SchizophreniaBREFORMNCT05036590
Efficiency Assessment of BREFORM. A Multicentric Stepped-wedge Randomized Control Trial.
A study testing Intervention group in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
Trial summary
In psychiatry, caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders Single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- people over 18yo
- first-degree relatives (parents, siblings, children) or spouse of the patient
- primary caregiver of a patient with schizophrenic disorders or first psychotic episode (DSM5)
- consenting to participate to the study
Who cannot join
- mental disorder on Axis I
- having already benefited from a family intervention such as psychoeducation
- caring for several people with severe psychiatric disorders
- receiving income for the caring activities
- being legally responsible of the patient
- having difficulty understanding fluent French
- illiterate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Vinatier
Bron, 69678
ROMAIN REY, PH, +33(0)437915280, Romain.Rey@ch-le-vinatier.fr
VERONIQUE VIAL, +33(0)437915531, Veronique.Vial@ch-le-vinatier.fr
About this study
Official title: Efficiency Assessment of a Mental Health Professionals' Training Course for a Short Psychoeducational Program (BREF) for Families and Caregivers of Patients With Schizophrenia or First Psychotic Episode.
In psychiatry, caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders Single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the caregiver and an indirect benefit on the health of the ill family member. It is associated with a reduction in the rate of relapse and re-hospitalization and with better compliance with treatment. For single-family psychoeducation, the number of caregivers to be treated to avoid re-hospitalization of the sick family member is 3. For caregivers, psychoeducation is accompanied by an improvement in knowledge of the disorders and coping strategies. Therefore, international recommendations recommend that psychoeducation for caregivers be systematic, early, and integrated into routine care.
Currently, the organization of the French care system does not allow these recommendations to be met. In order to increase the use of psychoeducation in France, early interventions for caregivers must be offered systematically. The effectiveness of early psychoeducation for caregivers needs to be evaluated; only three randomized controlled trials are available in the literature and none have been conducted in France.
Read the detailed description
The BREFORM project proposes to train health professionals in an early psychoeducation program, the BREF program, in order to implement it in their structure, and to evaluate its impact on the burden of caregivers of users living with a first psychotic episode or a schizophrenic disorder.
Regarding caregivers' outcomes:
outcome measures will be assessed at baseline (visit 1, V1), 6 weeks (Visit 2, V2), 6 months (Visit 3, V3), 12 months (Visit 4, V4) after baseline in the active group and in the treatment as usual group
Regarding patients' outcomes:
outcome measures will be assessed at baseline and 12 months after baseline in the active group and in the treatment as usual group
Regarding mental health professionals' outcomes:
outcome measures will be assessed before, after and 16 months after the training course
Regarding the psychiatric departments' outcomes:
outcome measures will be assessed at baseline and 36 months after baseline
- Conditions
- Schizophrenia
- Being tested
- control group, Intervention group
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupOther
The control group consisted of caregivers included during the control period, before the intervention was deployed, i.e., before the BREF program was implemented by the centers.
Intervention groupOther
The intervention group consists of caregivers included during the intervention period. Caregivers in the intervention group will benefit from the BREF program.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The design is a stepped-wedge cluster randomized controlled trial. The study will be conducted in 9 centers (clusters) and will be conducted in 6 successive phases of 4 months each.
During the first period, groups will be in the control period, then sequentially and according to a randomly defined order, at each time, one group will go into the intervention period after a transition period of 4 months allowing the intervention to be deployed (training of three health professionals for each center and then implementation of the BREF program).
Thus, each cluster will belong successively to the control group and the intervention group. During the control period, caregivers will be supported according to the usual practices of each center. During the intervention period, the BREF program will be offered to all eligible caregivers. Receives: Other: control group |
| intervention group | Experimental | Thus, each cluster will belong successively to the control group and the intervention group. During the intervention period, the BREF program will be offered to all eligible caregivers. Receives: Other: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the severity of caregiver burden between V1 and V4 by the Zarit Burden Inventory scale (ZBI)
The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. A score of 17 or more was considered high burden.
Measured: one year
Secondary outcomes (33)
Changes in caregiver burden severity at V1,V2 and V3 by the Zarit Burden Inventory (ZBI) scale
The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. A score of 17 or more was considered high burden.
Measured: 8 months
Evolution of the caregivers' perceived-stress between V1, V2, V3, V4 by the Perceived Stress Scale-14 (PSS-14)
Total score of the PSS can be obtained by summing the 14 items' scores . The total score ranges from 0 to a maximum of 56, a higher score indicating a higher level of perceived stress.
Measured: one year
Evolution of the caregivers' mood between V1, V2, V3, V4 by the Center for Epidemiologic Studies-Depression Scale (CES-D)
The CES-D consists of 20 items in a self-report format measuring depressive symptoms experienced in the past week on a 4-point Likert scale ranging from 0 (rarely or none of the time) to 3 (most or all of the time).
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. ... PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.
Measured: one year
Evolution of the caregivers' family functioning between V1, V2, V3, V4
Assessed by the Family Assessment Device scale (FAD)
Measured: one year
Evolution of the caregivers' quality of life between V1, V2, V3, V4
Assessed by the Schizophrenia CareGiver Quality of Life scale (S-CGQoL)
Measured: one year
Evolution of the caregivers' sense of competence between V1, V2, V3, V4
assessed by the Sense of Competence Questionnaire scale (SCQ)
Measured: one year
Evolution of the caregivers' number of consultations with the general practitioner (GP)
Change in number of consultations with the general practitioner (GP) n the 12 months prior to inclusion compared to the 12 months following inclusion
Measured: 12 months period before baseline assessment versus 12 months period after baseline assessment
Evolution of the caregivers' number of days off work
Change in number the caregivers' number of days off work in the 12 months prior to inclusion compared to the 12 months following inclusion
Measured: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the caregivers' number of days on long-term leave or disability
Change in the number of long-term leaves of absence or disability related to the caregiver situation in the 12 months prior to inclusion compared to the 12 months following inclusion
Measured: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the caregivers' number of work days
Change in the number of work days related to the caregiver situation in the 12 months prior to inclusion compared to the 12 months following inclusion
Measured: 12 months
Evolution of the caregivers' willingness to pay someone to replace them in their caring activities during one hour
Change in caregivers' willingness to pay someone to replace them in their caregiving activities for one hour in the 12 months prior to inclusion versus 12 months after inclusion.
Measured: 12 months
Evolution of the caregivers' number of suicide attempts assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
The Columbia Suicide Severity Rating Scale (C-SSRS) is a measure used to identify and assess individuals at risk for suicide. Questions are phrased for use in an interview format, but can be completed as a self-report measure if necessary.
The score is created at each assessment for each patient and is used for determining treatment emergence. Suicidal Ideation Score: The maximum suicidal ideation category (1-5 on the C- SSRS) present at the assessment. Assign a score of 0 if no ideation is present.
Measured: 12 months period before baseline assessment vs. 12 months period after baseline assessment
caregivers' satisfaction
questionnaire
Measured: 12 months
Evolution of the caregivers' living status (shared or non-shared household) between V1, V2, V3, V4
questionnaire
Measured: 12 months
Evolution of the caregivers' informal caregiving activities between V1, V2, V3, V4
questionnaire
Measured: 12 months
Evolution of the caregivers' number of hours spent providing informal caregiving between V1, V2, V3, V4
questionnaire
Measured: 12 months
Evolution of the patients' psychotic symptoms severity between baseline and 12 months after baseline assessed by the Positive And Negative Syndrome Scale (PANSS)
PANSS items are rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme); because the absence of symptoms is equal to 1 point, the lowest possible total score on both PANSS scales is 7.
Measured: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the patients' functioning level between baseline and 12 months after baseline
Assessed by the Global Assessment of Functionning scale (GAF)
Measured: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' functioning level assessed by the Personal and social Performance scale (PSP)
The patient's degree of severity in the four domains is to be rated on a six-point scale from absent (which means no problems on this dimension) over mild, manifest, marked, severe to very severe difficulties in the given area. Out of the ratings on the four subdimensions, one total score on a 100-point scale can be created. A variation of eight points is already to be classified as a clinically relevant difference. The items "self-care" and "disturbing and aggressive behavior" are of greater concern for patients with acute
Measured: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' quality of life between baseline and 12 months after baseline
Assessed by the Schizophrenia-quality of Life scale (S-QoL)
Measured: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' clinical severity between baseline and 12 months after baseline
Assessed by the Clinical Global Impression (CGI)
Measured: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' depressive symptoms between baseline and 12 months after baseline
Assessed by the Calgary Depression Scale for Schizophrenia scale (CDSS)
Measured: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' relapse risk factors between baseline and 12 months after baseline
Composite score assessed by the Medication Adherence Rating Scale (MARS) and Birchwood Scale (Birchwood), substance use disorders (declarative questionnaire)
Measured: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' number of suicide attempts
Assessed by the Columbia Suicide Severity Rating Scale " (C-SSRS)
Measured: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the patients' suicide risk level
Assessed by the Columbia Suicide Severity Rating Scale " (C-SSRS)
Measured: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' aggressive behaviors
questionnaire
Measured: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the patients' number of hospitalization in psychiatry
number of hospitalization in psychiatry
Measured: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the mental health professionals' beliefs and knowledge about psychoeducation to caregivers
questionnaire
Measured: Assessed before, after and 16 months after the training course
Evolution of the mental health professionals' sense of competence about psychoeducation to caregivers
Self-assessment before, after and 16 months after the training course
Measured: Assessed before, after and 16 months after the training course
Evolution of the mental health professionals' satisfaction of the training course
questionnaire
Measured: Assessed after and 16 months after the training course
Evolution of the mental health professionals' satisfaction of the BREF program
questionnaire
Measured: Assessed 16 months after the training course
Evolution of the psychiatric department organization regarding caregivers interventions
questionnaire
Measured: Assessed at baseline and 36 months after baseline
Sustainability of the BREF program in each psychiatric department
Question the referent person at the center to know if the program is still used 3 years after its implementation
QUESTION THE REFERENT PERSON AT THE CENTER TO KNOW IF THE PROGRAM IS STILL USED 3 YEARS AFTER ITS IMPLEMENTATION
Question the referent perso of the center to know if the program is still used 3 years after its implementation
Measured: Assessed 36 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start5 Apr 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (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
- Model description
- Multicentric Stepped-wedge Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain REY, MD, PhD, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036590
- Sponsor's protocol ID
- 2020-A00269-30
- Acronym
- BREFORM
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Assessment of a Mental Health Professionals' Training Course for a Short Psychoeducational Program (BREF) for Families and Caregivers of Patients With Schizophrenia or First Psychotic Episode.
- ClinicalTrials.gov ID
- NCT05036590
- Acronym / sponsor ID
- BREFORM / 2020-A00269-30
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Sep 2021 (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.
In psychiatry, caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders Single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the caregiver and an indirect benefit on the health of the ill family member. It is associated with a reduction in the rate of relapse and re-hospitalization and with better compliance with treatment. For single-family psychoeducation, the number of caregivers to be treated to avoid re-hospitalization of the sick family member is 3. For caregivers, psychoeducation is accompanied by an improvement in knowledge of the disorders and coping strategies. Therefore, international recommendations recommend that psychoeducation for caregivers be systematic, early, and integrated into routine care.
Currently, the organization of the French care system does not allow these recommendations to be met. In order to increase the use of psychoeducation in France, early interventions for caregivers must be offered systematically. The effectiveness of early psychoeducation for caregivers needs to be evaluated; only three randomized controlled trials are available in the literature and none have been conducted in France.
Detailed description
The BREFORM project proposes to train health professionals in an early psychoeducation program, the BREF program, in order to implement it in their structure, and to evaluate its impact on the burden of caregivers of users living with a first psychotic episode or a schizophrenic disorder.
Regarding caregivers' outcomes:
outcome measures will be assessed at baseline (visit 1, V1), 6 weeks (Visit 2, V2), 6 months (Visit 3, V3), 12 months (Visit 4, V4) after baseline in the active group and in the treatment as usual group
Regarding patients' outcomes:
outcome measures will be assessed at baseline and 12 months after baseline in the active group and in the treatment as usual group
Regarding mental health professionals' outcomes:
outcome measures will be assessed before, after and 16 months after the training course
Regarding the psychiatric departments' outcomes:
outcome measures will be assessed at baseline and 36 months after baseline
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentric Stepped-wedge Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: control groupThe design is a stepped-wedge cluster randomized controlled trial. The study will be conducted in 9 centers (clusters) and will be conducted in 6 successive phases of 4 months each. During the first period, groups will be in the control period, then sequentially and according to a randomly defined order, at each time, one group will go into the intervention period after a transition period of 4 months allowing the intervention to be deployed (training of three health professionals for each center and then implementation of the BREF program). Thus, each cluster will belong successively to the control group and the intervention group. During the control period, caregivers will be supported according to the usual practices of each center. During the intervention period, the BREF program will be offered to all eligible caregivers. |
| intervention group | Experimental | Other: Intervention groupThus, each cluster will belong successively to the control group and the intervention group. During the intervention period, the BREF program will be offered to all eligible caregivers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- people over 18yo
- first-degree relatives (parents, siblings, children) or spouse of the patient
- primary caregiver of a patient with schizophrenic disorders or first psychotic episode (DSM5)
- consenting to participate to the study
Key exclusion criteria (7 listed)
- mental disorder on Axis I
- having already benefited from a family intervention such as psychoeducation
- caring for several people with severe psychiatric disorders
- receiving income for the caring activities
- being legally responsible of the patient
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 |
|---|---|---|
| control groupThe control group consisted of caregivers included during the control period, before the intervention was deployed, i.e., before the BREF program was implemented by the centers. | Other | Control group |
| Intervention groupThe intervention group consists of caregivers included during the intervention period. Caregivers in the intervention group will benefit from the BREF program. | Other | intervention group |
Primary outcome
Changes in the severity of caregiver burden between V1 and V4 by the Zarit Burden Inventory scale (ZBI)
Time frame: one year
The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. A score of 17 or more was considered high burden.
