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Positive framing on perceptions of biologic treatment for inflammatory bowel disease: An intervention study

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000771358
Enrollment
3
Registered
2026-06-29
Start date
2026-08-13
Completion date
2026-09-30
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with IBD can be concerned about biologics due to side effect burden and how patients interpret treatment-related symptoms. Honest positive framing of mild, medically non-severe symptoms as signs that treatment is active may reduce distress and support adherence. This study hypothesises that a brief mindset intervention for IBD patients can improve beliefs about biologic treatment and reduce side effect burden by helping interpret mild symptoms in a less threatening way when starting or switching biologic medication.

Interventions

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 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.

Sponsors

Dr Kate MacKrill, The University of Auckland
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026