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

Not Applicable

Terminated

• Conditions: Bipolar Disorders; Euthymic Status
• Interventions: Behavioral: Bipolife® group

• Registration Number: NCT02936466
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2014-12-09
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Primary Completion: 2017-05-12
• Study Completion: 2017-05-12
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	Bipolife® group	Bipolife group

Primary Outcome Measures

Name	Time	Method
Compliance rate	At 4 months after the inclusion	Evaluation of patient compliance by Medication Adherence Rating Scale (MARS) score.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Montpellier Hospital; 🇫🇷 Montpellier, France