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Testing the effects of a novel psychological program for adults with chronic pain

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000803998
Enrollment
206
Registered
2020-08-10
Start date
2021-08-29
Completion date
2022-05-11
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 musculos

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.

Sponsors

Queensland University of Technology (QUT)
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 14, 2026