Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000803998
Ethics application status
Approved
Date submitted
9/06/2020
Date registered
10/08/2020
Date last updated
31/10/2022
Date data sharing statement initially provided
10/08/2020
Date results information initially provided
31/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the effects of a novel psychological program for adults with chronic pain
Scientific title
Testing the effects of a novel psychological program on perceived pain intensity, pain interference, and engagement for adults with chronic pain: A randomised, double-blind, placebo-controlled trial
Secondary ID [1] 301314 0
None
Universal Trial Number (UTN)
U1111-1252-1954
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 317502 0
Condition category
Condition code
Mental Health 315600 315600 0 0
Studies of normal psychology, cognitive function and behaviour
Musculoskeletal 316229 316229 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research aims to investigate the effects of a gamified web-based attentional bias modification training (ABMT) program on pain intensity, pain-related outcomes (i.e., pain interference, anxiety, and depression), cognitive biases (i.e., attention and interpretation bias for pain), behavioural (i.e., program attrition and completion rates) and self-reported (i.e., task-related engagement, enjoyment and interest) engagement, and perceived improvement in a sample of adults with chronic musculoskeletal pain. This research is a randomised, double-blind, placebo-controlled, 3-arm, parallel-group trial. Participants will be randomly assigned to complete six online sessions of non-gamified sham control ABMT (i.e., control condition), non-gamified standard ABMT, or gamified ABMT, across a period of three weeks.

The 3 arms include:
1. Behavioural: non-gamified standard ABMT
A non-gamified standard ABMT, administered via an internet-delivered modified dot-probe task that trains attention away from pain-related information, using pain and neutral stimuli (with the probe replacing neutral cues on 87.5% of trials and pain cues on 12.5% of trials).
2. Behavioural: non-gamified sham control ABMT
A non-gamified sham control ABMT, administered via an internet-delivered modified dot-probe task that does not train attention towards or away from any stimuli type, using the same pain and neutral stimuli (with the probe replacing the pain vs. neutral stimuli equally often).
3. Behavioural: gamified ABMT
The gamified ABMT condition is similar to the non-gamified standard ABMT task, with the exception that it has additional game-like features. Specifically, the gamified version incorporates a combination of five game elements: clear gamified goal, feedback loops, task-related progress (i.e., progress bar and written indicator), rewards (i.e., points and badges), and sound effect (with the reward).

Stage 1: All recruitment materials will include a survey hyperlink that will direct prospective participants to the necessary study information to decide on participation. Interested participants will be asked to provide informed consent electronically (i.e., e-consent), before being taken to the screening questions, and then to the first screen of the baseline assessment. Participants will complete the initial online survey (approximately 35 minutes), at a time and place of their convenience, to assess baseline levels of key outcome and demographic variables. At the end of the survey, participants will also be asked to provide an email address so that the research team can send links to the training sessions. Participants will then be randomised into one of three groups and be invited by email to start their first training session. This email will include a web-link to the appropriate version of the intervention as well as instructions on how to download the program.

Stage 2: Participants will complete the online training sessions, at their place of convenience (using their own computer), twice a week on a separate pair of days (Monday/Thursday or Tuesday/Friday) for 3 consecutive weeks. It is anticipated that the first and final sessions will take approximately 30 minutes, as it includes cognitive assessment measures. Sessions 2 to 5 will take approximately 15 minutes to complete. Each session includes instruction screens and comprise 272 trials, which includes practice trials using neutral stimuli. A booster block of 68 trials will also be given at the end of session 6.

Stage 3. Immediately after each session, participants will rate their experience with the task (< 2 minutes).

Stage 4. Immediately after completion of the final training session, participants will receive a web link to the post-assessment (approximately 15 minutes), with questions relating to their experience of pain, mood, and other relevant psychological experiences associated with their pain.

Stage 5. Finally, one month following the final sessions, participants will receive an email invitation containing a web link for the follow-up assessment (approximately 10 minutes), with similar questions to that of the post-assessment.

