Attentional Bias Modification Training for People With Chronic Musculoskeletal Pain

NCT02232100 | Unknown

• 1 other identifier: ABMT2014
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Attentional bias modification training; Chronic pain; Visual-probe task; Internet-delivered therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Anxiety - change from baseline to endline (4 or 8 weeks)

  Baseline, following intervention (4 or 8 weeks)

• Depression - change from baseline to endline (4 or 8 weeks)

  Baseline, following intervention (4 or 8 weeks)

• Pain-related fear - change from baseline to endline (4 or 8 weeks)

  Baseline, following intervention (4 or 8 weeks)

• Sleeping impairment - change from baseline to endline (4 or 8 weeks)

  Baseline, following intervention (4 or 8 weeks)

• Anxiety - change from baseline to 6-month follow-up

  Baseline, 6-month follow-up

Other Outcomes (1)

• Satisfaction with the online ABMT

  Following intervention (4 or 8 weeks)

Study Arms (4)

10AMG

EXPERIMENTAL

Attentional bias modification group - 10 training sessions

Behavioral: Attentional bias modification training (AMG)

10ACG

PLACEBO COMPARATOR

Attentional control group - 10 placebo sessions

Behavioral: Attentional bias placebo (ACG)

18AMG

EXPERIMENTAL

Attentional bias modification group - 18 training sessions

Behavioral: Attentional bias modification training (AMG)

18ACG

PLACEBO COMPARATOR

Attentional control group - 18 placebo sessions

Behavioral: Attentional bias placebo (ACG)

Interventions

Attentional bias modification training (AMG) BEHAVIORAL

Attentional bias modification, administered via an internet-delivered visual-probe task that trains attention away from pain-related information

10AMG; 18AMG

Attentional bias placebo (ACG) BEHAVIORAL

Attentional bias placebo, administered via an internet-delivered visual-probe task that does not train attention either away or towards pain-related information

10ACG; 18ACG

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (1)

University of Southampton

Southampton, Hampshire, SO17 1BJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32086350 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

acceleratory factor from growth hormone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christina Liossi, DPsych

  University of Southampton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Liossi, DPsych

CONTACT

+44 23 8059 4645; c.liossi@soton.ac.uk

Daniel E Schoth, PhD

CONTACT

+44 23 8059 4518; d.e.schoth@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: September 4, 2014
• Study Start: November 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)