_frame>
    <description>Change over time in scores on the Generalized Anxiety Scale (GAD-7) (score range is 0-21 with decreases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change over time in Quality of Life as measured by the PROMIS GLOBAL- 10</measure>
    <time_frame>baseline, at treatment end (6-weeks after beginning treatment) and 3 months later</time_frame>
    <description>Change over time in scores on the Physical Health and Mental Health Quality of Life scores from the PROMIS GLOBAL-10 (score range is 7-35 with increases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes over time in Mindfulness</measure>
    <time_frame>baseline, at treatment end (6-weeks after beginning treatment) and 3 months later</time_frame>
    <description>Changes over time in score on the Mindfulness Attention and Awareness Scale (MAAS) (score range is 15-90 with increases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Client Satisfaction</measure>
    <time_frame>post treatment (6 weeks after beginning the treatment)</time_frame>
    <description>Scores on the Client Satisfaction Questionnaire</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who will receive the 6-session Group-Based Virtual Self-Compassion for Chronic Pain treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-Compassion for Chronic Pain Virtual Group Treatment Program</intervention_name>
    <description>6-session group via video-conferencing for informational and experiential exercises to increase self-compassion in individuals with chronic pain</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Seeking services from a Chronic Pain Specialty Services (tertiary care&#xD;
        multi-disciplinary clinic, or health psychologist). Having sufficient internet capacity to&#xD;
        participate in the video conferences, and proficiency in speaking and understanding English&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: severe depressive symptoms; acute suicidality&#xD;
&#xD;
        -&#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>Brigitte C Sabourin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brigitte C Sabourin, PhD</last_name>
    <phone>204-787-1506</phone>
    <email>bsabourin@hsc.mb.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amanda Shamblaw, BsC</last_name>
    <phone>204-787-3739</phone>
    <email>ashamblaw@hsc.mb.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brigitte C Sabourin, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Virtual treatment</keyword>
  <keyword>Group Treatment</keyword>
  <keyword>Self-Compassion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</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/NCT04413006
org study id: sccpvgtbsas2020
nct id: NCT04413006
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As a result of COVID-19 and measures taken by the Canadian Government to reduce the
      transmission of the virus, in-person psychology services have been suspended. Psychology
      services are now being conducted via video conferencing. The purpose of the current project
      is to pilot-test a 6-week Self Compassion Treatment for Chronic Pain delivered virtually, in
      order to understand its utility in the current environment. The treatment is to be delivered
      through a secure professional ZOOM licence. Objective 1 of the project is to assess the
      feasibility and acceptability of attending the treatment group through virtual participation.
      Objective 2 is to assess the effectiveness of the group treatment in improving
      self-compassion, mental health, relationship with pain, and quality of life.
Participants will be adult psychology outpatients of one of the two tertiary care pain
      clinics in Winnipeg, or patients of one of the psychologists working in the Clinical Health
      Psychology Program, and who would normally have been invited to attend an in-person
      group-based intervention at the Health Sciences Centre.

      Participants will complete a set of questionnaires that are standard in our clinic, and that
      will be accessed via the online survey platform, Survey Gizmo.

      Participants will complete 6-weeks of the virtual Self-Compassion for Chronic Pain Treatment
      Group. Session 1: Participant introductions. Introduction of concepts: Self-Compassion (and
      how it differs from Self-Esteem, Self-Pity, or Self-Indulgence), rationale of self-compassion
      for chronic pain. Introductory experiential self-compassion exercises. Assignment of
      homework. Session 2: Check-in and homework review. Introduction to mindfulness and its
      applicability in self-compassion. Brief body scan and mindfulness of the breath exercises.
      ACT Matrix exercise. Additional experiential self-compassion exercises. Discussion of
      awareness of pleasant experiences. Assignment of homework (including awareness of pleasant
      experiences throughout the week). Session 3: Check-in and homework review. Self-Compassion in
      relationships and being present and compassionate in our relationships. Loving-kindness
      meditation. Additional experiential self-compassion exercises Assignment of homework. Session
      4: Check-in and homework review. Self-Compassion in the face of difficulties. Working with
      difficult emotions (e.g., shame, guilt, anger, self-criticism) with self-compassion.
      Additional experiential self-compassion exercises. Assignment of homework. Session 5:
      Check-in and homework review. Self-care in chronic pain management. Cultivating gratitude,
      self-appreciation and savouring attitudes. Additional experiential self-compassion exercises.
      Assignment of homework. Session 6: Check-in and homework review. Compassionate body scan.
      Review of program. A look forward (strategies to maintain practices, prepare for setbacks and
      get back on track). Wrap-up.

