Cognitive Bias Modification for Interpretation Individuals With Chronic Musculoskeletal Pain

The Effectiveness and Mediators of Cognitive Bias Modification for Interpretation in the Reduction of Negative Emotional Response to Pain in Individuals With Chronic Musculoskeletal Pain

Cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign, rather than interpret it as being related to pain. The goal of this randomised controlled trial was to explore the feasibility and potential clinical benefits of CBM-I in people with chronic pain and also healthy, pain-free individuals.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Musculoskeletal Pain Disorder
• Intervention / Treatment: Behavioral: Benign cognitive bias modification for interpretation; Behavioral: Pain-related cognitive bias modification for interpretation

Detailed Description

This study investigated whether Cognitive Bias Modification for Interpretation (CBM-I) could reduce negative emotional response to pain and to pain-related images, and whether reductions in interpretation bias (IB) and fear of pain mediated this effect. Participants with chronic musculoskeletal pain (N = 41) were randomised to benign CBM-I or no CBM-I, and healthy participants (N = 41) were randomised to benign CBM-I or pain-related CBM-I. After CBM-I, the study assessed pain-related IB and fear of pain, as well as negative emotional response to exercise-induced pain and images of musculoskeletal pain.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO17 1BJ
      • University of Southampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Chronic pain group Inclusion criteria

• Experience musculoskeletal pain (pain in muscles, bones, joints, tendons, or ligaments) that has lasted for at least the last 3 months before enrolment in the study
• Have visited a healthcare professional for their pain
• Aged 18-70 years
• Normal or corrected to normal vision
• Fluency in the English language Exclusion criteria
• Any known reading difficulty

Healthy group Inclusion criteria

• Aged 18-70 years
• Normal or corrected to normal vision
• Fluency in the English language Exclusion criteria
• Experience frequent or continuous pain for the past three months before enrolment in the study
• Currently experiencing pain
• Any known reading difficulty

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Benign CBM-I - Chronic pain; Chronic pain participants randomised to receive benign CBM-I, which uses the Ambiguous Situations Task to train participants to neutral meanings of ambiguous scenarios.	Behavioral: Benign cognitive bias modification for interpretation; Benign cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign rather than pain-related.
No Intervention: No CBM-I - Chronic pain; Chronic pain participants randomised to the 'no CBM-I' condition complete the Ambiguous Situations Task without any form of bias modification.
Experimental: Benign CBM-I - Healthy; Healthy participants randomised to receive benign CBM-I, which uses the Ambiguous Situations Task to train participants to neutral meanings of ambiguous scenarios.	Behavioral: Benign cognitive bias modification for interpretation; Benign cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign rather than pain-related.
Other: Pain-related CBM-I - Healthy; Healthy participants randomised to receive pain-related CBM-I, which uses the Ambiguous Situations Task to train participants to painful meanings of ambiguous scenarios.	Behavioral: Pain-related cognitive bias modification for interpretation; Pain-related cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as pain-related.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional response to exercise induced pain	Sensory and emotional pain words from the McGill Pain Questionnaire (MPQ) were presented, grouped as they are on the MPQ. Participants chose one word from each group most representing the pain experienced performing a dynamic arm exercise (rotating their arms in small circles forwards for 10 seconds then backwards for 10 seconds, repeating the process as many times as possible). Participants rated each word from 0 (not at all representative) to 10 (extremely representative) or indicated if none represented their exercise pain. Emotional response to exercise pain was calculated from intensity and representativeness scores. For intensity, words were assigned a numeric score according to MPQ instructions and summed for emotional and sensory words. For representativeness, mean rating of representativeness was calculated for sensory and emotional pain words. The sensory score was subtracted from the emotional score to compute emotional response to pain relative to the sensory experience.	Immediately post-intervention
Emotional response to pain-related images	Participants were presented twenty pain-related images, and asked to rate the extent to which they felt negative emotions while viewing the image. After a fixation cross presented for 500 ms, a pain-related picture was presented for 6000 ms. This was followed by another cross presented for 500 ms then numbers from 0 (not at all negative) to 10 (very negative) was displayed. Participants were instructed to look at the picture on the screen then to rate their negative emotion from 0 (not at all negative) to 10 (very negative). The mean rating of emotional response to pain-related images was calculated for each participant.	Immediately post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of Pain	Fear of Pain Questionnaire - III. A 30-item scale (0 - Not at all, to 5 - Extreme), including three subscales: major pain (e.g., a car accident), minor pain (e.g. biting your tongue), and medical pain (e.g. an injection), with 10 items in each subscale. Higher scores indicate higher levels of pain-related fear.	Immediately post-intervention
Anxiety	Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). A seven-item subscale of the 14-item HADS (ranging from 0 - 3, or 3 - 0), with higher scores indicating higher levels of anxiety.	Baseline
Depression	Depression subscale of the Hospital Anxiety and Depression Scale (HADS). A seven-item subscale of the 14-item HADS (ranging from 0 - 3, or 3 - 0), with higher scores indicating higher levels of depression.	Baseline
Emotional response to average clinical pain	Sensory and emotional pain words from the McGill Pain Questionnaire (MPQ) were presented, grouped as they are on the MPQ. Participants chose one word from each group that was most representative of their average experience of clinical musculoskeletal pain. Participants rated each word on a scale from 0 (not at all representative) to 10 (extremely representative), or indicated if none of the words were representative of their pain. Indices of emotional response to musculoskeletal pain were calculated from intensity and representativeness scores. For intensity, words were assigned a numeric score according to the MPQ scoring instructions and these were summed for emotional and sensory words separately. For representativeness, the mean rating of representativeness was calculated for sensory and affective/evaluative (emotional) pain words separately. The sensory score was subtracted from the emotional score to determine the emotional response to pain relative to the sensory experience.	Immediately post-intervention
Pain severity	Pain severity subscale of the Brief Pain Inventory - Short Form, assessing pain at its worst and least in the last 24 hours, on average, and right now on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).	Baseline
Pain interference	Pain interference subscale of the Brief Pain Inventory - Short Form. A seven-item subscale which assesses the extent to which pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life over the past 24 hours on a scale of 0 (does not interfere) to 10 (completely interferes).	Baseline
Pain-related interpretation bias index	Assessed via Ambiguous Scenarios Task. The training phase presents ambiguous scenarios with a fragment of the last word shown, which participants completed. In the pain-related modification condition, the final word gave the scenario a pain-related meaning. In the benign modification condition, the final word gave the scenario a neutral meaning. The test phase assesses whether participants interpret new ambiguous scenarios as pain-related or benign, with participants rating the similarity of four endings (two pain-related and two neutral) to the original scenario from 1 (very different in meaning) to 4 (very similar in meaning). The mean score for benign target endings was subtracted from the mean score for negative endings to give an index of interpretation bias (a positive index indicates pain-related interpretation bias). To assess visual imagery, participants rated how easily they could imagine themselves as the protagonist in the scenarios from 1 (not at all) to 5 (extremely).	Immediately post-intervention

Collaborators and Investigators

• Sponsor: University of Southampton
• Collaborators: Economic and Social Research Council, United Kingdom
• Investigators: Principal Investigator: Daniel E Schoth, PhD, University of Southampton

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive bias modification; Interpretation bias
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Chronic Pain; Somatoform Disorders; Rheumatic Diseases; Collagen Diseases; Musculoskeletal Pain
• Other Study ID Numbers: CBM-I001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised participant dataset that underlies the results reported in this article may be requested from the authors.
• IPD Sharing Time Frame: Twelve months following publication of the results.
• IPD Sharing Access Criteria: Email the study authors.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No