First Episode Psychosis (FEP)

8

Review clinical trials related to First Episode Psychosis (FEP). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Psychoeducation Program for Family Caregivers Coordinated by an APRN

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.

Participants needed: 180
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Hôpital le VinatierUpdated: Jun 9, 2026Locations: 5
Eligibility criteria

Caregiver relative of a patient under the care of the FEP team and meeting the c... [+2]

Caregiver under curatorship, guardianship, safeguard of justice, family habilita... [+4]

Status: Not yet recruiting

Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis

The objective of the current study is to assess the impact of a five-week digital heart rate variability biofeedback (HRV-B) intervention or music listening on the well-being of first episode psychosis patients. Heart rate variability (HRV) is a measure of how an individual's heart rate can adapt to a changing environment and mental and physiological challenges. It has been well established that HRV can be regulated through actions such as slow breathing and meditation. HRV Biofeedback (HRV-B) involves breathing at a specific frequency, usually around 6 breaths per minute, which has been shown to maximize HRV. Research has shown that HRV-B interventions improved mental health symptoms in various populations including individuals at clinical high risk for psychosis.

Participants needed: 80
Trial details
Age: 18-55Biological sex: AllType: InterventionalSponsor: The University of Hong KongUpdated: Jun 5, 2026Locations: 1
Eligibility criteria

Patients with first-episode-psychosis who have been in treatment for less than 5... [+6]

Any organic neurological or cardiac conditions [+5]

Status: Recruiting

Early Psychosis: Investigating Cognition

The project aims to explore changes in brain chemistry in individuals who have recently experienced psychosis. Recent research suggests that chemicals in the brain, specifically one called glutamate, may behave differently in people who have experienced psychosis compared to those who have not. It is also known that some individuals with psychosis can find tasks involving memory and attention more challenging. This study aims at understanding how brain chemistry is linked to memory and attention, and if this is different between people who have and have not experienced psychosis. The study will also investigate how a commonly used brain stimulation technique might help people with psychosis and other conditions by altering brain chemistry for a very short period. Non-invasive brain stimulation using very weak electrical stimulation has been used to help improve symptoms in individuals with psychosis and many other conditions, and has been shown to alter brain chemistry for a few hours after stimulation. However, it does not work for everyone. It will be investigated if levels of glutamate can predict whether brain stimulation will help an individual or not. In other words, the study investigates if glutamate can be used as a marker for tailoring treatments. This project also aims to collect personal experiences or challenges that individuals with psychosis face. This information will be gathered through interviews. This will help to understand what specific difficulties individuals have, such as with certain aspects of memory and attention. The interview will also gather opinions and concerns about brain imaging and brain stimulation and current understandings of chemicals in the brain. For example, the study will explore why individuals may not want to take part in brain imaging or brain stimulation.

Participants needed: 106
Trial details
Age: 18-55Biological sex: AllType: InterventionalSponsor: University of NottinghamUpdated: May 4, 2026Locations: 1
Eligibility criteria

Aged 18-55 years. [+5]

Clinically significant neurological or comorbid psychiatric disorder in the opin... [+28]

Status: Not yet recruiting

Testing the Efficacy of the Cannabis Clinic for Patients With Psychosis (CCP) Intervention for Cannabis Use Reduction/Cessation in Patients With First Episode Psychosis (FEP)

People suffering from psychosis who use cannabis experience more relapses, long and compulsory admissions, with huge costs to the individual, families and health services. The Cannabis Clinic for Psychosis (CCP) was developed to respond to this clinical need. A published review of the CCP's intervention showed its safety and efficacy in supporting people suffering from psychosis with reducing their cannabis use. Nevertheless, for the CCP model of care to be applied widely and benefit a larger clinical population, its intervention needs to be tested in a Randomised Control Trial (RCT). The proposed CCP RCT is a waiting list randomised controlled trial that aims to evaluate the clinical efficacy of the existing CCP intervention. Participants will be adults currently under the care of South London and Maudsley (SLaM) Early Intervention Teams for first onset psychosis, who are dependent on cannabis and who express an intention to reduce or stop their use. The RCT primary outcome will measure changes in all participants' cannabis use. Participants will be randomised to either the intervention group or the waiting list control group receiving Treatment As Usual (TAU). The CCP intervention comprises 12 weekly (+/- 4 weeks) one-to-one sessions, with optional participation in a weekly online peer group. Sessions are delivered by trained clinicians and include evidence-based psychosocial techniques, including Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT), SMART goal settings and support for co-occurring tobacco use. The treatment is non-pharmacological and administered via participant-led approach that accommodates online or face-to-face sessions to meet the patient preference. Qualitative data from the recent CCP proof of concept paper indicate that the flexibility in allowing patients choice on the session's modality (online/face to face, hybrid) increased and maintained engagement. The study is fully funded by the Maudsley Charity and due to last 30 months from the start of recruitment.

