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Supportive Text Messaging versus Supportive E-mail Messaging for Patients with Major Depressive Disorder: Randomized Hybrid Type II Effectiveness-Implementation Trial Protocol (Preprint)


 BACKGROUND
 Major Depressive Disorder (MDD) accounts for 40·5% of disability-adjusted life years caused by mental and substance use disorders. Barriers such as stigma, financial and physical access to care have been reported, highlighting need for innovative, accessible and cost-effective psychological interventions. The effectiveness of supportive text messaging in alleviating depression symptoms has been proven in clinical trials, but this approach can only those with active cell phones. Consequently, this study seeks to evaluate the feasibility, comparative effectiveness, and user satisfaction of daily supportive daily e-mail messaging as an effective strategy compared to daily supportive text messaging, as part of treatment of patients with MDD.
 
 
 OBJECTIVE
 The Supportive Text versus Email Messaging (STEM) trial aims to evaluate comparatively the implementation and impact of two implementation strategies (text messaging and email messaging) for delivering supportive messages to patients with MDD.
 
 
 METHODS
 This trial will be carried out using a type II implementation-effectiveness hybrid trial. This design evaluates the effectiveness of an implementation strategy or intervention, while also evaluating the implementation context associated with the intervention. In this innovative pilot trial, 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 six months. The Patient Health Questionnaire (PHQ)-9 scale, the Generalized Anxiety Disorder (GAD)-7 scale and the WHO (Five) Well-Being Index will be used to evaluate the effectiveness of both strategies. Implementation evaluation will be guided by the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE_AIM) framework, as well as the Consolidated Framework for Implementation Research (CFIR). All outcome measures will be analyzed using descriptive and inferential statistics. Qualitative data will be analyzed using thematic analysis.
 
 
 RESULTS
 Data collection for this trial began in April 2021. We expect the study results to be available within 18 months of study commencement. The study 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.
 
 
 CONCLUSIONS
 The outcome of this trial will have translational impact on routine patient care, access to mental health as well as potentially support mental health policy decision making for healthcare resource allocation.
 
 
 CLINICALTRIAL
 ClinicalTrials.gov Identifier: NCT04638231
