Cognitive Bias Modification for Interpretation (CBM-I) in People With Type 2 Diabetes and Persistent Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Under 18 years of age
No diagnosis of Type 2 diabetes
No persistent pain
Not fluent in English
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Bias Modification for Interpretation
BehavioralCognitive 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
BehavioralThe 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.
Treatment groups
319 Participants
are divided into 2 treatment groupsGroup A: Cognitive Bias Modification for InterpretationExperimental treatment 1 intervention
Group B: Placebo Cognitive Bias Modification for InterpretationPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain severity
Intensity subscale of the Brief Pain Inventory (range 0 - 40; lower scores represent less pain severity, i.e. better outcome)
Time frame
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)2
Pain interference
Interference subscale of the Brief Pain Inventory (range 0 - 70; lower scores represent less pain interference, i.e. better outcome)
Time frame
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)Secondary outcomes
1
Interpretation bias to pain (1)
Bias score on the Interpretation Bias Recognition Task (range -4 to 4; lower scores represent smaller interpretation bias to pain, i.e. better outcome)
Time frame
Post intervention (day 14)2
Interpretation bias to pain (2)
Bias score on the Ambiguous Cues task (range from 0 - 14; lower scores represent smaller interpretation bias to pain, i.e. better outcome)
Time frame
Post intervention (day 14)3
Health-related quality of life
12 Item Short Form Health Survey score (scores are reported as Z scores, with a mean of 50 and a standard deviation of 10. Scores greater than 50 are indicative of better than average health-related quality of life).
Time frame
Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)4
Depression
Depression subscale of the 21 item Depression Anxiety Stress Scales (range 0 - 21; lower scores represent less depression, i.e. better outcome)
Time frame
Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)Sponsors and contacts
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Source ClinicalTrials.gov