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

Condition(s) studied

Investigational drug(s) / intervention(s)

Cognitive 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.

Placebo: 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.

Study 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

Primary outcome measure(s)

• Pain severity — Baseline, post intervention (day 14), Pre intervention session 2 (day 4), pre intervention session 3 (day 7) [primary timepoint], two week follow up post intervention (day 28) [primary timepoint], three month post intervention follow up (3 months)
  Intensity subscale of the Brief Pain Inventory (range 0 - 40; lower scores represent less pain severity, i.e. better outcome)
• Pain interference — Baseline, post intervention (day 14), Pre intervention session 2 (day 4), pre intervention session 3 (day 7) [primary timepoint], two week follow up post intervention (day 28) [primary timepoint], three month post intervention follow up (3 months)
  Interference subscale of the Brief Pain Inventory (range 0 - 70; lower scores represent less pain interference, i.e. better outcome)

Trial sites (1)

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