33 secondary outcomes
Changes in caregiver burden severity at V1,V2 and V3 by the Zarit Burden Inventory (ZBI) scale
Time frame: 8 months
Evolution of the caregivers' perceived-stress between V1, V2, V3, V4 by the Perceived Stress Scale-14 (PSS-14)
Time frame: one year
Evolution of the caregivers' mood between V1, V2, V3, V4 by the Center for Epidemiologic Studies-Depression Scale (CES-D)
Time frame: one year
Evolution of the caregivers' family functioning between V1, V2, V3, V4
Time frame: one year
Evolution of the caregivers' quality of life between V1, V2, V3, V4
Time frame: one year
Evolution of the caregivers' sense of competence between V1, V2, V3, V4
Time frame: one year
Evolution of the caregivers' number of consultations with the general practitioner (GP)
Time frame: 12 months period before baseline assessment versus 12 months period after baseline assessment
Evolution of the caregivers' number of days off work
Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the caregivers' number of days on long-term leave or disability
Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the caregivers' number of work days
Time frame: 12 months
Evolution of the caregivers' willingness to pay someone to replace them in their caring activities during one hour
Time frame: 12 months
Evolution of the caregivers' number of suicide attempts assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
caregivers' satisfaction
Time frame: 12 months
Evolution of the caregivers' living status (shared or non-shared household) between V1, V2, V3, V4
Time frame: 12 months
Evolution of the caregivers' informal caregiving activities between V1, V2, V3, V4
Time frame: 12 months
Evolution of the caregivers' number of hours spent providing informal caregiving between V1, V2, V3, V4
Time frame: 12 months
Evolution of the patients' psychotic symptoms severity between baseline and 12 months after baseline assessed by the Positive And Negative Syndrome Scale (PANSS)
Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the patients' functioning level between baseline and 12 months after baseline
Time frame: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' functioning level assessed by the Personal and social Performance scale (PSP)
Time frame: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' quality of life between baseline and 12 months after baseline
Time frame: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' clinical severity between baseline and 12 months after baseline
Time frame: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' depressive symptoms between baseline and 12 months after baseline
Time frame: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' relapse risk factors between baseline and 12 months after baseline
Time frame: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' number of suicide attempts
Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the patients' suicide risk level
Time frame: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' aggressive behaviors
Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the patients' number of hospitalization in psychiatry
Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
Evolution of the mental health professionals' beliefs and knowledge about psychoeducation to caregivers
Time frame: Assessed before, after and 16 months after the training course
Evolution of the mental health professionals' sense of competence about psychoeducation to caregivers
Time frame: Assessed before, after and 16 months after the training course
Evolution of the mental health professionals' satisfaction of the training course
Time frame: Assessed after and 16 months after the training course
Evolution of the mental health professionals' satisfaction of the BREF program
Time frame: Assessed 16 months after the training course
Evolution of the psychiatric department organization regarding caregivers interventions
Time frame: Assessed at baseline and 36 months after baseline
Sustainability of the BREF program in each psychiatric department
Time frame: Assessed 36 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Romain REY, 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 Intervention group in people with Schizophrenia, 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 7 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain REY, MD, PhD (+33437915495, romain.rey@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the severity of caregiver burden between V1 and V4 by the Zarit Burden Inventory scale (ZBI) (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 12 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.