Skip to main content
NCBI home page
Wiley Open Access Collection logoLink to Wiley Open Access Collection
. 2026 Oct 12;35(5):e70373. doi: 10.1111/inm.70373

Reducing Caregiver Burden in First‐Episode Psychosis: Effects of a Psychoeducational Pathway Led by an Advanced Practice Nurse—A Multicentre Stepped‐Wedge Randomized Trial

Damasceno Caroline 1,✉, Haesebaert Julie 2,3, Subtil Fabien 4, Rey Romain 5,6,7, Haesebaert Frédéric 1,5
PMCID: PMC13656333  PMID: 42861836

ABSTRACT

Family caregivers play a pivotal role in the recovery of people experiencing first‐episode psychosis (FEP). However, they may suffer from high levels of psychological distress and lack access to structured support. Although international recommendations highlight the need for psychoeducational interventions for caregivers, their implementation in France remains limited. This study aims to evaluate the impact of a structured, multicomponent support pathway, coordinated by advanced practice nurses (APNs), for family caregivers of people with FEP. This multicentre, stepped‐wedge (cluster with sequential permutation) randomized controlled trial involves six centres specializing in FEP in France. The intervention includes an initial consultation conducted by an APN, a single‐family psychoeducational programme (BREF) and a multifamily psychoeducational programme (PEPs Aidant). The primary outcome measure is the change in caregiver burden between 0 and 6 months. Secondary outcome measures include caregiver mood, self‐efficacy and quality of life, as well as patient engagement and perception of recovery. A qualitative study will explore the processes and experiences related to the implementation of the intervention. The reporting of the study follows the SPIRIT guidelines. The intervention aims to reduce caregiver burden, improving their coping strategies and self‐efficacy and strengthening patient engagement. The results should enable the development of evidence‐based guidelines for structured caregiver support in FEP services. This project aims to provide families with support and a structured, coordinated care pathway led by advanced nurse practitioners with rigorous comparative evaluation and potential generalization to other FEP services. The present trial has been registered in the ClinicalTrials.gov database (NCT07041463) since 26 June 2025.

Keywords: advanced practice nurse, caregiver burden, first‐episode psychosis, psychoeducation, stepped‐wedge trial

1. Background

1.1. Public Health Context

Mental disorders affect about 25% of the population worldwide during their lifetime, making them the third leading cause of disease after cancer and cardiovascular conditions (WHO 2013). Among those, first‐episode of psychosis (FEP) affects 3% of the population, mainly adolescents and young adults, the majority of whom (51%) subsequently develop a persistent psychotic disorder (Kirkbride et al. 2017). FEP is also associated with serious consequences, such as suicidal behaviour (Pompili et al. 2011). From the onset of the first symptoms and for the next 2–5 years, the early stages of psychotic disorders represent an opportunity for targeted treatment and prevention.

1.2. Importance of Early Intervention

FEP typically occurs between ages 15 and 25, a critical period for identity building and psychosocial development. Early intervention helps reduce symptom severity, improves recovery prospects and lowers relapse rates (Correll et al. 2018). The duration of untreated psychosis is a key prognostic factor (Howes et al. 2021) and is now considered an important target of clinical intervention in FEP patients (NICE 2014; ORYGEN 2016; PIPEP 2019). Evidence supports the establishment of multidisciplinary teams to detect and treat people experiencing FEP (Bertolote and McGorry 2005). The sooner the progression of psychosis is halted through treatment and interventions, the better the prognosis (Penttilä et al. 2014).

1.3. Specialized Programmes and Case Management

FEP teams deliver specialized care for two to 5 years after the first FEP consultation, combining low doses of second‐generation antipsychotics, strategies to reduce substance use, cognitive‐behavioural therapy, psychoeducation and coordinated case management. Teams must be multidisciplinary, autonomous, accessible and continuously trained to ensure effectiveness (NICE 2014; ORYGEN 2016; PIPEP 2019).

Case management ensures continuity of care, coordinates interventions and develops individualised care plans for the patient and their family. This model improves treatment adherence, reduces hospitalisations and enhances quality of life for patients and their families (Alvarez‐Jimenez et al. 2012; Dieterich et al. 2010).

1.4. Adherence and Relapse Issues

Despite this structured and specialised care pathway, relapse rates remain high: 28% after 1 year and 54% after 3 years (Alvarez‐Jimenez et al. 2012). Contributing factors include severe symptoms, substance use, lack of family support and poor adherence (Casey et al. 2016). Relapses shorten remission, increase treatment resistance and heighten suicide risk (Ayesa‐Arriola et al. 2015). Adherence to treatment is a major challenge, with up to 50% of young patients discontinuing care (Lal and Malla 2015). Poor adherence alone increases relapse risk 3.7‐fold (Charpentier et al. 2009).

1.5. Family Support and Caregivers

Most patients still live with their parents at the onset of psychosis and their families therefore play a major role in providing informal care throughout their recovery (Gleeson et al. 2023). Consistent family support is associated with more efficient use of health services, better treatment adherence and health outcomes for the patient (Bjornestad et al. 2017). In addition, a positive and supportive family environment appears to be a beneficial factor for improved functioning in patients experiencing a first episode of psychosis (FEP), while criticism and hostility from caregivers are risk factors for psychotic relapse (Alston et al. 2019).

While families are a key support for young people experiencing psychosis, they also face a significant burden. Caregivers often experience distress, guilt or helplessness, along with financial and social difficulties. These pressures make caregivers a vulnerable population whose physical and mental health may deteriorate (Fekadu et al. 2019). The onset of first‐episode psychosis is associated with a significant caregiver burden, adversely affecting caregivers' psychological and physical well‐being (Ma et al. 2018; Schulz and Sherwood 2008).

Family interventions reduce relapse and hospitalisation rates and improve patient functioning (Gleeson et al. 2025). Guidelines recommend offering family interventions early and systematically (Galletly et al. 2016), focusing on psychoeducation and collaborative support (Mottaghipour and Bickerton 2005; Sin and Norman 2013). The family care pyramid provides a structured model to tailor support, from general education to specialised therapy (Mottaghipour and Bickerton 2005).

