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Completed

NCT Number: NCT06368362

Cognitive Bias Modification for Interpretation 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southampton

Southampton, Hampshire, SO17 1BJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benign cognitive bias modification for interpretation

Behavioral

Benign cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign rather than pain-related.

Pain-related cognitive bias modification for interpretation

Behavioral

Pain-related cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as pain-related.

Primary outcomes

  1. Emotional response to exercise induced pain

    Time frame: Immediately post-intervention

    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.

  2. Emotional response to pain-related images

    Time frame: Immediately post-intervention

    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.

Secondary outcomes

  1. Fear of Pain

    Time frame: Immediately post-intervention

    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.

  2. Anxiety

    Time frame: Baseline

    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.

  3. Depression

    Time frame: Baseline

    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.

  4. Emotional response to average clinical pain

    Time frame: Immediately post-intervention

    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.

  5. Pain severity

    Time frame: Baseline

    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).

  6. Pain interference

    Time frame: Baseline

    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).

  7. Pain-related interpretation bias index

    Time frame: Immediately post-intervention

    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).

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Collaborators

  • Economic and Social Research Council, United Kingdom

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 16, 2024
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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