Tasks will be programmed and presented by the Inquisit Web/Millisecond software package (Seattle, WA: Millisecond Software) on participants’ internet-connected desktop or laptop computers, and questionnaires will be administered using the online system Qualtrics (Provo, Utah, USA), except for self-reported engagement, which will be administered using Inquisit Web/Millisecond.
Intervention code [1] 317617 0
Behaviour
Intervention code [2] 317623 0
Treatment: Other
Comparator / control treatment
Non-gamified sham placebo control comparator: non-gamified sham control ABMT, administered via an internet-delivered modified dot-probe task that does not train attention towards or away from any stimuli type (with the probe replacing the pain vs. neutral stimuli equally often), twice per week for 3 weeks. All tasks and stimuli are equivalent to the non-gamified standard ABMT, except for the modification probe-target contingencies.
Control group
Placebo

Outcomes
Primary outcome [1] 323854 0
Pain intensity, assessed via the PROMIS Pain intensity- short form 3a (v1.0; 3 items). The first two items assess pain intensity using a 7–day recall period and are rated on a 5-point Likert scale that ranges from 1 (had no pain) to 5 (very severe). The last item asks participants to rate their level of pain “right now” and is rated on a 5-point Likert scale that ranges from 1 (no pain) to 5 (very severe). Raw score totals are transformed to T-score metrics using the PROMIS conversion tables, such that the average score for the general population is 50 and the standard deviation 10 (more information can be found at www.healthmeasures.net). Higher T-scores represent worse pain.
Timepoint [1] 323854 0
At baseline, at the end of the 6 sessions of training (post-intervention) (primary endpoint), and at 1-month follow-up (1-month after the last training session).
Primary outcome [2] 323855 0
Pain interference, assessed via the PROMIS Pain interference- short form 8a (v1.0; 8 items). The items have a 7-day time frame and are rated on a 5-point Likert scale that ranges from 1 (not at all) to 5 (very much). Raw score totals are transformed to T-score metrics using the PROMIS conversion tables, such that the average score for the general population is 50 and the standard deviation 10 (more information can be found at www.healthmeasures.net). Higher T-scores represent greater pain interference.
Timepoint [2] 323855 0
At baseline, at the end of the 6 sessions of training (post-intervention) (primary endpoint), and at 1-month follow-up (1-month after the last training session).
Primary outcome [3] 323856 0
Self-report engagement, assessed via a single-item question. The single-item question (“How engaging was this session?") is rated on a 10-point Likert scale, ranging from 1 (not at all) to 10 (very much), with a higher score indicating greater engagement. Data will be downloaded from the Inquisit Web/Millisecond server.
Timepoint [3] 323856 0
Measured after each training session (6 times).
Secondary outcome [1] 383063 0
Primary outcome [4]:
Self-report engagement, assessed via the Intrinsic Motivation Inventory-interest/enjoyment subscale. The Intrinsic Motivation Inventory-interest/enjoyment subscale comprises 7 items, which are scored on a 7-point Likert scale ranging from 1 (not at all) to 7 (very true), with higher scores representing higher levels of interest and enjoyment. Data will be downloaded from the Inquisit Web/Millisecond server.
Timepoint [1] 383063 0
Primary timepoint [4]:
Measured at the end of the 6 sessions of training (post-intervention).
Secondary outcome [2] 383064 0
Primary outcome [5]:
Behavioural engagement, assessed via intervention attrition rates (i.e., the proportion of participants who discontinue using the program at each training session). Data will be downloaded from the Inquisit Web/Millisecond server.
Timepoint [2] 383064 0
Primary timepoint [5]:
Measured after each training session (6 times).
Secondary outcome [3] 383065 0
Primary outcome [6]:
Behavioural engagement, assessed via completion rates (i.e., the proportion of sessions, out of six, that each participant completed during the training period). Data will be downloaded from the Inquisit Web/Millisecond server.
Timepoint [3] 383065 0
Primary timepoint [6]:
Measured after each training session (6 times).
Secondary outcome [4] 383066 0