The EPPIC guidelines recommend flexible family psychoeducation for first‐episode psychosis (Crisp et al. 2014) and evidence supports the effectiveness of brief programmes in reducing caregiver distress and burden (Gleeson et al. 2025; Rexhaj et al. 2023; Zhang et al. 2024).

1.6. Current Barriers

Despite proven benefits, family support remains underused. Barriers include lack of training and awareness among professionals (Davis 2013), difficulties in building a dual alliance with patient and family (De Boer et al. 2019) and fears related to confidentiality (Galletly et al. 2016; Galvao 2012). Families often share critical information but receive little feedback, leaving them feeling unsupported (Davis 2013; Whitley and Lawson 2010).

1.7. The Emerging Role of Advanced Practice Nurses (APNs)

France introduced Advanced Practice Nursing (APN) in 2016, aligning with roles established internationally since the 1950s (NACNS 2004; Neuman 2004). The French definition of an APN encompasses the historical roles of clinical nurse and nurse practitioner, emphasising clinical expertise, team support and an expanded role that includes the delegation of tasks (both medical, such as expanded prescribing authority and psychotherapeutic) to APNs. Master's degree holders, APNs combine advanced clinical assessment, care coordination, psychoeducation and research (Delamaire and Lafortune 2010).

In French psychiatry, APNs assess patient conditions, support adherence, coordinate pathways and deliver psychoeducation (JORF 2019).

International studies show that APNs improve access to care, reduce wait times and achieve outcomes comparable to physicians while offering more personalised patient education (Delamaire and Lafortune 2010). Although their role is still evolving in France, APNs show strong potential in FEP teams for structuring care and supporting families through their expertise.

1.8. The Potential of APNs in Caregiver Support

Indeed, French APNs are authorized to design and implement actions to support treatment adherence and prevent relapses (JORF 2019). They can assess family coping abilities, resources and quality of life and deliver targeted psychoeducation and counselling (Deschamps 2003). Through caregiver distress detection and pathway coordination, APNs can help families fully embrace their role and improve patient outcomes.

1.9. Coordinated Caregiver Pathway

This study aims to implement a structured caregiver pathway in FEP teams. The three components of the pathway (intake consultation, single‐family programme, multi‐family programme) will be implemented in each centre before the start of the intervention phase. The APN will ensure the systematic offering of support to caregivers by conducting the intake and orientation consultation.

The implemented structured support pathway for family caregivers, coordinated by an APN, addresses the first three levels of the family care pyramid and has the potential to reduce caregiver burden and support recovery in individuals with FEP, compared with standard care pathways.

1.10. Objective of the Study

We hypothesised that an APN‐led family psychoeducational pathway would reduce caregiver burden and improve caregivers' mental health by enhancing knowledge, self‐efficacy and coping skills, while improving patient outcomes through better family support and treatment engagement.

The primary objective of this study is to evaluate the impact of an APN‐led FEP‐caregiver consultation, integrated into a structured and coordinated family psychoeducational pathway, on the evolution of caregiver burden. This impact will be assessed by comparing changes in caregiver burden from the time of inclusion to 6 months, relative to standard care. By focusing on this key outcome, the study aims to determine whether this specialised intervention provides measurable benefits for caregivers supporting individuals experiencing a first episode of psychosis.

The secondary objectives address both caregivers' and patients' psychosocial outcomes, as well as the implementation process. For caregivers, the study will examine the evolution of caregiver burden at 3 and 12 months, monitor mood and self‐efficacy at multiple time points (inclusion, 3, 6 and 12 months) and assess changes in quality of life between enrolment and 12 months. For patients, it will assess changes in their involvement in care between 6 and 12 months and perceived recovery between inclusion and 12 months. From an implementation perspective, the study will assess the fidelity, acceptability and feasibility of the intervention at 12 months and explore the potential transferability of this structured, APN‐coordinated support pathway to other FEP teams.

2. Methods

2.1. Study Design

The reporting of the study follows the SPIRIT guidelines (Chan et al. 2025) and the Consolidated Standards of Reporting Trials extension for the stepped‐wedge cluster randomized trial (Hemming et al. 2018) Appendix S1.

This study is a multicentre, mixed‐method, stepped‐wedge cluster randomized controlled trial (SW‐CRCT) designed to evaluate the impact of an APN‐coordinated psychoeducational pathway for family caregivers of individuals experiencing FEP. Six specialized FEP teams across France will sequentially transition from usual care to the intervention phase, allowing all centres to implement the support pathway while ensuring robust evaluation (Figure 1).

FIGURE 1.

FIGURE 1

Open in a new tab

Stepped wedge design of the APIPEP study.

Each centre was assessed for eligibility based on predefined feasibility criteria, namely the presence of an APN specialised in psychiatry and mental health working within a first‐episode psychosis team. Participation was voluntary after presentation of the project at meetings of the APN association for early intervention that existed prior to the project and authorization from the management of the institutions.

All participating centres will begin the study in a control period (usual practices without any changes related to the study), then sequentially, according to a randomly defined order for each period, one centre will switch to intervention (implementation of the coordinated support pathway).

In total, the study will include six 6‐month inclusion periods and five randomization stages. At the end of the study, all centres will be in the intervention period.

Semi‐structured interviews will be conducted with APNs and caregivers in the experimental group at the end of the study (intervention period), using interview guides developed and validated before the study begins. The guides will draw on existing literature and focus on themes such as intervention acceptability, caregiver burden and empowerment, organizational barriers and relationships among caregivers, professionals and patients. Interviews will be held in person or via video conference and all sessions will be audio recorded and transcribed.

The experimental group will consist of caregivers included during the intervention periods in each participating centre, after implementation of the APN‐coordinated support pathway. The control group will comprise caregivers included during the control periods in each centre, benefiting from usual practices. These will be described in detail with regard to family support and psychoeducational programmes already offered. To take into account inclusion capacities, centres 5 and 6 will be grouped together in the same cluster.

