Mobile Technologies and Post-stroke Depression (MOTIV-POSDEP)

University Hospital of Bordeaux

Status: Completed

Conditions: Stroke; Depression

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04043052

CHUBX 2017/49

Details and patient eligibility

About

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.

Enrollment: 401 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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401 participants in 2 patient groups

Treatment As Usual (TAU)

Active Comparator group

Description:

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

Treatment:

Biological: Biological assessment

Other: Functional evaluation

Other: Psychological evaluation

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

Experimental group

Description:

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.

Treatment:

Biological: Biological assessment

Other: Functional evaluation

Other: Ecological Momentary Assessment

Other: Psychological evaluation