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Trial registered on ANZCTR


Registration number
ACTRN12616001460493
Ethics application status
Approved
Date submitted
17/10/2016
Date registered
19/10/2016
Date last updated
31/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of attention bias modification (ABM) on chronic pain and associated health outcomes in Defence personnel
Scientific title
Effect of attention bias modification (ABM) on pain-related attention biases, mental health and well-being in Defence personnel
Secondary ID [1] 290184 0
Nil known
Universal Trial Number (UTN)
U1111-1186-7215
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 299997 0
Condition category
Condition code
Mental Health 299891 299891 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to determine whether multiple sessions of an ABM using pain cues will reduce attention bias to pain cues, reduce pain severity and related disability (e.g., pain interference) and improve mental health in ADF members (serving and ex-serving) with chronic pain. The study will be a parallel-groups randomized superiority trial comparing 5 sessions of ABM (using pain-related word cue attention modification training via a modified dot-probe task) versus sham training (i.e., placebo control condition, via a dot-probe task) in Defence personnel who self-report chronic pain experience lasting at least 3 months.
The 2 arms include:
1. Behavioural: Attention bias modification (ABM) treatment
Attention training using a computerized spatial attention task (dot-probe, DPT) modified to alter pain-related attention patterns using pain and neutral stimuli (with the probe placed in the opposite location to the pain stimuli).
2. Behavioural: Sham ABM placebo control condition
Attention training using a computerized spatial attention task (dot-probe) not intended to alter pain-related attention patterns using the same pain and neutral stimuli (with the probe replacing the pain vs. neutral stimuli equally often).

Stage 1: Participants will complete a series of online (or hard-copy option upon request) validated questionnaires to assess baseline (and at post-intervention) levels of key outcome and demographic variables. Participants will then be randomised to receive double-blinded administration of either ABM or sham (placebo control) training.

Stage 2: Participants attend 1 training session a week for 5 weeks (of ABM or sham training). Prior to the first training session and at the completion of the final training session, pre- and post-intervention attention biases will be assessed, respectively, via a computerised visual probe task (<10 mins) where reaction times for different categories of pain words related to sensory and affective experiences will be measured. Participants are randomly allocated to receive either ABM or sham training, taking approximately 10 minutes each session (n = 50 each).
*ABM, ‘away pain’ – in this condition, participants’ attention is implicitly re-directed away from pain-related cues (compared to neutral cues). This occurs via the placement of the dot probe in the opposite location of the pain cue on all trials.
*Sham ABM control – participants’ attention is not trained toward or away from any stimuli type in this condition (i.e., similar to the assessment task, with the location of the dot probe replacing the pain cues 50% of the time). This condition serves as a placebo control group.
During the 5-week intervention period, a brief (5-10 min) online survey will be completed the day following each training session to assess incremental changes in mood and pain ratings.

Stage 3: Online questionnaires (or hard copy upon request) will be administered immediately and at 1-month following the final training session to assess acute and sustained or delayed effects on key clinical outcome variables (e.g., pain, disability, negative affect).

Session 1 includes pre-intervention DPT assessment prior to ABM trials (20 min). Sessions 2-4 include only ABM trials (10 min). Session 5 includes post-intervention DPT assessment following the ABM trials (20 min). Each session includes instruction screens and practice trials using neutral stimuli.

The interventions are delivered face-to-face by trained research assistants (with postgraduate psychology qualifications) via the experiment presentation software, E-prime 2.0, on laptop computers at a workstation (individual testing) in an office space or consulting room at the participant's local Defence base (e.g., local Barracks office space), local ex-service organisation, public library meeting room, or in a quiet room at one of the QUT campuses. All participant instructions for performing the dot probe task are contained within the program, such that the participant can read these at their own pace, pause to ask any questions of the research assistant before proceeding from the practice block to the intervention or assessment block.
Intervention code [1] 295690 0
Behaviour
Intervention code [2] 296162 0
Treatment: Other
Comparator / control treatment
Sham Placebo Control Comparator: Sham Attention Bias Modification, using a standard dot-probe task with the same stimuli and number of trials (without modification probe-target contingencies), once per week for 5 weeks. All tasks are equivalent to the Experimental (ABM) group, with the exception of the sham ABM trials in place of the ABM trials. Participants’ attention is not trained toward or away from any stimuli type in this condition (i.e., similar to the assessment task, with the location of the dot probe replacing the pain cues 50% of the time).
Control group
Placebo

Outcomes
Primary outcome [1] 299372 0
Attention bias scores for pain-related cues (vs. neutral cues), via reaction times from the dot-probe task.
Timepoint [1] 299372 0
At the beginning of the first session (baseline) and at the end of the 5 sessions of ABM (post-intervention).
Primary outcome [2] 299373 0
Pain Intensity, assessed via the modified Brief Pain Inventory.
Timepoint [2] 299373 0
At baseline, at the end of the 5 sessions of training (post-intervention) and at 1-month follow-up (1-month after the last training session).
Primary outcome [3] 299374 0
Pain Interference, assessed via the modified Brief Pain Inventory.
Timepoint [3] 299374 0
At baseline, at the end of the 5 sessions of training (post-intervention) and at 1-month follow-up (1-month after the last training session).
Secondary outcome [1] 326958 0
Anxiety symptoms over the past 2 weeks assessed using the total score from the Generalized Anxiety Disorder 7 item (GAD-7) Scale.
Timepoint [1] 326958 0
At baseline, at the end of the 5 sessions of training (post-intervention) and at 1-month follow-up (1-month after the last training session).
Secondary outcome [2] 326959 0
Depressive symptoms over the past 2 weeks assessed using the total score from the Patient Health Questionnaire (PHQ)
Timepoint [2] 326959 0
At baseline, at the end of the 5 sessions of training (post-intervention) and at 1-month follow-up (1-month after the last training session).
Secondary outcome [3] 326960 0
Trauma symptoms over the past month, assessed using the total symptom severity score from the PTSD Checklist for DSM-5 (PCL-5).
Timepoint [3] 326960 0
At baseline and at 1-month follow-up (1-month after the last ABM session).
Secondary outcome [4] 326971 0
Quality of Life, assessed using the EuroQOL five dimensions questionnaire (EQ-5D)
Timepoint [4] 326971 0
At baseline, at the end of the 5 sessions, and at 1-month follow-up.
Secondary outcome [5] 328422 0
Pain Catastrophising Scale, assessed using the Pain Catastrophising Scale.
Timepoint [5] 328422 0
At baseline, at the end of the 5 sessions of training (post-intervention) and at 1-month follow-up (1-month after the last training session).
Secondary outcome [6] 328423 0
Metacognitions about symptoms control, assessed using the Metacognitions about Symptom Control Scale (MaSCS).
Timepoint [6] 328423 0
At baseline and at 1-month follow-up (1-month after the last ABM session).
Secondary outcome [7] 328424 0
Hazardous alcohol use, assessed using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) summed score.
Timepoint [7] 328424 0
At baseline, at the end of the 5 sessions of training (post-intervention) and at 1-month follow-up (1-month after the last training session).
Secondary outcome [8] 328425 0
Number of cigarettes smoked per day, via an item on the Fagerstrom Test for Nicotine Dependence (FTND).
Timepoint [8] 328425 0
At baseline, at the end of the 5 sessions of training (post-intervention) and at 1-month follow-up (1-month after the last training session).
Secondary outcome [9] 328426 0
Nicotine dependence, assessed using the Fagerstrom Test for Nicotine Dependence (FTND) total score.
Timepoint [9] 328426 0
At baseline and at 1-month follow-up (1-month after the last ABM session).
Secondary outcome [10] 328427 0
Cannabis frequency of use in past month, assessed via single item preceding the Severity of Dependence Scale (SDS) items for cannabis use.
Timepoint [10] 328427 0
At baseline and at 1-month follow-up (1-month after the last ABM session).
Secondary outcome [11] 328428 0
Cannabis dependence, assessed using the Severity of Dependence Scale (SDS).
Timepoint [11] 328428 0
At baseline and at 1-month follow-up (1-month after the last ABM session).
Secondary outcome [12] 328429 0
Amphetamines or ecstasy frequency of use in past month, assessed via single item preceding the Severity of Dependence Scale (SDS) items for amphetamines or ecstasy.
Timepoint [12] 328429 0
At baseline and at 1-month follow-up (1-month after the last ABM session).
Secondary outcome [13] 328430 0
Amphetamines or ecstasy dependence, assessed using the Severity of Dependence Scale (SDS) items for amphetamines or ecstasy.
Timepoint [13] 328430 0
At baseline and at 1-month follow-up (1-month after the last ABM session).
Secondary outcome [14] 328431 0
Other substances (excluding alcohol, nicotine, cannabis, amphetamines or ecstasy) frequency of use in past month, assessed via single item preceding the Severity of Dependence Scale (SDS) items for other substances.
Timepoint [14] 328431 0
At baseline and at 1-month follow-up (1-month after the last ABM session).
Secondary outcome [15] 328432 0
Other substance dependence (excluding alcohol, nicotine, cannabis, amphetamines or ecstasy), assessed using the Severity of Dependence Scale (SDS) items for other substances.
Timepoint [15] 328432 0
At baseline and at 1-month follow-up (1-month after the last ABM session).
Secondary outcome [16] 328433 0
Pain Severity during the ABM treatment period, assessed via a Visual Analogue Scale (VAS), with 0 = No pain and 10 = Pain as bad as you can imagine.
Timepoint [16] 328433 0
Day after each of the 5 treatment sessions.
Secondary outcome [17] 328434 0
Pain Intensity during the ABM treatment period, assessed via a 5-point rating scale (1-mild, 5-excruciating).
Timepoint [17] 328434 0
Day after each of the 5 treatment sessions.
Secondary outcome [18] 328436 0
Pain experience (quality and intensity), assessing using the McGill Pain Questionnaire (MPQ).
Timepoint [18] 328436 0
At baseline and at 1-month follow-up (1-month after the last ABM session).
Secondary outcome [19] 328437 0
Aggressive behaviour in the past month, assessed using 4 likert-scaled items (“Never” to “Five or more times”) assessing frequency of different examples of aggressive behaviour with others.
Timepoint [19] 328437 0
At baseline, at the end of the 5 sessions of training (post-intervention) and at 1-month follow-up (1-month after the last training session).
Secondary outcome [20] 328438 0
Feelings of anger in the past week, assessed using the Profile of Mood States (POMS) Anger Scale.
Timepoint [20] 328438 0
At baseline, at the end of the 5 sessions of training (post-intervention) and at 1-month follow-up (1-month after the last training session).
Secondary outcome [21] 328457 0
Attention bias scores for depression-related cues (vs. neutral cues), via reaction times from the dot-probe task.
Timepoint [21] 328457 0
At the beginning of the first session (baseline) and at the end of the 5 sessions of ABM (post-intervention).
Secondary outcome [22] 328458 0
Attention bias scores for anxiety-related cues (vs. neutral cues), via reaction times from the dot-probe task.
Timepoint [22] 328458 0
At the beginning of the first session (baseline) and at the end of the 5 sessions of ABM (post-intervention).
Secondary outcome [23] 328481 0
Anxious affect during the ABM treatment period, assessed via 10-point Visual Analogue Scale item.
Timepoint [23] 328481 0
Day after each of the 5 treatment sessions.
Secondary outcome [24] 328482 0
Depressive affect during the ABM treatment period, assessed via 10-point Visual Analogue Scale item.
Timepoint [24] 328482 0
Day after each of the 5 treatment sessions.
Secondary outcome [25] 328483 0
Feelings of anger during the ABM treatment period, assessed via 10-point Visual Analogue Scale item.
Timepoint [25] 328483 0
Day after each of the 5 treatment sessions.
Secondary outcome [26] 328484 0
Relative happiness or sadness during the ABM treatment period, assessed via 10-point Visual Analogue Scale item.
Timepoint [26] 328484 0
Day after each of the 5 treatment sessions.

