通过一个基于远程医疗的网络为成年糖尿病患者提供的低强度心理健康支持（LISTEN）：一项混合 1 型有效性实施试验的方案。

Low-Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes (LISTEN): protocol for a hybrid type 1 effectiveness implementation trial.

机构信息

School of Psychology, Deakin University, Geelong, VIC, Australia.

The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia.

出版信息

Trials. 2023 May 23;24(1):350. doi: 10.1186/s13063-023-07338-5.

DOI:10.1186/s13063-023-07338-5

PMID:37221629

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10204211/

Abstract

BACKGROUND

Mental health problems are common among people with diabetes. However, evidence-based strategies for the prevention and early intervention of emotional problems in people with diabetes are lacking. Our aim is to assess the real-world effectiveness, cost-effectiveness, and implementation of a Low-Intensity mental health Support via a Telehealth Enabled Network (LISTEN), facilitated by diabetes health professionals (HPs).

METHODS

A hybrid type I effectiveness-implementation trial, including a two-arm parallel randomised controlled trial, alongside mixed methods process evaluation. Recruited primarily via the National Diabetes Services Scheme, Australian adults with diabetes (N = 454) will be eligible if they are experiencing elevated diabetes distress. Participants are randomised (1:1 ratio) to LISTEN-a brief, low-intensity mental health support program based on a problem-solving therapy framework and delivered via telehealth (intervention) or usual care (web-based resources about diabetes and emotional health). Data are collected via online assessments at baseline (T0), 8 weeks (T1) and 6 months (T2, primary endpoint) follow-up. The primary outcome is between-group differences in diabetes distress at T2. Secondary outcomes include the immediate (T1) and longer-term (T2) effect of the intervention on psychological distress, general emotional well-being, and coping self-efficacy. A within-trial economic evaluation will be conducted. Implementation outcomes will be assessed using mixed methods, according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Data collection will include qualitative interviews and field notes.

DISCUSSION

It is anticipated that LISTEN will reduce diabetes distress among adults with diabetes. The pragmatic trial results will determine whether LISTEN is effective, cost-effective, and should be implemented at scale. Qualitative findings will be used to refine the intervention and implementation strategies as required.

TRIAL REGISTRATION

This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622000168752) on 1 February, 2022.

摘要

背景

心理健康问题在糖尿病患者中很常见。然而，缺乏针对糖尿病患者情绪问题的预防和早期干预的循证策略。我们的目的是评估由糖尿病健康专业人员（HPs）提供的通过远程医疗启用的网络（LISTEN）进行的低强度心理健康支持的真实世界效果、成本效益和实施情况。

方法

一项混合类型 I 的有效性-实施试验，包括一项两臂平行随机对照试验，以及混合方法的过程评估。通过国家糖尿病服务计划（National Diabetes Services Scheme）主要招募，患有糖尿病的澳大利亚成年人（N=454）如果出现糖尿病困扰增加，则有资格参加。参与者以 1:1 的比例随机分配到 LISTEN（一种基于问题解决治疗框架的简短、低强度的心理健康支持计划，并通过远程医疗提供（干预）或常规护理（关于糖尿病和情绪健康的网络资源）。数据通过基线（T0）、8 周（T1）和 6 个月（T2，主要终点）随访时的在线评估收集。主要结局是 T2 时组间糖尿病困扰的差异。次要结局包括干预对心理困扰、一般情绪健康和应对自我效能的即时（T1）和长期（T2）影响。将进行内部试验经济评估。根据实施、有效性、可接受性、适用性和维持性（RE-AIM）框架，将使用混合方法评估实施结果。数据收集将包括定性访谈和现场记录。