Articlehybrid2024

A real-world longitudinal study implementing digital screening and treatment for distress in inflammatory bowel disease (IBD): The COMPASS-IBD study protocol

Annie S. K. Jones · Natasha Seaton · Joanna L. Hudson · Alexa Duff · Abigail L. Wroe · Sam Norton +2 more

11 citations0/0 files storedContemporary Clinical Trials

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Digital Mental Health Interventions Inflammatory Bowel Disease Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes

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).

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References

2002The PHQ-9: A New Depression Diagnostic and Severity Measure 2022Thematic Analysis: A Practical Guide 2008The PHQ-8 as a measure of current depression in the general population 2006The Brief Illness Perception Questionnaire 2016The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample 2014Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis 2016Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials 2024A randomized controlled trial of a digital cognitive-behavioral therapy program (COMPASS) for managing depression and anxiety related to living with a long-term physical health condition

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2025A Real-World Longitudinal Case-Study Implementing Digital Screening and Treatment for Distress in Inflammatory Bowel Disease: The COMPASS-IBD Patient Journey

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