Mobile Technologies and Post-stroke Depression

NCT ID: NCT04043052

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2025-03-23

Brief Summary

The recent development of acute phase treatments has dramatically improved stroke functional outcome but post-stroke neuropsychiatric disorders, notably post-stroke depression, continue to contribute to the heavy burden of stroke. While these conditions affect about 25% of stroke patients at 3 months, they are under-reported spontaneously by patients and are under-evaluated and treated by clinicians. Other than stroke severity and psychiatric history, risk factors for post-stroke depression remain a matter of debate, thus preventing identification of high-risk patients. Moreover, to date, neither pharmacological nor nonpharmacological treatments have demonstrated a significant benefit in the prevention of this disorder, thereby also impeding the development of early treatment strategies. Yet,the early management of post-stroke depression is critical given its negative influence on long-term functional outcomes, medication adherence, efficient use of rehabilitation services and the risk of stroke recurrence or vascular events. There is a pressing need to develop new tools allowing for the early detection of post-stroke neuropsychiatric complications for each individual patient. The rapid expansion of ambulatory monitoring techniques, such as Ecological Momentary Assessment (EMA), allows daily evaluations of mood symptoms in real time and in the natural contexts of daily life. The investigators have previously validated the feasibility and validity of EMA to assess daily life emotional symptoms after stroke, demonstrating its utility to investigate their evolution during the 3 months following stroke and to identify early predictors of post-stroke depression such as stress reactivity and social support, suggesting that EMA could be used in the early personalized care management of these neuropsychiatric complications. Recently, preliminary data have also emphasized the potential of EMA interventions to improve the outcome of psychiatric disorders.

Conditions

Stroke; Depression

Study Design

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

Study Groups

Treatment As Usual (TAU)

Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination

Group Type: ACTIVE_COMPARATOR

Psychological evaluation

Intervention Type: OTHER

Psychological evaluation including: MINI (current diagnosis) ; HDRS ; MDQ ; GAD-7 ; PC-PTSD-5 ; Quality of Sleep (item 6 of the Pittsburgh Sleep Quality Index) ; CES-D ; BAI ; RRS-short form ; IES-R ; mYFAS2.0;

Functional evaluation

Intervention Type: OTHER

Functional evaluation including : EQ5-D ; MFI ; LUNS ; SSQ ; Physical activity (IPAQ)

Biological assessment

Intervention Type: BIOLOGICAL

Biological assessment : White and red blood cells count ; platelets count ; Haemoglobin ; CRPus ; Glycaemia ; Plasmatic HbA1c ; Plasmatic LDLc ; HDLc and triglyceride ; Creatinin clearance, Transaminases.

EMA intervention assocuated to Treatment As Usual (EMA-TAU)

Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination in addition with Ecological Momentary Assessment (EMA) evaluation.

Group Type: EXPERIMENTAL

Psychological evaluation

Intervention Type: OTHER

Psychological evaluation including: MINI (current diagnosis) ; HDRS ; MDQ ; GAD-7 ; PC-PTSD-5 ; Quality of Sleep (item 6 of the Pittsburgh Sleep Quality Index) ; CES-D ; BAI ; RRS-short form ; IES-R ; mYFAS2.0;

Functional evaluation

Intervention Type: OTHER

Functional evaluation including : EQ5-D ; MFI ; LUNS ; SSQ ; Physical activity (IPAQ)

Biological assessment

Intervention Type: BIOLOGICAL

Biological assessment : White and red blood cells count ; platelets count ; Haemoglobin ; CRPus ; Glycaemia ; Plasmatic HbA1c ; Plasmatic LDLc ; HDLc and triglyceride ; Creatinin clearance, Transaminases.

Ecological Momentary Assessment

Intervention Type: OTHER

During 3 months after inclusion, a 3 to 5 minutes daily interview will administer questions concerning mood symptoms, activities, stress experience, substance use, social relationships and medication intake, activities, social interaction, environmental conditions, experience of depressed mood, anhedonia, changes in weight, appetite, sleep, fatigue, feelings of worthlessness or inappropriate guilt, concentration or decision-making difficulty

Interventions

Psychological evaluation

Psychological evaluation including: MINI (current diagnosis) ; HDRS ; MDQ ; GAD-7 ; PC-PTSD-5 ; Quality of Sleep (item 6 of the Pittsburgh Sleep Quality Index) ; CES-D ; BAI ; RRS-short form ; IES-R ; mYFAS2.0;

Intervention Type: OTHER

Functional evaluation

Functional evaluation including : EQ5-D ; MFI ; LUNS ; SSQ ; Physical activity (IPAQ)

Intervention Type: OTHER

Biological assessment

Biological assessment : White and red blood cells count ; platelets count ; Haemoglobin ; CRPus ; Glycaemia ; Plasmatic HbA1c ; Plasmatic LDLc ; HDLc and triglyceride ; Creatinin clearance, Transaminases.

Intervention Type: BIOLOGICAL

Ecological Momentary Assessment

During 3 months after inclusion, a 3 to 5 minutes daily interview will administer questions concerning mood symptoms, activities, stress experience, substance use, social relationships and medication intake, activities, social interaction, environmental conditions, experience of depressed mood, anhedonia, changes in weight, appetite, sleep, fatigue, feelings of worthlessness or inappropriate guilt, concentration or decision-making difficulty

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Male or Female.
• Recent (≤ 15 days) clinically-symptomatic ischemic or hemorrhagic stroke documented through brain imaging (CT or MRI) or a Transient Ischemic Attack with an ABCD2 score ≥ 4.
• Patient discharged to home after hospitalization in the stroke unit.
• No severe neurological handicap: modified Rankin scale ≤ 3 at inclusion.
• No severe cognitive impairment or dementia: MoCA ≥ 16 at inclusion.
• Written informed consent by the patient.
• Covered by French Social Insurance

Exclusion Criteria

• Transient Non Cerebrovascular Event.
• Subarachnoid hemorrhage.
• Dementia syndrome or other neurologic disorder and/or severe aphasia (NIHSS item 9 ≥ 2) interfering with the completion of evaluations and the utilization of EMA.
• Severe visual impairment interfering with the utilization of EMA.
• Severely impaired physical and/or mental health that, according to the investigator, may affect the participant's compliance with the study
• Patients with a severe substance use disorder (DSM-5 criteria)
• Patients under antidepressant and/or anxiolytic and/or neuroleptic and/or mood stabilizer treatment during the month preceding inclusion
• Participation in another protocol modifying the patient's follow-up status.
• Pregnancy or breastfeeding
• Inability to read French or to use a smartphone
• Individuals under legal protection or unable to express personnally their consent
• Individuals living in an area without 3G/4G internet coverage

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

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Igor SIBON

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

CHRU de Brest

Brest, , France

CHU Dijon Bourgogne

Dijon, , France

CHU de Montpellier

Montpellier, , France

Assistance Publique Hopitaux de Paris - Groupe Hospitalier Paris Saint Joseph

Paris, , France

Countries

France

Other Identifiers

CHUBX 2017/49

Identifier Type: -

Identifier Source: org_study_id