Attentional bias scores for pain-related cues (vs. neutral cues), via reaction times from the dot-probe task. After completing the task, a data file containing participant's reaction times and accuracy scores will be automatically and securely saved to the researcher’s online Inquisit Web/Millisecond account.
Timepoint [4] 383066 0
At the beginning of the first session (baseline) and at the end of the 6 sessions of ABMT (post-intervention).
Secondary outcome [5] 383067 0
Anxiety symptoms, assessed via the PROMIS Anxiety 8a (v1.0; 8 items). The items have a 7-day period and are rated on a 5-point Likert scale that ranges from 1 (never) to 5 (always). Raw score totals are transformed to T-score metrics using the PROMIS conversion tables, such that the average score for the general population is 50 and the standard deviation 10 (more information can be found at www.healthmeasures.net). Higher T-scores represent greater symptoms of anxiety.
Timepoint [5] 383067 0
At baseline, at the end of the 6 sessions of training (post-intervention), and at 1-month follow-up (1-month after the last training session).
Secondary outcome [6] 384581 0
Depression symptoms, assessed via PROMIS Depression 8b (v1.0; 8 items). The items have a 7-day period and are rated on a 5-point Likert scale that ranges from 1 (never) to 5 (always). Raw score totals are transformed to T-score metrics using the PROMIS conversion tables, such that the average score for the general population is 50 and the standard deviation 10 (more information can be found at www.healthmeasures.net). Higher T-scores represent greater symptoms of depression.
Timepoint [6] 384581 0
At baseline, at the end of the 6 sessions of training (post-intervention), and at 1-month follow-up (1-month after the last training session).
Secondary outcome [7] 384582 0
Perceived improvement, assessed via the Patient Global Impression of Change scale. This measure consists of a single-item rated on a 7-point Likert scale, from 1 (very much improved) to 7 (very much worse), with no change at the middle of the scale.
Timepoint [7] 384582 0
At the end of the 6 sessions of training (post-intervention) and at 1-month follow-up (1-month after the last training session).
Secondary outcome [8] 384583 0
Interpretation bias, assessed using an adapted version of the computerised Interpretations of Bodily Threat task (Heathcote et al., 2016), in which participants complete eight ambiguous body-related situations and eight ambiguous social situations. After completing the task, a data file containing participant's responses will be automatically and securely saved to the researcher’s online Inquisit Web/Millisecond account.
Timepoint [8] 384583 0
At the beginning of the first session (baseline) and at the end of the 6 sessions of ABMT (post-intervention).
Secondary outcome [9] 385412 0
Exploratory outcome [1]:
Attentional control, assessed with the Attentional Control Scale (Derryberry & Reed, 2002). The scale is a 20-item self-report questionnaire used to measure attention focusing and attention shifting. The questionnaire is adapted by including a 7-day time frame to the items. Items are scored on a 4-point Likert scale from 1 (almost never) to 4 (always). Higher scores indicate better ability to direct and maintain attention.
Timepoint [9] 385412 0
Exploratory timepoint [1]:
At the beginning of the first session (baseline) and at the end of the 6 sessions of ABMT (post-intervention).
Secondary outcome [10] 385413 0
Exploratory outcome {2}:
Personality traits, measured by the Behavioural Inhibition System (BIS) and Behavioural Activation System (BAS) Scales (Carver & White, 1994), a 20-item self-report questionnaire that measures trait sensitivity levels of the BIS (punishment; 7 items) and BAS (reward; 13 items). The scales are scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree).
Timepoint [10] 385413 0
Exploratory timepoint [2]:
At the beginning of the first session (baseline).
Secondary outcome [11] 385414 0
Exploratory outcome {3}:
Pain-related worrying, assessed using the Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995). The scale is a 13-item self-report measure that evaluates three subscales: rumination, magnification and helplessness. Using a 5-point Likert scale, ranging from 0 (not at all) to 4 (all the time), participants are asked to recall past painful experiences and to indicate to what extent 13 thoughts or feelings are associated with these experiences.
Timepoint [11] 385414 0
Exploratory timepoint [3]:
At the beginning of the first session (baseline).

