SchizophreniaMetaCOGNITIONNCT04590300
Impact of Cognitive & Metacognitive Performance on Knowledge Learning When Conducting Therapeutic Education Programs
A study testing QUESTIONNAIRES in people with Schizophrenia and Bipolar Disorder, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
Trial summary
People with schizophrenia and bipolar disorder display alterations in cognition and metacognition. These alterations may have an impact on learning during therapeutic education programs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- QUESTIONNAIRES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2020to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent to participate in the study,
- Suffering from a chronic condition for which an therapeutic patient education (TEP) program is proposed.
- Mastering the French language.
- Be a beneficiary of health insurance
Who cannot join
- Poor understanding of instructions that make it impossible to consent or assess
- Neurodegenerative disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Des Performances Cognitives et métacognitives Sur l'Apprentissage de Connaissances Lors de la réalisation de Programmes d'éducation thérapeutique
People with schizophrenia and bipolar disorder display alterations in cognition and metacognition. These alterations may have an impact on learning during therapeutic education programs.
Read the detailed description
Patient Therapeutic Education (FTE) is defined as a practice to help patients to acquire or maintain the skills needed to best manage their lives with a chronic disease. FTE includes organized awareness, information, learning and psychological and social assistance about the disease, prescribed treatments, various treatments offered, as well as information on organization of the global health system, and health behaviours. Performed by health professionals trained in this practice, FTE is intended to help patients and their close relatives and to understand their pathology, their treatments, collaborate with health care teams, and maintain or improve their quality of life. It aims to produce a complementary therapeutic effect of other health care interventions
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- QUESTIONNAIRES
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUESTIONNAIRESOther
1 questionnaire at the beginning of the study, before FTE program
1 questionnaire at the end of FTE
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Other | 1 questionnaire at the beginning of the study, before FTE program
1 questionnaire at the end of FTE Receives: Other: QUESTIONNAIRES |
| Bipolar disorder | Other | 1 questionnaire at the beginning of the study, before FTE program
1 questionnaire at the end of FTE Receives: Other: QUESTIONNAIRES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of cognitive impairments on knowledge acquired through a therapeutic education program with Montreal Cognitive Assessment (MoCA)
assess the impact of possible cognitive impairments on knowledge acquired through a therapeutic education program Minimum value = 0 \& Maximum value = 30 Score < 26 is considered as abnormal
Measured: 1 year
Evaluation of metacognitive impairments on knowledge acquired through a therapeutic education program with Subjective Scale To Investigate Cognition in Schizophrenia (SSTICS)
assess the impact of possible metacognitive impairments on knowledge acquired through a therapeutic education program Minimum value 21
Measured: 1 year
Secondary outcomes (4)
assess the impact of self esteem acquired through a therapeutic education program with Rosenberg scale
assess the evolution in self-esteem following this program.
Measured: 1 year
assess the impact of level of anxiety, acquired through a therapeutic education program with State-Trait-Anxiety Inventory (Forme Y) (STAI-Y) questionnaire
assess the evolution in level of anxiety following this program.
Measured: 1 year
assess the impact of depressive symptomatology acquired through a therapeutic education program with Center for Epidemiologic Studies-Depression (CES-D) scale
assess the evolution in depressive symptoms following this program.
Measured: 1 year
assess the impact of literacy on knowledge acquired through a therapeutic education program with Rapid Estimate for Adult Literacy in Medicine (REALM-R) questionnaire
assess the evolution in quality of life following this program.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start6 Oct 2020
- Primary completion1 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Clelia QUILES, MD, Principal investigator, CH Charles Perrens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590300
- Sponsor's protocol ID
- 2020-A00980-39
- Acronym
- MetaCOGNITION
- Status last verified
- Mar 2023
- First submitted
- 10 Sep 2020
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xia J, Merinder LB, Belgamwar MR. Psychoeducation for schizophrenia. Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD002831. doi: 10.1002/14651858.CD002831.pub2.
PubMed 21678337Soo SA, Zhang ZW, Khong SJ, Low JEW, Thambyrajah VS, Alhabsyi SHBT, Chew QH, Sum MY, Sengupta S, Vieta E, McIntyre RS, Sim K. Randomized Controlled Trials of Psychoeducation Modalities in the Management of Bipolar Disorder: A Systematic Review. J Clin Psychiatry. 2018 May/Jun;79(3):17r11750. doi: 10.4088/JCP.17r11750.
PubMed 29727072Flavell J.H. Metacognition and cognitive monitoring. A new area of cognitive-developmental inquiry. Am Psychol. 1979; 34(10):906-11
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Des Performances Cognitives et métacognitives Sur l'Apprentissage de Connaissances Lors de la réalisation de Programmes d'éducation thérapeutique
- ClinicalTrials.gov ID
- NCT04590300
- Acronym / sponsor ID
- MetaCOGNITION / 2020-A00980-39
- Conditions
- Schizophrenia, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- 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.
People with schizophrenia and bipolar disorder display alterations in cognition and metacognition. These alterations may have an impact on learning during therapeutic education programs.
Detailed description
Patient Therapeutic Education (FTE) is defined as a practice to help patients to acquire or maintain the skills needed to best manage their lives with a chronic disease. FTE includes organized awareness, information, learning and psychological and social assistance about the disease, prescribed treatments, various treatments offered, as well as information on organization of the global health system, and health behaviours. Performed by health professionals trained in this practice, FTE is intended to help patients and their close relatives and to understand their pathology, their treatments, collaborate with health care teams, and maintain or improve their quality of life. It aims to produce a complementary therapeutic effect of other health care interventions
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | Other | Other: QUESTIONNAIRES1 questionnaire at the beginning of the study, before FTE program 1 questionnaire at the end of FTE |
| Bipolar disorder | Other | Other: QUESTIONNAIRES1 questionnaire at the beginning of the study, before FTE program 1 questionnaire at the end of FTE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consent to participate in the study,
- Suffering from a chronic condition for which an therapeutic patient education (TEP) program is proposed.
- Mastering the French language.
- Be a beneficiary of health insurance
Key exclusion criteria (2 listed)
- Poor understanding of instructions that make it impossible to consent or assess
- Neurodegenerative disease
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 |
|---|---|---|
| QUESTIONNAIRES1 questionnaire at the beginning of the study, before FTE program 1 questionnaire at the end of FTE | Other | Bipolar disorder, Schizophrenia |
Primary outcome
Evaluation of cognitive impairments on knowledge acquired through a therapeutic education program with Montreal Cognitive Assessment (MoCA)
Time frame: 1 year
assess the impact of possible cognitive impairments on knowledge acquired through a therapeutic education program Minimum value = 0 \& Maximum value = 30 Score < 26 is considered as abnormal
Evaluation of metacognitive impairments on knowledge acquired through a therapeutic education program with Subjective Scale To Investigate Cognition in Schizophrenia (SSTICS)
Time frame: 1 year
assess the impact of possible metacognitive impairments on knowledge acquired through a therapeutic education program Minimum value 21
4 secondary outcomes
assess the impact of self esteem acquired through a therapeutic education program with Rosenberg scale
Time frame: 1 year
assess the impact of level of anxiety, acquired through a therapeutic education program with State-Trait-Anxiety Inventory (Forme Y) (STAI-Y) questionnaire
Time frame: 1 year
assess the impact of depressive symptomatology acquired through a therapeutic education program with Center for Epidemiologic Studies-Depression (CES-D) scale
Time frame: 1 year
assess the impact of literacy on knowledge acquired through a therapeutic education program with Rapid Estimate for Adult Literacy in Medicine (REALM-R) questionnaire
Time frame: 1 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 18 Jun 2024.
- Background: PubMed 21678337Xia J, Merinder LB, Belgamwar MR. Psychoeducation for schizophrenia. Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD002831. doi: 10.1002/14651858.CD002831.pub2.
- Background: PubMed 29727072Soo SA, Zhang ZW, Khong SJ, Low JEW, Thambyrajah VS, Alhabsyi SHBT, Chew QH, Sum MY, Sengupta S, Vieta E, McIntyre RS, Sim K. Randomized Controlled Trials of Psychoeducation Modalities in the Management of Bipolar Disorder: A Systematic Review. J Clin Psychiatry. 2018 May/Jun;79(3):17r11750. doi: 10.4088/JCP.17r11750.
- BackgroundFlavell J.H. Metacognition and cognitive monitoring. A new area of cognitive-developmental inquiry. Am Psychol. 1979; 34(10):906-11
- Individual participant dataSharing planned: No
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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.
Clelia QUILES, MD principal investigator
CH Charles Perrens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QUESTIONNAIRES in people with Schizophrenia and Bipolar Disorder, run by Centre Hospitalier Charles Perrens, Bordeaux 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 18 Jun 2024. 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?
Evaluation of cognitive impairments on knowledge acquired through a therapeutic education program with Montreal Cognitive Assessment (MoCA) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590300, which also lists 3 linked publications.
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 18 Jun 2024.