Online interpretation training to reduce pain in people with Type 2 diabetes
Assessing Cognitive Bias Modification for Interpretation (CBM-I) on Pain Severity and Interference in People With Type 2 Diabetes and Persistent Pain
This trial will try an online training (CBM-I) to encourage less pain-focused interpretations and reduce pain in adults with Type 2 diabetes and persistent pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 319 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sydney Academic / other |
| Locations | 1 site (Camperdown, New South Wales) |
| Trial ID | NCT06908486 on ClinicalTrials.gov |
What this trial studies
Adults with Type 2 diabetes and persistent pain are assigned to either a cognitive bias modification for interpretation (CBM-I) program or a placebo/comparator delivered online. The active program involves four ~30-minute sessions that present ambiguous scenarios resolved in benign ways to train less pain-focused interpretations. Interpretation bias is measured after the fourth session, and pain severity and interference (alongside mood, quality of life, and related measures) are collected at baseline, post-training, two-week, and three-month follow-ups. Eligibility requires age ≥18, a diagnosis of Type 2 diabetes, persistent pain for ≥3 months, average BPI pain severity ≥3, English fluency, and internet/computer access.
Who should consider this trial
Good fit: Adults with diagnosed Type 2 diabetes who have persistent pain (on most days for ≥3 months) and an average pain severity ≥3 on the Brief Pain Inventory, who are fluent in English and can use the internet for three months.
Not a fit: People without Type 2 diabetes or persistent pain, those with average pain below 3 on the BPI, or those unable to use English or internet-based tools are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, the intervention could reduce pain severity and interference by shifting how people interpret ambiguous situations related to pain.
How similar studies have performed: Cognitive bias modification approaches have produced mixed results in anxiety and mood disorders, and CBM-I for chronic pain is relatively novel with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Under 18 years of age * No diagnosis of Type 2 diabetes * No persistent pain * Not fluent in English * No access to internet nor ability to use a computer.
Where this trial is running
Camperdown, New South Wales
- University of Sydney — Camperdown, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: Louise Sharpe — University of Sydney
- Study coordinator: Tessa Rooney
- Email: tessa.rooney@sydney.edu.au
- Phone: +61449610131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.