2.2. Control Phase

Current standard practices do not include systematic consultation with caregivers by a service professional, nor do they include a specific multi‐family psychoeducational programme for caregivers.

Each caregiver will receive information and sign a written consent form. Follow‐up will last 12 months with four visits: inclusion, 3, 6 and 12 months for the collection of caregivers' and patients' data through questionnaires. Assessments will be conducted face‐to‐face at the time of inclusion and then by follow‐up calls by a dedicated assessor other than the APN.

2.3. Transition Phase

The initial process of consultation, listening and guidance by the APN will be harmonized during a preparatory meeting aimed at setting up the study with all the centres and the scientific committee. The APN‐led consultation must include, at a minimum: empathic listening to the caregiver's concerns, a tour of the inpatient unit with explanations of the patient's care pathway and an overview of the proposed structured support pathway.

The study will be launched in each centre after a four‐month transition period between the control phase and the intervention phase. This transition will allow for training (four people per centre) in the single‐family psychoeducational programme entitled “BREF” (1 day training course) and the multi‐family psychoeducational programme entitled “PEPs aidant” (1 day training course). Both programmes have been developed by Dr. Romain Rey's team at the Centre Lyonnais des Aidants en Psychiatrie (CLAP) at CH le Vinatier (coordinating centre), thereby enabling the harmonization and standardization of practices.

2.4. Intervention Phase

After implementation of the coordinated support pathway, the APN of each specialized FEP service will invite family caregivers of patients followed by the FEP service to participate in the support pathway and study (Figure 2).

  • An initial consultation for welcoming, listening to and orienting the caregiver, conducted by an APN and standardized through a preparatory meeting prior to study launch.

  • Two psychoeducational programmes, a single‐family one, followed by a multi‐family one. Each participating centre will receive training on standardized tools to harmonize practices:

  • BREF: a single‐family psychoeducational programme consisting of a three‐session, in‐person, single‐family intervention and a phone call follow‐up 3 months after the programme. Each session is facilitated by two trained mental health providers and dedicated to a specific aspect of caregiving. A trained volunteer from a family association co‐facilitates the third session, enriching exchanges and fostering connections to the peer support network.
    • ○
      The first session allows caregivers to recount their journey, share difficulties and feelings and ask questions
    • ○
      The second session focuses on the patient—their illness, diagnosis and treatment pathway.
    • ○
      The third session returns to the caregiver's perspective, offering reflection and support (Rey et al. 2023).
  • PEPs Aidant: A structured multi‐family psychoeducational programme developed at the coordinating centre. It consists of 5 sessions, each 2 h long, for groups of 6–8 caregivers.
    • ○
      Session 1 introduces the family role and early intervention.
    • ○
      Session 2 covers symptoms and treatments, with the presence of a physician.
    • ○
      Session 3 introduces communication concepts and includes, when available, a peer support worker.
    • ○
      Session 4 focuses on the caregiver's own journey and is co‐facilitated by a family association volunteer, if available.
    • ○
      Session 5 addresses relapse prevention strategies.

FIGURE 2.

FIGURE 2

Open in a new tab

Caregiver journey in the APIPEP study during the intervention phase.

This is a closed group format, meaning participants follow all sessions together from start to finish.

  • A final APN‐led consultation allows for debriefing and referral to other support structures for caregivers if necessary.

Participation in the study will be offered to one caregiver per patient within 6 months of the start of their follow‐up in the FEP specialised service.

2.5. Primary Outcome

First‐episode psychosis is often overwhelming for family members, generating psychological distress and a substantial caregiving burden that can negatively affect their mental and physical health (Caqueo‐Urízar et al. 2017; Ma et al. 2018; Schulz and Sherwood 2008).

The impact on caregiver burden will be assessed by comparing the change between 0 and 6 months in the Zarit Burden Interview (ZBI) scores (Bocquet et al. 1996) between groups. The evolution of caregiver burden will be measured by the difference in ZBI scores between baseline (inclusion) and 6 months (to ensure adequate exposure to the psychoeducational programme) and this change will be compared between the intervention and control groups.

The Zarit Burden Interview is a validated self‐report questionnaire that assesses the emotional, physical and financial burden experienced by caregivers of individuals with health conditions. It consists of 22 items, each scored using a Likert scale (Never, Rarely, Sometimes, Quite Often, Nearly Always) and rated from 0 to 4, yielding a total score between 0 and 88. This is the most commonly used scale for assessing the burden on caregivers in psychiatry. Previous research has shown that caregivers in psychiatry often score in the higher ranges of the scale (Ampalam et al. 2012).

2.6. Secondary Outcomes

We chose to examine the effects on caregivers reported in the literature, which may vary depending on the psychoeducational objectives of the intervention. This study will evaluate several secondary outcome measures for caregivers to better understand the effects of the intervention on their well‐being and coping abilities. Caregiver burden will be measured at Months 3 and 12 using the Zarit Burden Interview (ZBI) to assess short‐ and medium‐term impacts and to understand how the burden changes over time. Mood will be assessed at baseline and at Months 3, 6 and 12 using the CES‐D scale, a validated 20‐item questionnaire designed to evaluate the frequency of depressive symptoms (Verdier‐Taillefer et al. 2001). Self‐efficacy will be measured at the same intervals with the General Self‐Efficacy Scale (GSE), which assesses confidence in managing stressful or demanding situations (Saleh et al. 2016). Finally, caregiver quality of life will be evaluated at Month 12 with the WHOQOL‐BREF, which examines physical health, psychological well‐being, social relationships and environmental factors (The WHOQOL Group 1998). In each case, the questionnaire will be completed independently by the primary caregiver during scheduled study visits.

