RecruitingNAINTERVENTIONAL

Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.

This study is investigating if having a specially trained support worker, known as a case manager, can make a positive difference for young people aged 16 to 30 who have recently experienced their first episode of psychosis. Psychosis is a mental health problem where someone may lose touch with reality, seeing or hearing things that aren't there. The researchers believe that these case managers, who are trained in supporting people with early psychosis, could offer better care than what's currently available. They will provide personalised help, explain the condition and treatments, support families, and assist with getting back into work or education. The main goal is to find out if this approach can lower the chances of these psychotic episodes happening again over a three-year period.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrolment target

256

Start

27 Sep 2021

Estimated completion

01 Nov 2028

Psychotic Episode

What is this study about?

This study is looking into a new way to help young people, aged 16 to 30, who have just had their first experience with psychosis. Psychosis is a serious mental health condition where someone might have confused thoughts, or see or hear things that aren't real. It can be a very frightening experience, both for the person going through it and for their family. Often, getting the right support early on can make a big difference to how well someone recovers and manages their mental health in the long term.

The researchers want to see if having a dedicated 'case manager' can improve this early support. A case manager is a trained professional who works closely with patients and their families. They offer one-on-one help, explain the illness and treatments in a clear way (called psycho-education), support the family, and help the person get back into their daily life, like school, work, or social activities. The idea is that this personal and ongoing support, based on best practices, could make a real difference across the country, especially since setting up many specialised clinics can be difficult and costly.

Ultimately, this study aims to find out if this case manager approach can reduce the chances of someone having another psychotic episode over the next three years. If it works, it could lead to better and more widespread support for young people experiencing psychosis for the first time, helping them to live healthier and more stable lives.

Key takeaways

It's about whether personal support helps young people with first-time psychosis.
A 'case manager' offers guidance on illness, treatment, family support, and getting back to daily life.
The study lasts three years to see if this support lowers repeat episodes.
It's for young people aged 16-30 who have recently had their first psychotic episode.
No new medications are being tested; the focus is on a support approach.

Who may be eligible?

To be part of this study, you need to be between 16 and 30 years old and have recently experienced your very first episode of psychosis. This means you would have had symptoms like seeing or hearing things that aren't there, or having strong fixed beliefs that aren't true, for at least a week. You also shouldn't have taken certain types of medication (called neuroleptics or antipsychotics) for this condition before, unless it was for the episode you're currently experiencing.

You would also need to be receiving care from a mental health service (either as an outpatient or in hospital) for this first episode of psychosis. The study aims to include people within three months of them starting care for this episode. You, or your close family member if you're a minor, would need to agree to take part and sign a consent form, and you should be able to attend follow-up appointments for the next three years.

There are also a few reasons why you wouldn't be able to join. For example, if you're already in another study involving a new treatment, or if you or your parent refuses to sign the consent form. Also, if the doctors can't properly explain the study to you so you understand it, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 16 and 30 years old?
Have you recently had your very first experience with psychosis?
Are you currently receiving mental health care for this first episode?
Are you willing and able to attend follow-up visits for three years?
Are you not currently part of another clinical trial testing a new treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive support from a specially trained case manager for a period of time. The study will then follow your progress for three years to see if this support helps prevent future psychotic episodes. This will likely involve regular check-ups and assessments, but the specific details of these visits and their frequency haven't been provided. There are no new medications involved, as the focus is on the support from the case manager and how it affects your recovery and well-being over time. The total duration of your participation in the study is three years.

Potential risks and benefits

A potential benefit of joining this study is receiving dedicated support from a trained case manager, which might help you manage your condition better and potentially reduce the chance of future psychotic episodes. There are no new medications involved, so you won't be exposed to unknown drug side effects. Potential risks are generally low, as the focus is on a support intervention rather than a medical one, but there's always the possibility of emotional distress from discussions about your condition. You are free to withdraw from the study at any time without giving a reason, and this will not affect the quality of your usual medical care.

Locations (6)

CHU de TOULOUSE
Verified postcode
Toulouse, France· Not yet recruiting
CH Saint Marie Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
CHU de Montpellier
Verified postcode
Montpellier, France· Recruiting
CHU Nice
Verified postcode
Nice, France· Not yet recruiting
CHU de Nîmes
Verified postcode
Nîmes, France· Recruiting
Centre Hospitalier Léon-Jean Grégory
Verified postcode
Thuir, France· Recruiting

Common questions

What exactly is a 'case manager'?

A case manager is a trained professional who provides personal support, explains your condition and treatment, assists your family, and helps you get back into daily life activities.

What is 'psychosis'?

Psychosis is a mental health problem where someone might have confused thoughts, or see or hear things that aren't real.

How long will I be followed in the study?

If you join, the study will follow your progress for three years.

Will I have to take new medicine?

No, this study focuses on the support from a case manager, not on new medications.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and your regular care won't be affected.

How to find out more

Aurélie Schandrin

aurelie.schandrin@chu-nimes.fr 04.66.68.34.26 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.