Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02778334 |
| Other study ID # |
COPING |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 13, 2015 |
| Est. completion date |
April 4, 2019 |
Study information
| Verified date |
April 2018 |
| Source |
Groupe Hospitalier Paris Saint Joseph |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
Studies of post-stroke depression reveal that symptoms related to mood, thoughts and
depressive emotions are more durable and predict diagnosis and depression intensity in the
longer term, then somatic symptoms (fatigue) during the acute phase of stroke showed no
significant association with long-term mental health.
Investigators found no published studies indicating the results on this subject regarding
post-stroke anxiety. However, in the Psycho-stroke current study, initial results show that
the psychic symptoms of anxiety three months after the stroke predicted anxiety in six
months. Investigators would like to deepen these results by focusing on these shorter-term
variables, that is to say from the first days after the occurrence of the accident, and study
their links with the mental health status and quality life during the first months following
the stroke.
Again, the use of modern evaluation methods (ESM / EMA) will capture the emotional and
psychological phenomena almost instantaneously, and thus promote the clinical understanding
of mental disorders after stroke. This approach, already applied in the context of
post-stroke depression, however, was not used in the study of anxiety in this population,
although research with d other populations are interested in anxiety as assessed.
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.
Methodology
Population
N waited 75 patients. Recruitment Location: Neuro-Vascular Unit at St. Joseph Hospital.
Study duration: 18 to 24 months depending on the pace of inclusion.
Procedure
After submission and approval of the project by the Patient Protection Committee will be
proposed to patients fulfilling the inclusion criteria to participate in the study after
being informed of its progress and its objectives (note (cf. . Annexes) and meeting with the
psychologist). Camille Vansimaeys, psychologist and principal investigator of this study will
also be the only one to see patients and to conduct interviews as part of this research.
Patients who accept will be seen in maintenance during hospitalization in Neuro-Vascular Unit
(T0 = 4 to 7 days post-stroke) to assess depression and anxiety (hetero-evaluation).
Socio-demographic and medical data will be collected in files and anonymous.
At the time of the release of the UNV (T1 = 12 day average hospitalization), patients will be
divided into 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). The application will be directly installed on
personal smartphones patients who have them. For patients who do not own a smartphone
configured only to be used for the application will be lent their time to the study by the
University Paris Descartes. Patients who will be entrusted these smartphones will sign an
additional form framing the terms of the loan. An explanation of the operation of the
application and smartphones will be made at the time of the first interview in hospital, a
training phase is then performed during hospitalization.
During phase measurements by smartphones, patients will be contacted three days after the
first evaluation, to address and resolve any difficulties of use, and to remind people with a
smartphone lent loading.
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 will be
reviewed in interview to assess depression and anxiety (hetero and self assessments) as well
as coping strategies and quality of life (self-questionnaires). Ambulatory measurement phase
(for 1 week, 5 times a day) also accompanied this evaluation. It will be made before the
interview to half our population, and then the other half to control a possible parasitic
effect.
ethical implications The intervention of this research with vulnerable patients by the
occurrence of a stroke, and therefore may have a certain psychic and emotional vulnerability
in a particularly challenging time for them, implies that Investigators are attentive to many
ethical considerations.
First, it is important to emphasize that proper monitoring will be offered to patients whose
psychic suffering is manifest in the different assessments. Investigators will verify if they
have followed up to these difficulties, and if so Investigators redirect to health
professionals so that they can be supported.
Similarly, patients who simply express a follow-up request will be directed to an appropriate
care.
It will also be checked that each patient and willing to participate in this research has
understood the objectives and conduct.
It will also be specified clearly that their participation, their refusal to participate or
withdrawal during the study in no case affect the management or the relationship with the
medical and nursing teams.
Tools
All tools used were validated their French version.
• Straight-evaluation The hetero-evaluative tools involve the identification of semiotic
elements in a semi-structured clinical interview conducted by an experienced evaluator and
trained in the award of these tools (in this case the clinical psychologist in charge of the
study). They are not filled by patients, it is the investigator (psychologist) who asks
questions based on these questionnaires, but that can be formulated differently in different
patients.
MINI (Mini International Neuropsychiatric Inventory) (Sheehan et al., 1998; Lecrubier et al.,
1998). This is a must-semi-structured interview guide in psychological research, the use of
which is part of the professional practice of psychologist. This inventory is to gather
information and semiotic elements to assist in the diagnosis of certain psychiatric disorders
according to DSM-IV. Modules A (major depressive disorder), B (dysthymia), I (post-traumatic
stress disorder), O (GAD) and L (psychotic disorders) MINI will be used to assess the
presence or absence of disorders mood (major depression, dysthymia), anxiety disorders
(generalized anxiety or post-traumatic stress, assess relevant in our study by the
traumatogenic dimension of Stroke) and identify subjects which present a psychotic disorder
to not to include in the study, mainly because of their altered perception of reality. In
addition, the module for psychotic disorders is introduced to the patient by telling him that
now the invastigator will ask him questions about some unusual or bizarre experiments that
can occur in some people. "Thereby depersonalize maintenance reassurance on the fact that
these issues are part of a standard valuation method and they are not raised in order to
argue a diagnostic hypothesis concerning him .
MADRS (10 items) (Montgomery and Asberg Depression Rating Scale) (Montgomery and Asberg,
1979; Lempérière, 1984) will be used to assess the intensity of depressive symptoms. This
scale is the reference scale in this area, it includes ten items that assess different
aspects of depressive symptomatology.
HAM-A (14 items) (Hamilton Anxiety Rating Scale) (Hamilton, 1959 Pichot, 1959) is a scale for
measuring state anxiety. This scale have an intensity score of general anxiety, consisting of
two sub-scores for somatic anxiety one hand, and on the other psychic anxiety.
• Self evaluation These tools are questionnaires that are completed by the person who
self-evaluated.
BDI-II (21 items) (Beck Depression Inventory 2nd ed) assesses the severity of depressive
symptoms. Twenty-one groups of statements on the different symptoms of depression are
available, the patient selects the one that best matches how he feels. The advantage of
choosing this tool is that it assesses different aspects of depression both in terms of
physical symptoms that cognitive and emotional.
HADS (14 items) (Hospital Anxiety Depression Scale). This scale assesses the severity of
depressive and anxious symptomatology. This is the most used tool in all somatic diseases and
neurological particular. This survey presents the advantage of being very short, while
assessing symptoms both somatic and psychological symptomatology of these.
Brief-COPE (28 items):
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 behavioral.
WHOQOL BREF is a scale assessing the quality of life using 26 items, including two related to
the overall quality of life. This questionnaire allows us to understand dimensionally the
subjective perception of the person's life, in the different fields that can compose.
Physical health: including aspects such as pain, fatigue or working abilities; mental health:
composed among others by the positive and negative emotions and self-esteem; social
relations: including personal, private life or the available social support; and finally the
living environment with elements such as financial resources, access to information
resources, recreation, etc ...
• Ambulatory Measures: ESM / EMA These measures will be carried out via a smartphone app. The
selected items are from previous studies that measured these variables, or built specifically
for the study on the basis of validated tools.
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 statements those that match their response,
for example: "I turned (e) to work or other activities to take my mind. "
Evaluation methods used at different times of the study:
Preservation and analysis of data:
A basic anonymous data will be created. Only the investigator will have access to the
concordance table to link the questionnaires completed by patients with data in the database
is created.
The statistical study will be conducted by the investigator himself locally in the hospital
Saint Joseph group. There will be no exchange of data. Different statistical tests will be
used to analyze the data: analyzes of variances, correlations, regressions. Investigators
will try and update significant associations between depressive and anxious symptoms, coping
and quality of life during the first months after stroke, controlling the influence variables
effect (neurological status, level autonomy, hospital stay and time of return home, etc ...).
Investigators will compare the evolution of different dimensions between the two subgroups of
patients (back home or inpatient rehabilitation T1 service).
Medical information on stroke and data on the effects (cognitive and motor functions
affected, severity of sequelae, areas in which autonomy would eventually be reduced, type and
location of stroke, etc ...) will be account when analyzing the results to investigate the
possible existence of links between and anxiety and depression levels.
The data stored on smartphones will be transferred directly to the smartphone to the computer
that will store the data; is hosted on a secure server certified. In this case, the server
will either already obtained the necessary authorizations CNIL; or an application will be
made.
Expected results
The general clinical significance of this project is to determine the elements for
identifying, at the time of initial hospitalization following a stroke, patients at risk of
adversely psychological evolution as physical and medical condition allows them to quickly
return home.
The results will have an interest in both the assessment on the management of post-stroke
psychiatric disorders: distinguishing characteristics of depression and anxiety consecutive
in this event in order to facilitate the diagnosis from the acute phase stroke and direct
support. The symptomatological risk profiles can thus be detected and specific therapies on
the prominent symptoms such disorders in the field of stroke may be proposed and / or
developed.
Moreover, the results will enable a greener and more detailed understanding of the process
connecting the individual coping strategies, post-stroke psychological problems and quality
of life in various important time of the disease.
project interests Our project has several interests. First, it provides a longitudinal study
tracking over the first months post-stroke, combining several complementary assessment
methods that will enable a more comprehensive representation of psychological manifestations:
standardized tools traditionally used and more environmentally friendly methods.
This design study should provide a better understanding of psychic and their development at
key stages of life process for patients after stroke (hospitalization in another service,
return home).
Several clinical implications are expected: develop prevention of post-stroke psychological
problems by allowing the specific identification of depression and anxiety from the acute
phase; identify targeted supported on the specifics of these disorders in the field of
stroke; improve Supported favoring the development of coping strategies associated with
long-term mental health and to reduce those associated with negative development; understand
how these healthy patients after stroke and quickly return home, live these important steps
to provide support tailored to suit their specific needs.
