Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000148471
Ethics application status
Approved
Date submitted
20/02/2007
Date registered
27/02/2007
Date last updated
14/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the attentional bias of chronic pain patients
Scientific title
Investigating the effect of attentional training combined with Cognitive Behavioural Therapy (CBT), on the maintenance of Chronic Pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 1642 0
Condition category
Condition code
Mental Health 1752 1752 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group: Attentional training using the Dot Probe computer task (4 sessions over 4 weeks, 30 minute task), Cognitive Behavioural Therapy (CBT) (8 individual, 1 hr sessions over 8 weeks).

All participants will receive CBT and it will involve education about chronic pain, activity pacing, relaxation training, goal setting, problem solving and cognitive restructuring. CBT will have a manual based approach.

The dot probe task is a non-invasive computer task. On each trial participants will be presented a target word and a neutral word in either the upper or lower half of the computer screen. This is then followed by a visual probe (either a ‘p’ or a ‘q’) presented in the location of one of the previously presented words. The task is to discriminate the probe’s identity as accurately and quickly as possible, by pressing one of two buttons labelled with a ‘p’ and ‘q’. Half of the participants will be randomly allocated to receive the experimental task (ie. attentional re-training which is a biased version of this task, whereby the visual probe always follows the neutral word, in an attempt to retrain participants attention). The other half of the participants will receive a placebo task (ie. an unbiased/randomised version of the task).

The control group will receive a placebo computer task and they will also receive CBT. The experimental and placebo computer tasks will be compared to assess whether the experimental task improves the effectiveness of CBT.
Intervention code [1] 1615 0
Treatment: Other
Comparator / control treatment
Control Group: Placebo Dot Probe computer task (4 sessions over 4 weeks, 30 minute task), Cognitive Behavioural Therapy (CBT) (8 individual, 1 hr sessions over 8 weeks).
Control group
Placebo

Outcomes
Primary outcome [1] 2441 0
Self report measures including: Fear of Pain Questionnaire (FPQ).
Timepoint [1] 2441 0
A+t baseline and at 4, 12, and 24 weeks after intervention commencement.
Primary outcome [2] 2442 0
Self report measures including: Tampa Kinesiophobia Scale.
Timepoint [2] 2442 0
A+t baseline and at 4, 12, and 24 weeks after intervention commencement.
Primary outcome [3] 2443 0
Self report measures including:Roland-Morris Disability Questionnaire.
Timepoint [3] 2443 0
A+t baseline and at 4, 12, and 24 weeks after intervention commencement.
Primary outcome [4] 2444 0
Self report measures including: Anxiety-Sensitivity Index (ASI).
Timepoint [4] 2444 0
A+t baseline and at 4, 12, and 24 weeks after intervention commencement.
Primary outcome [5] 2445 0
Self report measures including: Pain Self-Efficacy Questionnaire (PSEQ).
Timepoint [5] 2445 0
A+t baseline and at 4, 12, and 24 weeks after intervention commencement.
Primary outcome [6] 2446 0
Self report measures including: Depression Anxiety and Stress Scales (DASS).
Timepoint [6] 2446 0
A+t baseline and at 4, 12, and 24 weeks after intervention commencement.
Primary outcome [7] 2447 0
Self report measures including: Level of pain visual analogue scale.
Timepoint [7] 2447 0
A+t baseline and at 4, 12, and 24 weeks after intervention commencement.
Secondary outcome [1] 4212 0
Attentional Bias Index
Timepoint [1] 4212 0
At baseline and 1, 2, 3 and 12 weeks after intervention commencement.

Eligibility
Key inclusion criteria
* experience chronic or recurrent pain * able to speak and write in English.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*unable to use both hands*history of a head injury*a serious mental illness or an illicit drug and alcohol problem.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects are blinded, and as the key outcomes are self-reported, the assessor is also considered to be blinded.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1903 0
University
Name [1] 1903 0
University of Sydney
Country [1] 1903 0
Australia
Primary sponsor type
Individual
Name
Assoc. Prof. Louise Sharpe
Address
Clinical Psychology Unit School of Psychology Brennan-MacCallum Building The University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 1718 0
Individual
Name [1] 1718 0
Ms. Melissa Mondello
Address [1] 1718 0
Clinical Psychology Unit Transient Building- F12 The University of Sydney NSW 2006
Country [1] 1718 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3549 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 3549 0
Ethics committee country [1] 3549 0
Australia
Date submitted for ethics approval [1] 3549 0
Approval date [1] 3549 0
01/02/2007
Ethics approval number [1] 3549 0
02-2007/9689

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27549 0
Address 27549 0
Country 27549 0
Phone 27549 0
Fax 27549 0
Email 27549 0
Contact person for public queries
Name 10804 0
Ms. Melissa Mondello
Address 10804 0
Clinical Psychology Unit
Transient Building- F12
The University of Sydney
NSW 2006
Country 10804 0
Australia
Phone 10804 0
+61 2 93518591
Fax 10804 0
Email 10804 0
[email protected]
Contact person for scientific queries
Name 1732 0
Assoc. Prof. Louise Sharpe
Address 1732 0
Clinical Psychology Unit
School of Psychology
Brennan-MacCallum Building
The University of Sydney
NSW 2006
Country 1732 0
Australia
Phone 1732 0
+61 2 93514558
Fax 1732 0
Email 1732 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.