Relevance of a Telemedicine Monitoring in the Management of Depression

NCT ID: NCT06076317

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 836 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-27
• Study Completion Date: 2029-02-02

Brief Summary

Major depressive disorder (MDD) is a common chronic disease. It is the main cause of morbidity and disability in the world with, among other things, an increase in cardio-metabolic risk and a reduction in life expectancy, regardless of suicide risk. MDD is the most expensive medical condition: 10-20 billion €/year in France. This cost is mainly attributable to the functional consequences of the disease, highlighting the medico-economic challenge represented by the optimization of the organization of care.

In France, more than 80% of MDD patients are enrolled in non-psychiatric care pathways, mainly primary care or MSO hospital care (medicine, surgery, obstetrics). Unfortunately, less than half of patients benefit from treatment at an appropriate dosage or duration, thus exposing them to the risks of relapse, recurrence and chronic evolution. It is necessary to optimize this management, in particular by improving secondary prevention, which consists of maintaining treatment in the months following symptomatic remission.

Several support programs (monitoring with assessment of symptomatology) have shown their effectiveness on depressive symptomatology with a favorable medico-economic report, in particular by allowing maintenance of antidepressant treatment. None of these studies have been conducted on French care pathways.

Investigators propose to evaluate the efficacy of telemedicine management (added to usual care) in non-psychiatric care pathways on the evolution of depressive symptomatology for MDD patients. Investigators hypothesize that telemedicine monitoring downstream of MSO hospitalization will increase the response rate to antidepressants at 6 months and reduce the costs attributed to depressive symptoms compared to usual care, in particular by optimizing secondary prevention strategies by maintaining treatment.

The main objective of the research is to assess the efficacy of telemedicine monitoring on depressive symptoms and treatments, added to the out-of-hospital downstream care pathways for patients initially hospitalized in MSO (medicine-surgery-obstetrics), compared to usual care.

Detailed Description

Major depressive disorder (MDD) is a common and often chronic disease. It is the main cause of morbidity and disability in the world with, among other things, an increase in cardio-metabolic risk (diabetes, cardiovascular diseases, high blood pressure) and a reduction in life expectancy, regardless of suicide risk. MDD is the most expensive medical condition: 10-20 billion €/year in France. This cost is mainly attributable to the functional consequences of the disease, highlighting the medico-economic challenge represented by the optimization of the organization of care.

In France, more than 80% of MDD patients are enrolled in non-psychiatric care pathways, mainly primary care or MSO hospital care (medicine, surgery, obstetrics). Unfortunately, less than half of patients benefit from treatment at an appropriate dosage or duration, thus exposing them to the risks of relapse, recurrence and chronic evolution. It is necessary to optimize this management, in particular by improving secondary prevention, which consists of maintaining treatment in the months following symptomatic remission.

Several support programs (monitoring with assessment of symptomatology) have shown their effectiveness on depressive symptomatology with a favorable medico-economic report, in particular by allowing maintenance of antidepressant treatment. None of these studies have been conducted on French care pathways.

Investigators propose to evaluate the efficacy of telemedicine management (added to usual care) in non-psychiatric care pathways on the evolution of depressive symptomatology for MDD patients. Investigators hypothesize that telemedicine monitoring downstream of MSO hospitalization will increase the response rate to antidepressants at 6 months and reduce the costs attributed to depressive symptoms compared to usual care, in particular by optimizing secondary prevention strategies by maintaining treatment.

The main objective of the research is to assess the efficacy of telemedicine monitoring on depressive symptoms and treatments, added to the out-of-hospital downstream care pathways for patients initially hospitalized in MSO (medicine-surgery-obstetrics), compared to usual care.

This is a randomized multicenter clinical trial with two parallel arms concerning a population of MDD patients downstream of an MSO hospitalization evaluating the interest of monitoring by telemedicine of the symptoms and treatments, added to out-of-hospital downstream care pathways compared to usual care. One arm consists in usual care and the other one in usual care + telemedicine monitoring. Included patients will be followed for 3 years, the main endpoint will be the clinical efficacy at 6 months from the start of treatment, as the percentage of patients in remission from depressive symptoms (a reduction in the HADS-depression scale score of 50% or more).

Inclusion is made during MCO hospitalization by the liaison psychiatrist. Will be included patients suffering from a MDD with the indication of antidepressant treatment.

The initial psychometric assessment includes the MINI to verify diagnostic criteria for MDD and the HADS to measure the severity of depressive symptoms. The participants are randomized into two groups: "Usual care + tele-monitoring (UC-Plus)" and "Usual care (UC)".

The "UC" group will follow the care prescribed by the liaison psychiatrist during their hospitalization. Each patient will also receive the contact details of his/her medico-psychological center.