For patients (users), engagement in care will be assessed at Month 12 using the Service Engagement Scale (SES), which evaluates collaboration with services, accessibility and treatment adherence (Tait et al. 2002). Recovery will be measured between baseline and Month 12 with the Stages of Recovery Instrument (STORI), which identifies progress across five stages: moratorium, awareness, preparation, rebuilding and growth (Andresen et al. 2006). From an implementation perspective, indicators such as fidelity, acceptability and feasibility of the intervention will be analysed at Month 12 through a combination of quantitative data (participation rates, number of sessions completed) and qualitative insights (interviews or open‐ended survey responses). Additionally, the transferability of the structured support pathway to other FEP teams will be assessed using the ASTAIRE grid, a tool that identifies key factors influencing the adaptation of interventions to new clinical settings (Cambon et al. 2015).

2.7. Eligibility Criteria

The term caregiver may refer not only to immediate family members such as parents or siblings but also to partners, close friends etc. For each patient, only one caregiver will be included in the study: the primary caregiver or the most involved family member.

This study will involve caregivers of patients receiving care from a specialized FEP team. The FEP teams participating in this study are located in six centres in France. These teams are multidisciplinary, specializing in the management of first episodes of psychosis in young people aged between 18 and 35 years, whose care started less than 6 months before inclusion.

Eligible caregivers for this study are defined as non‐professional individuals (family members, partners and friends) who provide regular, ongoing support to a loved one receiving care for an FEP. They must be volunteers and the support they provide must be free of charge.

2.8. Population

Potential volunteers for the study will be identified during follow‐up visits with their loved ones at the centres. Only one caregiver per patient will be selected to participate in the study: either the primary caregiver or the family member most involved in caregiving, as designated by the families. They will receive comprehensive information free of charge about the APIPEP study (objectives, evaluation methods) from a healthcare professional trained in the study protocol. After a short period of reflection (2 days), the professional will ask the caregiver participant for their written consent. This consent will be recorded for quality control purposes. An additional consent will be asked for participation in the qualitative survey for caregivers included in the intervention phase.

To be eligible for the study, caregivers must meet all inclusion criteria. They must be caregivers of a patient being treated by one of the participating FEP teams. The patient must be between 18 and 35 years of age, have been diagnosed with a first episode of psychosis and must not have been treated for more than 6 months prior to being followed by the FEP team. The caregivers themselves must be at least 18 years old, have voluntarily agreed to participate by providing written informed consent and be affiliated with a social security system or equivalent coverage to ensure administrative compliance.

Non‐inclusion criteria ensure the integrity and safety of the study. Caregivers will be excluded if they are under legal protection such as guardianship or trusteeship, are participating in another research study that could interfere with the protocol, or cannot understand or speak French sufficiently to engage in the intervention or complete the required questionnaires. Exclusion also applies if the caregiver has already completed a psychoeducational programme related to FEP, or if the patient explicitly refuses to allow their caregiver to take part in the study.

2.9. Sample Size

The primary outcome is the change in the ZARIT score between baseline and 6 months. A decrease of 12.9 points in the ZARIT score without intervention (standard deviation = 10) is anticipated as well as a decrease of 21.5 points with the intervention and a correlation of 0.5 between the baseline and 6‐month measures. Taking into account an intra‐cluster correlation of 0.15 for the change in the ZARIT score, the study design includes 6 centres over 6 periods (two centres included in the same cluster), with a stepped implementation of the intervention in 5 of these periods. Enrolment across centres will not be uniform (24%, 24%, 18%, 12%, 12%, 10%); the sample size calculation accounts for this imbalance. Assuming a 10% loss to follow‐up, a total of 198 cases will be required for 91% power (two‐sided alpha level of 5%). The assumptions used for the sample size calculation are based on published data (Navidian et al. 2012). The study focuses on the primary family caregiver; thus, the sample size has been calculated assuming one caregiver per case.

For the qualitative survey, all APNs participating in the study (N = 5) and a sample of 15 to 20 caregivers will be interviewed among volunteers. A maximum variation approach will guide the recruitment of caregivers (by centre, age, gender and relatedness with the FEP patient). Sample size for the qualitative survey will be adapted according to data saturation attainment.

2.10. Statistical Analysis

For the primary outcome, changes in the ZARIT score between baseline and 6 months will be analysed using a linear mixed‐effects model. Fixed effects will include time of assessment (baseline, 3, 6 and 12 months) and an interaction between the intervention status (training implemented or not) and time. Adjustments will be made for caregiver characteristics such as age, sex and cohabitation status with the patient. Random effects will account for clustering by including a random intercept for each centre and for each caregiver nested within the centre. If time trends are observed, a time period variable may be included as an ordinal factor to better quantify these effects. Interaction terms will allow for the assessment of heterogeneity across centres and data transformations may be applied if model assumptions are not met. Secondary outcomes will be analysed using similar mixed‐effects models and a Holm correction will be applied to adjust for multiple comparisons when evaluating changes across multiple time points. A significance threshold of 5% will be used for the analyses; 95% confidence intervals will be provided. Statistical analyses will be conducted using SAS version 9.4 and R version 4.5.0 software.

2.11. Qualitative Analysis

Semi‐structured interviews will be conducted with caregivers and APNs to explore their experiences, acceptability of the intervention and perceived barriers and facilitators. Interviews will be transcribed verbatim and analysed thematically using NVivo software, following a reflexive thematic analysis approach.

A thematic analysis of the transcripts of interviews will be conducted for the qualitative data, to deepen results on study objectives for efficacy and implementation of the intervention. The data will be analysed both by population and study site and then globally. The thematic analysis will follow the steps recommended by Braun & Clarke (Braun and Clarke 2006) (familiarization, coding, categorization into themes and subthemes, refined iteratively). It will be carried out using the NVivo qualitative analysis software (Version 1.4, QSR International Pty Ltd.; 2020). A double coding procedure with reconciliation will be performed to enhance the internal validity of the analysis. We will explore differences related to caregivers' characteristics, APN practices and contextual environment.

The qualitative findings will be integrated with the quantitative results and presented alongside the effectiveness outcomes to support the interpretation of the observed results, particularly the primary endpoint and will also contribute to the implementation analysis.

