Attentional Bias Modification Training for People With Chronic Musculoskeletal Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Attentional bias modification training (AMG)
* Behavioral: Attentional bias placebo (ACG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 16 to 60 years old 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) able to sit at a personal computer for forty minutes normal or corrected to normal vision access to the internet at least twice a week access to, and familiarity using, a Windows-based computer (g) successful completion of primary school living in the United Kingdom. Exclusion Criteria: experiencing malignant CMSK (i.e., pain caused due to a tumour) a diagnosis of any psychiatric disorder, either currently or within the last 5 years 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10AMG<br>Attentional bias modification group - 10 training sessions | Behavioral: Attentional bias modification training (AMG)<br>* Attentional bias modification, administered via an internet-delivered visual-probe task that trains attention away from pain-related information<br>|
| Placebo Comparator: 10ACG<br>Attentional control group - 10 placebo sessions | Behavioral: Attentional bias placebo (ACG)<br>* Attentional bias placebo, administered via an internet-delivered visual-probe task that does not train attention either away or towards pain-related information<br>|
| Experimental: 18AMG<br>Attentional bias modification group - 18 training sessions | Behavioral: Attentional bias modification training (AMG)<br>* Attentional bias modification, administered via an internet-delivered visual-probe task that trains attention away from pain-related information<br>|
| Placebo Comparator: 18ACG<br>Attentional control group - 18 placebo sessions | Behavioral: Attentional bias placebo (ACG)<br>* Attentional bias placebo, administered via an internet-delivered visual-probe task that does not train attention either away or towards pain-related information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference. | Baseline, following intervention (4 or 8 weeks) | 
| Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to endline (4 or 8 weeks) | Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference. | Baseline, following intervention (4 or 8 weeks) | 
| 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 | Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference. | Baseline, 6-month follow-up | 
| Pain interference- change from baseline on an 11-point scale (0 does not interfere, 10 completely interferes) to 6-month follow-up | Likert scale from the Brief Pain Inventory-Short Form (BPS-SF), a commonly used measure of pain intensity and pain interference. | Baseline, 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety - change from baseline to endline (4 or 8 weeks) | State and Trait Anxiety Subscales from the State-Trait Anxiety Inventory (STAI), a 40-item measure of state and trait anxiety (20 items each). Each item is measured on a four point scale, with possible scores for both state and trait levels ranging between 20 and 80. State and trait subscales are not combined. Higher scores on each subscale represent more intense or more frequent feelings of anxiety. | Baseline, following intervention (4 or 8 weeks) | 
| Depression - change from baseline to endline (4 or 8 weeks) | Depression Subscale from Hospital Anxiety and Depression Scale, which is comprised of 7 items each measured on a four point scale. Possible scores for the depression subscale range between 0 and 21, with higher scores indicating higher levels of anxiety and depression. | Baseline, following intervention (4 or 8 weeks) | 
| Pain-related fear - change from baseline to endline (4 or 8 weeks) | Fear of Pain questionnaire III. On a 5-point scale, respondents are asked to rate how fearful they are of pain associated with specific situations and events (e.g., being in an automobile accident). Possible scores range between 30 and 150, with higher scores representing a more intense fear of pain. In addition to a total score, the measure also provides subscales of minor, severe, and medical pain-related fear. | Baseline, following intervention (4 or 8 weeks) | 
| Sleeping impairment - change from baseline to endline (4 or 8 weeks) | Medical Outcome Study Sleep Scale, a twelve-item questionnaire developed for patients with chronic illness, measuring six dimensions of sleep over the past four weeks; sleep initiation (time to fall asleep - five responses), quantity (the participant writes hours per night sleeping), maintenance, respiratory problems, perceived adequacy, and somnolence rated on a 6-point scale. A sleep problems index which summarises information from nine items is also be scored. Responses are recoded on a 0 - 100 scale, with higher scores indicating more of the concept being measured (e.g., greater difficulties falling asleep). | Baseline, following intervention (4 or 8 weeks) | 
| Anxiety - change from baseline to 6-month follow-up | State and Trait Anxiety Subscales from State-Trait Anxiety Inventory(STAI), a 40-item measure of state and trait anxiety (20 items each). Each item is measured on a four point scale, with possible scores for both state and trait levels ranging between 20 and 80. State and trait subscales are not combined. Higher scores on each subscale represent more intense or more frequent feelings of anxiety. | Baseline, 6-month follow-up | 
| Depression - change from baseline to 6-month follow-up | Depression Subscale from Hospital Anxiety and Depression Scale, which is comprised of 7 items each measured on a four point scale. Possible scores for the depression subscale range between 0 and 21, with higher scores indicating higher levels of anxiety and depression. | Baseline, 6-month follow-up | 
| Pain-related fear - change from baseline to 6-month follow-up | Fear of Pain questionnaire III. On a 5-point scale, respondents are asked to rate how fearful they are of pain associated with specific situations and events (e.g., being in an automobile accident). Possible scores range between 30 and 150, with higher scores representing a more intense fear of pain. In addition to a total score, the measure also provides subscales of minor, severe, and medical pain-related fear. | Baseline, 6-month follow-up | 
| Sleeping impairment - change from baseline to 6-month follow-up | Medical Outcome Study Sleep Scale, a twelve-item questionnaire developed for patients with chronic illness, measuring six dimensions of sleep over the past four weeks; sleep initiation (time to fall asleep - five responses), quantity (the participant writes hours per night sleeping), maintenance, respiratory problems, perceived adequacy, and somnolence rated on a 6-point scale. A sleep problems index which summarises information from nine items is also be scored. Responses are recoded on a 0 - 100 scale, with higher scores indicating more of the concept being measured (e.g., greater difficulties falling asleep). | Baseline, 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attentional bias modification training, Chronic pain, Visual-probe task, Internet-delivered therapy