Self-compassion for Chronic Pain Virtual Group Treatment Program

June 1, 2020 updated by: University of Manitoba

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Recruiting
        • University of Manitoba
        • Contact:
          • Brigitte C Sabourin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Seeking services from a Chronic Pain Specialty Services (tertiary care multi-disciplinary clinic, or health psychologist). Having sufficient internet capacity to participate in the video conferences, and proficiency in speaking and understanding English -

Exclusion Criteria: severe depressive symptoms; acute suicidality

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm
Participants who will receive the 6-session Group-Based Virtual Self-Compassion for Chronic Pain treatment
Behavioral: Self-Compassion for Chronic Pain Virtual Group Treatment Program
6-session group via video-conferencing for informational and experiential exercises to increase self-compassion in individuals with chronic pain

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
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
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)
baseline, at treatment end (6-weeks after beginning treatment) and 3 months later

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
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
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)
baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
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
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)
baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
Change over time in Pain Intensity
Time Frame: at treatment end (6-weeks after beginning treatment) and 3 months later
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)
at treatment end (6-weeks after beginning treatment) and 3 months later
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
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)
baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
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
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)
baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
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
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)
baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
Changes over time in Mindfulness
Time Frame: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later
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)
baseline, at treatment end (6-weeks after beginning treatment) and 3 months later

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Client Satisfaction
Time Frame: post treatment (6 weeks after beginning the treatment)
Scores on the Client Satisfaction Questionnaire
post treatment (6 weeks after beginning the treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brigitte C Sabourin, PhD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • sccpvgtbsas2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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