一种为 1 型糖尿病合并饮食失调患者共同设计的认知行为疗法干预措施（STEADY）的安全性：一项可行性随机对照试验。

Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trial.

作者信息

Stadler Marietta, Zaremba Natalie, Harrison Amy, Brown Jennie, Pillay Divina, Allan Jacqueline, Tan Rachael, Ayis Salma, Konstantara Emmanouela, Treasure Janet, Hopkins David, Ismail Khalida

机构信息

Department of Diabetes, Faculty of Life Sciences and Medicine, King's College London, London, UK.

Department of Psychological Medicine, Diabetes, Psychology and Psychiatry Research Group, King's College London, London, UK.

出版信息

Lancet Reg Health Eur. 2025 Jan 20;50:101205. doi: 10.1016/j.lanepe.2024.101205. eCollection 2025 Mar.

DOI:10.1016/j.lanepe.2024.101205

PMID:39902232

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11788855/

Abstract

BACKGROUND

Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY) is a complex intervention for people with type 1 diabetes and mild-to-moderate disordered eating (T1DE) integrating cognitive behavioural therapy (CBT) with diabetes education. Aim was to test feasibility of STEADY in a randomised controlled trial.

METHODS

Feasibility parallel-group, randomised (blocks of four) controlled open-label trial (RCT) of STEADY against usual care (Control) at King's College London, UK. Participants were referred by clinicians or self-referred via social media advertisements. Forty adults with T1DE (Hba1c < 15%, body mass index 15-35 kg/m, age ≥ 18 years) were randomised. STEADY was delivered in 12 sessions by a CBT-trained Diabetes Specialist Nurse through video-conferencing and mobile app. Main outcome at 6 months post-randomisation was feasibility. Baseline mental health data (Structured Clinical Interview for DSM-5, SCID-5RV), and secondary biomedical outcomes (HbA1c; glucose time in range; TIR) and person-reported outcome measures (PROM: Diabetes Eating Problems Survey-Revised, DEPS-R; Eating Disorder Examination Questionnaire Short, EDE-QS; Type 1 Diabetes Distress Scale, T1DDS; Generalised Anxiety Disorder Assessment, GAD-7; Patient Health Questionnaire, PHQ-9; Impact of Diabetes Profile, DIDP) were collected. Analyses were conducted as intention-to-treat. ClinicalTrials.govNCT05140564.

FINDINGS

Of the 98 screened, 40 participants with T1DE were randomised (recruitment rate: 40.81%; 95% CI: 31.60%, 50.72%): 38 women, 1 man, 1 trans man (37 White, 1 White/Asian, 1 Black; 39 ± 11 years old, diabetes duration 22 ± 15 years, HbA1c 9.1 ± 2.6%). The drop-out rate was 3/20 = 15% (4.39%, 36.55%) in STEADY and 2/20 = 10% (1.57%, 31.32%) in Control. STEADY reported lower GAD-7 (5.75 ± 2.89 vs 10.18 ± 5.31, p = 0.0060) and higher DIDP (3.13 ± 0.63 vs 2.46 ± 0.87, p = 0.020) at follow-up compared with Control, indicating lower anxiety and higher diabetes-specific quality-of-life. Compared to baseline, STEADY improved in DEPS-R, EDE-QS, GAD-7, PHQ-9 and T1DDS.

INTERPRETATION

The STEADY-feasibility RCT demonstrated proof-of-concept for feasibility and mental health improvements in T1DE without deteriorating glycaemic control. A full scale RCT of STEADY will test effectiveness and implementation.

FUNDING

National Institute for Health Research (CS-2017-17-023).

摘要

背景

1型糖尿病与饮食失调患者安全管理研究（STEADY）是一项针对1型糖尿病和轻度至中度饮食失调（T1DE）患者的综合干预措施，将认知行为疗法（CBT）与糖尿病教育相结合。目的是在一项随机对照试验中检验STEADY的可行性。

方法

在英国伦敦国王学院进行了一项STEADY与常规护理（对照）对比的可行性平行组随机（每组4例）对照开放标签试验（RCT）。参与者由临床医生转诊或通过社交媒体广告自荐。40名T1DE成人患者（糖化血红蛋白<15%，体重指数15 - 35kg/m²，年龄≥18岁）被随机分组。由经过CBT培训的糖尿病专科护士通过视频会议和移动应用程序进行12次STEADY干预。随机分组后6个月的主要结局是可行性。收集了基线心理健康数据（DSM - 5结构化临床访谈，SCID - 5RV）、次要生物医学结局（糖化血红蛋白；血糖达标时间；血糖达标率）和患者报告结局指标（PROM：糖尿病饮食问题调查修订版，DEPS - R；饮食失调检查表简版，EDE - QS；1型糖尿病困扰量表，T1DDS；广泛性焦虑症评估量表，GAD - 7；患者健康问卷，PHQ - 9；糖尿病影响量表，DIDP）。分析采用意向性分析。ClinicalTrials.gov注册号：NCT05140564。

研究结果

在98名筛查对象中，40名T1DE参与者被随机分组（招募率：40.81%；95%置信区间：31.60%，50.72%）：38名女性，1名男性，1名跨性别男性（37名白人，1名白人/亚洲人，1名黑人；年龄39±11岁，糖尿病病程22±15年，糖化血红蛋白9.1±2.6%）。STEADY组的脱落率为3/20 = 15%（4.39%，36.55%），对照组为2/20 = 10%（1.57%，31.32%）。与对照组相比，随访时STEADY组的GAD - 7得分更低（5.75±2.89 vs 10.18±5.31，p = 0.0060），DIDP得分更高（3.13±0.63 vs 2.46±0.87，p = 0.020），表明焦虑程度更低，糖尿病特异性生活质量更高。与基线相比，STEADY组在DEPS - R、EDE - QS、GAD - 7、PHQ - 9和T1DDS方面有所改善。