Clinical trial NCT02232100: Attentional Bias Modification Training for People With Chronic Musculoskeletal Pain
Official title: Internet-Delivered Attentional Bias Modification Training in People With Chronic Musculoskeletal Pain: A Double-Blind Randomised Control Trial and a Qualitative Investigation of Participants' Experience.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Attentional bias modification training
Chronic pain
Visual-probe task
Internet-delivered therapy
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic musculoskeletal pain is a complex medical condition associated with significant distress, disability, and reduction in quality of life. Research has shown that patients with chronic musculoskeletal pain demonstrate attentional biases towards pain-related information.

The purpose of this study is to determine whether internet-delivered attentional bias modification, which aims to implicitly train attention away from pain-related information, has beneficial effects upon pain and pain-related distress in patients with chronic musculoskeletal pain.

Participants will be randomised to either an attentional training condition, or to a no-training placebo condition. The primary outcome measures are pain intensity and pain interference, and secondary outcome measures include anxiety, depression, pain-related fear and sleep problems.

Data will be analysed and reported separately for participants aged 16 - 24 and 25 - 60. It is hypothesized that participants receiving internet-delivered attentional bias modification will show significantly greater reductions in pain and pain-related distress compared to participants receiving placebo training.

Detailed description: Chronic musculoskeletal pain is a complex medical condition. Patients often experience increased levels of pain-related distress, including anxiety, depression and disability, impaired sleep, poor well-being and diminished quality of life. Over the past decade, numerous studies have provided evidence for the existence of attentional bias towards pain-related information in chronic pain patients. A critical question remaining unanswered is whether pain-related bias is simply an epiphenomenon of chronic pain, or whether it has a causal role in the maintenance of pain. Recently, there has been growing interest in the potential benefits of attentional retraining in individuals with various emotional disorders, with focus upon attentional bias modification (ABM).

ABM is a theory-driven intervention which uses computer-based paradigms, typically the visual-probe task, to implicitly manipulate attention away from sources of threat relevant to the individual's fears or concerns. To date, three published studies using ABM with chronic pain patients exist, the combined results of which support the therapeutic benefits of ABM on pain, pain-related distress and disability. Considering these encouraging results, it is important to expand this field of research and explore ABM in chronic pain in greater depth. In particular, all former studies assessed the clinical effectiveness of ABM in laboratory environments. The purpose of this double-blind RCT study is to determine whether internet-delivered ABM training (I-ABMT) has therapeutic benefits for patients with chronic musculoskeletal pain on pain and pain-related distress, thereby assessing training effects in real-world settings.

The visual-probe task will be used for assessment and modification of pain-related attentional biases. This is a computerised paradigm which records participant response times to a series of visual stimuli. Following an initial fixation point, each trial presents a stimulus pair in distinct locations (e.g. left and right of the initial fixation point), for a specified length of time (i.e., 500 or 1250ms). Stimuli may consist of words or images, with experimental trials featuring one pain-related stimulus and one neutral stimulus. Following this, both stimuli are removed, with a visual probe replacing one stimulus. Participants indicate the location of this probe as quickly and accurately as possible via manual response. Response times are faster to probes appearing in an attended region of the screen than an unattended region, providing a measure of attentional allocation. Averaged response times are calculated, which are converted into an index of attentional bias. In the standard and control (i.e., placebo) versions of the visual probe task, the probe replaces pain-related and neutral stimuli an equal number of times, while in the I-ABMT version, the probe always replaces neutral stimuli thus training attention away from pain-related stimuli.

Dose effects will be explored in this study, with participants randomised to one of four conditions: (i) 10-session Attentional Modification Group , (ii) 10-session Attentional Control Group, (iii) 18-session Attentional Modification Group, and (iv) 18-session Attentional Control Group. The primary outcome measures are pain intensity and pain interference, and secondary outcome measures include anxiety, depression, pain-related fear and sleeping impairment, including engagement to and satisfaction with the online visual-probe training task. It is hypothesized that participants receiving ABM training will show significantly greater reductions in pain and pain-related distress compared to participants receiving placebo training. Dose effects will be investigated in an exploratory manner, and data will be analysed and reported separately for participants aged 16 - 24 and 25 - 60.

Eligibility criteria: Inclusion Criteria:

1. aged between 16 to 60 years old
2. experiencing any type of CMSK (i.e., any condition that involves pain lasting for more than three months and arises from bones, muscles and/or joints)
3. able to sit at a personal computer for forty minutes
4. normal or corrected to normal vision
5. access to the internet at least twice a week
6. access to, and familiarity using, a Windows-based computer (g) successful completion of primary school
7. living in the United Kingdom.

Exclusion Criteria:

1. experiencing malignant CMSK (i.e., pain caused due to a tumour)
2. a diagnosis of any psychiatric disorder, either currently or within the last 5 years
3. currently under psychiatric therapy.

No restrictions are placed on concomitant care and participants are not required to make any changes to current treatments they may be receiving.

Primary outcomes:
measure: Pain intensity - change from baseline on an 11-point scale (0 no pain, 10 pain as bad as you can imagine) to endline (4 or 8 weeks)
timeFrame: Baseline, following intervention (4 or 8 weeks)
measure: Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to endline (4 or 8 weeks)
timeFrame: Baseline, following intervention (4 or 8 weeks)
measure: Pain intensity - change from baseline on an 11-point scale (0 no pain, 10 pain as bad as you can imagine) to 6-month follow-up
timeFrame: Baseline, 6-month follow-up
measure: Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to 6-month follow-up
timeFrame: Baseline, 6-month follow-up
Secondary outcomes:
measure: Anxiety - change from baseline to endline (4 or 8 weeks)
timeFrame: Baseline, following intervention (4 or 8 weeks)
measure: Depression - change from baseline to endline (4 or 8 weeks)
timeFrame: Baseline, following intervention (4 or 8 weeks)
measure: Pain-related fear - change from baseline to endline (4 or 8 weeks)
timeFrame: Baseline, following intervention (4 or 8 weeks)
measure: Sleeping impairment - change from baseline to endline (4 or 8 weeks)
timeFrame: Baseline, following intervention (4 or 8 weeks)
measure: Anxiety - change from baseline to 6-month follow-up
timeFrame: Baseline, 6-month follow-up
measure: Depression - change from baseline to 6-month follow-up
timeFrame: Baseline, 6-month follow-up
measure: Pain-related fear - change from baseline to 6-month follow-up
timeFrame: Baseline, 6-month follow-up
measure: Sleeping impairment - change from baseline to 6-month follow-up
timeFrame: Baseline, 6-month follow-up
Other outcomes:
measure: Satisfaction with the online ABMT
timeFrame: Following intervention (4 or 8 weeks)
Locations:
city: Southampton
country: United Kingdom
facility: University of Southampton
state: Hampshire
Study officials:
affiliation: University of Southampton
name: Christina Liossi, DPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liossi C, Georgallis T, Zhang J, Hamilton F, White P, Schoth DE. Internet-delivered attentional bias modification training (iABMT) for the management of chronic musculoskeletal pain: a protocol for a randomised controlled trial. BMJ Open. 2020 Feb 20;10(2):e030607. doi: 10.1136/bmjopen-2019-030607.