Eligibility
Key inclusion criteria
Aged 18 years or older,
currently serving or ex-serving Defence member,
have been experiencing pain for at least 3 months, and
had this pain experience in the last few months
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria. Participants are only required to meet the inclusion criteria.

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)
Allocations are computer-generated and are concealed until all eligibility criteria are confirmed as fulfilled and baseline questionnaire assessment is completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocations are computer-generated in permuted blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A minimum sample size of 34 was estimated to be required to test the effects of the ABM on the AB scores and primary pain outcome measures based upon a G*Power calculation for planned comparisons via repeated measures ANOVA, with 2 groups and 2 timepoints of measurements (baseline and 1-month follow-up), medium effect size (f=0.25), p<.05, power=0.80, and correlation amongst the repeated measures of 0.5. The same estimate was given to test the interaction between ABM condition and time (via mixed ANOVA with repeated measures and between factors), while an estimate of N=98 for the total sample size was given to test all effects of this mixed ANOVA. Thus, a total target sample size of 100 completions is sought. Planned comparisons via mixed ANOVAs will compare the intervention and control groups' attention biases pre- vs. post-intervention, and clinical outcomes from baseline to 1-month post-intervention, and between conditions at post-intervention and 1-month follow-up. Individual differences (e.g., age, gender, time since injury, medication) will be examined as moderators of the intervention's effects.

