RecruitingNot Applicable

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

France240 participantsStarted 2022-11-09

Plain-language summary

Bipolar disorder (BD) has a huge impact on the lives of patient and their relatives. Psychoeducation programs on BD has been shown to be effective on the burden of patients and their caregivers. However, actual programs appear to be incompatible with patients obligations and services requirements of the service. The development of "minute" programs (in one day) is justified.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patient inclusion Criteria: * Be over 18 years old; * Meet the criteria for bipolar disorder (I, II, unspecified) according to the DSM-5 criteria; * Be able to understand the nature, purpose and methodology of the study; * Presence of a caregiver Patient Exclusion Criteria: * Subject unable to adhere to the group requirements (cognitive disorder, decompensated mood state ...); * Subject protected by law (subject under guardianship and / or guardianship) or deprived of liberty by a judicial or administrative decision; * Subject unable to understand, speak and write French; * Subject in a period of exclusion from another protocol. * Subject not having signed an informed consent * Subject not affiliated with a social security scheme or such a scheme Caregiver inclusion criteria ; * Subject over 18 years old; * Subject designated as a regular caregiver of a patient with bipolar disorder. A regular caregiver is a trusted person designated by the patient as being one of his main support, having knowledge of the diagnosis of bipolar disorder and who can be called upon in the context of care. * Subject able to understand the nature, purpose and methodology of the study; Caregiver exclusion criteria : * Subject unable to adhere to the groupre quirements (cognitive disorder, decompensated mood state ...); * Subject protected by law (subject under guardianship and / or curatorship) or deprived of liberty by a judicial or administrative decision ; * Subject unable to understand, s…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

caregivers burden

Timeframe: Day65 for experimental group, Day35 for control group

Trial details

NCT IDNCT05178966

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

Contact for this trial

Kathlyne DUPUIS MAURIN

+33467335663 k-dupuis@chu-montpellier.fr

View on ClinicalTrials.gov More Bipolar Disorder trials