- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01630005
Talk Therapy After Stroke (PS-POST AVC)
October 30, 2015 updated by: Centre Hospitalier Universitaire de Nice
Talk Therapy After Stroke. PS-POST AVC
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nice, France, 06200
- CHU Nice
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Talk therapy
A cohort of 25 patients
|
Psychotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
acceptability
Time Frame: at 6 months
|
Participation rate in the study
|
at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
at 3 and 6 months
|
|
Evaluation of quality of life
Time Frame: at 3 and 6 months
|
MM20-QOL scale
|
at 3 and 6 months
|
|
Evaluation of functional recovery
Time Frame: at 3 and 6 months
|
|
at 3 and 6 months
|
|
Assessment of apathy
Time Frame: at 3 and 6 months
|
apathy index
|
at 3 and 6 months
|
|
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)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Hélène MAHAGNE, PH, Centre Hospitalier Universitaire de Nice
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
February 20, 2012
First Submitted That Met QC Criteria
June 26, 2012
First Posted (Estimate)
June 28, 2012
Study Record Updates
Last Update Posted (Estimate)
November 1, 2015
Last Update Submitted That Met QC Criteria
October 30, 2015
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-A00905-34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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