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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Over 18 years of age

• Have a diagnosis of Type 2 diabetes.

• Have persistent pain (pain present on more days than not, for 3 months or longer).

• Score ≥ 3 on average pain severity on the Brief Pain Inventory (BPI).

• Fluent in English

• Have access to internet and ability to use a computer over a three month period.

Locations
Other Locations
Australia
University of Sydney
RECRUITING
Camperdown
Contact Information
Primary
Tessa Rooney
tessa.rooney@sydney.edu.au
+61449610131
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2025-10-15
Participants
Target number of participants: 319
Treatments
Experimental: Cognitive Bias Modification for Interpretation
The Ambiguous Scenarios paradigm is administered remotely online. The intervention is administered four times: at day 1, day 4, day 7, and day 14. Each intervention presents 30 ambiguous scenarios and associated comprehension questions, and should take approximately 20 minutes to complete. All scenarios in this arm are resolved to be benign.
Placebo_comparator: Placebo Cognitive Bias Modification for Interpretation
The placebo Ambiguous Scenarios paradigm is administered remotely online. The intervention is administered four times: at day 1, day 4, day 7, and day 14. Each intervention presents 30 ambiguous scenarios and associated comprehension questions, and should take approximately 20 minutes to complete. Scenarios are resolved as either benign or pain-related, with equal numbers (15) of each per session.
Related Therapeutic Areas
Sponsors
Leads: University of Sydney

This content was sourced from clinicaltrials.gov