Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000771358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
4/06/2026
Date registered
Help: Date registered
29/06/2026
Date last updated
Help: Date last updated
2/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
29/06/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Positive framing on perceptions of biologic treatment for inflammatory bowel disease: An intervention study
Scientific title
Evaluating a Positive Signal Mindset Intervention for perception of biologic treatment for inflammatory bowel disease in newly prescribed or switching patients: A Randomised Controlled Trial in New Zealand
Additional trial identifiers [1] 317497 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Inflammatory Bowel Disease 342217 0
Condition category
Condition code
Oral and Gastrointestinal 338334 338334 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is based on that developed by Yielder et al. (2025), which was validated in a sample of Rheumatoid Arthritis patients prescribed methotrexate. The intervention has been adapted for Inflammatory Bowel Disease (IBD) patients prescribed any of the funded biologics.

The intervention consists of a 5-minute video comprised of 'talking heads', voiceover and information text on screen. The video starts by providing standard information about biologic treatment. The video then explains the potential symptoms and experiences that may occur as result of taking biologic treatments and patient mindsets towards the medication are addressed by framing potential symptoms as positive signals that the treatment is working inside the body. The video informs patients of the importance of ongoing monitoring of health while taking their treatment and will distinguish between non-severe symptoms that may cause discomfort but are medically safe, and severe side effects that are picked up and monitored through regular blood tests. The intervention has been reviewed for medical accuracy by an IBD Nurse Practitioner at Middlemore Hospital.

The intervention will be delivered by tablet by a student researcher at the patient's routine biologic education clinic appointment or at their infusion appointment. Patients will also receive a pamphlet explaining the key points of the video. They will also receive a booster phone call from the student researcher two weeks later to remind them of the topics covered in the video. The video and pamphlet were designed specifically for this study.
Intervention code [1] 334286 0
Behaviour
Intervention code [2] 334288 0
Treatment: Other
Description of the comparator or control
The control condition also consists of a 5-minute video comprised of 'talking heads', voiceover and information text on screen. The video starts by providing the same standard information about biologic treatment. The video explains the potential symptoms and experiences that may occur as result of taking biologic treatments, however, patient mindsets towards the medication are not manipulated as they are informed that potential symptoms are unfortunate side effects of the treatment (as is the typical framing of side effects). The video informs patients of the importance of ongoing monitoring of health while taking their treatment and will distinguish between non-severe symptoms that may cause discomfort but are medically safe, and severe side effects that are picked up and monitored through regular blood tests. The control video has been reviewed for medical accuracy by an IBD Nurse Practitioner at Middlemore Hospital.

The video will be delivered by tablet by a student researcher at the patient's routine biologic education clinic appointment or at their infusion appointment. Patients will also receive a pamphlet explaining the key points of the video. They will also receive a phone call from the student researcher two weeks later to remind them of the topics covered in the video. Participants will receive the intervention content alongside the debriefing form after the study has been completed.
Control group
Active

Outcomes
Primary outcome [1] 345662 0
Side effect burden
Timepoint [1] 345662 0
Immediately post-intervention, one-month follow-up
Primary outcome [2] 345663 0
Treatment mindsets
Timepoint [2] 345663 0
Baseline, post-intervention, one-month follow-up
Primary outcome [3] 345664 0
Anticipated adherence
Timepoint [3] 345664 0
Baseline, post-intervention, one-month follow-up
Secondary outcome [1] 462747 0
Illness perceptions
Timepoint [1] 462747 0
Baseline, post-intervention, one-month follow-up

Eligibility
Key inclusion criteria
Participants in the study will be patients diagnosed with a form of inflammatory bowel disease and who are being newly prescribed or switching to a new a biologic treatment. Participants will be patients in Auckland and aged between 18 and 65.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants will be excluded if they feel unable to fill out the questionnaires and participate, and/or cannot understand English, or have no access to a phone or device with an internet connection.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants randomly allocated to intervention or control by Qualtrics online survey software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Repeated-measures between-within ANOVA will be used to assess differences between study groups, from baseline to 1-month follow-up in symptom occurrence, attitude towards biologic treatment, mindset, illness and treatment perceptions, and disease status. Pearson’s Chi-square test will be used to assess differences between the two groups in self-reported adherence. Independent samples t-tests will be conducted to assess differences in groups’ symptom attribution. Independent samples t-tests and Chi-Square for independence will also be used to assess differences between groups in demographic variables and baseline measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2026
Actual
13/08/2026
Date of last participant enrolment
Anticipated
30/09/2026
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
48
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 28185 0
New Zealand
State/province [1] 28185 0

Funding & Sponsors
Funding source category [1] 322064 0
University
Name [1] 322064 0
University of Auckland
Country [1] 322064 0
New Zealand
Primary sponsor type
Individual
Name
Dr Kate MacKrill, The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 324944 0
None
Name [1] 324944 0
Address [1] 324944 0
Country [1] 324944 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320593 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 320593 0
Ethics committee country [1] 320593 0
New Zealand
Date submitted for ethics approval [1] 320593 0
28/05/2026
Approval date [1] 320593 0
19/06/2026
Ethics approval number [1] 320593 0

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

Contacts
Principal investigator
Name 150998 0
Dr Kate MacKrill
Address 150998 0
The University of Auckland, 22-30 Park Ave, Grafton, Auckland 1023
Country 150998 0
New Zealand
Phone 150998 0
+64 9 3737 999
Fax 150998 0
Email 150998 0
[email protected]
Contact person for public queries
Name 150999 0
Kate MacKrill
Address 150999 0
The University of Auckland, 22-30 Park Ave, Grafton, Auckland 1023
Country 150999 0
New Zealand
Phone 150999 0
+64 9 3737 999
Fax 150999 0
Email 150999 0
[email protected]
Contact person for scientific queries
Name 151000 0
Kate MacKrill
Address 151000 0
The University of Auckland, 22-30 Park Ave, Grafton, Auckland 1023
Country 151000 0
New Zealand
Phone 151000 0
+64 9 3737 999
Fax 151000 0
Email 151000 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.