The "UC-Plus" group will follow usual care and benefit from telemedicine sessions led by a nurse/psychologist working under the supervision of a psychiatrist. These sessions follow a standardized protocol with 4 evaluations (maximum duration of 20 minutes): (1) evaluation of the tolerance and efficacy of the psychotropic treatment; (2) assessment of depressive symptoms (PHQ-9 scale); (3) identification of daily difficulties; (4) therapeutic orientation and recommendation. A standardized report (score, evolutionary curve, etc.) validated by a psychiatrist will be sent to the patient and his treating physicians (general practitioner, psychiatrist, oncologist, other). The frequency of sessions is defined by the clinical symptomatology:

• Initially: weekly frequency until response to treatment (reduction of PHQ-9 score>50%)
• After response to treatment: variable frequency (weekly to monthly) decided with the patient until remission (score PHQ-9<5)
• After remission: monthly frequency for 6 months, then end of intervention. An increase in the session frequency is possible in the case of relapse or recurrence.

Evaluations at 3, 6, 12, 18, 24, 30 and 36 months, relating to HADS and medico-economic variables, will be carried out in the 2 arms, by telephone blinded to group membership by a technician clinical study. In the event of a high suicide risk, the patient is referred urgently to appropriate care.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard arm

Patients will have the usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional arm

Patients will have telemedicine session

Group Type: EXPERIMENTAL

Telemedicine session

Intervention Type: BEHAVIORAL

The content of telemedicine session is semi-standardized and includes: (1) evaluation of the tolerance and efficacy of drug treatment; (2) evaluation of depressive symptoms (PHQ9 scale); (3) identification of the daily difficulties; (4 ) personalized advice and orientation towards appropriate care pathways. Among the personalized advice, investigators will use the digital tools available to maintain remission, psychoeducation and monitoring tools (for example, application to learn mindfulness meditation, conversational chatbot coupled with artificial intelligence, etc.). Support on the use of these tools can be provided during telemedicine sessions.

Interventions

Telemedicine session

The content of telemedicine session is semi-standardized and includes: (1) evaluation of the tolerance and efficacy of drug treatment; (2) evaluation of depressive symptoms (PHQ9 scale); (3) identification of the daily difficulties; (4 ) personalized advice and orientation towards appropriate care pathways. Among the personalized advice, investigators will use the digital tools available to maintain remission, psychoeducation and monitoring tools (for example, application to learn mindfulness meditation, conversational chatbot coupled with artificial intelligence, etc.). Support on the use of these tools can be provided during telemedicine sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Presence of DSM5 criteria for the diagnosis of a characterized depressive episode
• Patient hospitalized in MCO with request for liaison psychiatry opinion whatever the hospitalization modality (full hospitalization, weekday hospitalization or day hospitalization)
• Initiation, change of molecule or modification of a psychotropic treatment (antidepressant or anxiolytic) during MCO hospitalization by the liaison psychiatrist
• Affiliated or entitled to a social security system (except AME)
• Obtaining free, written and informed consent

Exclusion Criteria

• Severity of the depressive episode incompatible with outpatient care and relevant to an indication for hospitalization in psychiatry
• Patient is part of a psychiatric care program at the time of the selection visit
• Presence of a mood disorder other than CDD
• Reason for MCO hospitalization secondary to psychiatric disorders, in particular suicide attempts
• MCO hospitalization prolonged beyond 3 weeks after initiation, change of molecule or modification of psychotropic treatment dosage
• Psychiatric comorbidities assessed by psychiatrist, in particular addictions (excluding tobacco), delusional disorders, post-traumatic stress disorder, anxiety disorders (excluding GAD)
• High suicidal risk at the screening visit assessed by psychiatrist
• Presence of a non-psychiatric condition with a vital prognosis of less than 3 years
• Contraindications to telemedicine (no internet access, major vision problems, major cognitive problems, marked impulsivity, clinical situation requiring information to be communicated in person, etc.)
• Conditions making consent impossible (major cognitive disorders, etc.)
• Deprived of liberty or under a protective measure (guardianship or under curatorship)
• Pregnant woman
• Refusal of the patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Yves ROTGE, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

Locations

Hôpital Pitié Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean Yves ROTGE, Pr

Role: CONTACT

jeanyves.rotge@aphp.fr

01 42 16 28 62

Facility Contacts

Jean Yves ROTGE, Pr

Role: primary

jeanyves.rotge@aphp.fr

01 42 16 28 62

Other Identifiers

2023-A00119-36

Identifier Type: OTHER

Identifier Source: secondary_id

APHP210990

Identifier Type: -

Identifier Source: org_study_id