RecruitingNot ApplicableNCT06908486

Cognitive Bias Modification for Interpretation (CBM-I) in People With Type 2 Diabetes and Persistent Pain

Assessing Cognitive Bias Modification for Interpretation (CBM-I) on Pain Severity and Interference in People With Type 2 Diabetes and Persistent Pain


Sponsor

University of Sydney

Enrollment

319 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to examine the efficacy of cognitive bias modification for interpretation (CBM-I) in people with Type 2 Diabetes and persistent pain. The main question\[s\] it aims to answer is whether interpretation bias training away from pain improves pain outcomes. Participants in the CBM-I group will complete 4 online training sessions approximately half an hour each. Each session will present participants with ambiguous scenarios which may be pain-related, however the final word of the sentence will resolve the scenario as benign (thus training participants to make benign interpretations). A measure of interpretation bias will be administered following the fourth training session, and pain severity and interference will be measured at baseline, post-training, two week follow up, and three month follow up. The study hypothesises that participants in the CBM-I group will demonstrate a greater reduction in the co-primary outcomes of pain severity and pain interference over time compared to those in the placebo control.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an online program called Cognitive Bias Modification for Interpretation (CBM-I), which helps people change how they interpret ambiguous situations, to see if it can reduce persistent (long-lasting) pain in people who also have type 2 diabetes. **You may be eligible if...** - You are over 18 years old - You have a diagnosis of type 2 diabetes - You have had persistent pain (most days for 3 months or longer) - Your average pain is rated 3 or higher out of 10 - You are fluent in English - You have access to a computer and internet for the 3-month study **You may NOT be eligible if...** - You are under 18 - You do not have type 2 diabetes - You do not have persistent pain - You are not fluent in English - You do not have access to a computer or internet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive Bias Modification for Interpretation

Cognitive Bias Modification involves administering the Ambiguous Scenarios paradigm. This is a series of ambiguous scenarios which could be resolved to be associated with pain. The task consists of 30 unique scenarios and an associated comprehension question (pertaining to the pain-relatedness of the scenario), which are presented in a random order to participants. Each scenario presents an ambiguous sentence, ending with a word fragment which the participant must complete. The statement remains ambiguous until the completion of the word fragment, which resolves the statement as either pain-related or benign. For example, the statement "You are bush walking. Suddenly, you trip over and fall onto your knees. Your knees feel all wet, and you look down to see..." can be followed by "le\_v\_s \[leaves\]" for a benign resolution, or "bl\_\_d \[blood\]" for a pain-related resolution. In the intervention group, all 30 scenarios will be followed with the benign word fragment.

BEHAVIORALPlacebo

The Ambiguous Scenarios paradigm described previously will be used for the placebo intervention. The same 30 scenarios will be presented to participants, however 50% (15) trials will be followed by the benign word fragment, ad 50% (15) trials will be followed by the pain-related word fragment.


Locations(1)

University of Sydney

Camperdown, New South Wales, Australia

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NCT06908486


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