Adams-Stokes SyndromePS-POST AVCNCT01630005
Talk Therapy After Stroke
A study testing talk therapy in people with Adams-Stokes Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adams-Stokes Syndrome
- What is being tested?
- talk therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic or aemoragic stroke minor 1 week, confirmed by cerebral imaging
Who cannot join
- severe aphasia (NIHSS criteria 9: sup or egal: 2)
- Chronic psychiatric preexistant desease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Adams-Stokes Syndrome
- Being tested
- talk therapy
- Medical subject headings
- Adams-Stokes Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talk therapyBehavioural
Psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Talk therapy | Experimental | A cohort of 25 patients Receives: Behavioral: talk therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptability
Participation rate in the study
Measured: at 6 months
Secondary outcomes (5)
Rates of anxiety and depression
Montgomery and Asberg Depression Rating Scale(depressive patients) and wide COVI (anxious patients)
Measured: at 3 and 6 months
Evaluation of quality of life
MM20-QOL scale
Measured: at 3 and 6 months
Evaluation of functional recovery
- Barthel index and Rankin score
- NIHSS score
Measured: at 3 and 6 months
Assessment of apathy
apathy index
Measured: at 3 and 6 months
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startFeb 2011
- Primary completionMay 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adams-Stokes SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène MAHAGNE, PH, Study director, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630005
- Sponsor's protocol ID
- 2010-A00905-34
- Acronym
- PS-POST AVC
- Status last verified
- Dec 2010
- First submitted
- 20 Feb 2012
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Talk Therapy After Stroke. PS-POST AVC
- ClinicalTrials.gov ID
- NCT01630005
- Acronym / sponsor ID
- PS-POST AVC / 2010-A00905-34
- Conditions
- Adams-Stokes Syndrome
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Talk therapy | Experimental | Behavioral: talk therapyA cohort of 25 patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ischemic or aemoragic stroke minor 1 week, confirmed by cerebral imaging
Key exclusion criteria (2 listed)
- severe aphasia (NIHSS criteria 9: sup or egal: 2)
- Chronic psychiatric preexistant desease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| talk therapyPsychotherapy | Behavioural | Talk therapy |
Primary outcome
acceptability
Time frame: at 6 months
Participation rate in the study
5 secondary outcomes
Rates of anxiety and depression
Time frame: at 3 and 6 months
Evaluation of quality of life
Time frame: at 3 and 6 months
Evaluation of functional recovery
Time frame: at 3 and 6 months
Assessment of apathy
Time frame: at 3 and 6 months
Categorization of patients
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène MAHAGNE, PH study director
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing talk therapy in people with Adams-Stokes Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acceptability (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015; AzTrials last refreshed its copy on 30 Oct 2026.