Cognitive Bias Modification for Interpretation Individuals With Chronic Musculoskeletal Pain

NCT ID: NCT06368362

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-17

Study Completion Date

2021-05-01

Brief Summary

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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

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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

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Chronic Pain Musculoskeletal Pain Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants are not informed of the conditioned they are randomised to in this psychological intervention.

Study Groups

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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.

Group Type EXPERIMENTAL

Benign cognitive bias modification for interpretation

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Benign cognitive bias modification for interpretation

Intervention Type 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 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.

Group Type OTHER

Pain-related cognitive bias modification for interpretation

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* Aged 18-70 years
* Normal or corrected to normal vision

Exclusion Criteria

* Any known reading difficulty

* Experience frequent or continuous pain for the past three months before enrolment in the study
* Currently experiencing pain
* Any known reading difficulty
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Economic and Social Research Council, United Kingdom

OTHER

Sponsor Role collaborator

University of Southampton

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel E Schoth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southampton

Locations

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University of Southampton

Southampton, Hampshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CBM-I001

Identifier Type: -

Identifier Source: org_study_id

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