3. Discussion

The APIPEP study addresses a critical gap in early psychosis care in France by implementing and rigorously assessing a structured, APN‐coordinated caregiver support pathway. International evidence strongly supports psychoeducational interventions for caregivers; however, their implementation remains limited and inconsistent in the French context. This study is one of the first to operationalise a harmonized, evidence‐based and APN‐led approach across multiple specialized centres.

The expected clinical impact includes a reduction in caregiver burden, improved coping strategies and increased engagement in care. These benefits extend to patients, who may benefit from better therapeutic alliances, improved adherence and better recovery trajectories. At the organizational level, the structured model promotes standardization of practices and encourages interdisciplinary collaboration.

3.1. Study Limitations

However, several points must be taken into account in the APIPEP protocol.

First, the stepped‐wedge cluster randomized design, while pragmatic and allowing all participating sites to eventually access the intervention, introduces risks of temporal bias and carry‐over effects. The progressive implementation may be influenced by changes in clinical practice or external factors (e.g., organizational restructuring, policy updates or variations in staff turnover) occurring over time. Although the analytical model accounts for time effects, residual confounding cannot be entirely excluded (Hemming et al. 2015).

Second, the study focuses exclusively on six specialized early intervention centres in France. These centres benefit from established multidisciplinary teams, organizational stability and strong leadership supporting innovation. The findings may therefore have limited generalizability to services with fewer resources or less structured early intervention programmes.

Third, the follow‐up period of 12 months provides important insights into short‐ and medium‐term outcomes but does not capture the potential longer‐term effects of the intervention, such as sustained reductions in caregiver burden or patient relapse rates beyond the first year.

Finally, despite efforts to minimize selection bias, caregivers who agree to participate may differ from those who decline, potentially leading to an overrepresentation of more motivated or engaged families. Similarly, patients who consent to the inclusion of their caregivers may be those with stronger therapeutic alliances or fewer symptoms of disorganization, limiting representativeness.

3.2. Challenges and Solutions

Implementing a complex, multi‐component intervention such as APIPEP across multiple sites inevitably raises significant operational challenges.

A key challenge is the standardization of intervention delivery across centres with different organizational cultures, resources and staff profiles. To address this, a comprehensive training programme for APNs and other team members has been implemented, including regular supervision sessions and fidelity monitoring. Standardized manuals and intervention checklists have been developed to ensure consistent delivery while allowing flexibility to adapt to local contexts.

Another challenge concerns the engagement of caregivers, particularly in families who may be experiencing high levels of distress, stigma or ambivalence toward services. Proactive strategies, such as early contact following the first hospitalisation, flexible scheduling and hybrid have been adopted to reduce barriers to participation. Collaboration with family association volunteers further strengthens trust and credibility, offering caregivers a peer support dimension that complements the clinical expertise of the APNs and the psychoeducational facilitators.

Finally, staff workload and competing clinical demands represent another challenge. The stepped‐wedge design was chosen precisely to facilitate gradual integration of the intervention, allowing teams to adjust workflows and build capacity progressively. In addition, ongoing support from site coordinators and project leaders ensures that teams receive timely guidance, helping to maintain motivation and adherence to the protocol. These implementation processes will be examined throughout the study and will contribute to the analysis of how the intervention is delivered. These findings will allow us to formulate recommendations to improve and adapt the caregiver support pathway after the study.

3.3. Ethical Considerations

This study complies with the strictest ethical and regulatory standards for research involving human participants. This protocol has been approved by a competent ethics committee.

Participation is strictly voluntary and informed consent is obtained from all caregivers, while patients provide non‐opposition for the collection and use of associated data. The consent process is designed to be clear, accessible and respectful, ensuring that participants fully understand their rights, including the right to withdraw at any time without consequences for their ongoing care.

The study maintains a delicate balance between respecting patient confidentiality and supporting family involvement by utilising the skills of advanced practice nurses to manage sensitive discussions and promote collaboration. It also anticipates potential psychological distress, with advanced practice nurses monitoring participants and offering immediate support or referring them to specialists to ensure their well‐being.

4. Conclusion

This study addresses a major gap in early psychosis care in France by implementing and rigorously evaluating a structured, APN‐coordinated support pathway for family caregivers. By combining an individual consultation, a single‐family psychoeducation and a multi‐family psychoeducational programme, the intervention aims to reduce caregiver burden, enhance coping and self‐efficacy and improve family engagement in care.

Using a stepped‐wedge cluster randomized design across six specialised centres, APIPEP will provide robust data on the effectiveness, feasibility and acceptability of this innovative model. Beyond its potential clinical impact, the study will generate valuable insights into the role and added value of Advanced Practice Nurses in psychiatric care, contributing to the evidence base supporting their integration into multidisciplinary teams.

This study model could inform national strategies for standardising caregiver support, foster the expansion of APN‐led interventions and ultimately improve outcomes for both caregivers and patients, shaping the future of family‐centred mental health care.

4.1. Relevance for Clinical Practice

This study targets a population of young people with FEP, who are therefore at risk of prognostic deterioration and progression to chronic psychiatric disorders such as schizophrenia, conditions associated with significant psychological, physiological and social consequences. Early intervention for individuals with FEP is currently being developed in France and is the subject of international recommendations. Research in this field is commonly conducted directly with service users, while comparatively less attention is given to their families and close social networks. Although family psychoeducation initiatives are frequently implemented by specialised teams, they are often neither systematically assessed nor integrated within a structured, hierarchical care pathway. This project proposes to support families in a structured and coordinated pathway led by APNs, new healthcare professionals with more advanced assessment and coordination skills. We propose a robust comparative evaluation combining an assessment of the clinical effectiveness of the support pathway among caregivers and users, an evaluation of its implementation, including the role and missions of APNs and its possible generalization to other FEP services.

Funding

This study was funded by the French Ministry of Health through the Programme Hospitalier de Recherche Infirmière et Paramédicale (PHRIP) 2022 call (grant number PHRIP‐22‐0039), with funding awarded in 2023. The funding body had no role in the design of the study, data collection, analysis, interpretation of data, or in writing the manuscript.

