Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services

NCT ID: NCT04842097

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2022-01-24

Brief Summary

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The goal of this project is to explore the feasibility and the efficacy of a online mindfulness-based stress reduction intervention for people with chronic pain waiting for secondary or tertiary health care services

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A two group parallel single blind pilot RCT
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
It is not possible to blind the participants to group allocation due to the nature of the mindfulness-based stress reduction intervention; however, the outcome assessor, who will administer the outcome questionnaires to the participants will be blinded to the participants' group allocation as well the investigator and the data analyst who will conduct the analysis ensuring neutrality of the outcome assessment.

Study Groups

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Mindfulness-based stress reduction intervention

Online 8-week group program, once per week

Group Type EXPERIMENTAL

Mindfulness-based stress reduction

Intervention Type BEHAVIORAL

An online mindfulness-based stress reduction intervention will be administered in a group format of maximum 15 participants, once a week for 120 minutes for 8 weeks by an experienced therapist trained in MBSR. Sessions will include sitting and lying meditation, hatha yoga and a body scan where attention is sequentially focused on different parts of the body. Individual autonomous practice between 30-45 minutes, 6 times / week will also be recommended. To support individual autonomous practice, a daily diary and two guided videos (around 35 minutes/each) were created.

Waiting list

Controls will not receive any intervention during this time. They are on chronic pain clinics waiting list

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-based stress reduction

An online mindfulness-based stress reduction intervention will be administered in a group format of maximum 15 participants, once a week for 120 minutes for 8 weeks by an experienced therapist trained in MBSR. Sessions will include sitting and lying meditation, hatha yoga and a body scan where attention is sequentially focused on different parts of the body. Individual autonomous practice between 30-45 minutes, 6 times / week will also be recommended. To support individual autonomous practice, a daily diary and two guided videos (around 35 minutes/each) were created.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 18-85
* Self-reported diagnosis of chronic non-cancer pain
* Chronic non-cancer pain duration of 3 months or more
* Chronic non-cancer pain experienced during 4 days or more per week
* Average pain intensity of 4 or more out of 10 in the last seven days
* French or English fluency
* Access to Wi-Fi
* Be able to attend a weekly two-hour MBSR virtual session for eight consecutive weeks

Exclusion Criteria

* Cancer-related chronic pain
* Currently receiving or have received in the last 24 months coordinated care in pain clinics, hospitals or rehabilitation centers.
* Current or recent participation (in the last 12 months and more than 12 sessions) of cognitive-behavioral therapy or MBSR program
* Having an unstable psychological conditions such as depression, bipolar disorder, post-traumatic stress disorder, psychotic disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

OTHER

Sponsor Role lead

Responsible Party

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Diana Zidarov

site researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Association québécoise de la douleur chronique

Montreal, Quebec, Canada

Site Status

Centre de réadaptation Layton-Lethbridge-Mackay

Montreal, Quebec, Canada

Site Status

Hôpital de Verdun

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CRIR-1499-1120/multi

Identifier Type: -

Identifier Source: org_study_id

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