BREATHE-T1D：使用迭代混合方法调整针对 1 型糖尿病青少年的正念干预：设计与开发

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-04-29 DOI:10.1016/j.cct.2024.107551

Francesca Lupini , Molly Basch , Frances Cooke , Jack Vagadori , Ana Gutierrez-Colina , Katherine Patterson Kelly , Randi Streisand , Lauren Shomaker , Eleanor R. Mackey

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引用次数: 0

摘要

背景负性情绪在患有 1 型糖尿病（T1D）的青少年中很普遍，它可能会通过与压力相关的行为（如饮食紊乱）影响糖尿病的自我管理和治疗效果。方法我们介绍了针对患有 T1D 和负性情绪的青少年的正念干预（MBI）的开发和设计。BREATHE-T1D是针对T1D青少年的独特生活经历而量身定制的一种针对负面情绪的MBI。通过对利益相关者和参与者进行定性访谈，在研究过程中对干预和对照课程进行了反复调整。本文的主要目的是介绍本试点可行性试验的设计、开发和方案。结论在干预措施的整个调整过程中采用迭代、定性的方法对于确保最终的干预措施对目标人群具有相关性和意义非常重要：NCT05268393

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BREATHE-T1D: Using iterative mixed methods to adapt a mindfulness-based intervention for adolescents with type 1 diabetes: Design and development

Background

Negative affect is prevalent among adolescents with type 1 diabetes (T1D) and may impact diabetes self-management and outcomes through stress-related behaviors such as disordered eating.

Methods

We describe the development of and design for the adaptation of a mindfulness-based intervention (MBI) for adolescents with T1D and negative affect. BREATHE-T1D is an MBI designed to target negative affect that has been tailored to address the unique lived experiences of adolescents with T1D. Qualitative interviews with stakeholders and participants were used to inform iterative adaptations to the intervention and control curricula over the course of the study. The primary aim of this paper is to describe the design, development, and protocol of the present pilot feasibility trial.

Conclusions

Iterative, qualitative methodology throughout the adaptation of an intervention is important for ensuring the resulting intervention is relevant and meaningful for the target population.

Clinical Trial Registration Number: NCT05268393

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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.