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

NCT06908486 | Recruiting

• 1 other identifier: 2024/HE000161
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Persistent Pain

Keywords

cognitive bias modification; interpretation bias; type 2 diabetes; pain

Outcome Measures

Primary Outcomes (2)

• Pain severity

  Intensity subscale of the Brief Pain Inventory (range 0 - 40; lower scores represent less pain severity, i.e. better outcome)

  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)

• Pain interference

  Interference subscale of the Brief Pain Inventory (range 0 - 70; lower scores represent less pain interference, i.e. better outcome)

  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 (8)

• Interpretation bias to pain (1)

  Post intervention (day 14)

• Interpretation bias to pain (2)

  Post intervention (day 14)

• Health-related quality of life

  Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)

• Depression

  Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)

• Anxiety

  Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)

Study Arms (2)

Cognitive Bias Modification for Interpretation

EXPERIMENTAL

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.

Behavioral: Cognitive Bias Modification for Interpretation

Placebo Cognitive Bias Modification for Interpretation

PLACEBO COMPARATOR

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.

Behavioral: Placebo

Interventions

Cognitive Bias Modification for Interpretation BEHAVIORAL

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.

Cognitive Bias Modification for Interpretation

Placebo BEHAVIORAL

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.

Placebo Cognitive Bias Modification for Interpretation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (1)

University of Sydney

Camperdown, New South Wales, 2006, Australia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pain

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Louise Sharpe

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tessa Rooney

CONTACT

+61449610131; tessa.rooney@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 3, 2025
• Study Start: April 15, 2025
• Primary Completion: July 15, 2025
• Study Completion: October 15, 2025
• Last Updated: June 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available immediately following publication, with no determined end date.
• Access Criteria: Data will be made available to researchers who specifically request the data, by contacting the authors.

Locations

AU (1)