Psychoeducation Program for Family Caregivers Coordinated by an APRN

NCT07041463 | Not Yet Recruiting

• 2 other identifiers: 2025-A00412-47PHRIP-22-0039
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of this study is to assess the impact of implementing a specific family program coordinated by APRNs, covering the 5 levels of the family care pyramid through a consultation, an individual psychoeducation program and a group psychoeducation program, on improving caregiver burden and thus contributing to the recovery of users suffering from FEP. Detailed Description: Psychotic disorders are among the most disabling chronic pathologies in psychiatry. These disorders modify the individual's perceptions, thoughts, moods, behaviours and day-to-day functioning (Implementing interventions as early as possible in the first psychotic episode (FEP) would be likely to decrease the severity and consequences of the illness and improve prospects for recovery. Evidence supports the establishment of multidisciplinary teams to detect early and treat early those experiencing FEP and those at increased risk of psychosis. Recommended interventions include cognitive-behavioral therapies, family interventions, employment and educational support, and above all, at the heart of the system, case management. These specialized teams need to be multidisciplinary, bringing together psychiatrists, psychologists and social workers in addition to case managers. More recently in France, Advanced practice nurse (APRN) have joined these teams. But getting young people to accept both disorders and care is a difficult necessity, and remains a major challenge. Poor compliance with treatment is said to be one of the primary causes of relapse after FEP. Factors that increase the risk of relapse include initially more severe symptoms, persistent substance abuse, poor adherence to treatment and inadequate support from family and friends. Nowadays, support from a close caregiver for a person living with a psychic disorder is recognized as a very favorable factor for long-term prognosis. But the occurrence of a FEP often has the effect of a tidal wave for loved ones, who present high levels of psychological distress and feelings of burden. Unfortunately, it is still difficult for families to gain access to family caregiver support services, which are still insufficiently available and often unknown to them. A number of barriers stand in the way of systematically proposing family interventions, such as health professionals' lack of awareness of the effectiveness of interventions aimed at family carers, their difficulty in establishing a double therapeutic alliance with the young person and his or her family, or the misperception that family interventions are in contradiction with professional secrecy. The pyramid of family care in early intervention presents the family support that should be available to families of young people with FEP. The levels of intervention are designed to meet the support needs of family caregivers and can be used flexibly depending on specific needs or the phase of the psychotic episode. Also, APRNs could contribute to the success of these caregiver support programs thanks to their skills in prevention, assessment and coordination of complex pathways. This study therefore aims to determine the extent to which a specific program coordinated by APRNs can influence the burden of a family caregiver of a young person suffering from FEP.

Conditions

First Episode Psychosis (FEP); Caregiver Burden; Nurse Practitioners; IMPACT OF A NEW PSYCHOEDUCATION PROGRAM COORDINATED BY AN ADVANCED PRACTICE NURSE ON THE BURDEN OF FAMILY CAREGIVERS OF PATIENTS WITH A FIRST PSYCHOTIC EPISODE

Keywords

First Episode Psychosis (FEP); Caregiver burden; Advanced Practice Nurse

Outcome Measures

Primary Outcomes (1)

• Caregiver's burden

  The ZARIT scale is a validated, self-reported questionnaire that assesses the emotional, physical and financial burden of caring for a sick person. It consists of 22 items, with response modalities on a Likert scale), rated from 0 to 4, giving a score from 0 to 88. A low score represents a limited level of perceived burden, while a high score reflects a heavy burden.

  2 times : Baseline and at 6 months

Secondary Outcomes (14)

• Caregiver's burden

  2 times : at 3 months and at 12 months

• The mood of the caregiver

  4 times : at inclusion, at 3 months, at 6 months and at 12 months

• The caregiver's personal effectiveness

  4 times : at inclusion, at 3 months, at 6 months and at 12 months

• Quality of life for caregivers

  2 times : at inclusion, at 12 months

• Involvement in patient care

  2 times : at inclusion, at 12 months

Study Arms (2)

Psychoeducation program coordinated by an APRN

EXPERIMENTAL

The intervention includes an APRN reception, listening and orientation consultation, harmonized during a preparatory meeting prior to setting up the study. At the very least, this should include empathetic listening to the young person's problems, a tour of the unit, an explanation of the young person's background and an explanation of the approach. * Individual and group psycho-education programs. Each investigating center will be trained in the same tools, in order to harmonize practices: * BREF: This is a 3-session psycho-educational program in which each family is received individually by a pair of caregivers who are not involved in the patient's care. * PEPs Caregiver: This is a group psycho-education program in 5 2-hour sessions developed in the coordinating center.

Other: Psychoeducation program coordinated by an APRN; Other: Usual Care

USUAL intervention

OTHER

The intervention includes an APRN reception, listening and orientation consultation, harmonized during a preparatory meeting prior to setting up the study. At the very least, this should include empathetic listening to the young person's problems, a tour of the unit, an explanation of the young person's background and an explanation of the approach. In the control phase, the caregiver will benefit from the interventions and referrals provided for caregivers "as usual" at each center.

Other: Usual Care

Interventions

Psychoeducation program coordinated by an APRN OTHER

Individual and group psycho-education programs. Each investigating center will be trained in the same tools, in order to harmonize practices: * BREF: This is a 3-session psycho-educational program in which each family is received individually by a pair of caregivers who are not involved in the patient's care. * PEPs Caregiver: This is a group psycho-education program in 5 2-hour sessions developed in the coordinating center.

Psychoeducation program coordinated by an APRN

Usual Care OTHER

The caregiver will benefit from the interventions and referrals provided for caregivers "as usual" at each center.

Psychoeducation program coordinated by an APRN; USUAL intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver relative of a patient under the care of the FEP team and meeting the criteria of international recommendations of FEP diagnosis made by the specialized team of less than 6 months, between 18 and 35 years of age.
• Caregiver having received information about the study and having giveń consent.
• Caregiver covered by a health insurance plan

You may not qualify if:

• Caregiver under curatorship, guardianship, safeguard of justice, family habilitation or future protection mandate
• Caregiver participating in another study that may interact with this one
• Caregiver not fluent in French (comprehension/reading)
• Caregiver who has already received psycho-education on FEP
• Patient's opposition to caregiver's participation in research

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (5)

CHRU de Brest - Hôpital de BOHARS,

Bohars, 29820, France

Location

CH le Vinatier

Bron, 69678, France

Location

Groupe Hospitalier Marius Lacroix

La Rochelle, 17000, France

Location

Hôpital La Colombière

Montpellier, 34295, France

Location

CHU de Nîmes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Caroline DAMASCENO, Nurse

CONTACT

07 85 58 68 10; caroline.damasceno@ch-le-vinatier.fr

Lydie SARTELET

CONTACT

0437915531; lydie.sartelet@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter randomized controlled stepped wedge cluster trial

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 27, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): October 15, 2029
• Study Completion (Estimated): October 15, 2030
• Last Updated: June 27, 2025

Record last verified: 2025-05

Locations

FR (5)