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Talk Therapy After Stroke (PS-POST AVC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01630005
Recruitment Status : Terminated
First Posted : June 28, 2012
Last Update Posted : November 1, 2015
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:
Strokes are the first cause of acquired physical disability among adults. Some studies proved that depression is often an unrecognized complication from stroke, associated with a vital prognosis, functional and cognitive pejorative diagnosis. It led us to pose the hypothesis of the existence of a particular psychological state after stroke particularly favorable to a psychotherapeutic alliance. So, this longitudinal monocentric study aims to estimate the feasibility of a talk therapy and its impact on the anxio-depressive symptomatology after stroke.

Condition or disease Intervention/treatment Phase
Adams-Stokes Syndrome Behavioral: talk therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Talk Therapy After Stroke. PS-POST AVC
Study Start Date : February 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: Talk therapy
A cohort of 25 patients
Behavioral: talk therapy

Primary Outcome Measures :
  1. acceptability [ Time Frame: at 6 months ]
    Participation rate in the study

Secondary Outcome Measures :
  1. Rates of anxiety and depression [ Time Frame: at 3 and 6 months ]
    Montgomery and Asberg Depression Rating Scale(depressive patients) and wide COVI (anxious patients)

  2. Evaluation of quality of life [ Time Frame: at 3 and 6 months ]
    MM20-QOL scale

  3. Evaluation of functional recovery [ Time Frame: at 3 and 6 months ]
    • Barthel index and Rankin score
    • NIHSS score

  4. Assessment of apathy [ Time Frame: at 3 and 6 months ]
    apathy index

  5. Categorization of patients [ Time Frame: 6 months ]
    according to their pattern of coping with specific scales and RWCQ (Revised Ways of Coping Questionnaire - stroke modified version) QSSP (Questionnaire de soutien social perçu)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ischemic or aemoragic stroke minor 1 week, confirmed by cerebral imaging

Exclusion Criteria:

  • severe aphasia (NIHSS criteria 9: sup or egal: 2)
  • Chronic psychiatric preexistant desease.

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 identifier (NCT number): NCT01630005

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CHU Nice
Nice, France, 06200
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Study Director: Hélène MAHAGNE, PH Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice Identifier: NCT01630005    
Other Study ID Numbers: 2010-A00905-34
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: November 1, 2015
Last Verified: December 2010
Additional relevant MeSH terms:
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Adams-Stokes Syndrome
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes