Efficiency Assessment of BREFORM. A Multicentric Stepped-wedge Randomized Control Trial.

Study Overview
=================
Brief 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 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

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.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Other: control group
* Other: Intervention group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentric Stepped-wedge Randomized Control Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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<br>* 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.<br>|
| Experimental: intervention group<br>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<br>* The intervention group consists of caregivers included during the intervention period. Caregivers in the intervention group will benefit from the BREF program.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | one year | 
| Evolution of the caregivers' family functioning between V1, V2, V3, V4 | Assessed by the Family Assessment Device scale (FAD) | 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) | one year | 
| Evolution of the caregivers' sense of competence between V1, V2, V3, V4 | assessed by the Sense of Competence Questionnaire scale (SCQ) | 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 | 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 | 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 | 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 | 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. | 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. | 12 months period before baseline assessment vs. 12 months period after baseline assessment | 
| caregivers' satisfaction | questionnaire | 12 months | 
| Evolution of the caregivers' living status (shared or non-shared household) between V1, V2, V3, V4 | questionnaire | 12 months | 
| Evolution of the caregivers' informal caregiving activities between V1, V2, V3, V4 | questionnaire | 12 months | 
| Evolution of the caregivers' number of hours spent providing informal caregiving between V1, V2, V3, V4 | questionnaire | 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. | 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) | 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 | 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) | 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) | 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) | 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) | 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) | 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) | Baseline assessment and 12 months after baseline assessment | 
| Evolution of the patients' aggressive behaviors | questionnaire | 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 | 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 | 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 | Assessed before, after and 16 months after the training course | 
| Evolution of the mental health professionals' satisfaction of the training course | questionnaire | Assessed after and 16 months after the training course | 
| Evolution of the mental health professionals' satisfaction of the BREF program | questionnaire | Assessed 16 months after the training course | 
| Evolution of the psychiatric department organization regarding caregivers interventions | questionnaire | 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 | Assessed 36 months after baseline |