Mobile Technologies and Post-stroke Depression

NCT04043052 | Completed

• 1 other identifier: CHUBX 2017/49
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 5

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

Keywords

Stroke; e-health; Depression; Anxiety; Prevention

Outcome Measures

Primary Outcomes (3)

• Hamilton Depression Rating Scale score (HDRS)

  Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score.

  Day 0

• Hamilton Depression Rating Scale score (HDRS)

  Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score.

  3 months

• Hamilton Depression Rating Scale score (HDRS)

  Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score.

  6 months

Secondary Outcomes (42)

• Mini International Neuropsychiatric Interview (MINI)

  Day 0

• Mini International Neuropsychiatric Interview (MINI)

  3 months

• Mini International Neuropsychiatric Interview (MINI)

  6 months

• Mood Disorder Questionnaire (MDQ)

  3 months

• Mood Disorder Questionnaire (MDQ)

  6 months

Study Arms (2)

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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

Other: Psychological evaluation; Other: Functional evaluation; Biological: Biological assessment

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

EXPERIMENTAL

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.

Other: Psychological evaluation; Other: Functional evaluation; Biological: Biological assessment; Other: Ecological Momentary Assessment

Interventions

Psychological evaluation 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;

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

Functional evaluation OTHER

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

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

Biological assessment 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); Treatment As Usual (TAU)

Ecological Momentary Assessment 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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Written informed consent by the patient.
• Covered by French Social Insurance

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (5)

CHU de Bordeaux

Bordeaux, 33 076, France

Location

CHRU de Brest

Brest, 29 609, France

Location

CHU Dijon Bourgogne

Dijon, 21 079, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

Assistance Publique Hopitaux de Paris - Groupe Hospitalier Paris Saint Joseph

Paris, 75 014, France

Location

MeSH Terms

Conditions

Stroke; Depression; Anxiety Disorders

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Igor SIBON

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 2, 2019
• Study Start: September 9, 2020
• Primary Completion: September 26, 2024
• Study Completion: March 23, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)