Clinical trial NCT04899622: Mindfulness Online and Virtual Exercise (MOVE) Compared With Self-Management for Chronic Pain
Official title: Mindfulness Combined With Virtual Exercise Online (MOVE) Compared With a Self-Management Guide for Adults With Chronic Pain: Study Protocol for a Feasibility Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Pain Management Programme
e-Health
Mindfulness Based Stress Reduction
Exercise
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Mater Misericordiae University Hospital
name: University College Dublin
First posted: 2021-05-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: This study is a parallel-groups, randomised-controlled, feasibility trial. Seventy-five participants aged 18 years and over, who have been diagnosed with a chronic pain condition by a Consultant in Pain Medicine or a General Practitioner will be recruited to the feasibility study. Participants will be individually randomised to one of two interventions. Group A will take part in live online weekly mindfulness sessions based on the Mindfulness Based Stress Reduction (MBSR) programme facilitated by a qualified mindfulness teacher, in addition to supervised exercise classes led by a Physiotherapist. The combined 3 hour intervention (2 hours MBSR, 1 hour exercise) will take place one day per week for 8 weeks. Group B will receive access to an 8 week online self-management guide containing 8 self-directed guides, with the material released biweekly.

The key outcomes measures will include; (1) recruitment rates, eligibility rates, willingness to be randomised; (2) feasibility and acceptability of data collection instruments and procedures; (3) intervention adherence, engagement and attrition rates; (4) feasibility and acceptability of the interventions and; (5) participants' subjective perceptions of the programmes.

The study will also include a preliminary examination of between group clinical effects at baseline, immediately post intervention and at a three month follow up, using the following validated patient reported outcome measures; Pain Self-Efficacy Questionnaire, Brief Pain Inventory, Pain Catastrophizing Scale, Generalised Anxiety Depression Assessment, Patient Health Questionnaire-9, Pain Disability Index, Fear Avoidance Belief Questionnaire, Short-Form-36 Health Survey, Patient Global Impression of Change Scale and measure of treatment satisfaction adapted from the Client Satisfaction Questionnaire (CSQ-8).

Physical activity levels (average daily step count, distance travelled and active minutes) will be measured for all participants using Fitbit Charge 4 activity monitors for the duration of the eight-week intervention period.

Analyses of the feasibility study will primarily be descriptive and will address the outcomes relating to the feasibility and acceptability of the interventions and the procedures of the study. Between-group comparisons of clinical treatment effects will be descriptive and exploratory to consider the viability of the combined MBSR and exercise intervention that may warrant further exploration in a fully powered RCT.

A sample of participants will be invited to attend focus groups where semi-structured interviews will be conducted with the aim of gathering information on the participants' subjective perceptions of the programme and its usefulness.

Eligibility criteria: Inclusion criteria:

•. Aged \>18 years

* Diagnosis of chronic pain by a Consultant in Pain Medicine or General Practitioner
* Presence of pain NRS ≥ 3 of greater than three months' duration
* Ability to provide informed consent
* Ability to communicate in English and understand English

Exclusion criteria:

* Need for further diagnostic evaluation (determined by doctor)
* Presence of any contraindications to participation in an exercise programme E.g. severe shortness of breath at rest, angina, uncontrolled diabetes or epilepsy, recent (previous 3 weeks) myocardial infarction, pulmonary embolism, deep vein thrombosis or asthma attack.
* Presence of active cancer
* Concurrent participation (or in the previous 3 months) with any form of psychological, physiotherapy or supervised exercise in addition to the study intervention.
* Presence of substance misuse (diagnosed by the Pain Consultant/GP).
* Inability to take part in an online exercise programme
* Standard MBSR exclusion criteria

Primary outcomes:
measure: Number of eligible participants identified per programme
timeFrame: Baseline
measure: Number of eligible participants recruited per programme
timeFrame: Baseline
measure: Reasons for non-participation
timeFrame: Baseline
measure: Number of participants who complete the study
timeFrame: immediately post intervention (8 weeks from baseline)
measure: Adherence to completion of baseline patient reported outcome measures
timeFrame: Baseline
measure: Adherence to completion of immediate follow-up patient reported outcome measures
timeFrame: Immediately post intervention (8 weeks from baseline)
measure: Adherence to completion of long term follow-up patient reported outcome measures
timeFrame: 3 months post intervention (20 weeks from baseline)
measure: Interaction with online self-management guide
timeFrame: Immediately post intervention (8 weeks from baseline)
measure: Treatment Acceptability (Satisfaction assessed by Client Satisfaction Questionnaire-8)
timeFrame: Immediately post intervention (8 weeks from baseline)
measure: Interface usability
timeFrame: immediately post intervention (8 weeks from baseline)
Secondary outcomes:
measure: Change in pain self-efficacy measured with the Pain Self-Efficacy Questionnaire
timeFrame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
measure: Change in symptoms of anxiety measured with the Generalized Anxiety Disorder Assessment
timeFrame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
measure: Changes in symptoms of depression measured with the Patient Health Questionnaire 9
timeFrame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
measure: Changes in pain severity and pain interference measured with the Brief Pain Inventory-Composite pain score
timeFrame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
measure: Changes in the impact of pain on individuals life participation measured with the Pain Disability Index
timeFrame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
measure: Changes in fear avoidance of physical activity measured with the Fear Avoidance Belief Questionnaire.
timeFrame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
measure: Change in pain catastrophising measured with the Pain Catastrophising Scale.
timeFrame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
measure: Change in quality of life measured with the Short Form-36 Health Survey
timeFrame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
measure: Patient Global Impression of Change Scale
timeFrame: immediately post intervention (8 weeks from baseline)
measure: Changes in step count (Fitbit)
timeFrame: immediately post intervention (8 weeks from baseline)
measure: Changes in distance travelled (Fitbit)
timeFrame: immediately post intervention (8 weeks from baseline)
measure: Changes in active minutes (Fitbit)
timeFrame: immediately post intervention (8 weeks from baseline)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
Study officials:
affiliation: University College Dublin
name: Catherine Doody
role: STUDY_DIRECTOR
References:
citation: Keogh E, Rosser BA, Eccleston C. e-Health and chronic pain management: current status and developments. Pain. 2010 Oct;151(1):18-21. doi: 10.1016/j.pain.2010.07.014. Epub 2010 Jul 31. No abstract available.
citation: Macea DD, Gajos K, Daglia Calil YA, Fregni F. The efficacy of Web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis. J Pain. 2010 Oct;11(10):917-29. doi: 10.1016/j.jpain.2010.06.005. Epub 2010 Jul 22.
citation: Bender JL, Radhakrishnan A, Diorio C, Englesakis M, Jadad AR. Can pain be managed through the Internet? A systematic review of randomized controlled trials. Pain. 2011 Aug;152(8):1740-1750. doi: 10.1016/j.pain.2011.02.012. Epub 2011 May 11.
citation: Mariano TY, Wan L, Edwards RR, Jamison RN. Online teletherapy for chronic pain: A systematic review. J Telemed Telecare. 2021 May;27(4):195-208. doi: 10.1177/1357633X19871746. Epub 2019 Sep 5.
citation: Deegan O, Fullen BM, Casey MB, Segurado R, Hearty C, Doody CM. Combined online interactive mindfulness and exercise programme (MOVE-Online) compared with a self-management guide for adults with chronic pain: protocol for a randomised controlled feasibility trial. BMJ Open. 2022 Feb 9;12(2):e058265. doi: 10.1136/bmjopen-2021-058265.