Talk Therapy After Stroke (PS-POST AVC)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01630005
First received: February 20, 2012
Last updated: January 23, 2013
Last verified: December 2010
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Talk Therapy After Stroke. PS-POST AVC

Resource links provided by NLM:


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

Primary Outcome Measures:
  • acceptability [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Participation rate in the study


Secondary Outcome Measures:
  • Rates of anxiety and depression [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    MM20-QOL scale

  • Evaluation of functional recovery [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: No ]
    • Barthel index and Rankin score
    • NIHSS score

  • Assessment of apathy [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: No ]
    apathy index

  • Categorization of patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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
Estimated 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01630005     History of Changes
Other Study ID Numbers: 2010-A00905-34
Study First Received: February 20, 2012
Last Updated: January 23, 2013
Health Authority: France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on August 20, 2014