Links Between Depression, Anxiety, Coping and Quality of Life After a Stroke

NCT02778334 | Completed DMC

• 1 other identifier: COPING
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction and literature review With 130 000 cases per year in France in 2010, stroke is one of the most common neurological diseases, often leaving many disabling sequelae physical and cognitive levels (currently live 500 000 disabled following a stroke) and leading and a loss of significant autonomy in these patients. However, many stroke survivors soon find a range comparable to their previous state. Investigators can then ask ourselves about the impact of this life event in these people who apparently do not show visible effects: what about the psychological repercussions of stroke in these patients healthy; what is changed in their daily lives, particularly in their mental functioning after this brutal confrontation with their own mortality? Objectives Our project aims to better understand the psychological repercussions of stroke in patients who quickly find a health and autonomy comparable to their previous state. The objective will be to investigate the relationship between depressive symptoms and anxiety, coping strategies and quality of life from the acute phase and during the first months after the onset of stroke. This period is particularly demanding for these patients must therefore adapt and readjust continuously: shock stroke, hospitalization in several services (intensive care, neurology, rehabilitation), back home, "new" life with the changes related stroke, resumption of a professional activity, etc ... Our methodology will combine tools conventionally used (standardized interview, validated questionnaires) to newer, ecological and true methods (Experience Sampling Method applied by the use of a smarphone application) to assess different variables studied. This initially be determined whether the various symptoms of the depression on the one hand and anxiety on the other hand, depending on their mode of expression (vs. outsourced internalized; ie emotional, cognitive, somatic), observed from the acute phase of stroke, are related and predict the quality of life, depression and anxiety in the longer term (four months after the stroke). Furthermore, our study will observe if the individual coping strategies (coping) daily and evolution influence the psychological status and quality of life during the months following the stroke.

Conditions

Cerebral Stroke

Outcome Measures

Primary Outcomes (1)

• Assessment the change of WHOQOL BREF (Life QUALITY) change

  T1 (Day 0 outside the neurovascular unit).T2 (Month 2 after Cerebral Stoke). T3 (Month 4 After Cerebral Stoke)

Secondary Outcomes (7)

• Assessment the change of MINI (Mini International Neuropsychiatric Inventory) score

  T0 (Day 4-7 after Cerebral Stoke). T3 (Month 4 after Cerebral Stoke)

• Assessment the change of MADRS (Montgoméry and Asberg Depression Rating Scale) score

  T0 (Day 4-7 after Cerebral Stoke). T3 (Month 4 after Cerebral Stoke)

• Assessment the change of HAM-A (Hamilton Anxiety Rating Scale) score

  T0 (Day 4-7 after Cerebral Stoke). T3 (Month 4 after Cerebral Stoke)

• Assessment the change of BDI-II (Beck Depression Inventory 2e ed) score

  T1 (Day 0 outside the neurovascular unit).T2 (Month 2 after Cerebral Stoke). T3 (Month 4 After Cerebral Stoke)

• Assessment the change of HADS (Hospital Anxiety Depression Scale) score

  T1 (Day 0 outside the neurovascular unit).T2 (Month 2 after Cerebral Stoke). T3 (Month 4 After Cerebral Stoke)

Study Arms (2)

patients who return home

NO INTERVENTION

patients who continued hospitalization in rehabilitation

EXPERIMENTAL

Other: survey

Interventions

survey OTHER

Patients who accept will be seen in maintenance during hospitalization in Neuro-Vascular Unit (UNV) (T0 = 4 to 7 days post-stroke) At the time of the release of the UNV two groups: 1. patients who return home and 2. patients who continued hospitalization in rehabilitation. Depression, anxiety, quality of life and coping strategies will be assessed by self-administered questionnaires. A first phase of ambulatory (ESM / EMA) will also take place following the (UNV) output: 5 times a day for 7 days patients will respond to questions evaluating depression, anxiety and coping strategies. Patients will answer these questions via a smartphone app (issues ESM). Another ambulatory phase on the same model as that performed at T1 (5 times daily for 7 days) accompanied by a self-assessment of depression, anxiety, coping strategies and quality of life will made 2 months post-stroke (T2). The last time the study will take place 4 months after stroke onset (T3).

patients who continued hospitalization in rehabilitation

Eligibility Criteria

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

You may qualify if:

• over 18 years,
• first diagnosis of ischemic or hemorrhagic stroke,
• with a rapid recovery prognosis from hospitalization in intensive care (NIHSS score less than or equal to 6 at the output of the intensive care unit).

You may not qualify if:

• diagnosis of other somatic or neurological chronic,
• Current diagnosis of psychotic disorder or past,
• Diagnosis of dementia,
• Severe aphasia (NIHSS subscore),
• Visual or motor disabilities prevent participation in the study (subscores NIHSS),
• Reduced autonomy (Rankin score greater than 3).

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• University of Paris 5 - Rene Descartes: collaborator
• Laboratoire Psychopathologie et Processus de Santé: collaborator

Study Sites (1)

Groupe Hopitalier Paris Saint Joseph Service de neurologie

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

• Alpers GW. Ambulatory assessment in panic disorder and specific phobia. Psychol Assess. 2009 Dec;21(4):476-85. doi: 10.1037/a0017489.

  PMID: 19947782 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mathieu ZUBER, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 19, 2016
• Study Start: April 13, 2015
• Primary Completion: November 11, 2017
• Study Completion: April 4, 2019
• Last Updated: April 25, 2019

Record last verified: 2018-04

Locations

FR (1)