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

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-08-08 DOI:10.1016/j.cct.2024.107658

Annie S.K. Jones , Sophie Harding , Natasha Seaton , Joanna L. Hudson , Alexa Duff , Abigail Wroe , Harinder Singh , Sam Norton , Federica Picariello , Rona Moss-Morris

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

导言：炎症性肠病（IBD）患者合并焦虑和抑郁（窘迫）会导致较差的治疗效果并增加医疗负担。为满足这一需求，IBD 服务需要可扩展的抑郁治疗路径。这项真实世界的纵向研究评估了新的综合治疗路径的实施情况，包括以下内容：1）常规心理健康筛查；2）治疗师指导的、针对 IBD 患者生活挑战的数字化 CBT（针对 IBD 的指南针：COMPASS-IBD）：我们描述了一项混合方法、观察性、真实世界纵向研究。IBD 服务中的常规心理健康筛查将识别出有心理困扰的患者（使用预先定义的临床临界值），这些患者将被分流以确定适当的治疗路径（包括参与 COMPASS-IBD 研究）。参与者将接受为期约 12 周的 COMPASS-IBD 在线治疗（包括 6 × 30 分钟的治疗师课程）。主要实施结果将通过心理健康筛查的接受率、COMPASS-IBD 的资格和同意率以及完成的 COMPASS-IBD 治疗次数等综合数据来评估新途径的覆盖范围和采用情况。对患者和医疗服务提供者的访谈将主要评估新路径的可接受性。将在干预前、12 周（干预后）和 6 个月的随访中使用参与者问卷对潜在效果进行评估。主要的有效性结果将是干预前和干预后的痛苦变化（PHQ-ADS 分数）。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：研究结果将为IBD患者共病困扰的治疗路径提供参考，并强调为提高未来的可扩展性和有效性而需要进行的调整：NCT05330299（clinicaltrials.gov）。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.