Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01481-44 | Other Identifier | Agence Nationale de Sécurité des Médicaments |
Not provided
Not provided
difficulties encountered in recruiting and stop of funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | Bipolife group |
|
| Control group | No Intervention | No specific intervention, treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bipolife® group | Behavioral | The participant is proposed to play to the serious game Bipolife® with following 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance rate | Evaluation of patient compliance by Medication Adherence Rating Scale (MARS) score. | At 4 months after the inclusion |
| 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 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Montpellier Hospital | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31668996 | Result | Maurin KD, Girod C, Consolini JL, Belzeaux R, Etain B, Cochet B, Leboyer M, Genty C, Gamon L, Picot MC, Courtet P, Olie DE. Use of a serious game to strengthen medication adherence in euthymic patients with bipolar disorder following a psychoeducational programme: A randomized controlled trial. J Affect Disord. 2020 Feb 1;262:182-188. doi: 10.1016/j.jad.2019.10.008. Epub 2019 Oct 9. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010342 | Patient Acceptance of Health Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |