Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000790347
Ethics application status
Approved
Date submitted
25/05/2017
Date registered
30/05/2017
Date last updated
16/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of mindfulness versus attention training on pain outcomes: What moderates the efficacy?
Scientific title
The impact of mindfulness versus attention training on pain outcomes in healthy volunteers: What moderates the efficacy?
Secondary ID [1] 292043 0
None
Universal Trial Number (UTN)
n/a
Trial acronym
n/a
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
pain 303442 0
Condition category
Condition code
Neurological 302850 302850 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a three arm design. There are two brief (single session) interventions [both less than 15 minutes in instruction]: Mindfulness interoceptive exposure task and Attention Training Task; and a no treatment control group (see below).

The MIET The Mindfulness-based Interoceptive Exposure Task (MIET) was developed as part of a broader mindfulness-integrated cognitive behavioural therapy approach. The purpose of MIET is to get participants to focus on painful sensations, but in a way that promotes the reappraising of the interoceptive experience of pain in terms of 4 characteristics of body sensations (mass, temperature, motion and cohesiveness/constriction). The aim of this strategy is to prevent participants from judgement of their interoceptive experience in order to decrease the activation of mental representations of pain and related distress and thereby minimize self-referential processing. This study used the Mindfulness-based interoceptive exposure task (MIET) in a 2 minute script which was recorded on an MP3 device and played through headphones to participants. Participants were instructed to close their eyes and focus non-judgmental attention on the most intense pain sensation felt at that moment and monitor the potential changes that may take place in 4 fundamental characteristics. They were instructed to utilise this same approach when placing their arm in the cold pressor.

The Attention Training Task: The ATT is a task that aims to train attention through listening to a sound array while being given instructions about which sound(s) to listen to. Throughout the ATT task, participants were directed through three attention tasks: selective attention, in which participants focused on one specific sound; switching attention, in which participants were required to focus on a specific sound and then another in rapid succession; and divided attention, in which participants were instructed to focus on as many different sounds as they could at once. In addition to being directed to focus their attention on sounds on the audio (e.g. bells, traffic, birds, running water), participants were to focus their attention on sounds in the room that were behind them, to their left and to their right. Therefore, the volume of the audio was set at a moderate level so that participants could also attend to any sounds in the background. The humming of the cold pressor apparatus, a small clock radio playing classical music and the tapping of a pen by the experimenter served as background noises, and were at a volume comparable to the sounds on the audio.
Intervention code [1] 298169 0
Behaviour
Comparator / control treatment
There are in total three groups. The control group is a no treatment control group in addition to the other two interventions against which the relative efficacy of each will be compared.
Control group
Active

Outcomes
Primary outcome [1] 302244 0
Threshold: After the interventions, the participants will complete the cold pressor task, the primary outcome will be the time in seconds between immersion of the arm in the cold water tank and when participants first report experiencing pain.
Timepoint [1] 302244 0
Immediately following intervention
Primary outcome [2] 302245 0
Tolerance: After the interventions, the participants will complete the cold pressor task, the co-primary outcome will be the time in seconds between immersion of the arm in the cold water tank and when participant removes their arm from the tank.
Timepoint [2] 302245 0
Immediately following intervention
Secondary outcome [1] 335264 0
Pain ratings: Using a visual analogue scale.
Timepoint [1] 335264 0
We will ask participants to indicate their pain at threshold, tolerance and 30 seconds after immersion.
Secondary outcome [2] 335265 0
Hesitance: After the interventions, the participants will complete the cold pressor task, the primary outcome will be the time in seconds between indicating that the participant can now immerse their arm in the cold pressor and when immersion of the arm in the cold water tank is complete.
Timepoint [2] 335265 0
Immediately following intervention
Secondary outcome [3] 335266 0
Distress: A visual analogue scale of distress will be administered (0-10)
Timepoint [3] 335266 0
Immediately following the cold pressor task participants will be asked to rate their pain during the task.

Eligibility
Key inclusion criteria
Participants must be first year psychology students, fluent in English.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Heart conditions, reynauld's disease, pregnancy, large intakes (over NHMRC guidelines) for alcohol or caffeine in the day prior to testing.

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)
Opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
one-way ANOVAs will compare the outcomes between groups on threshold, tolerance, distress and hesitance.

Pain will be analyzed using a 3 (time) x 3 (group) ANOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2017
Actual
31/07/2017
Date of last participant enrolment
Anticipated
31/08/2017
Actual
31/08/2017
Date of last data collection
Anticipated
Actual
31/08/2017
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 16183 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 296574 0
Self funded/Unfunded
Name [1] 296574 0
n/a
Country [1] 296574 0
Primary sponsor type
University
Name
The University of Sydney
Address
Brennan MacCallum A18
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 295531 0
None
Name [1] 295531 0
none
Address [1] 295531 0
none
Country [1] 295531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297791 0
The University of Sydney
Ethics committee address [1] 297791 0
Jane Foss Russell Building
The University of Sydney
NSW 2006
Ethics committee country [1] 297791 0
Australia
Date submitted for ethics approval [1] 297791 0
Approval date [1] 297791 0
24/05/2017
Ethics approval number [1] 297791 0
2017/284

Summary
Brief summary
This study will compare two brief interventions to see whether attention training or a mindfulness-based task is more efficacious in improving pain outcomes in healthy control participants.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 75126 0
Prof Louise Sharpe
Address 75126 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Australia
Country 75126 0
Australia
Phone 75126 0
+61293514558
Fax 75126 0
n/a
Email 75126 0
louise.sharpe@sydney.edu.au
Contact person for public queries
Name 75127 0
Jessica Curtes
Address 75127 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Australia
Country 75127 0
Australia
Phone 75127 0
+61293514558
Fax 75127 0
n/a
Email 75127 0
jcur7764@uni.sydney.edu.au
Contact person for scientific queries
Name 75128 0
Louise Sharpe
Address 75128 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Australia
Country 75128 0
Australia
Phone 75128 0
+61239514558
Fax 75128 0
n/a
Email 75128 0
louise.sharpe@sydney.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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