NCT04413006

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

May 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 21, 2020

Last Update Submit

June 1, 2020

Conditions

Keywords

Virtual treatmentGroup TreatmentSelf-Compassion

Outcome Measures

Primary Outcomes (2)

  • 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)

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

  • 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)

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

Secondary Outcomes (8)

  • Change over time in Scores on the Chronic Pain Acceptance Questionnaire - 8

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

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

    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

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

  • Change over time in Pain Intensity

    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)

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

  • +3 more secondary outcomes

Other Outcomes (1)

  • Client Satisfaction

    post treatment (6 weeks after beginning the treatment)

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Interventions

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

Treatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brigitte C Sabourin, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brigitte C Sabourin, PhD

CONTACT

Amanda Shamblaw, BsC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

June 2, 2020

Study Start

May 25, 2020

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

June 2, 2020

Record last verified: 2020-05

Locations