Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000833662
Ethics application status
Approved
Date submitted
19/07/2023
Date registered
3/08/2023
Date last updated
13/04/2024
Date data sharing statement initially provided
3/08/2023
Date results information initially provided
13/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet delivered mindfulness-based cognitive therapy (iMBCT) for chronic pain: A pilot randomised controlled trial
Scientific title
Internet delivered mindfulness-based cognitive therapy (iMBCT) for chronic pain symptom management in adults: A pilot randomised controlled trial
Secondary ID [1] 310101 0
None
Universal Trial Number (UTN)
U1111-1295-0224
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 330666 0
Persistent Pain 330863 0
Condition category
Condition code
Musculoskeletal 327480 327480 0 0
Other muscular and skeletal disorders
Anaesthesiology 327662 327662 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
From the inception of this research program we have adopted a community-based participatory research (CBPR) framework. This is a patient-centred and community driven approach that is well suited to the adaptation of treatment to improve patient access and uptake, as is undertaken in this research.

In this trial, those assigned to the treatment condition will complete the co-designed 4-week, internet delivered mindfulness-based cognitive therapy (iMBCT) program. The iMBCT for chronic pain protocol integrates psychoeducation and cognitive-behavioural therapy techniques with mindfulness-based interventional strategies to form a streamlined approach to training the mind to respond more adaptively to pain. Participants in MBCT will be taught to apply the skills they learn not only to pain but also the problems pain causes for them including sleep disturbance, depressed mood, stress, and other problems. Each of the four weekly modules will include mini-modules on pain psychoeducation (e.g., a neurological understanding of pain; the relationship between stress and pain etc.), cognitive-behavioural therapy exercises (e.g., stressful experiences diary; pleasant events activity scheduling), and mindfulness-based content and practices (e.g., videos describing the rationale for the meditation technique taught in that module, as well as then guided audio recordings of a 3-minute breathing space meditation and formal extended meditations). Handouts will be provided to accompany each online module to reinforce learning. All written content will be at the 7th grade reading level or lower for health literacy purposes. Between-module cognitive-behavioural exercises will be assigned, as well as mindfulness exercises which will be provided as digital recordings.

In terms of the time commitment, completing each module involves listening to several brief videos which range from 2-10 minutes long, featuring Associate Professor Melissa Day who is a Clinical and Health Psychologist. For the guided meditation practices included in each module, options of a 20-minute or 45-minute recording are provided for daily practice. In total, we encourage participants to devote at least 40-50 minutes to the program daily for 6 days of the week for the 4-weeks. Website analytics will be used to monitor adherence to the intervention.
Intervention code [1] 326499 0
Behaviour
Comparator / control treatment
Participants randomised to the control condition will continue treatment as usual during the delayed treatment time period. Treatment as usual is defined as participants continuing the treatments, therapies or other interventions they are using for managing their pain at the time of enrolment. Following completion of this treatment as usual period, participants assigned to the control group will be offered access to iMBCT treatment about 4-6 weeks after start date, depending on what time they complete the post-assessment.
Control group
Active

Outcomes
Primary outcome [1] 335346 0
Numerical Rating Scale (NRS) of current, least, worst & average pain in past week which will be calculated as a composite score of characteristic pain intensity
Timepoint [1] 335346 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [1] 424430 0
PROMIS Pain Interference 4-item scale
Timepoint [1] 424430 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [2] 424431 0
PROMIS Depression 4-item scale
Timepoint [2] 424431 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [3] 424432 0
Positive and Negative Affect Schedule (PANAS)
Timepoint [3] 424432 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [4] 424433 0
PROMIS Sleep Interference 4-item scale
Timepoint [4] 424433 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [5] 424434 0
Study specific questionnaire of self-reported pain medication use
Timepoint [5] 424434 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [6] 424435 0
Study specific questionnaire of self-reported healthcare use, defined as the # of visits to a healthcare professional in the past week
Timepoint [6] 424435 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [7] 424436 0
Mechanism: Pain Catastrophizing Scale
Timepoint [7] 424436 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [8] 424437 0
Mechanism: State Mindfulness Scale
Timepoint [8] 424437 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [9] 424438 0
Mechanism: Five facet mindfulness questionnaire (FFMQ) short form
Timepoint [9] 424438 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [10] 424439 0
Mechanism: Pain Self-Efficacy Questionnaire
Timepoint [10] 424439 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [11] 424440 0
Mechanism: Chronic Pain Acceptance Questionnaire-SF
Timepoint [11] 424440 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [12] 424441 0
Mechanism: Metacognitive Processes of Decentering-Trait (MPoD-t)
Timepoint [12] 424441 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)
Secondary outcome [13] 424751 0
Mechanism: Metacognitive Processes of Decentering-State (MPoD-s)
Timepoint [13] 424751 0
Pre-treatment (baseline), mid-treatment (2 weeks post-commencement of iMBCT or the treatment as usual waiting period) and post-treatment (post-completion of final module, 4 weeks post-commencement of iMBCT or the treatment as usual waiting period)

