TerminatedNot Applicable

Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group

Stopped: difficulties encountered in recruiting and stop of funding

France42 participantsStarted 2014-12-09

Plain-language summary

Bipolar disorder is a condition characterized by succession of episodes- manic, hypomanic, and depressive episodes. Major risks factors of relapses are poor compliance, sleep disorder, and toxics consumption. The aims of psychoeducation programs are to increase compliance and knowledge about bipolar disorder. Serious game are supposed, in bipolar disorder, to strengthen the efficacy of psychoeducation programs. Bipolife® is a serious game which purpose is to help bipolar patients to deal with their conditions, through 3 mains messages : to pursue the treatment, to have daily routine and to request the psychiatrist in case of relapse. This is a multicentric randomized controlled study with two harms parallels. After a classic psychoeducation group program, patients are randomized in two groups : interventional group and control group with treatment as usual. The main objective is to evaluate the observance in the two groups. The other objectives are to evaluate daily routine, global functioning, and access to health care. Evaluations are realized at one and four months after inclusion visit. Acceptability and satisfaction about the serious game Bipolife® will be assessed in the interventional group.

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: * diagnosis of bipolar disorder according to the Diagnostic and Statistical Manual (DSM) IV * euthymic status at least since 3 months * participation to a psychoeducation group ending on the 15 last days * realized at less 50% of the sessions of psychoeducation group * free access to a computer with internet connection * signed informed consent Exclusion criteria: * decline of participation * patient on protective measures (guardianship or trusteeship)

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

Compliance rate

Timeframe: At 4 months after the inclusion

Trial details

NCT IDNCT02936466

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05-12

View on ClinicalTrials.gov More Bipolar Disorders trials