Clinical trial NCT06368362: Cognitive Bias Modification for Interpretation Individuals With Chronic Musculoskeletal Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain Disorder
Keywords: Cognitive bias modification
Interpretation bias
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: Economic and Social Research Council, United Kingdom
First posted: 2024-04-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Emotional response to exercise induced pain
timeFrame: Immediately post-intervention
measure: Emotional response to pain-related images
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Fear of Pain
timeFrame: Immediately post-intervention
measure: Anxiety
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
measure: Emotional response to average clinical pain
timeFrame: Immediately post-intervention
measure: Pain severity
timeFrame: Baseline
measure: Pain interference
timeFrame: Baseline
measure: Pain-related interpretation bias index
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University of Southampton
state: Hampshire
Study officials:
affiliation: University of Southampton
name: Daniel E Schoth, PhD
role: PRINCIPAL_INVESTIGATOR
References: