StrokeMOTIV-POSDEPNCT04043052
Mobile Technologies and Post-stroke Depression
A study testing Psychological evaluation, Functional evaluation and Biological assessment in people with Stroke and Depression, run by University Hospital, Bordeaux at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Depression
- What is being tested?
- Psychological evaluation, Functional evaluation and Biological assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 5 sitesFrance
- Study dates
- 9 Sep 2020to 23 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Bordeaux
Bordeaux, 33 076
CHRU de Brest
Brest, 29 609
CHU Dijon Bourgogne
Dijon, 21 079
CHU de Montpellier
Montpellier, 34295
Assistance Publique Hopitaux de Paris - Groupe Hospitalier Paris Saint Joseph
Paris, 75 014
About this study
Official title: MObile Technologies In the preVention of POSt-stroke DEPression
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
- Being tested
- Psychological evaluation, Functional evaluation, Biological assessment, Ecological Momentary Assessment
- Keywords
- Stroke, e-health, Depression, Anxiety, Prevention
- Medical subject headings
- Stroke, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological evaluationOther
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 evaluationOther
Functional evaluation including : EQ5-D ; MFI ; LUNS ; SSQ ; Physical activity (IPAQ)
Biological assessmentBiological
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 AssessmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Evaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination Receives: 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. Receives: Other: Psychological evaluation; Other: Functional evaluation; Biological: Biological assessment; Other: Ecological Momentary Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (42)
Mini International Neuropsychiatric Interview (MINI)
Measured: Day 0
Mini International Neuropsychiatric Interview (MINI)
Measured: 3 months
Mini International Neuropsychiatric Interview (MINI)
Measured: 6 months
Mood Disorder Questionnaire (MDQ)
13 questions on mood symptoms and 2 additional questions on the co-occurrence and psychosocial impact of these symptoms. This questionnaire assesses the probability of an existing bipolar disorder. A positive screen include : a) answering 'Yes' to at least 7 of 13 questions, and b) reporting that several of these symptoms have been experienced during the same period of time, and c) reporting that psychosocial impairment has been caused by these symptoms.
Measured: 3 months
Mood Disorder Questionnaire (MDQ)
13 questions on mood symptoms and 2 additional questions on the co-occurrence and psychosocial impact of these symptoms. This questionnaire assesses the probability of an existing bipolar disorder. A positive screen include : a) answering 'Yes' to at least 7 of 13 questions, and b) reporting that several of these symptoms have been experienced during the same period of time, and c) reporting that psychosocial impairment has been caused by these symptoms.
Measured: 6 months
Generalized Anxiety Disorder-7 scale (GAD-7)
7 items that assess GAD symptoms experienced over the past two weeks. Patients are asked the frequency of these symptoms using a 4-point scale, ranging from 0 (Not at all) to 3 (Nearly every day). A cutoff score of greater than 10 is commonly used to identify cases of GAD.
Measured: 3 months
Generalized Anxiety Disorder-7 scale (GAD-7)
7 items that assess GAD symptoms experienced over the past two weeks. Patients are asked the frequency of these symptoms using a 4-point scale, ranging from 0 (Not at all) to 3 (Nearly every day). A cutoff score of greater than 10 is commonly used to identify cases of GAD.
Measured: 6 months
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
5-item screen designed to identify individuals with probable PTSD. It begins with an item designed to assess whether the respondent has had any exposure to traumatic events. If a respondent denies exposure, the scale is completed with a score of 0. If the respondent indicates a trauma history, he/she has additional Yes/No questions about how the traumatic event has affected him/her over the past month. If the total score is 3 or more, the screen indicates probable PTSD.
Measured: 3 months
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
5-item screen designed to identify individuals with probable PTSD. It begins with an item designed to assess whether the respondent has had any exposure to traumatic events. If a respondent denies exposure, the scale is completed with a score of 0. If the respondent indicates a trauma history, he/she has additional Yes/No questions about how the traumatic event has affected him/her over the past month. If the total score is 3 or more, the screen indicates probable PTSD.
Measured: 6 months
Center of Epidemiological Studies-Depression Scale (CES-D)
20-item. It measures symptoms of depression in nine different groups as defined by the DSM-5: Sadness (Dysphoria, 3 items), Loss of Interest (Anhedonia, 2 items), Appetite (2 items), Sleep (3 items), Thinking (Concentration, 2 items), Guilt or Worthlessness (2 items), Fatigue (2 items), Agitation (2 items), Suicidal ideation (2 items).
