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

2021 ◽  
Author(s):  
Medard Adu ◽  
Reham Shalaby ◽  
Ejemai Eboreime ◽  
Adegboyega Sapara ◽  
Nnamdi Nkire ◽  
...  

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

2021 ◽  
Author(s):  
Vincent Agyapong ◽  
Medard Adu ◽  
Reham Shalaby ◽  
Ejemai Eboreime ◽  
Adegboyega Sapara ◽  
...  

BACKGROUND 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 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. OBJECTIVE Objective: 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. METHODS Methods: 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. RESULTS 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 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 Conclusions: The outcome of this trial will have a translational impact on routine patient care and access to mental health, as well as potential support mental health policy decision-making for health care resource allocation CLINICALTRIAL Trial Registration: ClinicalTrials.gov NCT04638231; https://clinicaltrials.gov/ct2/show/NCT04638231 International Registered Report Identifier (IRRID): DERR1-10.2196/29495


10.2196/29495 ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. e29495
Author(s):  
Medard Kofi Adu ◽  
Reham Shalaby ◽  
Ejemai Eboreime ◽  
Adegboyega Sapara ◽  
Nnamdi Nkire ◽  
...  

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 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. Objective 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. Methods 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. 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 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 and access to mental health, as well as potentially support mental health policy decision-making for health care resource allocation. Trial Registration ClinicalTrials.gov NCT04638231; https://clinicaltrials.gov/ct2/show/NCT04638231 International Registered Report Identifier (IRRID) DERR1-10.2196/29495


2021 ◽  
Vol 11 (1) ◽  
pp. 8
Author(s):  
Carol S. North ◽  
David Baron

Agreement has not been achieved across symptom factor studies of major depressive disorder, and no studies have identified characteristic postdisaster depressive symptom structures. This study examined the symptom structure of major depression across two databases of 1181 survivors of 11 disasters studied using consistent research methods and full diagnostic assessment, addressing limitations of prior self-report symptom-scale studies. The sample included 808 directly-exposed survivors of 10 disasters assessed 1–6 months post disaster and 373 employees of 8 organizations affected by the September 11, 2001 terrorist attacks assessed nearly 3 years after the attacks. Consistent symptom patterns identifying postdisaster major depression were not found across the 2 databases, and database factor analyses suggested a cohesive grouping of depression symptoms. In conclusion, this study did not find symptom clusters identifying postdisaster major depression to guide the construction and validation of screeners for this disorder. A full diagnostic assessment for identification of postdisaster major depressive disorder remains necessary.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jakub Tomasik ◽  
Sung Yeon Sarah Han ◽  
Giles Barton-Owen ◽  
Dan-Mircea Mirea ◽  
Nayra A. Martin-Key ◽  
...  

AbstractThe vast personal and economic burden of mood disorders is largely caused by their under- and misdiagnosis, which is associated with ineffective treatment and worsening of outcomes. Here, we aimed to develop a diagnostic algorithm, based on an online questionnaire and blood biomarker data, to reduce the misdiagnosis of bipolar disorder (BD) as major depressive disorder (MDD). Individuals with depressive symptoms (Patient Health Questionnaire-9 score ≥5) aged 18–45 years were recruited online. After completing a purpose-built online mental health questionnaire, eligible participants provided dried blood spot samples for biomarker analysis and underwent the World Health Organization World Mental Health Composite International Diagnostic Interview via telephone, to establish their mental health diagnosis. Extreme Gradient Boosting and nested cross-validation were used to train and validate diagnostic models differentiating BD from MDD in participants who self-reported a current MDD diagnosis. Mean test area under the receiver operating characteristic curve (AUROC) for separating participants with BD diagnosed as MDD (N = 126) from those with correct MDD diagnosis (N = 187) was 0.92 (95% CI: 0.86–0.97). Core predictors included elevated mood, grandiosity, talkativeness, recklessness and risky behaviour. Additional validation in participants with no previous mood disorder diagnosis showed AUROCs of 0.89 (0.86–0.91) and 0.90 (0.87–0.91) for separating newly diagnosed BD (N = 98) from MDD (N = 112) and subclinical low mood (N = 120), respectively. Validation in participants with a previous diagnosis of BD (N = 45) demonstrated sensitivity of 0.86 (0.57–0.96). The diagnostic algorithm accurately identified patients with BD in various clinical scenarios, and could help expedite accurate clinical diagnosis and treatment of BD.


Nutrients ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1728
Author(s):  
Dinyadarshini Johnson ◽  
Sivakumar Thurairajasingam ◽  
Vengadesh Letchumanan ◽  
Kok-Gan Chan ◽  
Learn-Han Lee

The field of probiotic has been exponentially expanding over the recent decades with a more therapeutic-centered research. Probiotics mediated microbiota modulation within the microbiota–gut–brain axis (MGBA) have been proven to be beneficial in various health domains through pre-clinical and clinical studies. In the context of mental health, although probiotic research is still in its infancy stage, the promising role and potential of probiotics in various mental disorders demonstrated via in-vivo and in-vitro studies have laid a strong foundation for translating preclinical models to humans. The exploration of the therapeutic role and potential of probiotics in major depressive disorder (MDD) is an extremely noteworthy field of research. The possible etio-pathological mechanisms of depression involving inflammation, neurotransmitters, the hypothalamic–pituitary–adrenal (HPA) axis and epigenetic mechanisms potentially benefit from probiotic intervention. Probiotics, both as an adjunct to antidepressants or a stand-alone intervention, have a beneficial role and potential in mitigating anti-depressive effects, and confers some advantages compared to conventional treatments of depression using anti-depressants.


2021 ◽  
Vol 14 (10) ◽  
pp. e239587
Author(s):  
Siobhan Helen Gee ◽  
Camille Wratten ◽  
Ruth Cairns ◽  
Alastair Santhouse ◽  
David Taylor

Major depressive disorder (MDD) is common in general medical settings, and can usually be treated with conventional oral antidepressants. For some patients, however, oral treatment is refused or not possible, and the untreated symptoms can have a significant impact on the treatment of the acute medical problem. Use of intravenous ketamine has been widely reported in mental health settings for the treatment of MDD. We describe use of intravenous ketamine in a general medical hospital for the treatment of MDD in an 83-year-old male patient who refused food, fluid and medical investigations following a stroke.


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