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Trial registered on ANZCTR


Registration number
ACTRN12616000953437
Ethics application status
Approved
Date submitted
18/04/2016
Date registered
20/07/2016
Date last updated
20/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of Attention Bias Modification and the Attention Training Technique on pain: Efficacy and mechanisms
Scientific title
A comparison of Attention Bias Modification and the Attention Training Technique on pain: Efficacy and mechanisms
Secondary ID [1] 289034 0
Nil known
Universal Trial Number (UTN)
n/a
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute pain 298449 0
Condition category
Condition code
Musculoskeletal 298550 298550 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three interventions.arms
(1) Attention Bias Modification (ABM): Attention Bias Modification is a 15 minute experimental manipulation of attentional bias. It is computer-administered and based on the dot-probe paradigm and implicitly trains participants to attend to non-painful stimuli (words) by changing contingencies.
(2) Attention Training Technique (ATT): ATT is an explicit training technique where participants listen to a sound array with the instruction to pay attention directly to one sound or another, switch attention and divide attention. The intervention is explicit and also takes about 15 minutes.
Intervention code [1] 294515 0
Treatment: Other
Comparator / control treatment
The control treatment will be a placebo that will use the same sound array as ATT (above) but will inform participants that the aim is to relax by listening to the sound array with no other instruction.
Control group
Placebo

Outcomes
Primary outcome [1] 298035 0
Threshold: The time taken to report pain after the participant has inserted their arm in a cold tank of water (5 degrees celcius). Timed with a stopwatch.
Timepoint [1] 298035 0
This is a single session trial. Participants do the cold pressor on one occasion at the end of the study and this is when the outcome is measured.
Secondary outcome [1] 322982 0
Pain: We will ask pain to be recorded on a Visual Analogue Scale (0 - 10) at threshold, 30 seconds later and at tolerance. An average will be used.
Timepoint [1] 322982 0
This is a single session trial. Participants do the cold pressor on one occasion at the end of the study and it is during this task when the outcome is measured.
Secondary outcome [2] 322984 0
Hesitance: The time taken (recorded by stopwatch) from when the person is given the instruction to place their hands in the cold pressor until when their arm is fully submerged.
Timepoint [2] 322984 0
This is a single session trial. Participants do the cold pressor on one occasion at the end of the study and this is when the outcome is measured.
Secondary outcome [3] 322985 0
Tolerance: The time that participants can keep their arm in the cold pressor (maximum 4 minutes, timed with a stopwatch).
Timepoint [3] 322985 0
This is a single session trial. Participants do the cold pressor on one occasion at the end of the study and this is when the outcome is measured.
Secondary outcome [4] 322986 0
Distress: Participant rating of subjective Unit of Distress (0 - 10) at the end of the cold pressor task.
Timepoint [4] 322986 0
This is a single session trial. Participants do the cold pressor on one occasion at the end of the study and this is when the outcome is measured.

Eligibility
Key inclusion criteria
Participants in this study are first year Psychology students at The University of Sydney.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they consume excessive caffeine, alcohol or analgesics in the 24 hours prior to participating (According to current NHMRC guidelines), or if they have current moderate pain (a rating of 4 or higher on an 11-point numerical scale, where 0 is no pain and 10 is extreme pain). We will also exclude participants with Reynauld's phenomena or a history of chronic pain.

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)
A series of numbers (1-3) will be generated (see below) and linked to consecutive participant numbers. The random allocation schedule will be concealed using opaque envelopes until the participant has completed the baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use randomizer.org to generate the sequence and the sequence will be generated by someone not involved in the testing of 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
A series of one-way AN(C)OVAs will be conducted to determine whether the pain outcomes differ between groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/05/2016
Date of last participant enrolment
Anticipated
19/08/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13094 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 293403 0
University
Name [1] 293403 0
The University of Sydney
Country [1] 293403 0
Australia
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] 292232 0
None
Name [1] 292232 0
Address [1] 292232 0
Country [1] 292232 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294855 0
The University of Sydney
Ethics committee address [1] 294855 0
Research Integrity
Human Research ethics Committee
Jane Foss Russell Building
City Rd.
The University of Sydney
NSW 2006
Ethics committee country [1] 294855 0
Australia
Date submitted for ethics approval [1] 294855 0
21/03/2016
Approval date [1] 294855 0
15/04/2016
Ethics approval number [1] 294855 0

Summary
Brief summary
This study compares two interventions that aim to modify attention (Attention Training Technique: ATT and Attention Bias Modification: ABM) with a placebo. The aim of the study is to determine the relative efficacy of the explicit training (ATT) compared to the implicit training (ABM) in terms of their impact on pain and to examine the likely mechanisms of treatment by assessing changes in attentional control (targeted by ATT) and attentional bias (targeted by ABM).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65242 0
Prof Louise Sharpe
Address 65242 0
Brennan MacCallum Building A 18
The University of Sydney
NSW 2006
Country 65242 0
Australia
Phone 65242 0
61293514558
Fax 65242 0
61293517328
Email 65242 0
[email protected]
Contact person for public queries
Name 65243 0
Prof Louise Sharpe
Address 65243 0
Brennan MacCallum Building A 18
The University of Sydney
NSW 2006
Country 65243 0
Australia
Phone 65243 0
61293514558
Fax 65243 0
61293517328
Email 65243 0
[email protected]
Contact person for scientific queries
Name 65244 0
Prof Louise Sharpe
Address 65244 0
Brennan MacCallum Building A 18
The University of Sydney
NSW 2006
Country 65244 0
Australia
Phone 65244 0
612 93514558
Fax 65244 0
612 93517328
Email 65244 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.