scholarly journals Exploring the Effects of In-App Components on Engagement With a Symptom-Tracking Platform Among Participants With Major Depressive Disorder (RADAR-Engage): Protocol for a 2-Armed Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Katie M White ◽  
Faith Matcham ◽  
Daniel Leightley ◽  
Ewan Carr ◽  
Pauline Conde ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Major Depressive Disorder ◽  
Clinical Practice ◽  
Data Collection ◽  
Depressive Disorder ◽  
Controlled Trial ◽  
Remote Measurement ◽  
Major Depressive ◽  
Randomized Controlled ◽  
Depression Status

BACKGROUND Multi-parametric remote measurement technologies (RMTs) comprise smartphone apps and wearable devices for both active and passive symptom tracking. They hold potential for understanding current depression status and predicting future depression status. However, the promise of using RMTs for relapse prediction is heavily dependent on user engagement, which is defined as both a behavioral and experiential construct. A better understanding of how to promote engagement in RMT research through various in-app components will aid in providing scalable solutions for future remote research, higher quality results, and applications for implementation in clinical practice. OBJECTIVE The aim of this study is to provide the rationale and protocol for a 2-armed randomized controlled trial to investigate the effect of insightful notifications, progress visualization, and researcher contact details on behavioral and experiential engagement with a multi-parametric mobile health data collection platform, Remote Assessment of Disease and Relapse (RADAR)–base. METHODS We aim to recruit 140 participants upon completion of their participation in the RADAR Major Depressive Disorder study in the London site. Data will be collected using 3 weekly tasks through an active smartphone app, a passive (background) data collection app, and a Fitbit device. Participants will be randomly allocated at a 1:1 ratio to receive either an adapted version of the active app that incorporates insightful notifications, progress visualization, and access to researcher contact details or the active app as usual. Statistical tests will be used to assess the hypotheses that participants using the adapted app will complete a higher percentage of weekly tasks (behavioral engagement: primary outcome) and score higher on self-awareness measures (experiential engagement). RESULTS Recruitment commenced in April 2021. Data collection was completed in September 2021. The results of this study will be communicated via publication in 2022. CONCLUSIONS This study aims to understand how best to promote engagement with RMTs in depression research. The findings will help determine the most effective techniques for implementation in both future rounds of the RADAR Major Depressive Disorder study and, in the long term, clinical practice. CLINICALTRIAL ClinicalTrials.gov NCT04972474; http://clinicaltrials.gov/ct2/show/NCT04972474 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/32653

Comparing Effectiveness of a Combined Herbal Drug Based on Echium Amoenum with Citalopram in the Treatment of Major Depressive Disorder

2019 ◽  
Vol 16 (2) ◽  
pp. 232-238 ◽  
Author(s):  
Majid Anushiravani ◽  
Ali A. Manteghi ◽  
Ali Taghipur ◽  
Mahdi Eslami
Keyword(s):  
Randomized Controlled Trial ◽  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Controlled Trial ◽  
Herbal Drug ◽  
Medical Sciences ◽  
Major Depressive ◽  
Dsm 5 ◽  
Randomized Controlled ◽  
Echium Amoenum

Background: According to new studies, only 60% of depressed patients respond to pharmaceutical treatment while suffering from their side effects. Natural products as adjuvant or alternative therapies should be examined to find safer and more effective ways to cope with depression. Objective: To find out the potential benefits of a combined herbal drug based on Echium amoenum compared with citalopram in the treatment of Major Depressive Disorder. Design and Setting: In psychiatry clinics of Mashhad University of Medical Sciences, 50 patients who met the criteria for Major Depressive Disorder based on DSM-5 were studied in a parallel randomized controlled trial. Design and Setting: In psychiatry clinics of Mashhad University of Medical Sciences, 50 patients who met the criteria for Major Depressive Disorder based on DSM-5 were studied in a parallel randomized controlled trial. Intervention: Subjects were randomly assigned to receive Echium amoenum compound syrup (EACS) or citalopram tablet for 8 weeks. Outcome Measures: The efficacy of treatments and recurrence of disease were surveyed and compared according to Hamilton depression rating scale at weeks 0, 4, 8, 12. Results: Patients in both groups of citalopram and EACS showed remarkable reduction in scores of Hamilton questionnaire. At the eighth week of treatment, the mean scores in EACS group were significantly lower than citalopram group (p-value = 0.03). 52% of patients suffered from various complications in citalopram group while just 12% of patients in EACS group reported few complications. Conclusion: Clinical efficacy of this herbal drug was significantly higher than citalopram, and complications were also less and lower in EACS group. Further studies with larger groups and para-clinical assessments such as serologic tests and QEEG would improve our understanding of the impacts and mechanisms of EACS.

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