Recruitment
Recruitment status
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)
QLD

Funding & Sponsors
Funding source category [1] 294359 0
Charities/Societies/Foundations
Name [1] 294359 0
Defence Health Foundation Medical Research Grant
Address [1] 294359 0
Post address
PO Box 7518
Melbourne VIC 3004

Street address
Level 4, 380 St Kilda Road
Melbourne VIC 3004
Country [1] 294359 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology (QUT)
Address
Queensland University of Technology
Kelvin Grove campus
Victoria Park Road, Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 293200 0
University
Name [1] 293200 0
University of the Sunshine Coast (USC)
Address [1] 293200 0
University of the Sunshine Coast
Locked Bag 4
Maroochydore, DC, QLD, 4558
Country [1] 293200 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295777 0
Australian Defence Human Research Ethics Committee (ADHREC)
Ethics committee address [1] 295777 0
CP3-6-036
Campbell Park Offices,
PO Box 7912,
Canberra BC ACT 2610
Ethics committee country [1] 295777 0
Australia
Date submitted for ethics approval [1] 295777 0
08/04/2016
Approval date [1] 295777 0
12/08/2016
Ethics approval number [1] 295777 0
Protocol number: 821-16
Ethics committee name [2] 296141 0
Queensland University of Technology (QUT) Human Research Ethics Committee (HREC)
Ethics committee address [2] 296141 0
Office of Research Ethics & Integrity, QUT
Level 4, 88 Musk Avenue,
Kelvin Grove, QLD, 4059
Ethics committee country [2] 296141 0
Australia
Date submitted for ethics approval [2] 296141 0
15/08/2016
Approval date [2] 296141 0
19/08/2016
Ethics approval number [2] 296141 0
1600000797
Ethics committee name [3] 298310 0
Queensland University of Technology (QUT) Human Research Ethics Committee (HREC)
Ethics committee address [3] 298310 0
Office of Research Ethics & Integrity, QUT Level 4, 88 Musk Avenue, Kelvin Grove, QLD, 4059
Ethics committee country [3] 298310 0
Australia
Date submitted for ethics approval [3] 298310 0
16/02/2017
Approval date [3] 298310 0
19/06/2017
Ethics approval number [3] 298310 0
1700000143

Summary
Brief summary
Pain confers a survival advantage by drawing our attention to injury. Yet this attention bias towards pain-related cues can become maladaptive in people with chronic pain. Importantly, the direction of attention can be modified using a method known as attention bias modification (ABM). Preliminary research suggests this approach may be effective for the treatment of chronic pain. This is the first study to examine its effectiveness in a military population.
This study aims to determine whether multiple sessions of an ABM using pain cues will reduce attention bias to pain cues, reduce pain severity and related disability (e.g., pain interference) and improve mental health in ADF members with chronic pain. The study will be a parallel-groups randomized superiority trial comparing 5 sessions of ABM (using pain-related word cue attention modification training via a modified dot-probe task) versus sham training (i.e., placebo control condition, via a dot-probe task) in 100 Defence personnel who self-report chronic pain experience lasting at least 3 months.

100 Australian Defence Force members who report chronic pain (persisting at least 3 months) will be recruited and randomly allocated to undergo either ABM training or sham training (placebo control comparison). Pre- and post-intervention attention biases will be assessed via a computerised task (<10 mins) where reaction times for different categories of pain words will be measured. At each of the five training sessions, participants in the intervention group will undergo a modified version of this computerised task (< 10 mins) which implicitly trains participants to direct their attention away from these target cues. Control group participants will complete an equivalent task without the training contingencies. Questionnaires assessing demographic and key outcome variables will be completed via an online survey prior to the first training session (baseline) and at 1-month follow-up. During the 5-week intervention period, a brief (5-10 mins) online survey will be completed the next day following each training session to assess incremental changes in mood and pain ratings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68330 0
Dr Melanie White
Address 68330 0
Queensland University of Technology
Kelvin Grove Campus
Victoria Park Road
Kelvin Grove, QLD, 4059
Country 68330 0
Australia
Phone 68330 0
+61 7 3138 4714
Fax 68330 0
+61 7 3138 0486
Email 68330 0
melanie.white@qut.edu.au
Contact person for public queries
Name 68331 0
Dr Melanie White
Address 68331 0
Queensland University of Technology
Kelvin Grove Campus
Victoria Park Road
Kelvin Grove, QLD, 4059
Country 68331 0
Australia
Phone 68331 0
+61 7 3138 4714
Fax 68331 0
+61 7 3138 0486
Email 68331 0
melanie.white@qut.edu.au
Contact person for scientific queries
Name 68332 0
Dr Melanie White
Address 68332 0
Queensland University of Technology
Kelvin Grove Campus
Victoria Park Road
Kelvin Grove, QLD, 4059
Country 68332 0
Australia
Phone 68332 0
+61 7 3138 4714
Fax 68332 0
+61 7 3138 0486
Email 68332 0
melanie.white@qut.edu.au

No information has been provided regarding IPD availability
Summary results
No Results