Psychoeducation Program for Family Caregivers Coordinated by an APRN

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital le Vinatier

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psychoeducation program coordinated by an APRN

    Other intervention

    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.

  • Usual Care

    Other intervention

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

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Psychoeducation program coordinated by an APRNExperimental treatment 2 interventions
Group B: USUAL interventionOther 1 intervention

Trial outcomes

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.

Time frame
2 times : Baseline and at 6 months

Secondary outcomes

1

Caregiver's burden

Change in ZARIT score of caregiver between inclusion and 3 months, between inclusion and 12 months the same as primary outcome measure

Time frame
2 times : at 3 months and at 12 months
2

The mood of the caregiver

The CES-D (center of epidemiologic studies depression) scale is a self-administered questionnaire that assesses the subject's mood by asking how often, in the past week, he or she has experienced symptoms or behaviors associated with depression. Symptom frequency is measured using a 4-point Likert scale (0=never to 3=frequently). The overall score ranges from 0 to 60. Higher scores correspond to more severe symptoms

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

The caregiver's personal effectiveness

General Self-Efficacy Scale GSE French version. This is a self-administered questionnaire where each statement refers to a successful adaptation and implies a stable internal attribution of success. It uses a 1-4 response scale of "Not at all true" "Barely true", "Moderately true" and "Totally true". The total score is calculated by adding up the responses to each statement: it can therefore vary from 10 to 40.

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

Quality of life for caregivers

The World Health Organization Quality of Life WHOQOL-BREF. This 26-item questionnaire is completed by the respondent. It comprises 4 domains: "physical health", "psychological well-being", "social relationships" and "environment". Items are answered using a five-level scale (from "not at all" to "rather no", 'about', "most of the time" to "completely"). The scales are highly internally consistent.

Time frame
2 times : at inclusion, at 12 months

Other outcomes

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