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Talk Therapy After Stroke (PS-POST AVC)

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ClinicalTrials.gov Identifier: NCT01630005
Recruitment Status : Terminated
First Posted : June 28, 2012
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Adams-Stokes Syndrome Behavioral: talk therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
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
Primary Completion Date : May 2012
Study Completion Date : March 2013
Arms and Interventions

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


Outcome Measures

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)


Eligibility Criteria

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 Posted: June 28, 2012    Key Record Dates
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