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NCT Number: NCT05036590

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Group

Other

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 group

Other

The intervention group consists of caregivers included during the intervention period. Caregivers in the intervention group will benefit from the BREF program.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in caregiver burden severity at V1,V2 and V3 by the Zarit Burden Inventory (ZBI) scale

    Time frame: 8 months

    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.

  2. Evolution of the caregivers' perceived-stress between V1, V2, V3, V4 by the Perceived Stress Scale-14 (PSS-14)

    Time frame: one year

    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.

  3. Evolution of the caregivers' mood between V1, V2, V3, V4 by the Center for Epidemiologic Studies-Depression Scale (CES-D)

    Time frame: one year

    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.

  4. Evolution of the caregivers' family functioning between V1, V2, V3, V4

    Time frame: one year

    Assessed by the Family Assessment Device scale (FAD)

  5. Evolution of the caregivers' quality of life between V1, V2, V3, V4

    Time frame: one year

    Assessed by the Schizophrenia CareGiver Quality of Life scale (S-CGQoL)

  6. Evolution of the caregivers' sense of competence between V1, V2, V3, V4

    Time frame: one year

    assessed by the Sense of Competence Questionnaire scale (SCQ)

  7. 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

    Change in number of consultations with the general practitioner (GP) n the 12 months prior to inclusion compared to the 12 months following inclusion

  8. Evolution of the caregivers' number of days off work

    Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment

    Change in number the caregivers' number of days off work in the 12 months prior to inclusion compared to the 12 months following inclusion

  9. 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

    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

  10. Evolution of the caregivers' number of work days

    Time frame: 12 months

    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

  11. Evolution of the caregivers' willingness to pay someone to replace them in their caring activities during one hour

    Time frame: 12 months

    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. 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

    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.

  13. caregivers' satisfaction

    Time frame: 12 months

    questionnaire

  14. Evolution of the caregivers' living status (shared or non-shared household) between V1, V2, V3, V4

    Time frame: 12 months

    questionnaire

  15. Evolution of the caregivers' informal caregiving activities between V1, V2, V3, V4

    Time frame: 12 months

    questionnaire

  16. Evolution of the caregivers' number of hours spent providing informal caregiving between V1, V2, V3, V4

    Time frame: 12 months

    questionnaire

  17. 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

    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.

  18. Evolution of the patients' functioning level between baseline and 12 months after baseline

    Time frame: Baseline assessment and 12 months after baseline assessment

    Assessed by the Global Assessment of Functionning scale (GAF)

  19. 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

    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

  20. Evolution of the patients' quality of life between baseline and 12 months after baseline

    Time frame: Baseline assessment and 12 months after baseline assessment

    Assessed by the Schizophrenia-quality of Life scale (S-QoL)

  21. Evolution of the patients' clinical severity between baseline and 12 months after baseline

    Time frame: Baseline assessment and 12 months after baseline assessment

    Assessed by the Clinical Global Impression (CGI)

  22. Evolution of the patients' depressive symptoms between baseline and 12 months after baseline

    Time frame: Baseline assessment and 12 months after baseline assessment

    Assessed by the Calgary Depression Scale for Schizophrenia scale (CDSS)

  23. Evolution of the patients' relapse risk factors between baseline and 12 months after baseline

    Time frame: Baseline assessment and 12 months after baseline assessment

    Composite score assessed by the Medication Adherence Rating Scale (MARS) and Birchwood Scale (Birchwood), substance use disorders (declarative questionnaire)

  24. Evolution of the patients' number of suicide attempts

    Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment

    Assessed by the Columbia Suicide Severity Rating Scale " (C-SSRS)

  25. Evolution of the patients' suicide risk level

    Time frame: Baseline assessment and 12 months after baseline assessment

    Assessed by the Columbia Suicide Severity Rating Scale " (C-SSRS)

  26. Evolution of the patients' aggressive behaviors

    Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment

    questionnaire

  27. Evolution of the patients' number of hospitalization in psychiatry

    Time frame: 12 months period before baseline assessment vs. 12 months period after baseline assessment

    number of hospitalization in psychiatry

  28. 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

    questionnaire

  29. 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

    Self-assessment before, after and 16 months after the training course

  30. Evolution of the mental health professionals' satisfaction of the training course

    Time frame: Assessed after and 16 months after the training course

    questionnaire

  31. Evolution of the mental health professionals' satisfaction of the BREF program

    Time frame: Assessed 16 months after the training course

    questionnaire

  32. Evolution of the psychiatric department organization regarding caregivers interventions

    Time frame: Assessed at baseline and 36 months after baseline

    questionnaire

  33. Sustainability of the BREF program in each psychiatric department

    Time frame: Assessed 36 months after baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Lise BOHEC, PhD

CONTACT

[email protected]

+33437915495

Romain REY, MD, PhD

CONTACT

[email protected]

+33437915495

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study 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.

Acronym: BREFORM

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2021
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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