Ethics Statement

The protocol has received approval from the relevant ethics committee (CPP) Ile de France IV on April 7, 2025.

Conflicts of Interest

The authors declare no conflicts of interest.

Supporting information

Appendix S1: inm70373‐sup‐0001‐AppendixS1.docx. SPIRIT 2025 checklist of items to address in a randomized trial protocol.

INM-35-0-s001.docx (26.2KB, docx)

Acknowledgements

The authors thank the family caregivers, patients and clinical teams from the participating centres for their commitment to this study. They are particularly grateful to the study biostatistician for their guidance in study design and planned analyses, the members of the scientific committee for their valuable input throughout the development of the project and to the UNAFAM representatives for their collaboration in the PEPs Aidant programme.

Data Availability Statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

References

  1. Alston, M. , Bennett C. F., and Rochani H.. 2019. “Treatment Adherence in Youth With First‐Episode Psychosis: Impact of Family Support and Telehealth Delivery.” Issues in Mental Health Nursing 40, no. 11: 951–956. 10.1080/01612840.2019.1630532. [DOI] [PubMed] [Google Scholar]
  2. Alvarez‐Jimenez, M. , Priede A., Hetrick S. E., et al. 2012. “Risk Factors for Relapse Following Treatment for First Episode Psychosis: A Systematic Review and Meta‐Analysis of Longitudinal Studies.” Schizophrenia Research 139, no. 1–3: 116–128. 10.1016/j.schres.2012.05.007. [DOI] [PubMed] [Google Scholar]
  3. Ampalam, P. , Gunturu S., and Padma V.. 2012. “A Comparative Study of Caregiver Burden in Psychiatric Illness and Chronic Medical Illness.” Indian Journal of Psychiatry 54, no. 3: 239–243. 10.4103/0019-5545.102423. [DOI] [PMC free article] [PubMed] [Google Scholar]
  4. Andresen, R. , Caputi P., and Oades L.. 2006. “Stages of Recovery Instrument: Development of a Measure of Recovery From Serious Mental Illness.” Australian & New Zealand Journal of Psychiatry 40, no. 11–12: 972–980. 10.1080/j.1440-1614.2006.01921.x. [DOI] [PubMed] [Google Scholar]
  5. Ayesa‐Arriola, R. , Alcaraz E. G., Hernández B. V., et al. 2015. “Suicidal Behaviour in First‐Episode Non‐Affective Psychosis: Specific Risk Periods and Stage‐Related Factors.” European Neuropsychopharmacology 25, no. 12: 2278–2288. 10.1016/j.euroneuro.2015.09.008. [DOI] [PubMed] [Google Scholar]
  6. Bertolote, J. , and McGorry P.. 2005. “Early Intervention and Recovery for Young People With Early Psychosis: Consensus Statement.” British Journal of Psychiatry. Supplement 48: s116–s119. 10.1192/bjp.187.48.s116. [DOI] [PubMed] [Google Scholar]
  7. Bjornestad, J. , Hegelstad W. T. V., Joa I., et al. 2017. ““With a Little Help From My Friends” Social Predictors of Clinical Recovery in First‐Episode Psychosis.” Psychiatry Research 255: 209–214. 10.1016/j.psychres.2017.05.041. [DOI] [PubMed] [Google Scholar]
  8. Bocquet, H. , Pous J., Charlet J. P., and Grand A.. 1996. “Measuring the Burden for Carers of Dependent Elderly With the Zarit Inventory.” Revue D'epidemiologie et De Sante Publique 44, no. 1: 57–65. [PubMed] [Google Scholar]
  9. Braun, V. , and Clarke V.. 2006. “Using Thematic Analysis in Psychology.” Qualitative Research in Psychology 3, no. 2: 77–101. 10.1191/1478088706qp063oa. [DOI] [Google Scholar]
  10. Cambon, L. , Minary L., Ridde V., and Alla F.. 2015. “Un outil pour accompagner la transférabilité des interventions en promotion de la santé: ASTAIRE.” Santé Publique 26, no. 6: 783–786. 10.3917/spub.146.0783. [DOI] [PubMed] [Google Scholar]
  11. Caqueo‐Urízar, A. , Rus‐Calafell M., Craig T. K. J., et al. 2017. “Schizophrenia: Impact on Family Dynamics.” Current Psychiatry Reports 19, no. 1: 2. 10.1007/s11920-017-0756-z. [DOI] [PubMed] [Google Scholar]
  12. Casey, D. , Brown L., Gajwani R., et al. 2016. “Predictors of Engagement in First‐Episode Psychosis.” Schizophrenia Research 175, no. 1–3: 204–208. 10.1016/j.schres.2016.04.030. [DOI] [PubMed] [Google Scholar]
  13. Chan, A.‐W. , Boutron I., Hopewell S., et al. 2025. “SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomised Trials.” BMJ 389: e081477. 10.1136/bmj-2024-081477. [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. Charpentier, A. , Goudemand M., and Thomas P.. 2009. “L'alliance thérapeutique, un enjeu dans la schizophrénie.” L'Encéphale 35, no. 1: 80–89. 10.1016/j.encep.2007.12.009. [DOI] [PubMed] [Google Scholar]
  15. Correll, C. U. , Galling B., Pawar A., et al. 2018. “Comparison of Early Intervention Services vs Treatment as Usual for Early‐Phase Psychosis: A Systematic Review, Meta‐Analysis, and Meta‐Regression.” JAMA Psychiatry 75, no. 6: 555–565. 10.1001/jamapsychiatry.2018.0623. [DOI] [PMC free article] [PubMed] [Google Scholar]
  16. Crisp, K. , Creek R., Fraser S., Stavely H., and Woodhead G.. 2014. In This Together: Family Work in Early Psychosis. Origen Youth Health Research Centre. https://www.orygen.org.au/Training/Resources/Psychosis/Manuals/In‐This‐Together‐Family‐Work. [Google Scholar]
