Psychoeducation Programmes - Patients With Bipolar Disorder
France352 participantsStarted 2021-02-01
Plain-language summary
This is a controlled, randomized, prospective, open-label, non-inferiority trial lasting 12 months. The effectiveness of using a psychoeducational smartphone application (SIMPLe) will be compared to the effectiveness of face-to-face group psychoeducation.
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.
Inclusion Criteria:
* Suffering from bipolar disorder (type 1 or 2) according to DSM-5 criteria
* Not presenting a mood episode according to DSM-5 criteria
* Stable for at least 1 month with scores on YMRS \< 8 and MADRS \< 8
* Owning a smartphone
* Agreeing to attend group psychoeducation sessions
* Having no problem understanding fluent French
* Having given free and informed consent and signed the consent to participate in the study
* Available for 12 onth follow-up
Exclusion Criteria:
* Not having a smartphone compatible with the SIMPLe application
* Cannot attend psychoeducation group sessions on a regular basis
* Not having given their consent to participate in the study or unable to give their informed consent
* Not affiliation with a social security scheme
* Having a legal protection measure (safeguard of justice or guardianship)
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.