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

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ClinicalTrials.gov Identifier: NCT02778334
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
University of Paris 5 - Rene Descartes
Laboratoire Psychopathologie et Processus de Santé
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

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.


Condition or disease Intervention/treatment Phase
Cerebral Stroke Other: survey Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Links Between Depression, Anxiety, Coping and Quality of Life After a Stroke: Depressive and Anxiety Symptoms and Individual Coping Strategies of the Acute Phase in the Fourth Month as a Factor Influencing Mental Health and Quality of Life
Actual Study Start Date : April 13, 2015
Actual Primary Completion Date : November 11, 2017
Actual Study Completion Date : April 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: patients who return home
Experimental: patients who continued hospitalization in rehabilitation Other: survey

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).





Primary Outcome Measures :
  1. Assessment the change of WHOQOL BREF (Life QUALITY) change [ Time Frame: T1 (Day 0 outside the neurovascular unit).T2 (Month 2 after Cerebral Stoke). T3 (Month 4 After Cerebral Stoke) ]

Secondary Outcome Measures :
  1. Assessment the change of MINI (Mini International Neuropsychiatric Inventory) score [ Time Frame: T0 (Day 4-7 after Cerebral Stoke). T3 (Month 4 after Cerebral Stoke) ]
  2. Assessment the change of MADRS (Montgoméry and Asberg Depression Rating Scale) score [ Time Frame: T0 (Day 4-7 after Cerebral Stoke). T3 (Month 4 after Cerebral Stoke) ]
  3. Assessment the change of HAM-A (Hamilton Anxiety Rating Scale) score [ Time Frame: T0 (Day 4-7 after Cerebral Stoke). T3 (Month 4 after Cerebral Stoke) ]
  4. Assessment the change of BDI-II (Beck Depression Inventory 2e ed) score [ Time Frame: T1 (Day 0 outside the neurovascular unit).T2 (Month 2 after Cerebral Stoke). T3 (Month 4 After Cerebral Stoke) ]
  5. Assessment the change of HADS (Hospital Anxiety Depression Scale) score [ Time Frame: T1 (Day 0 outside the neurovascular unit).T2 (Month 2 after Cerebral Stoke). T3 (Month 4 After Cerebral Stoke) ]
  6. Assessment the change of Brief-COPE score [ Time Frame: T1 (Day 0 outside the neurovascular unit).T2 (Month 2 after Cerebral Stoke). T3 (Month 4 After Cerebral Stoke) ]
    This questionnaire assesses 14 separate dimensions of coping (two items per dimensions): active coping, planning, instrumental support, emotional support, expression of feelings, positive reinterpretation, acceptance, denial, blame, humor, religion, entertainment, substance use and disengagement Behavioural

  7. Assessment the change of ESM score [ Time Frame: T1 (Day 0 outside the neurovascular unit).T2 (Month 2 after Cerebral Stoke). T3 (Month 4 After Cerebral Stoke) ]

    These measures will be carried out via a smartphone app. Symptoms of depression and anxiety: the symptoms of depression and anxiety present in the DSM-IV-TR and show a variability in a day will be assessed dimensionally on a Likert scale 7 points. Eg for depression: sad mood, anhedonia, fatigue, difficulty concentrating, negative / pessimistic thoughts.

    Life events: questions will focus on the occurrence in the last three hours of events that have a positive impact on one hand, and negative on the other. Participants should indicate the specific areas of life for these events .

    strategies to adapt to stressful events: coping strategies will be evaluated by adapting the questions brief-COPE. Participants will indicate how they reacted to the negative event previously identified by selecting from a list of st




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778334


Locations
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France
Groupe Hopitalier Paris Saint Joseph Service de neurologie
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
University of Paris 5 - Rene Descartes
Laboratoire Psychopathologie et Processus de Santé
Investigators
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Principal Investigator: Mathieu ZUBER, MD Groupe Hospitalier Paris Saint Joseph

Publications:
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02778334     History of Changes
Other Study ID Numbers: COPING
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2018

Additional relevant MeSH terms:
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Stroke
Depression
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms