Mindfulness Online and Virtual Exercise (MOVE) Compared With Self-Management for Chronic Pain

NCT04899622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-10-05

No results posted yet for this study

Summary

The aim of this study is to assess the feasibility and acceptability of a combined Mindfulness Based Stress Reduction (MBSR) and exercise online programme compared to an online self-management guide. Pain management programmes are the recommended treatment for chronic pain, however a number of barriers to their widespread implementation have been identified including geographical distance from speciality programmes, functional disability limiting the mobility of people with CP and economic limitations(1). eHealth interventions have the potential to address a number of these barriers and recent reviews have reported reductions in pain(2), improved knowledge and understanding about chronic pain and chronic pain management, improved function(3) and improvements in quality of life(4) following eHealth interventions.

The intervention in this study will be delivered online. Participants will be randomly allocated to a combined MBSR and exercise programme (Group A) or an online self-management guide (Group B). Group A will take part in an 8 week live online weekly mindfulness sessions based on the Mindfulness Based Stress Reduction (MBSR) programme facilitated by a qualified mindfulness teacher, in addition to a supervised exercise classes led by a Physiotherapist. Group B will receive access to an 8 week online self-management guide containing 8 self-directed guides, which will be made available to participants biweekly.

Outcomes of feasibility and acceptability will be investigated in addition to a preliminary examination of between group clinical effects at baseline immediately post intervention and at a three month follow up, using validated patient reported outcome measures. In addition all participants will wear a Fitbit activity monitor for the duration of the eight-week interventions to capture activity measures. A qualitative study will also be conducted to gather participants' perceptions of the programme and its usefulness

Conditions

Interventions

BEHAVIORAL

MBSR

Participants will attend weekly online classes (two hours duration) of MBSR for eight weeks. The classes will be delivered live online to groups of up to fifteen participants and will be led by Mindfulness instructors with MSc degrees in Mindfulness Based Interventions. The programme content will be based on the standard MBSR programme and is tailored towards key concerns and difficulties experienced by individuals with chronic pain.

BEHAVIORAL

Exercise

Participants will attend weekly classes of supervised classes (1 hour) for eight weeks, following the MBSR class. The exercise class will be delivered live online to the group by an experienced Physiotherapist and will consist of a range of flexibility and strengthening exercises which will be advanced every two weeks for the duration of the eight week programme. The exercises will also be available in video format on the mobile application "Physitrack" which each participant will be invited to download. This will allow the participants to review the exercises between sessions, record online if they have completed each exercise and in addition rate their pain experience while completing the exercises.

BEHAVIORAL

Online Self-Management Guide

Participants will receive standard evidence based self-guided information which they will access independently via the members area of the study website. This 'Online Self-Management Guide' will consist of eight categories of self-management; (1) What is chronic pain? (2) Chronic pain and nutrition (3) Sleep issues with chronic pain (4) Activity and exercise (5) Pacing (6) Using a pain diary (7) Relaxation and mindfulness and (8) Course summary. The information will be presented in the form of general text, links to online resources and videos. The information in this area will be updated biweekly during the eight week programme with the participants receiving bi-weekly email reminders.

Sponsors & Collaborators

  • Mater Misericordiae University Hospital

    collaborator OTHER
  • University College Dublin

    collaborator OTHER
  • Orla Deegan

    lead OTHER

Principal Investigators

  • Catherine Doody · University College Dublin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-03-15
Completion
2022-07-01

Countries

  • Ireland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04899622 on ClinicalTrials.gov