Talk Therapy After Stroke | NCT01630005

Studies
Talk Therapy After Stroke

NCT01630005

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Terminated

Last Update Posted

Nov 2, 2015Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

Adams-Stokes Syndrome

Interventions

talk therapy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

May 2012Actual

Completion Date

Mar 2013Actual

First Submitted Date

Feb 20, 2012

First Submission Date that Met QC Criteria

Jun 26, 2012

First Posted Date

Jun 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2015

Last Update Posted Date

Nov 2, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Talk therapy	Experimental	A cohort of 25 patients	Behavioral: talk therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
talk therapy	Behavioral	Psychotherapy	Talk therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
acceptability	Participation rate in the study	at 6 months

Secondary Outcomes

Measure	Description	Time Frame
Rates of anxiety and depression	Montgomery and Asberg Depression Rating Scale(depressive patients) and wide COVI (anxious patients)	at 3 and 6 months
Evaluation of quality of life	MM20-QOL scale

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hélène MAHAGNE, PH	Centre Hospitalier Universitaire de Nice	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Nice		Nice		06200	France

Condition Browse Module

MeSH Terms

ID	Term
D000219	Adams-Stokes Syndrome

Ancestor Terms

ID	Term
D006327	Heart Block
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011613	Psychotherapy

Ancestor Terms

ID	Term
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided