Actively Recruiting
Assessing Cognitive Bias Modification for Interpretation (CBM-I) on Pain Severity and Interference in People With Type 2 Diabetes and Persistent Pain
Led by University of Sydney · Updated on 2025-06-02
319
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of cognitive bias modification for interpretation (CBM-I) on pain severity and interference in people with Type 2 diabetes who experience persistent pain. The main focus is to see if training participants to interpret ambiguous situations in a benign way can improve their pain outcomes compared to a placebo control. The study uses a randomized, triple-blind design to compare these effects. Participants will complete four online training sessions over 14 days, with each session presenting 30 ambiguous scenarios resolved as benign in the CBM-I group or a mix of benign and pain-related in the placebo group. Sessions occur on days 1, 4, 7, and 14, each taking about 20 minutes. Baseline questionnaires are completed before training, and additional questionnaires are administered immediately after the final session, with follow-ups at two weeks and three months post-intervention. During the study, participants complete various assessments including pain severity and interference using the Brief Pain Inventory at multiple points. Other measures include depression, anxiety, stress, quality of life, fear of disease progression, and treatment adherence. Training adherence is monitored via automated email links. The study lasts approximately three months, with ongoing data collection and safety monitoring throughout. If beneficial, the CBM-I training will be offered to placebo participants after the study ends.
CONDITIONS
Brief Title
Cognitive Bias Modification for Interpretation (CBM-I) in People With Type 2 Diabetes and Persistent Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Have a diagnosis of Type 2 diabetes
- Have persistent pain present on more days than not for 3 months or longer
- Score 23 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (online)
Duration - 14 days
Participants complete four online training sessions of Cognitive Bias Modification for Interpretation or placebo over 14 days, with pain severity questionnaires prior to each session.
4 training sessions (remote, online) at days 1, 4, 7, and 14
Duration - 3 months
Participants complete questionnaires at 2 weeks and 3 months after treatment to assess pain severity, quality of life, and other health-related measures.
2 follow-up assessments (remote, online) at 2 weeks and 3 months post-treatment
Trial Site Locations
Total: 1 location
1
University of Sydney
Camperdown, New South Wales, Australia, 2006
Actively Recruiting
Research Team
T
Tessa Rooney
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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