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Talk Therapy After Stroke (PS-POST AVC)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01630005
First Posted: June 28, 2012
Last Update Posted: November 2, 2015
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.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
  Purpose
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 Intervention
Adams-Stokes Syndrome Behavioral: talk therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Talk Therapy After Stroke. PS-POST AVC

Further study details as provided by Centre Hospitalier Universitaire de Nice:

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


Secondary Outcome Measures:
  • 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)

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

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

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

  • 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)


Enrollment: 2
Study Start Date: February 2011
Study Completion Date: March 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Talk therapy
A cohort of 25 patients
Behavioral: talk therapy
Psychotherapy

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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): NCT01630005


Locations
France
CHU Nice
Nice, France, 06200
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Study Director: Hélène MAHAGNE, PH CHU de Nice
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01630005     History of Changes
Other Study ID Numbers: 2010-A00905-34
First Submitted: February 20, 2012
First Posted: June 28, 2012
Last Update Posted: November 2, 2015
Last Verified: December 2010

Additional relevant MeSH terms:
Adams-Stokes Syndrome
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes