Schizophrenia, UndifferentiatedEPRNCT03028545
Representations and Strategies for Recovery
A study testing Collection of the individual narrative, semi-directed interviews in people with Schizophrenia, Undifferentiated and Anorexia, run by Hôpital le Vinatier at 1 site in France.
Trial summary
In the recent context of deinstitutionalization and longitudinal studies pointing to a large number of positive long-term outcommes for people affected by a psychiatric disorder (schizophrenia, bipolar disorder, eating disorder, severe personality disorder, etc.), the possibility of overcoming the consequences of a… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Schizophrenia, Undifferentiated, Anorexia, Bipolar Disorders
- What is being tested?
- Collection of the individual narrative, semi-directed interviews
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2017to 31 Mar 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years
- Psychiatric diagnosis according to DSM V critera of schizophrenia, eating disorder, bipolar disorder, personality disorder
- In recovery scale
- Informed of their diagnosis
Who cannot join
- Acute psychiatric state
- Poor understanding of french language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Representations, Strategies and Identity Redefinition in the Recovery Process: Exploratory Study
In the recent context of deinstitutionalization and longitudinal studies pointing to a large number of positive long-term outcommes for people affected by a psychiatric disorder (schizophrenia, bipolar disorder, eating disorder, severe personality disorder, etc.), the possibility of overcoming the consequences of a psychiatric pathology emerges as a solid fact. Therefore, the existence of this possibility calls for the identification of the determinants underlying of the various outcomes over time of those affected by a severe psychiatric disorder, in particular those likely to underpin the most positive developments.
While it is well known from a medical point of view that certain dimensions affect the prognosis of persons affected by a severe psychiatric disorder (such as the persistence of negative symptoms or cognitive disorders in schizophrenic disorders), prognosis from a purely medical perspective (and putting aside the role of the person and his environment) seems to be able to account only for a modest proportion of the prognosis of people affected by a serious psychiatric disorder.
Read more
It is this fact that has gradually led to the emergence of complementary models capable of enriching the understanding of the determinants of the future of people affected by a severe psychiatric disorder, in particular models inviting to separate "becoming of the person" from the " psychiatric disorder "to take into account the" personal role of the person "in his or her own healing. This perspective is the "recovery" perspective.
Recovery process is defined as a personal trajectory which includes the person's experiences and the reactions of his / her environment following the installation of a psychiatric disorder, which can support a mode of release of the status of "psychiatric patient". Recovery thus implies an "approach underpinned by the understanding of the human response to pathology" (Noiseux) and, one might add, of its environment.
However, while these studies point to a number of crucial dimensions involved in the recovery of a severe psychiatric disorder, one of the important limitations of these studies is the distance from any psychopathological consideration, thus setting aside the possibility of specific processes of recovery depending of the pathology. The identification of recurrent experiential logics specific to the various psychiatric disorders therefore appears to be an important field of investigation. It would potentially be able to guide the development of new therapeutic devices based on the recovery model.
Read the detailed description
- Elaboration of a semi directed grid (exploratory phase)
- Collection of individual narratives
- Data analysis, according to IPA method (interpretative phenomenological analysis)
- On the basis of individual narratives
- On the basis of a focus group
- Publication of results
- Being tested
- Collection of the individual narrative, semi-directed interviews
- Keywords
- schizophrenia, anorexia, bipolar disorders, personality disorders
- Medical subject headings
- Schizophrenia, Disorders of Sex Development, Anorexia, Bipolar Disorder, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of the individual narrative, semi-directed interviewsBehavioural
Visit one : individual interview Individual narrative Passing Psychometric Measurement Scales of Recovery: Score at Warwick and Wellness Scale Andreasen scale score Visit two Focus group
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia | Other | Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in schizophrenia Receives: Behavioral: Collection of the individual narrative, semi-directed interviews |
| bipolar disorders | Other | Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in bipolar disorders Receives: Behavioral: Collection of the individual narrative, semi-directed interviews |
| eating disorders | Other | Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in eating disorders Receives: Behavioral: Collection of the individual narrative, semi-directed interviews |
| personality disorders | Other | Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in personality disorders Receives: Behavioral: Collection of the individual narrative, semi-directed interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of individual narratives to understand the recovery process
Semi-directed maintenance grid
Measured: one year
Secondary outcomes (2)
Change from baseline in the Quality of Well-Being at one year
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Measured: one year
Change from baseline in measures of psychological recovery at one year
Stages of recovery instrument (STORI ANDREASEN)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start4 Jan 2017
- Primary completion30 Sep 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia, UndifferentiatedStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARTIN BRICE, MD/PhD, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028545
- Sponsor's protocol ID
- 2016-A01049-42
- Acronym
- EPR
- Status last verified
- Jun 2020
- First submitted
- 17 Jan 2017
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Representations, Strategies and Identity Redefinition in the Recovery Process: Exploratory Study
- ClinicalTrials.gov ID
- NCT03028545
- Acronym / sponsor ID
- EPR / 2016-A01049-42
- Keywords
- schizophrenia, anorexia, bipolar disorders, personality disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 23 Jan 2017 (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.
In the recent context of deinstitutionalization and longitudinal studies pointing to a large number of positive long-term outcommes for people affected by a psychiatric disorder (schizophrenia, bipolar disorder, eating disorder, severe personality disorder, etc.), the possibility of overcoming the consequences of a psychiatric pathology emerges as a solid fact. Therefore, the existence of this possibility calls for the identification of the determinants underlying of the various outcomes over time of those affected by a severe psychiatric disorder, in particular those likely to underpin the most positive developments.
While it is well known from a medical point of view that certain dimensions affect the prognosis of persons affected by a severe psychiatric disorder (such as the persistence of negative symptoms or cognitive disorders in schizophrenic disorders), prognosis from a purely medical perspective (and putting aside the role of the person and his environment) seems to be able to account only for a modest proportion of the prognosis of people affected by a serious psychiatric disorder.
It is this fact that has gradually led to the emergence of complementary models capable of enriching the understanding of the determinants of the future of people affected by a severe psychiatric disorder, in particular models inviting to separate "becoming of the person" from the " psychiatric disorder "to take into account the" personal role of the person "in his or her own healing. This perspective is the "recovery" perspective.
Recovery process is defined as a personal trajectory which includes the person's experiences and the reactions of his / her environment following the installation of a psychiatric disorder, which can support a mode of release of the status of "psychiatric patient". Recovery thus implies an "approach underpinned by the understanding of the human response to pathology" (Noiseux) and, one might add, of its environment.
However, while these studies point to a number of crucial dimensions involved in the recovery of a severe psychiatric disorder, one of the important limitations of these studies is the distance from any psychopathological consideration, thus setting aside the possibility of specific processes of recovery depending of the pathology. The identification of recurrent experiential logics specific to the various psychiatric disorders therefore appears to be an important field of investigation. It would potentially be able to guide the development of new therapeutic devices based on the recovery model.
Detailed description
- Elaboration of a semi directed grid (exploratory phase)
- Collection of individual narratives
- Data analysis, according to IPA method (interpretative phenomenological analysis)
- On the basis of individual narratives
- On the basis of a focus group
- Publication of results
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| schizophrenia | Other | Behavioral: Collection of the individual narrative, semi-directed interviewsExploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in schizophrenia |
| bipolar disorders | Other | Behavioral: Collection of the individual narrative, semi-directed interviewsExploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in bipolar disorders |
| eating disorders | Other | Behavioral: Collection of the individual narrative, semi-directed interviewsExploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in eating disorders |
| personality disorders | Other | Behavioral: Collection of the individual narrative, semi-directed interviewsExploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in personality disorders |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80 years
- Psychiatric diagnosis according to DSM V critera of schizophrenia, eating disorder, bipolar disorder, personality disorder
- In recovery scale
- Informed of their diagnosis
Key exclusion criteria (2 listed)
- Acute psychiatric state
- Poor understanding of french language
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 |
|---|---|---|
| Collection of the individual narrative, semi-directed interviewsVisit one : individual interview Individual narrative Passing Psychometric Measurement Scales of Recovery: Score at Warwick and Wellness Scale Andreasen scale score Visit two Focus group | Behavioural | bipolar disorders, eating disorders, personality disorders, schizophrenia |
Primary outcome
Collection of individual narratives to understand the recovery process
Time frame: one year
Semi-directed maintenance grid
2 secondary outcomes
Change from baseline in the Quality of Well-Being at one year
Time frame: one year
Change from baseline in measures of psychological recovery at one year
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: No
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.
MARTIN BRICE, MD/PhD principal investigator
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of the individual narrative, semi-directed interviews in people with Schizophrenia, Undifferentiated and Anorexia, run by Hôpital le Vinatier 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 4 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: finished, as of the sponsor's last update on 17 Jun 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Collection of individual narratives to understand the recovery process (time frame: one year). 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 17 Jun 2020.