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临床试验/NCT02778334
NCT02778334已完成不适用

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

Fondation Hôpital Saint-Joseph2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2015年4月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Assessment the change of WHOQOL BREF (Life QUALITY) change

研究概览

简要总结

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.

详细描述

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? Research on psychology and psychiatric disorders post-stroke indicate a frequency of occurrence of depression in 30-40% of patients, while the occurrence of anxiety disorders in 20% to 30% of patients. Depression and anxiety after stroke is influenced by the presence of sequels, but in a preliminary study (see Psycho-stroke current study) with patients with no impairment of their independence three months after stroke Investigators observed the presence of depressive and anxious symptoms.

The psychological health influences the patient's quality of life overall. Recent results have thus demonstrated that post-stroke depression increased the risk of short- and long-term mortality. It therefore seems essential to identify risk factors and influence of depression and anxiety after stroke, particularly in patients rapidly and almost completely recovering from the aftermath of their accident, to prevent the emergence and to support them.

In the scientific literature, individual coping strategies or coping strategies, and their development are identified as a factor of influence of post-stroke psychological health. Thus, an active coping centered on the problem would be associated with better mental health status, while a passive coping centered on managing emotions would instead be a poor prognostic factor. However, the clinical understanding of the everyday process of adaptation among survivors of stroke is limited by the assessment methods conventionally used in the research, which questioned the memory "in general" of the subject.

Modern techniques and increasingly used, as Experiences Sampling Method (ESM) or the Ecological Momentary Assessment (EMA) allow the assessment of individual functioning in more ecologically being carried out in the natural environment of the subject and greatly limit through retrospective recall. The application of these methods to a population of stroke survivors has already been validated and one study also shows that the active behaviors (work, sport) would be a post-stroke depression risk factor, whereas the presence of a social environment (among friends, relatives) would be a protective factor. However, this study is only interested in certain types of behavior, comparable to some coping strategies (active coping, social support research) but not representative of a whole, while other studies specifically interested in the evaluation of coping with this method but not with stroke patients. It seems interesting to use a similar methodology to observe in vivo finer and more accurate adaptation strategies in stroke survivors, and thus have an ecological representation of their coping.

The other factor of influence that Investigators chose to investigate in our study relates to the symptomatic forms of depression and anxiety. It is important first to note that the somatic and cognitive consequences of stroke are close to some depression and anxiety manifestations. This symptomatic overlap makes it difficult locating and diagnosing these disorders. Determine their specific seems necessary, and would involve the identification of symptoms of these psychopathological that would significantly associated with depression and anxiety lasting and intense.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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).

研究组 & 干预措施

patients who return home

No Intervention

patients who continued hospitalization in rehabilitation

Experimental

干预措施: survey (Other)

结局指标

主要结局

Assessment the change of WHOQOL BREF (Life QUALITY) change

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

次要结局

  • Assessment the change of Brief-COPE score(T1 (Day 0 outside the neurovascular unit).T2 (Month 2 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 MINI (Mini International Neuropsychiatric Inventory) score(T0 (Day 4-7 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))
  • Assessment the change of ESM score(T1 (Day 0 outside the neurovascular unit).T2 (Month 2 after Cerebral Stoke). T3 (Month 4 After Cerebral Stoke))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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