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Trial registered on ANZCTR


Registration number
ACTRN12616001318471p
Ethics application status
Submitted, not yet approved
Date submitted
15/09/2016
Date registered
20/09/2016
Date last updated
20/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does attention bias predict which pain patients benefits from mindfulness and distraction
Scientific title
A comparison of the efficacy of mindfulness interoceptive exposure and distraction in the management of chronic pain: The moderating role of attentional bias
Secondary ID [1] 290162 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 300286 0
Condition category
Condition code
Musculoskeletal 300152 300152 0 0
Other muscular and skeletal 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 clinical psychologist in this technique in a single, 45 minute face-to-face session and the asked to practice daily over a period of two weeks. Adherence will be determined by logs retrieved from the patient. A booklet to describe the task and record practice will be given. As it is a single, brief intervention no check for fidelity will be made.
Intervention code [1] 295916 0
Treatment: Other
Comparator / control treatment
There are two control groups (1) a wait-list control group; and (2) a distraction group. The latter is an active control group.

The control group will continue to have their usual care, but will not have any psychosocial intervention during the treatment period.

Distraction: This technique encourages participants to use distraction based around visualisation of a relaxing scene, such as imagining themselves on a beach. Participants are trained in this technique in a single, 45 minute session and the asked to practice over a period of two weeks. All aspects of this intervention are matched to the mindfulness intervention described above.
Control group
Active

Outcomes
Primary outcome [1] 299646 0
Pain Intensity: The pain intensity subscale of the Brief Pain Inventory will be used to measure pain.
Timepoint [1] 299646 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, 3 month and 6 months' post-intervention.
Primary outcome [2] 299647 0
Disablity: We will administer the modified Roland-Morris Disablity Scale. In the modified version, participants are asked questions in relation to 'your pain", rather than "your back pain".
Timepoint [2] 299647 0
Three months following the initial session where the skills are taught is considered to be the primary outcome point afor this outcome. Also measured at 1 month, 3 month and 6 months' post-intervention.
Secondary outcome [1] 327728 0
Pain Interference: The pain interference subscale of the Brief Pain Inventory will be used to assess pain interference.
Timepoint [1] 327728 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, 3 month and 6 months' post-intervention.
Secondary outcome [2] 327729 0
Pain Catastrophizing Scale
Timepoint [2] 327729 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, 3 month and 6 months' post-intervention.
Secondary outcome [3] 327730 0
McGill Pain Questionnaire
Timepoint [3] 327730 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, 3 month and 6 months' post-intervention.
Secondary outcome [4] 327731 0
Depression: The depression subscale of the Depression Anxiety and Stress Scales.
Timepoint [4] 327731 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, 3 month and 6 months' post-intervention.
Secondary outcome [5] 327732 0
Anxiety. The anxiety subscale of the Depression Anxiety and Stress Scales.
Timepoint [5] 327732 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, 3 month and 6 months' post-intervention.
Secondary outcome [6] 327733 0
Stress: the stress subscale of the Depression Anxiety and Stress Scales.
Timepoint [6] 327733 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, 3 month and 6 months' post-intervention.
Secondary outcome [7] 327735 0
Philadelphia Mindfulness Scale
Timepoint [7] 327735 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. However, we are interested in this measure as a potential mediator of outcome. Also measured at 1 month, 3 month and 6 months' post-intervention.
Secondary outcome [8] 327736 0
Self-Attention check: This is a single item assessment to ascertain whether attention is focused internally or externally before and after the mindfulness interoceptive exposure or distraction task. This measure will not be given to the control group.
Timepoint [8] 327736 0
Immediately following the training at the end of 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. However, we are interested in this measure as a potential mediator of outcome.
Secondary outcome [9] 327738 0
Attention bias: This is an experimental paradigm based on the dot-probe task, with sensory pain words. During this task which presents two competing stimuli (one sensory pain word/one neutral word) on the screen simultaneously for 1250 msecs, participants are asked to read both words. The words are then replaced by a probe (i.e. a p or q) and participants are asked to discriminate between the probes. We will monitor gaze behaviour during the task and will use the duration of first fixation on the pain word as an indicator of difficulty disengaging from pain. This will be a moderating variable, such that it is expected that participants who have more difficulty disengaging from the task will be less likely to benefit from the mindfulness interoceptive exposure. This measure will not be given to the control group.
Timepoint [9] 327738 0
Immediately following the training at the end of 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. However, we are interested in this measure as a potential moderator of outcome.

Eligibility
Key inclusion criteria
1. A diagnosis of chronic pain for at least three months
2. A current pain rating of > 3/10 on a 11 point numeric pain scale
3. Over the age of 18
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. People with a history of serious psychiatric disorder (e.g. psychosis) or current suicidality that requires immediate treatment.
2. People with substance abuse problems

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 and then the participants allocation will be revealed to the experimenter.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator (randomizer.org) will be used to generate random numbers between 1 and 3 on a 1:1:1 ratio. The numbers will be generated by a researcher independent of the assessment or treatment of the participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will use a 2 (time: pre and post-treatment/3 month follow-up for disability) x 3 (Treatment: Mindfulness vs distraction vs control) ANOVA to assess the primary end-points. In order to assess moderation effects, we will conduct a 2 (Attention bias: high and low) x 2 (Treatment: Mindfulness vs distraction) ANOVA on change in pain between pre and post-intervention. Outcomes over times for the two groups, will be compared using linear mixed models. We will also determine whether (a) change in mindfulness mediates the relationship between group and change in pain intensity; and (b) whether change in pain intensity mediates the relationship between group and change in disability at three months follow-up.

Sample size estimates were calculated on the basis of G-power, given the effect size found on pain outcomes from a previous study in our lab where we found an effect size of f = 0.38. According to g-power we needed 87 participants to find this effect if present with an alpha of 0.05 and 80% power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2016
Actual
Date of last participant enrolment
Anticipated
2/10/2017
Actual
Date of last data collection
Anticipated
1/05/2018
Actual
Sample size
Target
87
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14317 0
2007 - Ultimo

Funding & Sponsors
Funding source category [1] 294529 0
University
Name [1] 294529 0
University of Sydney
Country [1] 294529 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Brennan MacCallum A18
School of Psychology
University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 293392 0
None
Name [1] 293392 0
None
Address [1] 293392 0
There is not one
Country [1] 293392 0
Other collaborator category [1] 279226 0
University
Name [1] 279226 0
University of Technology Sydney
Address [1] 279226 0
Graduate School of Health
67 Thomas St
Ultimo
Sydney 2007
Country [1] 279226 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295963 0
The University of Sydney
Ethics committee address [1] 295963 0
Jane Foss Russell Building
City Rd
The University of Sydney
NSW
2006
Ethics committee country [1] 295963 0
Australia
Date submitted for ethics approval [1] 295963 0
13/06/2016
Approval date [1] 295963 0
Ethics approval number [1] 295963 0
Ethics committee name [2] 295964 0
University of Technology Sydney
Ethics committee address [2] 295964 0
67 Thomas St
Ultimo
NSW 2007
Ethics committee country [2] 295964 0
Australia
Date submitted for ethics approval [2] 295964 0
05/09/2016
Approval date [2] 295964 0
Ethics approval number [2] 295964 0

Summary
Brief summary
This study aims to determine (a) whether a mindfulness interoceptive exposure task is more efficacious than distraction and no treatment for people with chronic pain problems; and (b) whether attentional bias towards pain-related stimuli moderates the efficacy of mindfulness versus distraction. Participants with chronic pain problems will be randomized to receive one of two active interventions (either mindfulness interoceptive exposure or distraction) or a control condition. Prior to the single-session intervention, those in the active intervention groups will complete a measure of attention bias using the dot-probe with eye tracking technology at the beginning of a single-session intervention. Participants will then complete the intervention within the session and be asked to practice at home. Participants will complete a assessment of attention bias (and self-attention check; as well as pain ratings) immediately before and after the intervention is administered. They will then be asked to practice either the mindfulness or distraction task for two weeks, before completing the outcome questionnaires. The primary outcome point for the intervention is two weeks after the intervention is administered, except for disability where it is anticipated positive outcomes will not be seen until three months post-intervention. Measures will be given at pre-treatment; post-treatment (i.e. two weeks); one, three and six months later.
Trial website
not applicable
Trial related presentations / publications
not applicable
Public notes
Nil

Contacts
Principal investigator
Name 69078 0
Prof Louise Sharpe
Address 69078 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 69078 0
Australia
Phone 69078 0
+61293514558
Fax 69078 0
+61293517328
Email 69078 0
[email protected]
Contact person for public queries
Name 69079 0
Mrs Alice Shires
Address 69079 0
67 Thomas St.
Graduate School of Health
University Technology Sydney
NSW 2007
Country 69079 0
Australia
Phone 69079 0
+61295141448
Fax 69079 0
+61295148300
Email 69079 0
[email protected]
Contact person for scientific queries
Name 69080 0
Mrs Alice Shires
Address 69080 0
67 Thomas St.
Graduate School of Health
University Technology Sydney
NSW 2007
Country 69080 0
Australia
Phone 69080 0
+61295141448
Fax 69080 0
+61295148300
Email 69080 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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