RecruitingNAINTERVENTIONAL

Evaluation of Efficiency of One Day Patient/Caregiver Psychoeducation on the Caregiver's Burden

This study is investigating a new, shorter education program for caregivers of people living with bipolar disorder. Often, existing programs are difficult for people to attend due to time commitments. This 'Bp OneDay' program is designed to be completed in a single day. Researchers want to find out if this one-day course can help reduce the feelings of stress and burden that caregivers often experience. The study will also look at whether the program helps caregivers and patients feel less judged or misunderstood, improves patients' ability to take their medication as prescribed, and increases everyone's understanding of bipolar disorder. The goal is to develop an accessible and effective support option.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Montpellier

Enrolment target

240

Start

09 Nov 2022

Estimated completion

30 Nov 2025

Bipolar Disorder Caregiver Burden

What is this study about?

Living with bipolar disorder can be challenging not just for the person affected, but also for their family and friends who support them. These caregivers often experience stress and feel burdened. We know that special education programs can help caregivers cope better and understand the condition more, which can also benefit the patient.

However, it can be hard for people to commit to long courses because of their daily responsibilities. This study is testing a new, shorter version of these education programs, called `Bp OneDay`, which can be completed in just one day. The main goal is to see if this one-day program can help reduce the burden and stress that caregivers feel.

Beyond just caregiver stress, we want to see if `Bp OneDay` helps caregivers feel less discriminated against, and if it helps patients feel less self-conscious about their condition. We also hope it will improve how well patients stick to their medication plan and generally increase everyone's knowledge about bipolar disorder and improve their quality of life. If this program works well, it could be a really helpful support tool for many families.

Key takeaways

This study tests a short, one-day education program for caregivers of people with bipolar disorder.
It aims to reduce caregiver stress and improve understanding of the condition.
Patients and caregivers will have three visits in total.
Participation involves being randomly assigned to either the program or a waiting list.
The study hopes to improve well-being for both caregivers and patients.

Who may be eligible?

To take part in this study, you would need to be both a patient with bipolar disorder and have a regular caregiver. Both the patient and the caregiver need to be over 18 years old. The patient must have a diagnosis of bipolar disorder (type I, II, or unspecified) and be able to understand what the study involves.

For caregivers, you must be the person the patient considers their main support and you should already know about their bipolar diagnosis. You also need to be able to understand the study details. Both the patient and caregiver must be able to speak, read, and write French.

You cannot take part if you have a condition that makes it hard to follow group activities, or if you are legally protected (like being under guardianship) or unable to make your own decisions. You also can't be in another study at the same time, or if you didn't sign the consent form to join this study.

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 both the patient and caregiver over 18 years old?
Does the patient have a diagnosis of bipolar disorder?
Is the caregiver the patient's main support and aware of the diagnosis?
Can both the patient and caregiver understand and communicate in French?
Are both able to understand what the study involves and attend the required visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you and your caregiver pair (known as a 'dyad') will be randomly placed into one of two groups. One group will attend the `Bp OneDay` education program. The other group will be placed on a waiting list and won't receive the program during the study.

Taking part will involve three visits in total. The first visit is to get you started in the study. Then there will be two follow-up visits to check in on how things are going. Researchers will ask questions to understand how the program has affected caregiver burden, stigma, knowledge about bipolar disorder, and other aspects of well-being for both patients and caregivers. The total duration of your involvement in the study would include these three visits and the period between them where the researchers are checking the effects of the program.

Potential risks and benefits

Taking part in this study could offer several potential benefits. If you are in the group that receives the `Bp OneDay` program, you might find it helps reduce the stress and burden of caregiving, improves your understanding of bipolar disorder, and helps you feel less judged. For patients, it might lead to a better understanding of their condition, better medication adherence, and less self-stigma. There are very few direct risks associated with an educational program, but some people might find discussing their experiences emotionally challenging. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual care.

Locations (1)

University Hospital of Montpellier
Verified postcode
Montpellier, France· Recruiting

Common questions

What is bipolar disorder?

Bipolar disorder is a mental health condition that causes extreme mood swings that include emotional highs (mania or hypomania) and lows (depression). It can affect a person's energy, sleep, judgment, behaviour, and ability to think clearly.

What is a 'caregiver's burden'?

A caregiver's burden refers to the emotional, physical, and financial strain that someone might experience when looking after a family member or friend with a long-term illness like bipolar disorder.

What is 'psychoeducation'?

Psychoeducation is a type of education that provides people with information and support about a mental health condition. It helps individuals and their families understand the illness, its treatment, and how to cope with its effects.

Will I definitely get the `Bp OneDay` program if I join?

Not necessarily. This study randomly puts participants into one of two groups. One group will receive the `Bp OneDay` program, and the other group will be on a waiting list. This allows researchers to compare the two groups fairly.

What does an 'open-label' study mean?

An 'open-label' study means that everyone involved – both the participants and the researchers – will know which group you are in (whether you receive the `Bp OneDay` program or are on the waiting list). This is different from a 'blinded' study where this information is kept secret.

How to find out more

Kathlyne DUPUIS MAURIN

k-dupuis@chu-montpellier.fr +33467335663 Official trial record

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