一项针对炎症性肠病（IBD）患者痛苦进行数字化筛查和治疗的真实世界纵向研究：COMPASS-IBD 研究方案。

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

机构信息

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

出版信息

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

DOI:10.1016/j.cct.2024.107658

PMID:39121990

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).

摘要

简介

炎症性肠病（IBD）合并焦虑和抑郁（苦恼）会导致预后较差和医疗保健负担增加。IBD 服务需要可扩展的治疗途径来解决苦恼问题，以满足这一需求。这项真实世界的纵向研究评估了一种新的综合苦恼护理途径的实施情况，包括：1）常规心理健康筛查和 2）针对 IBD 生活挑战的治疗师指导、数字认知行为疗法（根据 IBD 进行调整：COMPASS-IBD），在英国国家卫生服务体系（NHS）大型胃肠病服务机构（约 5000 名患者）中实施。

方法

我们描述了一项混合方法、观察性、真实世界的纵向研究。IBD 服务中的常规心理健康筛查将识别出苦恼患者（使用预先定义的临床截止值），这些患者将进行分诊，以确定适当的治疗途径（包括参与 COMPASS-IBD 研究）。参与者将接受 COMPASS-IBD 的在线治疗，为期约 12 周（包括 6 次 30 分钟的治疗师会议）。主要实施结果将使用心理健康筛查的参与率、资格和 COMPASS-IBD 的同意率以及完成的 COMPASS-IBD 会议次数等综合数据评估新途径的覆盖范围和采用情况。对患者和医疗保健提供者的访谈将主要评估新途径的可接受性。使用参与者在干预前、12 周（干预后）和 6 个月随访时的问卷评估潜在效果。主要有效性结果将是苦恼（PHQ-ADS 评分）的预后变化。定量数据将使用描述性统计进行总结，定性数据将使用反思性主题分析进行分析。