Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial

BackgroundMajor 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,...

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Main Authors: Medard Kofi Adu, Reham Shalaby, Ejemai Eboreime, Adegboyega Sapara, Nnamdi Nkire, Rajan Chawla, Chidi Chima, Michael Achor, Felix Osiogo, Pierre Chue, Andrew J Greenshaw, Vincent Israel Agyapong
Format: Article
Language:English
Published: JMIR Publications 2021-10-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2021/10/e29495
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author Medard Kofi Adu
Reham Shalaby
Ejemai Eboreime
Adegboyega Sapara
Nnamdi Nkire
Rajan Chawla
Chidi Chima
Michael Achor
Felix Osiogo
Pierre Chue
Andrew J Greenshaw
Vincent Israel Agyapong
author_facet Medard Kofi Adu
Reham Shalaby
Ejemai Eboreime
Adegboyega Sapara
Nnamdi Nkire
Rajan Chawla
Chidi Chima
Michael Achor
Felix Osiogo
Pierre Chue
Andrew J Greenshaw
Vincent Israel Agyapong
author_sort Medard Kofi Adu
collection DOAJ
description BackgroundMajor 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. ObjectiveThis 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. MethodsThis 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. ResultsData 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. ConclusionsThe 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. Trial RegistrationClinicalTrials.gov NCT04638231; https://clinicaltrials.gov/ct2/show/NCT04638231 International Registered Report Identifier (IRRID)DERR1-10.2196/29495
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spelling doaj.art-d47cbaed95e44756aa13fb87bf8ae3c22023-08-28T19:31:21ZengJMIR PublicationsJMIR Research Protocols1929-07482021-10-011010e2949510.2196/29495Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation TrialMedard Kofi Aduhttps://orcid.org/0000-0001-9593-0275Reham Shalabyhttps://orcid.org/0000-0002-3717-6398Ejemai Eboreimehttps://orcid.org/0000-0001-8277-2570Adegboyega Saparahttps://orcid.org/0000-0003-1467-4770Nnamdi Nkirehttps://orcid.org/0000-0002-1156-7585Rajan Chawlahttps://orcid.org/0000-0002-3914-4146Chidi Chimahttps://orcid.org/0000-0002-2972-6644Michael Achorhttps://orcid.org/0000-0002-6807-4925Felix Osiogohttps://orcid.org/0000-0001-8760-6627Pierre Chuehttps://orcid.org/0000-0002-7916-415XAndrew J Greenshawhttps://orcid.org/0000-0002-9097-900XVincent Israel Agyaponghttps://orcid.org/0000-0002-2743-0372 BackgroundMajor 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. ObjectiveThis 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. MethodsThis 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. ResultsData 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. ConclusionsThe 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. Trial RegistrationClinicalTrials.gov NCT04638231; https://clinicaltrials.gov/ct2/show/NCT04638231 International Registered Report Identifier (IRRID)DERR1-10.2196/29495https://www.researchprotocols.org/2021/10/e29495
spellingShingle Medard Kofi Adu
Reham Shalaby
Ejemai Eboreime
Adegboyega Sapara
Nnamdi Nkire
Rajan Chawla
Chidi Chima
Michael Achor
Felix Osiogo
Pierre Chue
Andrew J Greenshaw
Vincent Israel Agyapong
Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial
JMIR Research Protocols
title Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial
title_full Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial
title_fullStr Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial
title_full_unstemmed Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial
title_short Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial
title_sort text messaging versus email messaging to support patients with major depressive disorder protocol for a randomized hybrid type ii effectiveness implementation trial
url https://www.researchprotocols.org/2021/10/e29495
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