Chronic PainNCT06368362
Cognitive Bias Modification for Interpretation Individuals With Chronic Musculoskeletal Pain
A study testing Benign cognitive bias modification for interpretation and Pain-related cognitive bias modification for interpretation in people with Chronic Pain and Musculoskeletal Pain Disorder, run by University of Southampton at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain Disorder
- What is being tested?
- Benign cognitive bias modification for interpretation and Pain-related cognitive bias modification for interpretation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Nov 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Southampton
Southampton, Hampshire, SO17 1BJ
About this study
Official 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
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.
Read the 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.
- Conditions
- Chronic Pain, Musculoskeletal Pain Disorder
- Being tested
- Benign cognitive bias modification for interpretation, Pain-related cognitive bias modification for interpretation
- Keywords
- Cognitive bias modification, Interpretation bias
- Medical subject headings
- Chronic Pain, Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benign cognitive bias modification for interpretationBehavioural
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 interpretationBehavioural
Pain-related cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as pain-related.
| Study group | Role | What they receive |
|---|---|---|
| Benign CBM-I - Chronic pain | Experimental | Chronic pain participants randomised to receive benign CBM-I, which uses the Ambiguous Situations Task to train participants to neutral meanings of ambiguous scenarios. Receives: Behavioral: Benign cognitive bias modification for interpretation |
| No CBM-I - Chronic pain | No intervention | Chronic pain participants randomised to the 'no CBM-I' condition complete the Ambiguous Situations Task without any form of bias modification. |
| Benign CBM-I - Healthy | Experimental | Healthy participants randomised to receive benign CBM-I, which uses the Ambiguous Situations Task to train participants to neutral meanings of ambiguous scenarios. Receives: Behavioral: Benign cognitive bias modification for interpretation |
| Pain-related CBM-I - Healthy | Other | Healthy participants randomised to receive pain-related CBM-I, which uses the Ambiguous Situations Task to train participants to painful meanings of ambiguous scenarios. Receives: Behavioral: Pain-related cognitive bias modification for interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately post-intervention
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start17 Nov 2020
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of participants (chronic musculoskeletal pain, healthy) were recruited, and within each group participants were randomised to one of two experimental conditions with a 1:1 allocation ratio with a parallel design. Participants with chronic musculoskeletal pain were randomised to benign CBM-I or no CBM-I, and healthy participants were randomised to benign CBM-I or pain-related CBM-I.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Economic and Social Research Council, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Daniel E Schoth, PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368362
- Sponsor's protocol ID
- CBM-I001
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised participant dataset that underlies the results reported in this article may be requested from the authors.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06368362
- Acronym / sponsor ID
- CBM-I001
- Conditions
- Chronic Pain, Musculoskeletal Pain Disorder
- Keywords
- Cognitive bias modification, Interpretation bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Economic and Social Research Council, United Kingdom
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Two groups of participants (chronic musculoskeletal pain, healthy) were recruited, and within each group participants were randomised to one of two experimental conditions with a 1:1 allocation ratio with a parallel design. Participants with chronic musculoskeletal pain were randomised to benign CBM-I or no CBM-I, and healthy participants were randomised to benign CBM-I or pain-related CBM-I.
| Arm | Type | Receives |
|---|---|---|
| Benign CBM-I - Chronic pain | Experimental | Behavioral: Benign cognitive bias modification for interpretationChronic pain participants randomised to receive benign CBM-I, which uses the Ambiguous Situations Task to train participants to neutral meanings of ambiguous scenarios. |
| No CBM-I - Chronic pain | No intervention | –Chronic pain participants randomised to the 'no CBM-I' condition complete the Ambiguous Situations Task without any form of bias modification. |
| Benign CBM-I - Healthy | Experimental | Behavioral: Benign cognitive bias modification for interpretationHealthy participants randomised to receive benign CBM-I, which uses the Ambiguous Situations Task to train participants to neutral meanings of ambiguous scenarios. |
| Pain-related CBM-I - Healthy | Other | Behavioral: Pain-related cognitive bias modification for interpretationHealthy participants randomised to receive pain-related CBM-I, which uses the Ambiguous Situations Task to train participants to painful meanings of ambiguous scenarios. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benign cognitive bias modification for interpretationBenign cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign rather than pain-related. | Behavioural | Benign CBM-I - Chronic pain, Benign CBM-I - Healthy |
| Pain-related cognitive bias modification for interpretationPain-related cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as pain-related. | Behavioural | Pain-related CBM-I - Healthy |
Primary outcome
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.
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.
7 secondary outcomes
Fear of Pain
Time frame: Immediately post-intervention
Anxiety
Time frame: Baseline
Depression
Time frame: Baseline
Emotional response to average clinical pain
Time frame: Immediately post-intervention
Pain severity
Time frame: Baseline
Pain interference
Time frame: Baseline
Pain-related interpretation bias index
Time frame: Immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Yes. Anonymised participant dataset that underlies the results reported in this article may be requested from the authors.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel E Schoth, PhD principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benign cognitive bias modification for interpretation and Pain-related cognitive bias modification for interpretation in people with Chronic Pain and Musculoskeletal Pain Disorder, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional response to exercise induced pain (time frame: Immediately post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.