Clinical trial NCT02936466: Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group
Official title: Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Disorders
Euthymic Status
Keywords: Psychiatry
Randomized controlled trial
Bipolar disorder
Serious game
Compliance
Psychoeducation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Compliance rate
timeFrame: At 4 months after the inclusion
Secondary outcomes:
measure: Evolution of toxic consumption
timeFrame: Between 1 and 4 months after the inclusion
measure: Evolution of sleep disturbance
timeFrame: Between 1 and 4 months after the inclusion
measure: Evolution of the alimentation
timeFrame: Between 1 and 4 months after the inclusion
measure: Global functioning
timeFrame: At 1 and 4 months after the inclusion
measure: Ability to access health care in emergency description : number of emergency consultation for psychiatric reason
timeFrame: At 1 and 4 months after the inclusion
measure: acceptability and satisfaction
timeFrame: At 1 and 4 months after the inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Montpellier Hospital
Study officials:
References: