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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
History of Changes
  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:

MedlinePlus related topics: Depression
U.S. FDA Resources

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
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 May 19, 2013