Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000822785
Ethics application status
Approved
Date submitted
25/03/2022
Date registered
10/06/2022
Date last updated
10/06/2022
Date data sharing statement initially provided
10/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness-Based Stress Reduction (MBSR) for Chronic Musculoskeletal Pain
Scientific title
The Feasibility and Preliminary Efficacy of an Online Mindfulness-Based Stress Reduction Program for Chronic Musculoskeletal Pain: A Pilot Randomised Trial
Secondary ID [1] 306755 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Musculoskeletal Pain 325765 0
Condition category
Condition code
Musculoskeletal 323101 323101 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the online live facilitated MBSR group (n=16) will receive an 8-week 2.5 hours online group training intervention plus one online half-day workshop. The workshop called “The Day of Mindfulness” will be scheduled between the 6th and 7th week. This will occur over 6 hours and is held in silence, with only the instructor speaking. This “retreat” will provide participants (n=16) with an opportunity to deepen what they learn in class. Participants will be encouraged to practice mindfulness daily throughout the 8 weeks. They will be encouraged to aim for a set duration of mindfulness meditation (e.g. 20-45 minutes per day). In addition, participants will receive access to a mobile application called Openground Mindfulness Training with recorded guided meditation practices that they can use throughout the program and a 100-page coursebook. The mobile app and coursebook are readily available resources created by Openground (https://www.openground.com.au/mindfulness-based-stress-reduction-mbsr). Participants will also receive ongoing individual support over the phone from the MBSR teacher if necessary. Adherence to the weekly sessions will be noted with an attendance checklist. Adherence to the home mindfulness practice will be monitored with the Mindfulness Adherence Questionnaire collected weekly via the Research Electronic Data Capture (REDCap). Any meditation-related adverse effects will also be collected weekly with The Meditation-Related Adverse Effects Scale, Mindfulness-Based Program version (MRAES-MBP) via REDCap.

The MBSR program combines mindfulness meditation, body awareness, yoga and exploration of patterns of behaviour, thinking, feeling and action. Mindfulness is defined as nonreactive awareness of the present experience, including body sensations, internal mental states, thoughts, emotions, impulses and memories. Mindfulness meditation is a mind training approach that cultivates cognitive control, emotion regulation and acceptance (i.e., nonreactivity), which leads to reduced stress and increased well-being. During the online MBSR program, participants will meet once a week (2.5 hours) via an online platform to practice mindfulness meditation and body awareness. During this time, participants also interact with their peers (16 participants) in discussions facilitated by a skilled, certified MBSR teacher. Each week the teacher presents the theoretical underpinnings of the mindfulness training and the application of self-regulatory skills and encourages dialogue and reflection on distinct topics as described below.

Week 1 - Recognising the present moment - Participants are experientially introduced to mindful eating, mindfulness of breathing and the body scan. The teacher facilitates an inner reflection on their experiences with the meditation practice.

Week 2 - Perception and how we make sense of the world - The role of self-responsibility in the positive development of short and long-term changes in health and health-enhancing behaviours is introduced. The teacher facilitates focused reflection concerning the role of perception and conditioning in the appraisal and assessment of stress.

Week 3 - Keeping the body in mind - The teacher facilitates inquiry and exploration of participants’ experiences and guides a reflection about pleasant events, focusing on physical sensations, emotions, and thoughts as they arise.

Week 4 - Investigating stressful experiences - The teacher facilitates an exploration of mindfulness as a means of reducing the negative effects of stress reactivity and developing more effective ways of responding positively and pro-actively to stressful situations.

Week 5 - Finding perspective: working with emotions and thoughts - This session emphasises the capacity of participants to adapt more rapidly and effectively to everyday challenges and stressors.

Week 6 - Relationships and kindness - The teacher facilitates a discussion around the continued development of “transformational coping strategies,” attitudes and behaviours that enhance the psychological characteristic known as “stress hardiness” or resilience.

Week 7 - Values and action - Participants are asked to purposefully reflect on lifestyle choices that are adaptive and self-nourishing and those that are maladaptive and self-limiting to integrate mindfulness practice more fully and personally into their daily lives.

Week 8 - Making mindfulness a part of your life - A review of the program is included with an emphasis on daily strategies for maintaining and deepening the skills developed during the program.
Intervention code [1] 323202 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control group will receive waitlist usual care and will be offered access to a passive, online, evidence-based resource for musculoskeletal pain (My Pain Hub) developed by the research team (https://mypainhub.com). This website, developed by a team of expert researchers, health professionals and people with musculoskeletal pain, provides trustworthy and up-to-date information/education about low back pain, neck pain and knee osteoarthritis.

Waitlist usual care includes the care that people usually receive while on the waitlist for one of the Pain Management Centres this study is recruiting from.
Control group
Active

Outcomes
Primary outcome [1] 330870 0
Feasibility Outcome 1: Recruitment rate measured as the % of eligible, invited participants who consent to participate in the study. Records will be kept of the number of individuals screened for eligibility, the number eligible and invited to participate and the number that consented to participate. We will also record the reasons for not entering the study. This outcome will be assessed based on the audit of study screening and enrolment logs.
Timepoint [1] 330870 0
This outcome will be assessed at the completion of the recruitment period.
Primary outcome [2] 330871 0
Feasibility Outcome 2: Drop-out rate measured as the % of participants who do not complete the follow-up (Week 8) assessment. This outcome will be assessed based on the audit of follow-up attendance logs.
Timepoint [2] 330871 0
8 weeks after the start of the intervention
Primary outcome [3] 330872 0
Feasibility Outcome 3: Adherence to the mindfulness practice. The amount and aspects of MBSR completed throughout the eight weeks program will be collected via self-reported online weekly using the Mindfulness Adherence Questionnaire (MAQ) via Research Electronic Data Capture (REDCap). The MAQ is a 12-item self-reported questionnaire that captures the adherence to the mindfulness practice occurring within the past week. It was designed to assess regular and sustained practice in attentional focus and non-judgmental acceptance (i.e., quantity, quality, subtype of practice). The first two items measure formal practice in terms of frequency and average duration of practice (in mins). The remaining 10 items measure the quality of formal practice and informal practice. Items are scored on a 7-point Likert-scale ranging from 0 (never) to 6 (always), with greater total subscale scores reflecting higher practice quality for that respective practice subtype.
Timepoint [3] 330872 0
Weekly during the eight-week intervention (i.e. Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8)
Secondary outcome [1] 407889 0
Secondary Outcome 1: Chronic pain acceptance measured using the Chronic Pain Acceptance Questionnaire (CPAQ).
Timepoint [1] 407889 0
Baseline and 8 weeks after the start of the intervention
Secondary outcome [2] 407890 0
Secondary Outcome 2: Pain intensity and pain interference will be collected with the Brief Pain Inventory (BPI),
Timepoint [2] 407890 0
Baseline and 8 weeks after the start of the intervention
Secondary outcome [3] 407891 0
Secondary Outcome 3: Pain self-efficacy will be collected with the Pain Self-Efficacy Questionnaire (PSEQ),
Timepoint [3] 407891 0
Baseline and 8 weeks after the start of the intervention
Secondary outcome [4] 409780 0
Secondary Outcome 4: Pain catastrophising will be collected with the Pain Catastrophising Scale (PCS).
Timepoint [4] 409780 0
Baseline and 8 weeks after the start of the intervention
Secondary outcome [5] 409781 0
Secondary Outcome 5: Depression, anxiety and stress will be collected using the Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [5] 409781 0
Baseline and 8 weeks after the start of the intervention.
Secondary outcome [6] 409782 0
Secondary Outcome 6: Medication intake will be collected using the electronic Persistent Pain Outcomes Collaboration (ePPOC).
Timepoint [6] 409782 0
Baseline and 8 weeks after the start of the intervention.
Secondary outcome [7] 409783 0
Secondary Outcome 7: Health care utilization will be collected using the electronic Persistent Pain Outcomes Collaboration (ePPOC)
Timepoint [7] 409783 0
Baseline and 8 weeks after the start of the intervention.

Eligibility
Key inclusion criteria
We will include people that:
- Are 18 years or older
- Have chronic musculoskeletal pain (any musculoskeletal pain [e.g. neck, shoulder, lower back, hip, knee] for more than 12 weeks)
- Are proficient in English (i.e. able to read and understand the Participant Information Sheet, Participant Consent Form and study materials without the need for assistance from a translator)
- Are able to access the internet via a computer (laptop or desktop) or via a smartphone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude people that:
- have self-reported active or uncontrolled mental illness (i.e., severe depression, bipolar disorder, schizophrenia that is not managed by a health care professional - psychologist, psychotherapist, psychiatrist) assessed by an experienced clinician during a telephone screening process;
- have a history of an unexplored, untreated traumatic experience or adverse childhood events assessed by an experienced clinician during the telephone screening process;
- are judged at the investigator’s discretion as being unsuitable to participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be performed by an independent, remote researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer-generated random allocation schedule (1:1 ratio).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In pilot studies, a sample size of at least 30 participants is advisable in many circumstances to provide an estimated standard deviation which can be used in the sample size calculation for a future full-scale trial. Based on this information, we have estimated that 16 participants in each group (32 participants in total) may be necessary to reach the feasibility purposes of this study.

Baseline demographics will be described using means and percentages and their standard deviations. Primary feasibility outcomes will be analysed using percentages (proportions) and 95% confidence intervals (CIs). Patient-reported outcome measures will be analysed using between-group comparisons of each outcome (i.e., physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity) as per intention-to-treat using linear mixed models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/07/2022
Actual
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22036 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 37558 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 311096 0
Other Collaborative groups
Name [1] 311096 0
Sydney Health Partners
Country [1] 311096 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, Camperdown, NSW 2006
Country
Australia
Secondary sponsor category [1] 312438 0
None
Name [1] 312438 0
Address [1] 312438 0
Country [1] 312438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310629 0
Sydney Local Health District (SLHD) Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310629 0
Ethics committee country [1] 310629 0
Australia
Date submitted for ethics approval [1] 310629 0
28/03/2022
Approval date [1] 310629 0
17/05/2022
Ethics approval number [1] 310629 0
X22-0086 & 2022/ETH00553

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118318 0
Dr Anita Amorim
Address 118318 0
Level 7 East, Susan Wakil Health Building D18, The University of Sydney, NSW 2006
Country 118318 0
Australia
Phone 118318 0
+61 2 9036 4196
Fax 118318 0
Email 118318 0
anita.amorim@sydney.edu.au
Contact person for public queries
Name 118319 0
Anita Amorim
Address 118319 0
Level 7 East, Susan Wakil Health Building D18, The University of Sydney, NSW 2006
Country 118319 0
Australia
Phone 118319 0
+61 2 9036 4196
Fax 118319 0
Email 118319 0
anita.amorim@sydney.edu.au
Contact person for scientific queries
Name 118320 0
Anita Amorim
Address 118320 0
Level 7 East, Susan Wakil Health Building D18, The University of Sydney, NSW 2006
Country 118320 0
Australia
Phone 118320 0
+61 2 9036 4196
Fax 118320 0
Email 118320 0
anita.amorim@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15554Ethical approval  anita.amorim@sydney.edu.au 383815-(Uploaded-18-05-2022-16-06-57)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.