Contemp Clin Trials. 2024 Oct:145:107658.doi: 10.1016/j.cct.2024.107658. Epub 2024 Aug 8.

Annie S K Jones ¹, Sophie Harding ², Natasha Seaton ², Joanna L Hudson ², Alexa Duff ³, Abigail Wroe ², Harinder Singh ⁴, Sam Norton ⁵, Federica Picariello ², Rona Moss-Morris ⁶

Author information

¹Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. Electronic address: annie.s.jones@kcl.ac.uk.

²Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

³Inflammatory Bowel Disease Unit, Guy's and St Thomas' Hospital, London, UK.

⁴Lead Patient and Public Involvement Representative, UK.

⁵Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK; Department of Inflammation Biology, Faculty of Life Sciences and Medicine, King's College London, London, UK.

⁶Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. Electronic address: rona.moss-morris@kcl.ac.uk.

Abstract

Introduction: Co-morbid anxiety and depression (distress) in inflammatory bowel disease (IBD) results in poorer outcomes and increased healthcare burden. IBD services require scalable treatment pathways for distress to meet this need. This real-world longitudinal study evaluates the implementation of a new integrated care pathway for distress including: 1) routine mental health screening and 2) therapist-guided, digital CBT tailored to the challenges of living with IBD (compass with adaptations for IBD: COMPASS-IBD) in a UK National Health Service (NHS) large gastroenterology service (∼ 5000 patients).

Methods: We describe a mixed-methods, observational, real-world longitudinal study. Routine mental health screening in the IBD service will identify patients with distress (using pre-defined clinical cut-offs), who will be triaged to determine appropriate treatment pathways (including participation in the COMPASS-IBD study). Participants will receive COMPASS-IBD online for ∼12 weeks (including 6 × 30-min therapist sessions). Key implementation outcomes will assess reach and adoption of the new pathway using aggregate data on uptake of mental health screening, eligibility, and consent rates for COMPASS-IBD, and number of COMPASS-IBD sessions completed. Interviews with patients and healthcare providers will primarily assess acceptability of the new pathway. Potential effectiveness will be assessed using participant questionnaires at pre-intervention, 12-weeks (post-intervention), and 6-month follow-up. The primary effectiveness outcome will be pre-post changes in distress (PHQ-ADS scores). Quantitative data will be summarised using descriptive statistics and qualitative data analysed using reflexive thematic analysis.

Conclusion: Study findings will inform treatment pathways for co-morbid distress in IBD, and highlight adaptations required to increase future scalability and effectiveness.

Trial registration number: NCT05330299 (clinicaltrials.gov).