Clinical Validation of Samsung Smartwatch

Status Recruiting

Clinical Trial Summary

Objective: Wearable technology holds promising potential for mental health monitoring and detection. Samsung has developed an algorithm that they believe can detect signs of depression and anxiety in smartwatch users. They have used this algorithm to create a "Mindfulness Index," which is an easily understood visual index of mental health. The primary aim of the study is to evaluate the performance of Samsung's Mindfulness Index in identifying those who have received a diagnosis of Major Depressive Disorder (MDD) from a clinician-administered semi-structured diagnostic interview. Research Procedures: The target sample size is 75 individuals diagnosed with current Major Depressive Disorder and 75 healthy controls. To meet this target, the recruitment target is set at 215 participants. Participants will be assigned to the MDD condition, or the healthy control condition based on their score on the Beck Depression Inventory. Each subject will be followed for 3 months. Participants will be provided with a Samsung smartphone and Samsung smartwatch. Participants will be asked to wear the smartwatch 24 hours per day, except while charging. This smartwatch will collect data on heartrate, sleep time, and step count. During the study, each day participants will receive texts prompting a link to a "daily diary." These surveys will ask about depression and anxiety symptoms. Additionally, during the first 3 weeks of the study, participants will participate in ecological momentary assessment; texts will be sent 5 times per day prompting participants to fill out a survey about how they currently feel in that moment. These extra surveys will stop after the first 3 weeks of the study, but the daily diary surveys will continue throughout the study. Furthermore, virtual clinician visits will occur at weeks 4, 8, and 12.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05767593
Study type	Observational
Source	Massachusetts General Hospital
Contact	Dhea Kothari
Phone	617-726-4299
Email	dkothari2@mgh.harvard.edu
Status	Recruiting
Phase
Start date	March 13, 2023
Completion date	December 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05537558` - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated	`NCT02192099` - Open Label Extension for GLYX13-C-202, NCT01684163	Phase 2
Completed	`NCT03142919` - Lipopolysaccharide (LPS) Challenge in Depression	Phase 2
Recruiting	`NCT05547035` - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders	N/A
Terminated	`NCT02940769` - Neurobiological Effects of Light on MDD	N/A
Recruiting	`NCT05892744` - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression	Phase 4
Recruiting	`NCT05537584` - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment	Phase 4
Active, not recruiting	`NCT05061706` - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder	Phase 3
Completed	`NCT04479852` - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder	Phase 2
Recruiting	`NCT04032301` - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans	Phase 1
Recruiting	`NCT05527951` - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study	N/A
Completed	`NCT03511599` - Cycloserine rTMS Plasticity Augmentation in Depression	Phase 1
Recruiting	`NCT04392947` - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation	N/A
Recruiting	`NCT05895747` - 5-HTP and Creatine for Depression R33 Phase	Phase 2
Recruiting	`NCT05273996` - Predictors of Cognitive Outcomes in Geriatric Depression	Phase 4
Recruiting	`NCT05813093` - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression	N/A
Recruiting	`NCT05135897` - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation	`NCT04509102` - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder	Early Phase 1
Recruiting	`NCT06026917` - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)	Phase 4
Recruiting	`NCT06145594` - EMA-Guided Maintenance TMS for Depression	N/A