Measured: 3 months
Center of Epidemiological Studies-Depression Scale (CES-D)
20-item. It measures symptoms of depression in nine different groups as defined by the DSM-5: Sadness (Dysphoria, 3 items), Loss of Interest (Anhedonia, 2 items), Appetite (2 items), Sleep (3 items), Thinking (Concentration, 2 items), Guilt or Worthlessness (2 items), Fatigue (2 items), Agitation (2 items), Suicidal ideation (2 items).
Measured: 6 months
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) assesses the severity of patient anxiety during the past week. Though anxiety can be thought of as having several components, including cognitive, somatic, affective, and behavioral components included only two components in the BAI's original version: cognitive and somatic symptoms, with the cognitive subscale providing a measure of fearful thoughts and impaired cognitive functioning whereas the somatic subscale measures the symptoms of physiological arousal. Care was taken during scale construction to eliminate items that would be confounded with depression items. Patients respond to the frequence of 21 symptoms using a scale from 0 (Never) to 3 (Frequently, Almost every day).
Measured: 3 months
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) assesses the severity of patient anxiety during the past week. Though anxiety can be thought of as having several components, including cognitive, somatic, affective, and behavioral components included only two components in the BAI's original version: cognitive and somatic symptoms, with the cognitive subscale providing a measure of fearful thoughts and impaired cognitive functioning whereas the somatic subscale measures the symptoms of physiological arousal. Care was taken during scale construction to eliminate items that would be confounded with depression items. Patients respond to the frequence of 21 symptoms using a scale from 0 (Never) to 3 (Frequently, Almost every day).
Measured: 6 months
Ruminative Response Scale-short form (RRS-short form)
Ruminative Response Scale-short form (RRS-short form) is one of the most widely used self-reported measures of rumination, comprising 9 items and describing the factors of brooding (5 items) and reflection (5 items). For each item, patients indicate the frequency of each event on a 4-point scale ranging from 1 ("almost never") to 4 ("almost always").
Measured: 3 months
Ruminative Response Scale-short form (RRS-short form)
Ruminative Response Scale-short form (RRS-short form) is one of the most widely used self-reported measures of rumination, comprising 9 items and describing the factors of brooding (5 items) and reflection (5 items). For each item, patients indicate the frequency of each event on a 4-point scale ranging from 1 ("almost never") to 4 ("almost always").
Measured: 6 months
Multidimensional Fatigue Inventory (MFI)
The MFI contains 20 items classified into four dimensions: general fatigue, mental fatigue, reduced activities and motivation. The statements are rated on a 5-point Likert scale (from "Yes, that is true" to "No, that is not true") representing the patient's current feeling. Low MFI scores reflect a higher degree of fatigue.
Measured: 3 months
Multidimensional Fatigue Inventory (MFI)
The MFI contains 20 items classified into four dimensions: general fatigue, mental fatigue, reduced activities and motivation. The statements are rated on a 5-point Likert scale (from "Yes, that is true" to "No, that is not true") representing the patient's current feeling. Low MFI scores reflect a higher degree of fatigue.
Measured: 6 months
EuroQoL 5-Dimensions Questionnaire (EQ-5D)
The EuroQoL 5-Dimensions Questionnaire (EQ-5D) is a standardized instrument for use as a measure of health outcome in stroke and was designed for self-completion by respondents. The 5 items of the questionnaire provide a simple descriptive profile and a single index value for health status. The EQ-Index has shown reasonable validity and acceptable responsiveness for detecting the health-related quality of life in stroke patients.
Measured: 3 months
EuroQoL 5-Dimensions Questionnaire (EQ-5D)
The EuroQoL 5-Dimensions Questionnaire (EQ-5D) is a standardized instrument for use as a measure of health outcome in stroke and was designed for self-completion by respondents. The 5 items of the questionnaire provide a simple descriptive profile and a single index value for health status. The EQ-Index has shown reasonable validity and acceptable responsiveness for detecting the health-related quality of life in stroke patients.
Measured: 6 months
Long-term Unmet Needs after Stroke (LUNS)
The Long-term Unmet Needs after Stroke (LUNS) includes 22 items that have each been worded to ask whether the respondent has a need and whether the need is met, and the potential complexity of "double-barrelled" questions was managed by providing Yes or No response modalities, with instructions to tick 'No' if there is no need or if the need has been met. Participants are also asked to indicate what level of help (from care givers/friends) they have received in completing the questionnaires, if any.