Eligibility
Key inclusion criteria
1) be aged 18 years or older
2) experience chronic musculoskeletal pain, that is, pain in bones, joints, muscles, or related soft tissues (e.g., rheumatoid arthritis pain, non-specific chronic back pain, fibromyalgia pain)
3) meet the criteria for chronic pain, that is, self-reported pain that lasts or recurs for more than 3 months
4) have normal or corrected-to-normal vision
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) are not native English speakers or are not fluent in reading and writing English
2) have no access to a desktop or laptop computer connected to reliable internet
3) are not able or willing to provide informed consent to participate

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 concealment will be used. Specifically, randomisation will be performed before participants are enrolled by an independent person blinded to all processes within the program, using a computerised random number generator (www.random.org/).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. 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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
To the best of our knowledge, there are no similar published studies on gamified pain ABMT nor on ABMT for adults with chronic pain that directly compare three groups (i.e., non-gamified sham control ABMT, non-gamified standard ABMT, and gamified ABMT), and therefore there is no previous effect size on which to base a sample size estimation. As such, a minimum sample size of 30 per training group is planned on the basis that this exceeds the sample size determined by several, similar, pain ABMT and gamified training studies. Considering attrition rates of previous trials in chronic pain treatment and given the 1-month follow-up measurement, a drop-out rate of approximately 30% is expected for the current trial. Therefore, a total target sample size of 120 participants, thus 40 participants per group, will be sought.

Analysis:
Continuous data will be presented as the means and standard deviations, whereas categorical data will be presented as frequencies and percentages. Analyses will follow the intention-to-treat (ITT) principle.
A series of multilevel modelling analyses with random intercepts will be conducted to determine symptom changes (i.e., pain intensity, pain interference, anxiety, and depression), cognitive changes (i.e., attentional bias, interpretation bias), perceived improvement changes, and self-reported engagement changes in the different training conditions.
A one-way ANOVA will be performed to analyse the impact of gamification on interest and enjoyment,
Regarding behavioural engagement, Kaplan-Meier survival curves will be calculated to assess the time at which attrition occurred in each training condition, and compared statistically using a log-rank test. A one-way ANOVA will be performed to determine whether there are differences in the mean number of sessions completed between training conditions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/09/2020
Actual
29/08/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
11/05/2022
Date of last data collection
Anticipated
30/08/2022
Actual
24/06/2022
Sample size
Target
120
Accrual to date
Final
206
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 16713 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 30314 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 305751 0
University
Name [1] 305751 0
Queensland University of Technology (QUT)
Country [1] 305751 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology (QUT)
Address
Kelvin Grove campus
170 Victoria Park Road
Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 306349 0
None
Name [1] 306349 0
Address [1] 306349 0
Country [1] 306349 0
Other collaborator category [1] 281348 0
Individual
Name [1] 281348 0
Dr. Melanie White
Address [1] 281348 0
Queensland University of Technology (QUT)
School of Psychology and Counselling, Institute of Health and Biomedical Innovation
170 Victoria Park Road
Kelvin Grove, QLD 4059
Country [1] 281348 0
Australia
Other collaborator category [2] 281349 0
Individual
Name [2] 281349 0
Professor Daniel Johnson
Address [2] 281349 0
Queensland University of Technology (QUT)
Science and Engineering Faculty
2 George St
Gardens Point, QLD 4000
Country [2] 281349 0
Australia
Other collaborator category [3] 281350 0
Individual
Name [3] 281350 0
Professor Geert Crombez
Address [3] 281350 0
Ghent University
Department of Experimental Clinical and Health Psychology
2 Henri Dunantlaan
Ghent, 9000
Country [3] 281350 0
Belgium
Other collaborator category [4] 281351 0
Individual
Name [4] 281351 0
Assistant Professor Dimitri Van Ryckeghem
Address [4] 281351 0
Maastricht University
Department of Clinical Psychological Science
Universiteitssingel 40
Maastricht, 6229 ER
Country [4] 281351 0
Netherlands
Other collaborator category [5] 281352 0
Individual
Name [5] 281352 0
Associate Professor Paul Gray
Address [5] 281352 0
Royal Brisbane and Women’s Hospital
Level 4, Dr James Mayne Building
Butterfield Street
Herston, QLD 4029
Country [5] 281352 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306025 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee ( RBWH HREC)
Ethics committee address [1] 306025 0
Royal Brisbane & Women's Hospital
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street
Herston, QLD 4029
Ethics committee country [1] 306025 0
Australia
Date submitted for ethics approval [1] 306025 0
27/03/2020
Approval date [1] 306025 0
28/04/2020
Ethics approval number [1] 306025 0
HREC/2020/QRBW/61743
Ethics committee name [2] 306038 0
Queensland University of Technology (QUT) University Human Research Ethics Committee (UHREC).
Ethics committee address [2] 306038 0
Office of Research Ethics & Integrity, QUT
Level 4, 88 Musk Avenue
Kelvin Grove, QLD 4059
Ethics committee country [2] 306038 0
Australia
Date submitted for ethics approval [2] 306038 0
14/05/2020
Approval date [2] 306038 0
16/09/2020
Ethics approval number [2] 306038 0

