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Chronic PainNCT04413006

Self-compassion for Chronic Pain Virtual Group Treatment Program

A study testing Self-Compassion for Chronic Pain Virtual Group Treatment Program in people with Chronic Pain, run by University of Manitoba at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Self-Compassion for Chronic Pain Virtual Group Treatment Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteCanada
Study dates
25 May 2020to 31 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

-

Trial locations and contacts

1 site in 1 country.

Brigitte C Sabourin, PhD contact

204-787-1506

bsabourin@hsc.mb.ca

Amanda Shamblaw, BsC contact

204-787-3739

ashamblaw@hsc.mb.ca

Canada1 site, 1 recruiting
  • University of Manitoba

    Winnipeg, Manitoba, R3A 1R9

    Brigitte C Sabourin, PhD

    Recruiting

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Chronic Pain
Being tested
Self-Compassion for Chronic Pain Virtual Group Treatment Program
Keywords
Virtual treatment, Group Treatment, Self-Compassion
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-Compassion for Chronic Pain Virtual Group Treatment ProgramBehavioural

    6-session group via video-conferencing for informational and experiential exercises to increase self-compassion in individuals with chronic pain

Study groups in NCT04413006
Study groupRoleWhat they receive
Treatment ArmExperimentalParticipants who will receive the 6-session Group-Based Virtual Self-Compassion for Chronic Pain treatment
Receives: Behavioral: Self-Compassion for Chronic Pain Virtual Group Treatment Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change over time in Scores on the Self-Compassion Scale (SCS)

    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)

    Measured: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later

  2. Change over time in Scores on the Pain Disability Index

    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)

    Measured: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later

Secondary outcomes (8)
  1. Change over time in Scores on the Chronic Pain Acceptance Questionnaire - 8

    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)

    Measured: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later

  2. Change over time in Scores on the Pain Catastrophizing Scale -6

    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)

    Measured: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later

  3. Change over time in Scores on the Pain Self-Efficacy Questionnaire-4

    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)

    Measured: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later

  4. Change over time in Pain Intensity

    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)

    Measured: at treatment end (6-weeks after beginning treatment) and 3 months later

  5. Change over time in Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)

    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)

    Measured: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later

  6. Changes over time in Anxiety Symptoms as measured by the Generalized Anxiety Scale-7

    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)

    Measured: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later

  7. Change over time in Quality of Life as measured by the PROMIS GLOBAL- 10

    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)

    Measured: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later

  8. Changes over time in Mindfulness

    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)

    Measured: baseline, at treatment end (6-weeks after beginning treatment) and 3 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start25 May 2020 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04413006
Sponsor's protocol ID
sccpvgtbsas2020
Status last verified
May 2020
First submitted
21 May 2020
Last updated
2 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-Compassion for Chronic Pain Virtual Group Treatment Program in people with Chronic Pain, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Brigitte C Sabourin, PhD (204-787-1506, bsabourin@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020; AzTrials last refreshed its copy on 28 Oct 2026.

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