Participants needed: 80
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: King's College LondonUpdated: Nov 24, 2025Locations: 1
Eligibility criteria

First episode psychosis Community Mental Health teams receiving care under of SL... [+3]

Lack capacity to consent [+3]

Status: Not yet recruiting

Dopamine and Insulin in Psychosis

Patients with schizophrenia have a high risk of developing metabolic disorders and current evidence points to an overlap in mechanisms underlying psychiatric symptoms and metabolic disturbances. The main goal of this study is to investigate effects of brain insulin on dopamine signaling and energy metabolism in patients with schizophrenia experiencing their first psychotic episode (FEP). To this end, patients with schizophrenia and healthy volunteers will undergo two \[11C\]-(+)-PHNO positron emission (PET) scans to measure the changes in dopamine receptor availability after nasally applied insulin, as well as single proton magnetic resonance spectroscopy (1H-MRS) to assess the impact of intranasal insulin on levels of glucose and glutamate in the hippocampus.

Participants needed: 46
Trial details
Age: 18-40Biological sex: AllType: InterventionalSponsor: Medical University of ViennaUpdated: Nov 28, 2025Locations: 1
Eligibility criteria

age 18-40 [+7]

severe or unstable medical or neurological illness or clinically significant abn... [+9]

Status: Not yet recruiting

Physical Exercise in Patients With First Psychotic Episode

Justification: Patients with first-episode psychosis are at increased risk of premature ageing and early mortality, associated with telomere shortening and increased inflammatory markers. Physical exercise has shown protective effects in the general population, but there are no intervention studies in this population. Objective: To evaluate the effect of a strength training programme on telomere length and other markers of cellular ageing in people with a first episode of psychosis. Material and methods: Quasi-experimental study with patients aged 18-35 years included in the PRINT programme (Salamanca). Standard treatment will be compared with standard treatment plus a 12-week strength training programme. Telomere length (qPCR), inflammatory and senescence markers (proteomics), body composition, frailty and quality of life will be analysed. Applicability: The results could support the inclusion of physical exercise programmes as a complementary intervention in early psychosis care, promoting overall health, quality of life and reducing the gap in life expectancy compared to the general population.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of SalamancaUpdated: Oct 6, 2025
Eligibility criteria

be at least 18 years of age [+1]

are unable to read and understand the patient information sheet and sign the inf...

Status: Recruiting

Nursing Intervention in Weight and Metabolic Syndrome Management in First-episode Psychosis (MetaKOP)

The goal of this clinical trial is to evaluate if a nursing intervention based on the carbohydrate-insulin model can effectively reduce weight and manage the risk of metabolic syndrome (MetS) in individuals with first-episode psychosis. The main questions it aims to answer are: Will the intervention lead to a clinically significant weight loss (≥5%)? Can the intervention improve metabolic parameters, psychopathological state, physical activity level, and quality of life? Researchers will compare participants receiving the specialized nursing consultations to those receiving routine care to see if the former group experiences greater improvements in weight loss and metabolic risk reduction. Participants will: Attend a series of 8 nursing consultations focused on dietary habits based on the carbohydrate-insulin model and physical activity. Complete assessments at the start, 6 months, and 12 months, including weight, metabolic parameters, and psychological evaluations.

Participants needed: 88
Trial details
Biological sex: AllType: InterventionalSponsor: Hospital de BasurtoUpdated: Oct 22, 2024Locations: 1
Eligibility criteria

Patients admitted to the Early Intervention Program (EIP). [+2]

Cognitive inability to learn or comorbid intellectual disability that interferes... [+4]

Status: Recruiting

Self-administered COgnitive Personalized Training in Early Psychosis

The overall objective of SCOPe is to improve early intervention in psychosis by providing an innovative eHealth tool that will enable personalized cognitive training, adapted to the individual's cognitive abilities. Cognitive remediation improves quality of life and functional outcome in patients with chronic psychosis. It would even be more efficacious in the early phase of psychosis by tackling the negative impact of psychosis on education achievement and employment. However, cognitive dysfunctions are often overlooked in FEP and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatizing tools, such as self administered, training applications so that all first-line clinical settings or professionals, and in fine all patients, can have access, wherever they live, to personalized cognitive training focusing on impaired functions. Early psychosis can be associated with inflammation, metabolic deficiency, as well as early structural brain anomalies that reflect brain plasticity abilities and could influence the prognosis and response to cognitive training. Our background hypothesis is that promoting neuroplasticity by cognitive training could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients experiencing FEP and that this effect is modulated by individual brain plasticity abilities.

Participants needed: 240
Trial details
Age: 16-35Biological sex: AllType: InterventionalSponsor: Centre Hospitalier St AnneUpdated: Oct 10, 2024Locations: 1
Eligibility criteria

Adolescent and young adults, both genders, aged 16 to 35, [+3]

Severe and unstabilized medical conditions, [+5]