A quantitative process evaluation of a feasibility randomised controlled trial of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and disordered eating (steady trial): Auditing treatment integrity and delivery

IF 3.4 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Diabetic Medicine Pub Date : 2025-09-12 DOI:10.1111/dme.70124

Amy Harrison, Natalie Zaremba, Jennie Brown, Divina Pillay, Jacqueline Allan, Rachael Tan, Janet Treasure, Khalida Ismail, Marietta Stadler

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Abstract

Aims

Safe management of people with Type 1 diabetes and Eating Disorders study (STEADY), a complex psychological intervention, defined by the Medical Research Council as involving multiple interacting components and individualised delivery, is a treatment designed for people with Type 1 diabetes and mild-to-moderate disordered eating (T1DE) which integrates cognitive behavioural therapy (CBT) with diabetes education. STEADY was previously tested in a feasibility randomised controlled trial (RCT), and the purpose of this work was to maximise trial learning to support future scaling up of STEADY in a multi-site RCT.

Methods

This study addressed three research questions: (1) Which STEADY toolkit tools were used in the intervention, and at which point? (2) To what extent was treatment delivered as intended, reflecting the minimum competency (≥3) on the Cognitive Therapy Rating Scale (Revised; CTS-R)? (3) How long did it take to deliver the STEADY intervention?

Results

A range of STEADY tools were used during the trial; the five most frequent tools were CBT formulation (72 uses), behavioural experiments (47 uses), thought records (43 uses), goal setting (40 uses) and understanding emotions and ‘riding the wave’ (40 uses). The CTS-R mean score was 3.81 ± 0.74, indicating competent adherence to CBT. Mean time to completion was 153.3 days (SD = 73).

Conclusions

When scaling up for a multi-site RCT, some participants may need greater flexibility regarding timing to access all STEADY sessions. STEADY can be personalised through its toolkit-based approach, and therapists should be mindful and trained in the range of tools available.

Abstract Image

查看原文本刊更多论文

对1型糖尿病和饮食失调患者共同设计的认知行为治疗干预的可行性随机对照试验（稳定试验）的定量过程评估：审计治疗的完整性和交付。

目的：1型糖尿病和饮食失调患者的安全管理研究（STEADY）是一种复杂的心理干预，由医学研究委员会定义为涉及多个相互作用的组成部分和个性化的交付，是一种针对1型糖尿病和轻度至中度饮食失调（T1DE）患者设计的治疗方法，将认知行为疗法（CBT）与糖尿病教育相结合。STEADY先前在一项可行性随机对照试验（RCT）中进行了测试，这项工作的目的是最大限度地提高试验学习，以支持未来在多地点RCT中扩大STEADY的规模。方法：本研究解决了三个研究问题：(1)在干预中使用了哪些STEADY工具包工具，以及在什么时候使用？(2)治疗在多大程度上符合预期，反映了认知治疗评定量表（修订；CTS-R）的最低能力（≥3）？(3)实施STEADY干预需要多长时间？结果：试验期间使用了一系列STEADY工具；五个最常见的工具是CBT制定（72次使用），行为实验（47次使用），思想记录（43次使用），目标设定（40次使用）以及理解情绪和“顺应潮流”（40次使用）。CTS-R平均评分为3.81±0.74，表明CBT的依从性良好。平均完成时间为153.3天（SD = 73）。结论：当扩大到多站点RCT时，一些参与者可能需要更大的灵活性来安排参加所有STEADY会议的时间。STEADY可以通过其基于工具包的方法来个性化，治疗师应该注意并接受可用工具范围的培训。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetic Medicine 医学-内分泌学与代谢

CiteScore

7.20

自引率

5.70%

发文量

229

审稿时长

3-6 weeks

期刊介绍： Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions. The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed. We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services. Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”