Crawford Joanna, Wilhelm Kay, Robins Lisa, Proudfoot Judy
Faces in the Street, Urban Mental Health Research Institute, St. Vincent's Health Australia, Sydney, Australia.
School of Psychiatry, Faculty of Medicine, University of New South Wales, Sydney, Australia.
JMIR Res Protoc. 2017 Mar 14;6(3):e42. doi: 10.2196/resprot.7151.
Diabetes mellitus is Australia's fastest growing chronic disease, and has high comorbidity with depression. Both subthreshold depression and diabetes distress are common amongst people with type 1 or type 2 diabetes, and are associated with poorer diabetes self-care. A need exists for low-intensity self-help interventions for large numbers of people with diabetes and diabetes distress or subthreshold depression, as part of a stepped-care approach to meeting the psychological needs of people with diabetes. Benefit-finding writing is a very brief intervention that involves writing about any positive thoughts and feelings about a stressful experience, such as an illness. Benefit-finding writing has been associated with increases in positive affect and positive growth, and has demonstrated promising results in trials amongst other clinical populations. However, benefit-finding writing has not yet been examined in people with diabetes.
The aim of this randomized controlled trial (RCT) is to evaluate the efficacy of an Internet-based benefit-finding writing (iBFW) intervention for adults with type 1 or type 2 diabetes (compared to a control writing condition) for reducing diabetes distress and increasing benefit-finding in diabetes, and also improving a range of secondary outcomes.
A two-arm RCT will be conducted, using the online program Writing for Health. Adults with type 1 or type 2 diabetes living in Australia will be recruited using diabetes-related publications and websites, and through advertisements in diabetes services and general practitioners' offices. Potential participants will be referred to the study-specific website for participant information and screening. All data will be collected online. Participants will be randomized to either iBFW about diabetes, or a control writing condition of writing about use-of-time. Both conditions involve three daily sessions (once per day for three consecutive days) of 15-minute online writing exercises. Outcome measures will be administered online at baseline, one-month, and three-month follow-ups.
This trial is currently underway. The primary outcomes will be diabetes distress and benefit-finding in diabetes. Secondary outcomes will be depression, anxiety, diabetes self-care, perceived health, and health care utilization. We aim to recruit 104 participants. All stages of the study will be conducted online using the Writing for Health program. Group differences will be analyzed on an intention-to-treat basis using mixed models repeated measures. Linguistic analyses of the writing exercise scripts, and examinations of the immediate emotional responses to the writing exercises, will also be undertaken.
This RCT will be the first study to examine iBFW for adults with type 1 or type 2 diabetes. If iBFW is found to be efficacious in reducing diabetes distress and improving diabetes self-care and other outcomes, iBFW may offer the potential to be a low-cost, easily accessible self-help intervention to improve the wellbeing of adults with diabetes.
Australia and New Zealand Clinical Trials Registry (ACTRN12615000241538).
糖尿病是澳大利亚增长最快的慢性病，且与抑郁症的共病率很高。阈下抑郁和糖尿病困扰在1型或2型糖尿病患者中都很常见，并且与较差的糖尿病自我护理相关。作为满足糖尿病患者心理需求的分级护理方法的一部分，需要为大量患有糖尿病困扰或阈下抑郁的患者提供低强度自助干预措施。益处发现写作是一种非常简短的干预措施，包括写下对诸如疾病等压力经历的任何积极想法和感受。益处发现写作与积极情绪和积极成长的增加有关，并且在其他临床人群的试验中已显示出有前景的结果。然而，益处发现写作尚未在糖尿病患者中进行过研究。
本随机对照试验（RCT）的目的是评估基于互联网的益处发现写作（iBFW）干预措施对1型或2型糖尿病成年人（与对照写作条件相比）在减轻糖尿病困扰、增加糖尿病益处发现以及改善一系列次要结局方面的疗效。
将使用在线程序“健康写作”进行双臂RCT。将通过糖尿病相关出版物和网站，以及在糖尿病服务机构和全科医生办公室发布广告，招募居住在澳大利亚的1型或2型糖尿病成年人。潜在参与者将被引导至特定研究网站获取参与者信息并进行筛查。所有数据将在线收集。参与者将被随机分配到关于糖尿病的iBFW组或关于时间利用的对照写作组。两种情况都包括每天三次（连续三天每天一次）15分钟的在线写作练习。结局指标将在基线、1个月和3个月随访时在线进行测量。
本试验正在进行中。主要结局将是糖尿病困扰和糖尿病益处发现。次要结局将是抑郁、焦虑、糖尿病自我护理、感知健康和医疗保健利用。我们的目标是招募104名参与者。研究的所有阶段都将使用“健康写作”程序在线进行。将使用混合模型重复测量，在意向性分析的基础上分析组间差异。还将对写作练习脚本进行语言分析，并检查对写作练习的即时情绪反应。
本RCT将是第一项针对1型或2型糖尿病成年人研究iBFW的研究。如果发现iBFW在减轻糖尿病困扰、改善糖尿病自我护理和其他结局方面有效，iBFW可能有潜力成为一种低成本、易于获得的自助干预措施，以改善糖尿病成年人的健康状况。
澳大利亚和新西兰临床试验注册中心（ACTRN12615000241538）。
