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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06908486




Registration number
NCT06908486
Ethics application status
Date submitted
1/04/2025
Date registered
3/04/2025

Titles & IDs
Public title
Cognitive Bias Modification for Interpretation (CBM-I) in People With Type 2 Diabetes and Persistent Pain
Scientific title
Assessing Cognitive Bias Modification for Interpretation (CBM-I) on Pain Severity and Interference in People With Type 2 Diabetes and Persistent Pain
Secondary ID [1] 0 0
2024/HE000161
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Persistent Pain 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Cognitive Bias Modification for Interpretation
BEHAVIORAL - Placebo

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.

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: 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.

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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain severity
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
Pain interference
Timepoint [2] 0 0
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 [1] 0 0
Interpretation bias to pain (1)
Timepoint [1] 0 0
Post intervention (day 14)
Secondary outcome [2] 0 0
Interpretation bias to pain (2)
Timepoint [2] 0 0
Post intervention (day 14)
Secondary outcome [3] 0 0
Health-related quality of life
Timepoint [3] 0 0
Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Secondary outcome [4] 0 0
Depression
Timepoint [4] 0 0
Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Secondary outcome [5] 0 0
Anxiety
Timepoint [5] 0 0
Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Secondary outcome [6] 0 0
Stress
Timepoint [6] 0 0
Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Secondary outcome [7] 0 0
Fear of disease progression
Timepoint [7] 0 0
Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)
Secondary outcome [8] 0 0
Treatment Adherence
Timepoint [8] 0 0
Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104)

Eligibility
Key inclusion criteria
Participants must meet all of the following criteria to be relevant for inclusion.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded where they meet any of the following 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2025
Actual
Sample size
Target
319
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Louise Sharpe
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tessa Rooney
Address 0 0
Country 0 0
Phone 0 0
+61449610131
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06908486