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Trial registered on ANZCTR
Registration number
ACTRN12619000260123p
Ethics application status
Submitted, not yet approved
Date submitted
15/02/2019
Date registered
20/02/2019
Date last updated
20/02/2019
Date data sharing statement initially provided
20/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Exploring the Effects of a Brief Online Mindfulness Exercise for individuals with Chronic Pain
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Scientific title
Exploring the Effects of a Brief Online Self-Implemented Mindfulness-Based Task for individuals with Chronic Pain
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Secondary ID [1]
297297
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Nil known
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Universal Trial Number (UTN)
N/A
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Trial acronym
N/A
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
Chronic Pain
311419
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Condition category
Condition code
Musculoskeletal
310048
310048
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0
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Other muscular and skeletal disorders
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Neurological
310262
310262
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Mindfulness Interoceptive Exposure Task. This is a mindfulness-based procedure which encourages participants to mindfully focus on their pain and monitor changes in four fundamental characteristics of body sensation, namely mass, temperature, motion, and cohesiveness/solidity. Participants are trained by a psychologist in this technique in a single 20 minute online session and then asked to practice daily over a period of two weeks. The participants will be asked to practice whenever they experience Chronic Pain in their day - thus each participant will practice the technique for different durations, depending on how often they experience Chronic Pain symptoms. Adherence will be determined by logs retrieved by the participant. A booklet to describe the task and record practice will be given. These instructions for practicing the technique will be the same as provided in a previous study (Cayoun, B., Simmons, A., & Shires, A. (2018). Immediate and Lasting Chronic Pain Reduction Following a Brief Self-Implemented Mindfulness-Based Interoceptive Exposure Task: a Pilot Study. Mindfulness, 1-13).
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Intervention code [1]
313566
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Treatment: Other
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Comparator / control treatment
There will be a wait-list control group, who will have continue to have their usual care. For the purposes of this study, usual care is defined as continuing any pain management the participant is already engaging in prior to the study (e.g. medications, physio, etc). They will not receive any psychological intervention until 6 weeks from the initial study enrollment. This group will just be asked to complete a questionnaire at the initial time-point, and two weeks later.
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Control group
Active
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Outcomes
Primary outcome [1]
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Pain Intensity: The pain intensity sub-scale of the Brief Pain Inventory will be used to measure pain. This is the primary outcome of the study.
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Assessment method [1]
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Timepoint [1]
318946
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Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the primary timepoint for this outcome. Also measured at 1 month (4 weeks later).
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Secondary outcome [1]
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Pain Interference: The pain interference subscale of the Brief Pain Inventory will be used to assess pain interference
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Assessment method [1]
366500
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Timepoint [1]
366500
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Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the second timepoint for this outcome. Also measured at 1 month (4 weeks later).
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Secondary outcome [2]
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Pain Catastrophising Scale
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Assessment method [2]
366501
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Timepoint [2]
366501
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Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the second timepoint for this outcome. Also measured at 1 month (4 weeks later).
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Secondary outcome [3]
366502
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Depression: The depression subscale of the Depression Anxiety and Stress Scales.
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Assessment method [3]
366502
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Timepoint [3]
366502
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Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the second timepoint for this outcome. Also measured at 1 month (4 weeks later).
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Secondary outcome [4]
366503
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Anxiety: The anxiety subscale of the Depression Anxiety and Stress Scales.
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Assessment method [4]
366503
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Timepoint [4]
366503
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Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the second timepoint for this outcome. Also measured at 1 month (4 weeks later).
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Secondary outcome [5]
366504
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Stress: The stress subscale of the Depression Anxiety and Stress Scales.
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Assessment method [5]
366504
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Timepoint [5]
366504
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Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the second timepoint for this outcome. Also measured at 1 month (4 weeks later).
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Secondary outcome [6]
366506
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Philadelphia Mindfulness Scale
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Assessment method [6]
366506
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Timepoint [6]
366506
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Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the second timepoint for this outcome. Also measured at 1 month (4 weeks later).
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Eligibility
Key inclusion criteria
1. A diagnosis of chronic pain (pain persisting for 3 months or more)
2. 18 years old or above
3. Residing in Australia
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Abusing prescribed medication, illicit drugs or alcohol to cope with pain
2. Past or present involvement in a mindfulness-based treatment program
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed until the participant has completed all baseline assessments. The method of allocation concealment will be central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator (randomizer.org) will be used to administer participants to either group 1 (treatment group) or group 2 (waitlist control group).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Both groups will receive the same intervention. However, the waitlist control will only receive the intervention 6 weeks after initial enrollment into the study.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
We will use a 2 (time: pre and post-treatment) x 2 (Treatment vs Waitlist Control) ANOVA to assess the primary end-points. Outcomes over times for the two groups will be compared using linear mixed models.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/02/2019
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Actual
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Date of last participant enrolment
Anticipated
29/05/2019
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Actual
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Date of last data collection
Anticipated
26/06/2019
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Technology Sydney
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Address [1]
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Building 7 Level 3 67 Thomas Street Ultimo NSW 2007
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Technology Sydney
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Address
Building 7 Level 3 67 Thomas Street Ultimo NSW 2007
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
301628
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Country [1]
301628
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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HREC University of Technology Sydney
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Ethics committee address [1]
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University of Technology Sydney
Building 1, Level 14
Broadway NSW 2007 Australia (PO Box 123)
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/11/2018
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Approval date [1]
302554
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Ethics approval number [1]
302554
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Summary
Brief summary
Recent research in Chronic Pain (CP) has shown that the maintenance of CP is associated with how we react to it, and that the way with which we pay attention to pain sensations during mindfulness practice helps manage pain more effectively. The purpose of this research is to investigate the effectiveness of a brief mindfulness-based intervention in alleviating chronic pain (i.e. intensity and interference with daily life) and associated distress (i.e. depression, anxiety and stress). The aim is to determine whether an online delivery of this mindfulness-based task is effective for individuals experiencing CP. It is hoped that the results will help improve treatments for people with CP. Namely, it is hypothesised that participants will experience reduced intensity of pain and reduced associated distress post midfulness intervention.
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Trial website
N/A
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Trial related presentations / publications
N/A
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Public notes
nil
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Contacts
Principal investigator
Name
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Mrs Alice Shires
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Address
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67 Thomas Street
Graduate School of Health
University of Technology Sydney
NSW 2007
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Country
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Australia
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Phone
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+61 2 95147239
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Alice Shires
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Address
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67 Thomas Street
Graduate School of Health
University of Technology Sydney
NSW 2007
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Country
90631
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Australia
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Phone
90631
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+61 2 95147239
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Fax
90631
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Email
90631
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[email protected]
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Contact person for scientific queries
Name
90632
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Mrs Alice Shires
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Address
90632
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67 Thomas Street
Graduate School of Health
University of Technology Sydney
NSW 2007
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Country
90632
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Australia
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Phone
90632
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+61 2 95147239
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Fax
90632
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Email
90632
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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