Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Compliance rate
研究概览
简要总结
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.
详细描述
Bipolife® is a serious game for bipolar patients, developed by Astra Zeneca laboratory in collaboration with a french company named Ubisoft. The aim of this interactive tool is to help patient to have a better understanding of their condition and to identify their daily routine which can impact on it.
Three visits :
At the inclusion visit (V0), on the 15days following the end of the psychoeducation group, the investigator evaluate mood, habits, daily routine, and verify inclusion criteria of the participants, in particular euthymic status. The participants are randomized by bloc in each center, in two groups : interventional group (Bipolife®) and control group.
Instructions on interventional group are to periodically connect to BIPOLIFE until next visit.
On the first visit, one month later (V1) and on the second visit, four months later (V2), the investigator evaluate compliance, routine habits and mood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •decline of participation
- •patient on protective measures (guardianship or trusteeship)
研究组 & 干预措施
Interventional group
Bipolife group
干预措施: Bipolife® group (Behavioral)
Control group
No specific intervention, treatment as usual
结局指标
主要结局
Compliance rate
时间窗: At 4 months after the inclusion
Evaluation of patient compliance by Medication Adherence Rating Scale (MARS) score.
次要结局
- Evolution of sleep disturbance(Between 1 and 4 months after the inclusion)
- Evolution of the alimentation(Between 1 and 4 months after the inclusion)
- Evolution of toxic consumption(Between 1 and 4 months after the inclusion)
- Global functioning(At 1 and 4 months after the inclusion)
- Ability to access health care in emergency description : number of emergency consultation for psychiatric reason(At 1 and 4 months after the inclusion)
- acceptability and satisfaction(At 1 and 4 months after the inclusion)