      Procedure. All participants who were scheduled to attend an in-person group-based therapy
      program will be contacted to invite them to participate in this new virtual group. They will
      be assured that their decision to participate (or to not participate) in this study will not
      impact their eligibility for participation in the next in-person group, when in-person groups
      resume. Additionally, current patients of pain psychologists in the Clinical Health
      Psychology Program will be invited to the new program at the discretion of the treating
      psychologist (this is in line with current practices). They will be informed that because
      they are participating in a new group, a novel delivery format, and a unique environment, the
      group program will be evaluated as part of a research study. If they agree to be part of the
      study verbally, they will be sent a link to the Consent form and baseline questionnaires
      through Survey Gizmo. Baseline questionnaires will be reviewed prior to beginning of the
      group, and all participants who score in the "severe" range on the PHQ-9 (i.e. a score of 20
      or higher), or who score a "2 or higher" on item number 9 (Thoughts that you would be better
      off dead, or thoughts of hurting yourself in some way) will be contacted by telephone for
      further screening. They may then be offered individual distance therapy rather than the
      group-based therapy, as per Dr. Sabourin's assessment. All consented participants will be
      contacted by one of the two therapists (Ms. Amanda Shamblaw, Psychology Resident or Dr.
      Brigitte Sabourin, PhD, CPsych) prior to beginning the group in order to test out the
      connection and problem-solve any difficulties. They will also be given some preliminary
      instructions regarding attending a video-based appointment, as per the Clinical Health
      Psychology Program's guidelines. These include a 2-part verification of patient
      identification (date of birth and Patient health identification number - PHIN), informing
      participants that "Despite our best efforts to ensure high level of privacy and secure
      technology, there is always a risk that the transmission be breached and accessed by
      unauthorized persons", "no sessions are recorded", "no personal information is shared with
      Zoom". They will then verbally consent to proceed. Participants will participate in the 6
      weekly sessions in groups of 10-12 participants. At the beginning of each session, each
      participant will be in a virtual "waiting room", and either Ms. Shamblaw or Dr. Sabourin will
      confirm the participant's location and phone number prior to admitting them to the group. The
      location and phone numbers are collected in order to be able to reach participants if needed.
      They will complete measures post-treatment and at a 3-month follow-up using Survey Gizmo.
      Finally, following treatment, participants will have the option to participate in a
      semi-structured qualitative interview to discuss their impressions of the group, impressions
      of attending virtually, support they felt from other group members, and general group
      cohesion feedback. Participants will be informed that the interview is voluntary and will not
      affect their participation in the treatment group.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change over time in Scores on the Self-Compassion Scale (SCS)
time frame: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
description: Change over time in scores on the Self-Compassion Scale (SCS) (score range is 12-60 with increases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)
measure: Change over time in Scores on the Pain Disability Index
time frame: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
description: Change over time in scores on the Pain Disability Index (score range is 0-70 with decreases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)
measure: Change over time in Scores on the Chronic Pain Acceptance Questionnaire - 8
time frame: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
description: Change over time in scores on the on the Chronic Pain Acceptance Questionnaire - 8 (CPAQ-8) (score range is 0-48 with increases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)
measure: Change over time in Scores on the Pain Catastrophizing Scale -6
time frame: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
description: Change over time in scores on the on the Pain Catastrophizing Scale-6 (PCS-6) (score range is 0-24 with decreases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)
measure: Change over time in Scores on the Pain Self-Efficacy Questionnaire-4
time frame: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
description: Change over time in Scores on the Pain Self-Efficacy Questionnaire-4 (PSEQ-4) (score range is 0-24 with increases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)
measure: Change over time in Pain Intensity
time frame: at treatment end (6-weeks after beginning treatment) and 3 months later
description: Change over time in scores on the Numeric Rating Scale (NRS) for pain (score range is 0-10 with decreases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)
measure: Change over time in Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
time frame: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
description: Change over time in scores on the Patient Health Questionnaire-9 (PHQ-9) (score range is 0-27 with decreases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)
measure: Changes over time in Anxiety Symptoms as measured by the Generalized Anxiety Scale-7
time frame: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
description: Change over time in scores on the Generalized Anxiety Scale (GAD-7) (score range is 0-21 with decreases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)
measure: Change over time in Quality of Life as measured by the PROMIS GLOBAL- 10
time frame: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
description: Change over time in scores on the Physical Health and Mental Health Quality of Life scores from the PROMIS GLOBAL-10 (score range is 7-35 with increases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)
measure: Changes over time in Mindfulness
time frame: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
description: Changes over time in score on the Mindfulness Attention and Awareness Scale (MAAS) (score range is 15-90 with increases in scores meaning better outcome). Change over time to be assessed via repeated measures Analysis of Variance (ANOVA)
measure: Client Satisfaction
time frame: post treatment (6 weeks after beginning the treatment)
description: Scores on the Client Satisfaction Questionnaire
arm group label: Treatment Arm
arm group type: Experimental
description: Participants who will receive the 6-session Group-Based Virtual Self-Compassion for Chronic Pain treatment
intervention type: Behavioral
intervention name: Self-Compassion for Chronic Pain Virtual Group Treatment Program
description: 6-session group via video-conferencing for informational and experiential exercises to increase self-compassion in individuals with chronic pain
arm group label: Treatment Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brigitte C Sabourin, PhD
role: Principal Investigator
affiliation: University of Manitoba
last name: Brigitte C Sabourin, PhD
phone: 204-787-1506
email: bsabourin@hsc.mb.ca
last name: Amanda Shamblaw, BsC
phone: 204-787-3739
email: ashamblaw@hsc.mb.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Chronic Pain