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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bipolar Disorders, Euthymic Status

Intervention / Treatment
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* Behavioral: Bipolife® group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>Bipolife group | Behavioral: Bipolife® group<br>* The participant is proposed to play to the serious game Bipolife® with following instructions : At least one connection per week during 4 weeks Connection time is free On add on of usual treatment After the 4 weeks and the first visit (V1), the participant can continue to participate to the serious game as much as he wishes, without any specific instructions. After connecting to the site www.bipolar.ubi.com, the participant is proposed to create his avatar and conduct him on his house. He realizes different kind of daily actions (like sleeping, sport activity, cooking) ; every action lead to win or to loose energy and mood points. The final aim is to stabilize the avatar's mood. Thanks to this experience, the participant can learn to distinguish positive and negative actions impacting on his condition.<br>|
| No Intervention: Control group<br>No specific intervention, treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance rate | Evaluation of patient compliance by Medication Adherence Rating Scale (MARS) score. | At 4 months after the inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of toxic consumption | evaluation of toxic consumption : patient will be asked about his consumption, and to pass the french scale Cut-down, Annoyed, Guilty, Eye-opener (CAGE- DETA) | Between 1 and 4 months after the inclusion | 
| Evolution of sleep disturbance | evaluation of sleep disturbance (by Pittsburgh Sleep Quality Index PSQI) | Between 1 and 4 months after the inclusion | 
| Evolution of the alimentation | evaluation of alimentation (patient will be asked about his alimentation) | Between 1 and 4 months after the inclusion | 
| Global functioning | evaluation of global functioning is realized by the Functioning Assessment Short Test (FAST) scale. | At 1 and 4 months after the inclusion | 
| Ability to access health care in emergency description : number of emergency consultation for psychiatric reason | evaluation of the ability to require to health care structures : Patients will be asked about their consultations and hospitalisations during the follow-up | At 1 and 4 months after the inclusion | 
| acceptability and satisfaction | only on the interventional group : evaluation of the acceptability and satisfaction by a home made acceptability scale. | At 1 and 4 months after the inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Serious game, Psychoeducation, Psychiatry, Bipolar disorder, Compliance