Eligibility
Key inclusion criteria
(1) age of at least 18 years; (2) chronic pain (3 months or more, with pain experienced on at least 50% of days); (3) average intensity of pain 4 or higher on a 11-point NRS for most days of the previous 3 months; (4) able to read, speak, and understand English to comprehend the worksheets, measures and intervention implemented; (5) if currently taking analgesic or psychotropic medication, they must have been stabilized for at least 4 weeks prior to this study; (6) availability of a telephone, computer/laptop/tablet, and daily internet access; and (7) living in Australia at the time of study participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) severe cognitive impairment, as evidenced by two or more error(s) on the Six-Item Screener; (2) current alcohol or substance dependence; (3) uncontrolled schizophrenia or bipolar affective disorder; (4) chronic pain due to malignancy (e.g., cancer) or autoimmune disorders (e.g., lupus), headache as the primary source of pain, or a pain condition for which surgery is recommended and/or planned; and, (5) currently receiving other psychosocial treatments for any pain condition (as this may influence the treatment results).

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)
Central randomisation, by software generated randomisation plan
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
This is a pilot randomised controlled trial, designed with ongoing consumer input, to develop and test an internet delivered mindfulness-based cognitive therapy for chronic pain program relative to a delayed treatment control. The sample size will be N=46 participants enrolled, to obtain N=40 study completers, allowing for a 15% attrition rate. The sample size for the pilot RCT is consistent with guidelines for pilot trials.

Descriptives, means, standard deviations and frequency data will be calculated for the pilot RCT process evaluation measures to determine feasibility, reach and acceptability. Changes in the outcomes and mechanisms, as well as tests of the moderators will be investigated via Preacher and Hayes PROCESS procedure using the bootstrapping technique (with n = 5000 bootstrap re-samples, and bias-corrected and accelerated confidence intervals). Bootstrapping is a nonparametric re-sampling procedure that makes no assumptions about the shape of the distributions of the variables or the sampling distribution of the statistic, and is suitable for small sample sizes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/08/2023
Actual
18/08/2023
Date of last participant enrolment
Anticipated
18/01/2024
Actual
17/10/2023
Date of last data collection
Anticipated
29/02/2024
Actual
6/03/2024
Sample size
Target
46
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314263 0
University
Name [1] 314263 0
The University of Queensland
Country [1] 314263 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Chronic Pain Australia
Address
P.O. Box 425
Baulkham Hills, NSW 1755
Country
Australia
Secondary sponsor category [1] 316202 0
None
Name [1] 316202 0
Address [1] 316202 0
Country [1] 316202 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313382 0
University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 313382 0
Research Ethics and Integrity
The University of Queensland
Brisbane Qld 4072 Australia
Ethics committee country [1] 313382 0
Australia
Date submitted for ethics approval [1] 313382 0
16/11/2022
Approval date [1] 313382 0
16/06/2023
Ethics approval number [1] 313382 0
2022/HE002172

Summary
Brief summary
Chronic pain affects millions of Australians and is the leading cause of disability globally. Frequently however, chronic pain is underdiagnosed and undertreated. In this pilot randomised controlled trial, we are investigating a co-designed, internet delivered mindfulness-based cognitive therapy (iMBCT) for chronic pain program to overcome these access barriers. From the inception of this research, we have adopted a community-based participatory research framework, which is a patient-centred and community driven approach that is well suited to treatment adaptation to improve access and uptake. Consumers and consumer representatives – including our partner, Chronic Pain Australia – are the grassroots voices that have shaped the development of this iMBCT program. In this trial, participants will be randomised to iMBCT or a delayed treatment control for process evaluation, and to determine the preliminary efficacy of iMBCT for reducing pain intensity (primary outcome) and improving quality of life indicators (secondary outcomes). We will also examine potential mediators and moderators underlying the expected improvements in pain-related outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127954 0
A/Prof Melissa Day, PhD
Address 127954 0
Associate Professor Melissa Day
330 McElwain Building
24 Campbell Rd
School of Psychology
The University of Queensland
Brisbane, QLD 4072
Country 127954 0
Australia
Phone 127954 0
+61 7 3365 6421
Fax 127954 0
Email 127954 0
m.day@uq.edu.au
Contact person for public queries
Name 127955 0
Ms Ingrid Bindicsova, BPsy(Hons)
Address 127955 0
Ingrid Bindicsova
330 McElwain Building
24 Campbell Rd
School of Psychology
The University of Queensland
Brisbane, QLD 4072
Country 127955 0
Australia
Phone 127955 0
+61 7 3365 6421
Fax 127955 0
Email 127955 0
i.bindicsova@uq.edu.au
Contact person for scientific queries
Name 127956 0
Ms Ingrid Bindicsova, BPsy(Hons)
Address 127956 0
Ingrid Bindicsova
330 McElwain Building
24 Campbell Rd
School of Psychology
The University of Queensland
Brisbane, QLD 4072
Country 127956 0
Australia
Phone 127956 0
+61 7 3365 6421
Fax 127956 0
Email 127956 0
i.bindicsova@uq.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
19740Informed consent form  m.day@uq.edu.au The research community will have access to this fi... [More Details]
19741Ethical approval    386224-(Uploaded-19-07-2023-14-31-31)-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.