Measured: 3 months
Long-term Unmet Needs after Stroke (LUNS)
The Long-term Unmet Needs after Stroke (LUNS) includes 22 items that have each been worded to ask whether the respondent has a need and whether the need is met, and the potential complexity of "double-barrelled" questions was managed by providing Yes or No response modalities, with instructions to tick 'No' if there is no need or if the need has been met. Participants are also asked to indicate what level of help (from care givers/friends) they have received in completing the questionnaires, if any.
Measured: 6 months
Short version of Sarason's Social Support Questionnaire (6 items SSQ)
Used to measure two dimensions of social support : satisfaction and availability perceptions of social support and satisfaction with that social support. Each item is a question that solicits a two-part answer: Part 1 asks participants to list all the people that fit the description of the question, and Part 2 asks participants to indicate how satisfied they are in general with these people using a 6-point Licket scale (from 1. Very unsatisfied to 6. Extremely satisfied).
Measured: 3 months
Short version of Sarason's Social Support Questionnaire (6 items SSQ)
Used to measure two dimensions of social support : satisfaction and availability perceptions of social support and satisfaction with that social support. Each item is a question that solicits a two-part answer: Part 1 asks participants to list all the people that fit the description of the question, and Part 2 asks participants to indicate how satisfied they are in general with these people using a 6-point Licket scale (from 1. Very unsatisfied to 6. Extremely satisfied).
Measured: 6 months
International Physical Activity Questionnaire (7 items IPAQ)
The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Measured: Day 0
International Physical Activity Questionnaire (7 items IPAQ)
The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Measured: 3 months
International Physical Activity Questionnaire (7 items IPAQ)
The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Measured: 6 months
Percentage of stroke risk
The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction
Measured: Day 0
Percentage of stroke risk
The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction
Measured: 3 months
Percentage of stroke risk
The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction
Measured: 6 months
Recurrent stroke
Recurrent stroke or TIA post-stroke defined by standard clinico-radiological criteria
Measured: 3 months
Recurrent stroke
Recurrent stroke or TIA post-stroke defined by standard clinico-radiological criteria
Measured: 6 months
Cardiovascular events post-stroke
Cardiovascular events post-stroke defined by standard clinical criteria
Measured: 3 months
Cardiovascular events post-stroke
Cardiovascular events post-stroke defined by standard clinical criteria
Measured: 6 months
Intensity of post-stroke pain
Intensity of post-stroke pain using a visual analog scale
Measured: Day 0
Intensity of post-stroke pain
Intensity of post-stroke pain using a visual analog scale
Measured: 3 months
Intensity of post-stroke pain
Intensity of post-stroke pain using a visual analog scale
Measured: 6 months
Pittsburgh Sleep Quality Index
Quality of sleep using the item 6 of the Pittsburgh Sleep Quality Index
Measured: Visit 1 ; 3 months ; 6 months
Blood pressure
Blood pressure
Measured: Visit 1 ; 3 months ; 6 months
HbA1c measure
Glycaemic control using the HbA1c measure
Measured: 3 months ; 6 months
LDLc plasmatic measure
Lipidic control using the LDLc plasmatic measure
Measured: 3 months ; 6 months
CRPus plasmatic measure
Systemic inflammation will be evaluated using CRPus plasmatic measure
Measured: 3 months ; 6 months
Smoking Index (HSI)
Tobacco use will be evaluated using the Heaviness of Smoking Index (HSI)
Measured: 3 months ; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start9 Sep 2020
- Primary completion26 Sep 2024
- Study completion23 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor SIBON, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043052
- Sponsor's protocol ID
- CHUBX 2017/49
- Other IDs
- 2019-A00898-49
- Acronym
- MOTIV-POSDEP
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2019
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MObile Technologies In the preVention of POSt-stroke DEPression
- ClinicalTrials.gov ID
- NCT04043052
- Acronym / sponsor ID
- MOTIV-POSDEP / CHUBX 2017/49
- Conditions
- Stroke, Depression
- Keywords
- Stroke, e-health, Depression, Anxiety, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 23 Mar 2025 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Other: Psychological evaluation, Other: Functional evaluation, Biological: Biological assessmentEvaluation of depression and anxiety disorders at 3 and 6 months post-stroke using psychological and functional examination |
| EMA intervention assocuated to Treatment As Usual (EMA-TAU) | Experimental | Other: Psychological evaluation, Other: Functional evaluation, Biological: Biological assessment, Other: Ecological Momentary AssessmentEvaluation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological evaluationPsychological 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; | Other | EMA intervention assocuated to Treatment As Usual (EMA-TAU), Treatment As Usual (TAU) |
| Functional evaluationFunctional evaluation including : EQ5-D ; MFI ; LUNS ; SSQ ; Physical activity (IPAQ) | Other | EMA intervention assocuated to Treatment As Usual (EMA-TAU), Treatment As Usual (TAU) |
| Biological assessmentBiological assessment : White and red blood cells count ; platelets count ; Haemoglobin ; CRPus ; Glycaemia ; Plasmatic HbA1c ; Plasmatic LDLc ; HDLc and triglyceride ; Creatinin clearance, Transaminases. | Biological | EMA intervention assocuated to Treatment As Usual (EMA-TAU), Treatment As Usual (TAU) |
| Ecological Momentary AssessmentDuring 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 | Other | EMA intervention assocuated to Treatment As Usual (EMA-TAU) |
Primary outcome
Hamilton Depression Rating Scale score (HDRS)
Time frame: Day 0
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.