  17. Davis, S. 2013. Community Mental Health in Canada: Theory, Policy, and Practice. Revised and expanded ed. UBC Press. [Google Scholar]
  18. De Boer, E. , Consack C., and Conus P.. 2019. “Comment mettre en place le case management et le suivi intensif lors des phases précoces?” In Troubles psychotiques: Protocoles d'intervention précoce, edited by Lecardeur L.. Elsevier Masson. [Google Scholar]
  19. Delamaire, M. L. , and Lafortune G.. 2010. “Nurses in advanced roles: A Description and Evaluation of Experiences in 12 Developed Countries.” https://www.oecd‐ilibrary.org/social‐issues‐migration‐health/nurses‐in‐advanced‐roles_5kmbrcfms5g7‐en.
  20. Deschamps, J.‐P. 2003. “Une « relecture » de la charte d'Ottawa.” Santé Publique 15, no. 3: 313–325. 10.3917/spub.033.0313. [DOI] [PubMed] [Google Scholar]
  21. Dieterich, M. , Irving C. B., Park B., and Marshall M.. 2010. “Intensive case management for severe mental illness.” Cochrane Database of Systematic Reviews 10: CD007906. 10.1002/14651858.CD007906.pub2. [DOI] [PMC free article] [PubMed] [Google Scholar]
  22. Fekadu, W. , Mihiretu A., Craig T. K. J., and Fekadu A.. 2019. “Multidimensional Impact of Severe Mental Illness on Family Members: Systematic Review.” BMJ Open 9, no. 12: e032391. 10.1136/bmjopen-2019-032391. [DOI] [PMC free article] [PubMed] [Google Scholar]
  23. Galletly, C. , Castle D., Dark F., et al. 2016. “Royal Australian and New Zealand College of Psychiatrists Clinical Practice Guidelines for the Management of Schizophrenia and Related Disorders.” Australian & New Zealand Journal of Psychiatry 50, no. 5: 410–472. 10.1177/0004867416641195. [DOI] [PubMed] [Google Scholar]
  24. Galvao, S. 2012. Les enjeux liés à la confidentialité dans la pratique du travail social en milieu d'urgence hospitalière. Mémoire de Maîtrise, Faculté des lettres et sciences humaines, Université de Sherbrooke. https://www.collectionscanada.gc.ca/obj/thesescanada/vol2/002/MR91022.PDF?is_thesis=1&oclc_number=912020558. [Google Scholar]
  25. Gleeson, J. F. M. , Koval P., Zyphur M., et al. 2023. “A Randomized Controlled Trial of Moderated Online Social Therapy for Family Carers of First‐Episode Psychosis Patients in a Specialist Treatment Setting.” Schizophrenia Research 255: 203–212. 10.1016/j.schres.2023.03.019. [DOI] [PubMed] [Google Scholar]
  26. Gleeson, J. F. M. , Ludwig K., Stiles B. J., et al. 2025. “Systematic Review and Meta‐Analysis of Family‐Based Interventions for Early Psychosis: Carer and Patient Outcomes.” Schizophrenia Research 276: 57–78. 10.1016/j.schres.2025.01.006. [DOI] [PubMed] [Google Scholar]
  27. Hemming, K. , Haines T. P., Chilton P. J., Girling A. J., and Lilford R. J.. 2015. “The Stepped Wedge Cluster Randomised Trial: Rationale, Design, Analysis, and Reporting.” BMJ (Clinical Research ed.) 350: h391. 10.1136/bmj.h391. [DOI] [PubMed] [Google Scholar]
  28. Hemming, K. , Taljaard M., McKenzie J. E., et al. 2018. “Reporting of Stepped Wedge Cluster Randomised Trials: Extension of the CONSORT 2010 Statement With Explanation and Elaboration.” BMJ k1614: k1614. 10.1136/bmj.k1614. [DOI] [PMC free article] [PubMed] [Google Scholar]
  29. Howes, O. D. , Whitehurst T., Shatalina E., et al. 2021. “The Clinical Significance of Duration of Untreated Psychosis: An Umbrella Review and Random‐Effects Meta‐Analysis.” World Psychiatry 20, no. 1: 75–95. 10.1002/wps.20822. [DOI] [PMC free article] [PubMed] [Google Scholar]
  30. JORF . 2019. “Décret du 12 août 2019 modifiant le décret du 18 juillet 2018 relatif au programme de formation menant au diplôme d’État en soins infirmiers de pratique avancée.” loi n° 0187. https://www.legifrance.gouv.fr.
  31. Kirkbride, J. B. , Hameed Y., Ankireddypalli G., et al. 2017. “The Epidemiology of First‐Episode Psychosis in Early Intervention in Psychosis Services: Findings From the Social Epidemiology of Psychoses in East Anglia [SEPEA] Study.” American Journal of Psychiatry 174, no. 2: 143–153. 10.1176/appi.ajp.2016.16010103. [DOI] [PMC free article] [PubMed] [Google Scholar]
  32. Lal, S. , and Malla A.. 2015. “Service Engagement in First‐Episode Psychosis: Current Issues and Future Directions.” Canadian Journal of Psychiatry 60, no. 8: 341–345. 10.1177/070674371506000802. [DOI] [PMC free article] [PubMed] [Google Scholar]
  33. Ma, C. F. , Chien W. T., and Bressington D. T.. 2018. “Family Intervention for Caregivers of People With Recent‐Onset Psychosis: A Systematic Review and Meta‐Analysis.” Early Intervention in Psychiatry 12, no. 4: 535–560. 10.1111/eip.12494. [DOI] [PubMed] [Google Scholar]
  34. Mottaghipour, Y. , and Bickerton A.. 2005. “The Pyramid of Family Care: A Framework for Family Involvement With Adult Mental Health Services.” Australian E‐Journal for the Advancement of Mental Health 4, no. 3: 210–217. 10.5172/jamh.4.3.210. [DOI] [Google Scholar]
  35. NACNS . 2004. National Association of Clinical Nurse Specialists. Statement on Clinical Nurse Specialist Practice and Education. NACNS. http://nacns.org/wp‐content/uploads/2016/11/NACNS‐Statement.pdf. [Google Scholar]
