An interventional study of control group and Intervention group in Schizophrenia, sponsored by Hôpital le Vinatier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Other
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Among 32 studies in Schizophrenia by Hôpital le Vinatier — 6 open to participants now, 6 under way, none of them phase 3. Schizophrenia · Hôpital le Vinatier.
Among the 32 studies in Schizophrenia by Hôpital le Vinatier, this one is the 2nd largest by planned enrollment of the 31 interventional ones that give a count, is the only one that started in 2022, is one of 31 with no phase, and was the 29th registered.
3,567 studies on the registry are indexed under Schizophrenia; 493 are open to participants now.
Browse Schizophrenia studies →6 of the 32 studies in Schizophrenia by Hôpital le Vinatier are open now, in 1 country. Recruiting first, the newest first:
Hôpital le Vinatier · Sites in France
Ages 45–80
Hôpital le Vinatier · Sites in France
Ages 18–45 · Healthy volunteers
Hôpital le Vinatier · Sites in France
Ages 18–40
Hôpital le Vinatier
Ages 18–65 · Healthy volunteers
Hôpital le Vinatier · Sites in France
Ages 18–50
By country, each count listing its studies:
Of the 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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32 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2022.
This study's planned enrollment of 206 is above the median of 71 across 2,947 interventional studies indexed under Schizophrenia.
Median enrollment 60 across the 31 interventional studies, 515 across the 1 observational. Of the 24 that completed or were terminated, 0 (0%) have results posted.
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Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.
2 of the studies in Schizophrenia by Hôpital le Vinatier that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04237155Hôpital le VinatierFrench Source-monitoring Task | 2027-02-01 |
| NCT04946916Hôpital le VinatierNeurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease | 2027-03-22 |
Add all 2 to your calendar (.ics) → With an account.
Among the 32 studies in Schizophrenia by Hôpital le Vinatier, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: control group
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.
Other: Intervention group
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.
The intervention group consists of caregivers included during the intervention period. Caregivers in the intervention group will benefit from the BREF program.
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.
Time frame: one year
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.
Time frame: 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.
Time frame: 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.
Time frame: one year
Evolution of the caregivers' family functioning between V1, V2, V3, V4
Assessed by the Family Assessment Device scale (FAD)
Time frame: 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)
Time frame: one year
Evolution of the caregivers' sense of competence between V1, V2, V3, V4
assessed by the Sense of Competence Questionnaire scale (SCQ)
Time frame: 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
Time frame: 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
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
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment
caregivers' satisfaction
questionnaire
Time frame: 12 months
Evolution of the caregivers' living status (shared or non-shared household) between V1, V2, V3, V4
questionnaire
Time frame: 12 months
Evolution of the caregivers' informal caregiving activities between V1, V2, V3, V4
questionnaire
Time frame: 12 months
Evolution of the caregivers' number of hours spent providing informal caregiving between V1, V2, V3, V4
questionnaire
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)
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.
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
Assessed by the Global Assessment of Functionning scale (GAF)
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)
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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline assessment and 12 months after baseline assessment
Evolution of the patients' aggressive behaviors
questionnaire
Time frame: 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
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
questionnaire
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
Self-assessment before, after and 16 months after the training course
Time frame: Assessed before, after and 16 months after the training course
Evolution of the mental health professionals' satisfaction of the training course
questionnaire
Time frame: Assessed after and 16 months after the training course
Evolution of the mental health professionals' satisfaction of the BREF program
questionnaire
Time frame: Assessed 16 months after the training course
Evolution of the psychiatric department organization regarding caregivers interventions
questionnaire
Time frame: 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
Time frame: Assessed 36 months after baseline
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2022 (actual). Primary completion is estimated for Jun 2026, 50 months after the start.
Of 756 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 50 months is above that.
Counting every sponsor, half of 769 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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