Summary
Brief summary
Research to date has found variable success in using attentional bias modification training (ABMT) procedures in pain samples. Several factors could contribute to these mixed findings, including boredom and low motivation. Indeed, the training paradigm is repetitive, which can lead to disengagement and high drop-out rates. A potential approach to overcome some of these barriers is to attempt to increase engagement and motivation through gamification (i.e., the use of game elements) of this task. This clinical trial aims to investigate the effects of a gamified web-based ABMT procedure in a sample of adults with chronic pain. One hundred and twenty adults with chronic musculoskeletal pain, recruited from a hospital outpatient waiting list and the wider community, will be included in this randomised, double-blind, placebo-controlled, 3-arm trial. Participants will be randomly assigned to complete six online sessions of dot-probe non-gamified sham control ABMT, non-gamified standard ABMT, or gamified ABMT, across a period of three weeks. Active ABMT conditions will aim at training attention away from pain-relevant words. Participant outcomes will be assessed at pre-training, during training, immediately post-training and at 1-month follow-up. Primary outcomes include pain intensity, pain interference, behavioural and self-reported engagement. Secondary outcomes include attentional bias for pain, anxiety, depression, interpretation bias for pain, and perceived improvement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102462 0
Mrs Julie Vermeir
Address 102462 0
Queensland University of Technology (QUT)
School of Psychology and Counselling, Institute of Health and Biomedical Innovation
170 Victoria Park Road
Kelvin Grove, QLD 4059
Country 102462 0
Australia
Phone 102462 0
+61 7 3138 4714
Fax 102462 0
Email 102462 0
[email protected]
Contact person for public queries
Name 102463 0
Mrs Julie Vermeir
Address 102463 0
Queensland University of Technology (QUT)
School of Psychology and Counselling, Institute of Health and Biomedical Innovation
170 Victoria Park Road
Kelvin Grove, QLD 4059
Country 102463 0
Australia
Phone 102463 0
+61 7 3138 4714
Fax 102463 0
Email 102463 0
[email protected]
Contact person for scientific queries
Name 102464 0
Mrs Julie Vermeir
Address 102464 0
Queensland University of Technology (QUT)
School of Psychology and Counselling, Institute of Health and Biomedical Innovation
170 Victoria Park Road
Kelvin Grove, QLD 4059
Country 102464 0
Australia
Phone 102464 0
+61 7 3138 4714
Fax 102464 0
Email 102464 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification and relevant publication.
When will data be available (start and end dates)?
Data will be available immediately following publication and will be available for 15 years following publication.
Available to whom?
Data will be available after dissemination upon request and at the discretion of the researchers.
Available for what types of analyses?
Data will be available for primary and secondary analyses on the basis that the secondary analysis is related to the topic of interest.
How or where can data be obtained?
Data will be available from the principal researcher ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8002Study protocol  [email protected]
8003Informed consent form  [email protected]
8004Ethical approval  [email protected]



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