SchizophreniaPlaniRevNCT04011774
Planning Your Everyday Life in Virtual Reality : a Study in Schizophrenia;
A study testing PLANI-REV and RELAXATION in people with Schizophrenia, run by Centre Hospitalier St Anne at 4 sites in France.
Trial summary
Patients with schizophrenia , who visit frenquently day-care or day-care activities clinics, often experience difficulties of daily living and cognitive deficits. Living independently is a key for recovery. Cognitive remediation is a therapy which reduces deficit and improves daily living. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- PLANI-REV and RELAXATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 4 sitesFrance
- Study dates
- 9 Oct 2018to 9 Aug 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years old.
- Diagnostic of schizophrenia or schizoaffective disorder (DSM V), attested by the MINI structured interview (Shehan et al. 1998)
- Who visit for months or year, weekly or several times per week, a day care, or therapeutic activity units outpatients clinics and nursing homes
- French Mother tongue
- Consent of the legal representative caregiver for the patients under representative law (tutelle in French).
- Clinical Stability - Therapeutic stability for at least one month.
- National healthcare assurance
Who cannot join
- Central Neurological or non stabilized somatic diseases.
- Treatments for somatic disease with putative psychotropic effect.
- Electroconvulsive therapy in the last six months
- Illetrism
- IQ< 70 established with the f-NART.
- Substance misuse or dependence (except Nicotine) or toxic for more than 5 years.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier DURANT
Étampes
François PETITJEAN, MD
- Recruiting
Hopital les Murets
La Queue-en-Brie, 94510
Olivier QUENZER, MD
- Recruiting
Centre Hospitalier Sainte Anne
Paris, 75674
Isabelle AMADO, MD, i.amado@ch-sainte-anne.fr
Sylvie DOROCANT, s.dorocant@ch-sainte-anne.fr
- Recruiting
Centre Hospitalier Guillaume Régnier
Rennes, 35703
David LEVOYER, MD
About this study
Official title: PLANning Your Every Day Life I Virtual REality : a Study Schizophrenia. Mathurin Serious Game
Patients with schizophrenia , who visit frenquently day-care or day-care activities clinics, often experience difficulties of daily living and cognitive deficits. Living independently is a key for recovery. Cognitive remediation is a therapy which reduces deficit and improves daily living. Nowadays no program exists targeting neurocognitive functions in virtual reality which could mimic everyday life in a virtual town.
Hypotheses :
- Persons with schizophrenia experience difficulties in daily living and disabilities to plan in everyday life. PLANI-REV program, a serious game with a navigation in a virtual town, in a 15 weekly group sessions could reduce these difficulties compared to the initial assessment. This improvement could be maintained 6 months after the end of the program.
- PLANI-REV could also improve prospective memory, attention, working memory, and visuospatial organization.
- PLANI-REV could induce a clinical improvement, as well as better perception of self-efficiency, self esteem, quality of life, and conversation skills.
- Conditions
- Schizophrenia
- Being tested
- PLANI-REV, RELAXATION
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLANI-REVOther
Cognitive remediation program.
RELAXATIONOther
Stimulation with no cognitive remediation.
| Study group | Role | What they receive |
|---|---|---|
| PLANI-REV | Experimental | Persons with schizophrenia who will benefit from the fifteen weekly sessions of PLANI-REV group program Receives: Other: PLANI-REV |
| RELAXATION | Active comparator | Persons with schizophrenia who will benefit from a non cognitive stimulation, namely RELAXATION, in a day-care clinic or day-care therapeutic activities center during fifteen weekly sessions. This activity will be 15 groups sessions of relaxation. Receives: Other: RELAXATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of PLANI-REV : questionnaire scores
the comparison pre/post PLANI-REV of the number of difficulties of daily life using the Profinteg questionnaire
Measured: 10 months
Secondary outcomes (1)
- Profinteg scores 6 months after PLANI-REV. Number of problematic activities; average score for difficulties of problematic activities.
To improve pre/post PLANI-REV and 6 months after, neuropsychological performances in prospective memory, attention, working memory, executive functions, and visual and spatial organization
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start9 Oct 2018
- Primary completion9 Aug 2024 (estimated)
- Study completion9 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle AMADO, MD, Principal investigator, CHSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011774
- Sponsor's protocol ID
- D17-P025
- Acronym
- PlaniRev
- Status last verified
- Jul 2022
- First submitted
- 29 Apr 2019
- Last updated
- 13 Dec 2022
- Results posted
- 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 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLANning Your Every Day Life I Virtual REality : a Study Schizophrenia. Mathurin Serious Game
- ClinicalTrials.gov ID
- NCT04011774
- Acronym / sponsor ID
- PlaniRev / D17-P025
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 9 Aug 2024 (estimated)
- Study completion
- 9 Aug 2024 (estimated)
- First posted
- 8 Jul 2019 (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.
Patients with schizophrenia , who visit frenquently day-care or day-care activities clinics, often experience difficulties of daily living and cognitive deficits. Living independently is a key for recovery. Cognitive remediation is a therapy which reduces deficit and improves daily living. Nowadays no program exists targeting neurocognitive functions in virtual reality which could mimic everyday life in a virtual town.
Hypotheses :
- Persons with schizophrenia experience difficulties in daily living and disabilities to plan in everyday life. PLANI-REV program, a serious game with a navigation in a virtual town, in a 15 weekly group sessions could reduce these difficulties compared to the initial assessment. This improvement could be maintained 6 months after the end of the program.
- PLANI-REV could also improve prospective memory, attention, working memory, and visuospatial organization.
- PLANI-REV could induce a clinical improvement, as well as better perception of self-efficiency, self esteem, quality of life, and conversation skills.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLANI-REV | Experimental | Other: PLANI-REVPersons with schizophrenia who will benefit from the fifteen weekly sessions of PLANI-REV group program |
| RELAXATION | Active comparator | Other: RELAXATIONPersons with schizophrenia who will benefit from a non cognitive stimulation, namely RELAXATION, in a day-care clinic or day-care therapeutic activities center during fifteen weekly sessions. This activity will be 15 groups sessions of relaxation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 and 50 years old.
- Diagnostic of schizophrenia or schizoaffective disorder (DSM V), attested by the MINI structured interview (Shehan et al. 1998)
- Who visit for months or year, weekly or several times per week, a day care, or therapeutic activity units outpatients clinics and nursing homes
- French Mother tongue
- Consent of the legal representative caregiver for the patients under representative law (tutelle in French).
Key exclusion criteria (6 listed)
- Central Neurological or non stabilized somatic diseases.
- Treatments for somatic disease with putative psychotropic effect.
- Electroconvulsive therapy in the last six months
- Illetrism
- IQ< 70 established with the f-NART.
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 |
|---|---|---|
| PLANI-REVCognitive remediation program. | Other | PLANI-REV |
| RELAXATIONStimulation with no cognitive remediation. | Other | RELAXATION |
Primary outcome
Efficacy of PLANI-REV : questionnaire scores
Time frame: 10 months
the comparison pre/post PLANI-REV of the number of difficulties of daily life using the Profinteg questionnaire
1 secondary outcome
- Profinteg scores 6 months after PLANI-REV. Number of problematic activities; average score for difficulties of problematic activities.
Time frame: 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- 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.
Isabelle AMADO, MD principal investigator
CHSA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLANI-REV and RELAXATION in people with Schizophrenia, run by Centre Hospitalier St Anne at 4 sites 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle AMADO, MD (+33 1 45 65 81 80, i.amado@ch-sainte-anne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of PLANI-REV : questionnaire scores (time frame: 10 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 13 Dec 2022.