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Remote Medical Monitoring of Patients With Depression

RecruitingPhase 1Ages 18 Years - anyAllThIA Santé Mentale
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if ThIA Suivi, a digital tool for remote monitoring of patients, can improve the care of adults with depression who are followed by a psychiatrist. The main question it aims to answer is: \* Does using ThIA Suivi in addition to usual psychiatric care increase the proportion of patients whose depression symptoms have clearly improved after 3 months, compared with usual care alone? (Improvement is measured with a questionnaire on depression symptoms, the PHQ-9, and is defined as a drop of at least 5 points from the starting score.) Researchers will compare patients who use ThIA Suivi with patients who receive usual care only, to see if ThIA Suivi leads to a greater improvement in symptoms. The researchers' hypothesis is that patients using ThIA Suivi will do better. \[ Participants will: * Continue to be followed by their psychiatrist as usu

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with a PHQ-9 score of ≥ 15 and a confirmed diagnosis of depression * Patients under the care of the investigator; * Patients who have not received any treatment for at least 6 weeks and to whom the investigator prescribes an antidepressant. * Patients with a smartphone, computer or tablet with internet access; * Patients covered by a health insurance scheme; * Patients able to read and understand French; * Patients who have signed a written, informed consent form in person to take part in the study. Exclusion Criteria: * Patients under guardianship, curatorship or judicial protection, or subject to any other administrative or judicial measure resulting in the deprivation of rights and freedoms; * Patients with neurocognitive disorders or psychiatric conditions (e.g. psychotic disorders, cognitive impairments or manic states) that may compromise their ability to give free and informed consent and/or to comply with the study protocol; * Patients at imminent risk of suicide or with severe depression accompanied by psychotic symptoms; * Patients deemed non-autonomous by the psychiatrist, i.e. those who, according to clinical assessment, are unable to manage their daily activities independently or lack sound judgement; * Patients already enrolled in another interventional study * Vulnerable persons as defined in Articles L. 1121-5 to 8 and L. 1122-1-2 of the French Public Health Code are excluded from the study.
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What it tests

  • Use of ThIA Medical Device
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Where

3 sites
Centre Hospitalier Le Vinatier
Bron, France
Hôpital Novo
Pontoise, France
Hôpital Uzès - Le Mas Careiron Secteur 30G07 - CMP de Saint Hippolyte du Fort
Uzès, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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