  36. Navidian, A. , Kermansaravi F., and Rigi S. N.. 2012. “The Effectiveness of a Group Psycho‐Educational Program on Family Caregiver Burden of Patients With Mental Disorders.” BMC Research Notes 5, no. 1: 399. 10.1186/1756-0500-5-399. [DOI] [PMC free article] [PubMed] [Google Scholar]
  37. Neuman, C. E. 2004. Nursing's Social Policy Statement. American Nurses Association (ANA). https://essentialguidetonursingpractice.files.wordpress.com/2012/07/pages‐from‐essential‐guide‐to‐nursing‐practice‐chapter‐1.pdf. [PubMed] [Google Scholar]
  38. NICE . 2014. Psychosis and Schizophrenia in Adults: Prevention and Management. Vol. 39. National Institute for Health and Care Excellence. [PubMed] [Google Scholar]
  39. ORYGEN . 2016. “The National Centre of Excellence in Youth Mental Health.” In Australian Clinical Guidelines for Early Psychosis. Orygen, The National Centre of Excellence in Youth Mental Health. [DOI] [PubMed] [Google Scholar]
  40. Penttilä, M. , Jääskeläinen E., Hirvonen N., Isohanni M., and Miettunen J.. 2014. “Duration of Untreated Psychosis as Predictor of Long‐Term Outcome in Schizophrenia: Systematic Review and Meta‐Analysis.” British Journal of Psychiatry 205, no. 2: 88–94. 10.1192/bjp.bp.113.127753. [DOI] [PubMed] [Google Scholar]
  41. PIPEP . 2019. “Cadre de référence des Programmes d'interventions pour premiers épisodes psychotiques.” https://publications.msss.gouv.qc.ca/msss/fichiers/2018/18‐914‐12W.pdf.
  42. Pompili, M. , Serafini G., Innamorati M., et al. 2011. “Suicide Risk in First Episode Psychosis: A Selective Review of the Current Literature.” Schizophrenia Research 129, no. 1: 1–11. 10.1016/j.schres.2011.03.008. [DOI] [PubMed] [Google Scholar]
  43. Rexhaj, S. , Martinez D., Golay P., et al. 2023. “A Randomized Controlled Trial of a Targeted Support Program for Informal Caregivers in Adult Psychiatry.” Frontiers in Psychiatry 14: 1284096. 10.3389/fpsyt.2023.1284096. [DOI] [PMC free article] [PubMed] [Google Scholar]
  44. Rey, R. , De Martène B., Baltazar M., et al. 2023. “A 1‐Day Training Course to Disseminate the BREF Psychoeducational Program to Caregivers and Promote Network Establishment Between Psychiatry Departments and Family Associations.” Academic Psychiatry 47, no. 5: 496–503. 10.1007/s40596-022-01632-1. [DOI] [PMC free article] [PubMed] [Google Scholar]
  45. Saleh, D. , Romo L., and Camart N.. 2016. “Validation of the General Self‐Efficacy Scale ‘GSE’ in French university students. (Validation de l'échelle du sentiment d'auto‐efficacité ‘GSE’ chez des étudiants universitaires français).” 10.13140/RG.2.2.21879.62885. [DOI]
  46. Schulz, R. , and Sherwood P. R.. 2008. “Physical and Mental Health Effects of Family Caregiving.” AJN, American Journal of Nursing 108, no. 9: 23–27. 10.1097/01.NAJ.0000336406.45248.4c. [DOI] [PMC free article] [PubMed] [Google Scholar]
  47. Sin, J. , and Norman I.. 2013. “Psychoeducational Interventions for Family Members of People With Schizophrenia: A Mixed‐Method Systematic Review.” Journal of Clinical Psychiatry 74, no. 12: e1145–e1162. 10.4088/JCP.12r08308. [DOI] [PubMed] [Google Scholar]
  48. Tait, L. , Birchwood M., and Trower P.. 2002. “A New Scale (SES) to Measure Engagement With Community Mental Health Services.” Journal of Mental Health 11, no. 2: 191–198. 10.1080/09638230020023570-2. [DOI] [PubMed] [Google Scholar]
  49. The Whoqol Group . 1998. “Development of the World Health Organization WHOQOL‐BREF Quality of Life Assessment.” Psychological Medicine 28, no. 3: 551–558. 10.1017/S0033291798006667. [DOI] [PubMed] [Google Scholar]
  50. Verdier‐Taillefer, M.‐H. , Gourlet V., Fuhrer R., and Alpérovitch A.. 2001. “Psychometric Properties of the Center for Epidemiologic Studies‐Depression Scale in Multiple Sclerosis.” Neuroepidemiology 20, no. 4: 262–267. 10.1159/000054800. [DOI] [PubMed] [Google Scholar]
  51. Whitley, R. , and Lawson W. B.. 2010. “The Psychiatric Rehabilitation of African Americans With Severe Mental Illness.” Psychiatric Services 61, no. 5: 508–511. 10.1176/ps.2010.61.5.508. [DOI] [PubMed] [Google Scholar]
  52. WHO . 2013. Plan d'action global pour la santé mentale 2013–2020. OMS. https://www.who.int/mental_health/action_plan_2013/fr/. [Google Scholar]
  53. Zhang, Z. J. , Lo H. H. M., Ho W. C., et al. 2024. “Mindfulness‐Based Family Psychoeducation Intervention for Caregivers of Young Adults With First‐Episode Psychosis: Results at 9‐Month Follow‐Up.” Frontiers in Psychiatry 15: 1460151. 10.3389/fpsyt.2024.1460151. [DOI] [PMC free article] [PubMed] [Google Scholar]

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Appendix S1: inm70373‐sup‐0001‐AppendixS1.docx. SPIRIT 2025 checklist of items to address in a randomized trial protocol.

INM-35-0-s001.docx (26.2KB, docx)

Data Availability Statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Articles from International Journal of Mental Health Nursing are provided here courtesy of Wiley

RESOURCES