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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
Scientific title
Exploring the Effects of a Brief Online Self-Implemented Mindfulness-Based Task for individuals with Chronic Pain
Secondary ID [1] 297297 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 311419 0
Condition category
Condition code
Musculoskeletal 310048 310048 0 0
Other muscular and skeletal disorders
Neurological 310262 310262 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 313566 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 318946 0
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.
Timepoint [1] 318946 0
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).
Secondary outcome [1] 366500 0
Pain Interference: The pain interference subscale of the Brief Pain Inventory will be used to assess pain interference
Timepoint [1] 366500 0
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).
Secondary outcome [2] 366501 0
Pain Catastrophising Scale
Timepoint [2] 366501 0
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).
Secondary outcome [3] 366502 0
Depression: The depression subscale of the Depression Anxiety and Stress Scales.
Timepoint [3] 366502 0
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).
Secondary outcome [4] 366503 0
Anxiety: The anxiety subscale of the Depression Anxiety and Stress Scales.
Timepoint [4] 366503 0
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).
Secondary outcome [5] 366504 0
Stress: The stress subscale of the Depression Anxiety and Stress Scales.
Timepoint [5] 366504 0
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).
Secondary outcome [6] 366506 0
Philadelphia Mindfulness Scale
Timepoint [6] 366506 0
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).

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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 concealed until the participant has completed all baseline assessments. The method of allocation concealment will be central randomisation by computer
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).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301860 0
University
Name [1] 301860 0
University of Technology Sydney
Address [1] 301860 0
Building 7 Level 3 67 Thomas Street Ultimo NSW 2007
Country [1] 301860 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Building 7 Level 3 67 Thomas Street Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 301628 0
None
Name [1] 301628 0
None
Address [1] 301628 0
Country [1] 301628 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302554 0
HREC University of Technology Sydney
Ethics committee address [1] 302554 0
University of Technology Sydney
Building 1, Level 14
Broadway NSW 2007 Australia (PO Box 123)
Ethics committee country [1] 302554 0
Australia
Date submitted for ethics approval [1] 302554 0
26/11/2018
Approval date [1] 302554 0
Ethics approval number [1] 302554 0

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.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
nil

Contacts
Principal investigator
Name 90630 0
Mrs Alice Shires
Address 90630 0
67 Thomas Street
Graduate School of Health
University of Technology Sydney
NSW 2007
Country 90630 0
Australia
Phone 90630 0
+61 2 95147239
Fax 90630 0
Email 90630 0
alice.shires@uts.edu.au
Contact person for public queries
Name 90631 0
Mrs Alice Shires
Address 90631 0
67 Thomas Street
Graduate School of Health
University of Technology Sydney
NSW 2007
Country 90631 0
Australia
Phone 90631 0
+61 2 95147239
Fax 90631 0
Email 90631 0
alice.shires@uts.edu.au
Contact person for scientific queries
Name 90632 0
Mrs Alice Shires
Address 90632 0
67 Thomas Street
Graduate School of Health
University of Technology Sydney
NSW 2007
Country 90632 0
Australia
Phone 90632 0
+61 2 95147239
Fax 90632 0
Email 90632 0
alice.shires@uts.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?
No other documents available
Summary results
No Results