RECRUITING

Sensor-based Characterization of Depression

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a longitudinal study where individual with Major Depressive Disorder (MDD) will be monitored for 12 weeks. The study aims to develop an objective, sensor-based, algorithm able to detect the presence of depression as well as predict treatment response. Measurement-based treatment is considered optimal and the development of a valid passive, objective, behavioral and biological assessment of depressive symptoms that does not rely on clinician interviews will improve monitoring and ultimately improve treatment significantly.

Official Title

Leveraging Artificial Intelligence for the Assessment of Severity of Depressive Symptoms

Quick Facts

Study Start:2020-01-28

Study Completion:2024-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04370002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults (ages 18-75), 2. Able to read, understand, and provide written informed consent in English, 3. Meet criteria for a primary psychiatric diagnosis of current major depressive disorder 4. Hamilton Depression Rating Scale (HDRS) total score ≥ 18, 5. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit), 6. Must own a working smartphone and use it regularly, 7. Must own a windows PC (or tablet) or a Mac computer (or laptop), 8. Must have access to Internet service every day. 9. Must have started antidepressant medications, changed medication dosage, or started therapy within 3 weeks	1. Active drug or alcohol use disorder in the past 3 months, 2. History of psychotic disorder, 3. History of mania or hypomania, 4. Epilepsy or history of Seizure Disorder (including PNES), narcolepsy, Alzheimer Disease, Parkinson's Disease, ALS, Severe TBI, Dementia, MS, Cerebral Palsy, and Neuralgia. 5. Untreated hypothyroidism, 6. Unstable medical disease, 7. Cognitive impairment that would impede adherence to study procedures, 8. Acute suicide or homicide risk, 9. Current treatment with electroconvulsive therapy, vagal nerve stimulation therapy, deep brain stimulation, transcranial magnetic stimulation therapy, or phototherapy, 10. Cannot comprehend or communicate in English, 11. Lack of working smartphone or lack of daily access to Internet service, 12. Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and 13. Inability or unwilling to, at minimum, wear the physiological sensor (E4) wristbands, download monitoring apps, and fill out the surveys. 14. Participants with more than two treatment failures (more than two adequate trials of meds on the basis of ATRQ) in the current mood episode.

Inclusion Criteria

Exclusion Criteria

1. Adults (ages 18-75),
2. Able to read, understand, and provide written informed consent in English,
3. Meet criteria for a primary psychiatric diagnosis of current major depressive disorder
4. Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
5. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
6. Must own a working smartphone and use it regularly,
7. Must own a windows PC (or tablet) or a Mac computer (or laptop),
8. Must have access to Internet service every day.
9. Must have started antidepressant medications, changed medication dosage, or started therapy within 3 weeks

1. Active drug or alcohol use disorder in the past 3 months,
2. History of psychotic disorder,
3. History of mania or hypomania,
4. Epilepsy or history of Seizure Disorder (including PNES), narcolepsy, Alzheimer Disease, Parkinson's Disease, ALS, Severe TBI, Dementia, MS, Cerebral Palsy, and Neuralgia.
5. Untreated hypothyroidism,
6. Unstable medical disease,
7. Cognitive impairment that would impede adherence to study procedures,
8. Acute suicide or homicide risk,
9. Current treatment with electroconvulsive therapy, vagal nerve stimulation therapy, deep brain stimulation, transcranial magnetic stimulation therapy, or phototherapy,
10. Cannot comprehend or communicate in English,
11. Lack of working smartphone or lack of daily access to Internet service,
12. Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and
13. Inability or unwilling to, at minimum, wear the physiological sensor (E4) wristbands, download monitoring apps, and fill out the surveys.
14. Participants with more than two treatment failures (more than two adequate trials of meds on the basis of ATRQ) in the current mood episode.

Contacts and Locations

Study Locations (Sites)

Depression Clinical Research Program

Boston, Massachusetts, 02114

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-28

Study Completion Date2024-11-30

Study Record Updates

Study Start Date2020-01-28

Study Completion Date2024-11-30

Terms related to this study

Keywords Provided by Researchers

Depression
Sensors

Additional Relevant MeSH Terms

Unipolar Depression