Hamilton Depression Rating Scale score (HDRS)
Time frame: 3 months
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.
Hamilton Depression Rating Scale score (HDRS)
Time frame: 6 months
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.
42 secondary outcomes
Mini International Neuropsychiatric Interview (MINI)
Time frame: Day 0
Mini International Neuropsychiatric Interview (MINI)
Time frame: 3 months
Mini International Neuropsychiatric Interview (MINI)
Time frame: 6 months
Mood Disorder Questionnaire (MDQ)
Time frame: 3 months
Mood Disorder Questionnaire (MDQ)
Time frame: 6 months
Generalized Anxiety Disorder-7 scale (GAD-7)
Time frame: 3 months
Generalized Anxiety Disorder-7 scale (GAD-7)
Time frame: 6 months
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
Time frame: 3 months
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
Time frame: 6 months
Center of Epidemiological Studies-Depression Scale (CES-D)
Time frame: 3 months
Center of Epidemiological Studies-Depression Scale (CES-D)
Time frame: 6 months
Beck Anxiety Inventory (BAI)
Time frame: 3 months
Beck Anxiety Inventory (BAI)
Time frame: 6 months
Ruminative Response Scale-short form (RRS-short form)
Time frame: 3 months
Ruminative Response Scale-short form (RRS-short form)
Time frame: 6 months
Multidimensional Fatigue Inventory (MFI)
Time frame: 3 months
Multidimensional Fatigue Inventory (MFI)
Time frame: 6 months
EuroQoL 5-Dimensions Questionnaire (EQ-5D)
Time frame: 3 months
EuroQoL 5-Dimensions Questionnaire (EQ-5D)
Time frame: 6 months
Long-term Unmet Needs after Stroke (LUNS)
Time frame: 3 months
Long-term Unmet Needs after Stroke (LUNS)
Time frame: 6 months
Short version of Sarason's Social Support Questionnaire (6 items SSQ)
Time frame: 3 months
Short version of Sarason's Social Support Questionnaire (6 items SSQ)
Time frame: 6 months
International Physical Activity Questionnaire (7 items IPAQ)
Time frame: Day 0
International Physical Activity Questionnaire (7 items IPAQ)
Time frame: 3 months
International Physical Activity Questionnaire (7 items IPAQ)
Time frame: 6 months
Percentage of stroke risk
Time frame: Day 0
Percentage of stroke risk
Time frame: 3 months
Percentage of stroke risk
Time frame: 6 months
Recurrent stroke
Time frame: 3 months
Recurrent stroke
Time frame: 6 months
Cardiovascular events post-stroke
Time frame: 3 months
Cardiovascular events post-stroke
Time frame: 6 months
Intensity of post-stroke pain
Time frame: Day 0
Intensity of post-stroke pain
Time frame: 3 months
Intensity of post-stroke pain
Time frame: 6 months
Pittsburgh Sleep Quality Index
Time frame: Visit 1 ; 3 months ; 6 months
Blood pressure
Time frame: Visit 1 ; 3 months ; 6 months
HbA1c measure
Time frame: 3 months ; 6 months
LDLc plasmatic measure
Time frame: 3 months ; 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor SIBON principal investigator
University Hospital, Bordeaux
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological evaluation, Functional evaluation and Biological assessment in people with Stroke and Depression, run by University Hospital, Bordeaux at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale score (HDRS) (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.