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NCT01630005 Clinical Trial

Talk Therapy After Stroke

Adams-Stokes Syndrome Clinical Trial

— PS-POST AVC  

Official title:
Talk Therapy After Stroke. PS-POST AVC

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01630005
Other study ID # 2010-A00905-34
Secondary ID
Status Terminated
Phase N/A
First received February 20, 2012
Last updated October 30, 2015
Start date February 2011
Est. completion date March 2013

Study information
Verified date December 2010
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date March 2013
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• talk therapy
Psychotherapy

Locations
Country Name City State
France CHU Nice Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary acceptability Participation rate in the study at 6 months No
Secondary Rates of anxiety and depression Montgomery and Asberg Depression Rating Scale(depressive patients) and wide COVI (anxious patients) at 3 and 6 months No
Secondary Evaluation of quality of life MM20-QOL scale at 3 and 6 months No
Secondary Evaluation of functional recovery Barthel index and Rankin score
NIHSS score		 at 3 and 6 months No
Secondary Assessment of apathy apathy index at 3 and 6 months No
Secondary Categorization of patients 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) 6 months No