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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Persistent Pain
• Intervention / Treatment: Behavioral: Cognitive Bias Modification for Interpretation; Behavioral: Placebo

Detailed Description

Pre-intervention stage The study will employ a dual consent process. First, participants will complete an "expression of interest" survey which contains the eligibility survey. Given it is crucial for the study to include people with diabetes and persistent pain, this eligibility survey will be used to ensure the sample meets our eligibility criteria of being 1) are over 18 years of age; 2) have been diagnosed with type 2 diabetes; 3) have persistent pain; 4) score ≥ 3 on pain severity subscale on BPI; 5) fluent in English; 6) have access to internet and ability to use a computer over three months.

Participants deemed eligible for the study will be provided with the Participant Information Statement and consent form via Qualtrics, which will provide detailed information about the study, the nature of their participation, and their rights as participants, including the right to withdraw at any point. Participants who do not consent to participate will be redirected to the end-of-survey.

After providing consent, participants will be asked to complete the baseline questionnaires: Brief Pain Inventory (BPI), Depression, Anxiety and Stress Scale (DASS-21), 12-Item Short Form Survey (SF-12), the Worries about Recurrence or Progression Scale (WARPS) and the Treatment adherence perception (TAPQ). The rationale of these measures is that they are theoretically related to interpretation biases and are hypothesised to change following training. This is expected to take approximately 15-20 minutes of their time.

Intervention stage Immediately following completion of baseline questionaries, participants will be randomised to either the CBM-I or placebo groups automatically using a computer algorithm in Qualtrics and invited to participate in the first session (training session 1) (day 1). Neither the participants nor the researchers will be aware of which group the participant has been allocated to.

Three days after completion of the first training session (day 4), participants will be invited via email automated by Qualtrics to the next training session (training session 2). On day 7, participants will be invited to the next training session (training session 3). Each training session is expected to take 10-15 minutes.

On day 14, participants will be invited to the final training session (training session 4), which will be followed immediately by the follow-up questions (follow-up 1). Participants will therefore complete four training sessions in total over the course of 14 days.

Participants will complete the BPI questionnaire prior to each CBM-I training session. Such that, BPI is measured at baseline, prior to CBM-I training session, and at two follow-up points: 2 weeks and 3 months post-intervention.

Note that participants will be asked to complete the training within two days of being email the link. The training sessions are not mandatory, and whether the participants complete each training session they will be still sent the links for the remaining training sessions.

Post-treatment On day 14, following the final training, participants will complete a series of questionnaires: BPI, DASS-21, SF-12, WARPS, TAPQ, Ambiguous cues task, Recognition Task, Post-Intervention Questionnaire. This survey is estimated to take up to approximately 30-35 minutes (inclusive of training time).

Follow-up 1 Exactly two weeks after post-treatment (day 28), participants will be invited via email and asked to complete the follow-up questionnaires (same as baseline), and the post-intervention questionnaire. This is estimated to take 15-20 minutes.

Follow-up 2 Three months after post-treatment, participants will be invited via email and asked to complete the follow-up questionnaires (same as baseline) and the post-intervention questionnaire. This is estimated to take 15-20 minutes. As outlined in the debrief statement, if the CBM-I intervention appears to be beneficial at the conclusion of the study, access to the training will be provided for all placebo group participants.

• Study Type: Interventional
• Enrollment (Estimated): 319
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tessa Rooney; Phone Number: +61449610131; Email: tessa.rooney@sydney.edu.au

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2006
      • Recruiting
      • University of Sydney
      • Contact: Tessa Rooney; Phone Number: +61449610131; Email: tessa.rooney@sydney.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Bias Modification for Interpretation; 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; 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 Comparator: Placebo Cognitive Bias Modification for Interpretation; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Post intervention (day 14)
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)	Post intervention (day 14)
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).	Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Depression	Depression subscale of the 21 item Depression Anxiety Stress Scales (range 0 - 21; lower scores represent less depression, i.e. better outcome)	Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Anxiety	Anxiety subscale of the 21 item Depression Anxiety Stress Scales (range 0 - 21; lower scores represent less anxiety, i.e. improved outcome)	Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Stress	Stress subscale of the 21 item Depression Anxiety Stress Scales (range 0 - 21; lower scores represent less stress, i.e. improved outcome)	Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Fear of disease progression	Worries about Recurrence or Progression Scale score (range 18 - 90; lower scores represent less worry about progression, i.e. better outcome)	Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Treatment Adherence	Treatment Adherence Perception Questionnaire (range 16 - 97; higher scores represent greater treatment adherence, i.e. better outcome)	Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)

Collaborators and Investigators

• Sponsor: University of Sydney
• Investigators: Principal Investigator: Louise Sharpe, University of Sydney

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): October 15, 2025

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: pain; type 2 diabetes; cognitive bias modification; interpretation bias
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2024/HE000161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after de-identification will be made available.
• IPD Sharing Time Frame: Data will be available immediately following publication, with no determined end date.
• IPD Sharing Access Criteria: Data will be made available to researchers who specifically request the data, by contacting the authors.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No