Adu Medard Kofi, Shalaby Reham, Eboreime Ejemai, Sapara Adegboyega, Nkire Nnamdi, Chawla Rajan, Chima Chidi, Achor Michael, Osiogo Felix, Chue Pierre, Greenshaw Andrew J, Agyapong Vincent Israel
Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Department of Psychiatry, Faculty of Medicine, Dalhousie University, Halifax, NS, Canada.
JMIR Res Protoc. 2021 Oct 13;10(10):e29495. doi: 10.2196/29495.
Major depressive disorder (MDD) accounts for 40.5% of disability-adjusted life years caused by mental and substance use disorders. Barriers such as stigma and financial and physical access to care have been reported, highlighting the need for innovative, accessible, and cost-effective psychological interventions. The effectiveness of supportive SMS text messaging in alleviating depression symptoms has been proven in clinical trials, but this approach can only help those with mobile phones.
This paper presents the protocol for a study that will aim to evaluate the feasibility, comparative effectiveness, and user satisfaction of daily supportive email messaging as an effective strategy compared to daily supportive text messaging as part of the treatment of patients with MDD.
This trial will be carried out using a hybrid type II implementation-effectiveness design. This design evaluates the effectiveness of an implementation strategy or intervention, while also evaluating the implementation context associated with the intervention. Patients with MDD receiving usual care will be randomized to receive either daily supportive email messaging or daily supportive text messaging of the same content for 6 months. The Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7, and the 5-item World Health Organization Well-Being Index will be used to evaluate the effectiveness of both strategies. The implementation evaluation will be guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, as well as the Consolidated Framework for Implementation Research. All outcome measures will be analyzed using descriptive and inferential statistics. Qualitative data will be analyzed using thematic analysis.
Data collection for this trial began in April 2021. We expect the study results to be available within 18 months of study commencement. The results will shed light on the feasibility, acceptability, and effectiveness of using automated emails as a strategy for delivering supportive messages to patients with MDD in comparison to text messaging.
The outcome of this trial will have translational impact on routine patient care and access to mental health, as well as potentially support mental health policy decision-making for health care resource allocation.
ClinicalTrials.gov NCT04638231; https://clinicaltrials.gov/ct2/show/NCT04638231.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29495.
重度抑郁症（MDD）在精神和物质使用障碍所致的伤残调整生命年中占40.5%。据报道，存在诸如耻辱感以及获得护理的经济和身体障碍等问题，这凸显了对创新、可及且具有成本效益的心理干预措施的需求。支持性短信在减轻抑郁症状方面的有效性已在临床试验中得到证实，但这种方法仅对有手机的人有帮助。
本文介绍一项研究的方案，该研究旨在评估每日支持性电子邮件消息传递作为一种有效策略的可行性、比较有效性和用户满意度，与每日支持性短信相比，将其作为MDD患者治疗的一部分。
本试验将采用混合型II实施 - 有效性设计进行。这种设计评估实施策略或干预措施的有效性，同时也评估与干预措施相关的实施背景。接受常规护理的MDD患者将被随机分组，分别接受为期6个月的相同内容的每日支持性电子邮件消息传递或每日支持性短信。将使用患者健康问卷 - 9、广泛性焦虑障碍 - 7和5项世界卫生组织幸福指数来评估这两种策略的有效性。实施评估将以RE - AIM（覆盖范围、有效性、采用率、实施和维持）框架以及实施研究综合框架为指导。所有结果指标将使用描述性和推断性统计进行分析。定性数据将使用主题分析进行分析。
本试验的数据收集于2021年4月开始。我们预计研究结果将在研究开始后的18个月内可得。结果将阐明与短信相比，使用自动电子邮件作为向MDD患者传递支持性消息的策略的可行性、可接受性和有效性。
本试验的结果将对常规患者护理和获得心理健康服务产生转化影响，并可能为医疗保健资源分配的心理健康政策决策提供支持。
ClinicalTrials.gov NCT04638231；https://clinicaltrials.gov/ct2/show/NCT04638231。
国际注册报告标识符（IRRID）：DERR1 - 10.2196/29495。
