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

NCT ID: NCT02936466

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-09
• Study Completion Date: 2017-05-12

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.

Conditions

Bipolar Disorders; Euthymic Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional group

Bipolife group

Group Type: EXPERIMENTAL

Bipolife® group

Intervention Type: BEHAVIORAL

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.

Control group

No specific intervention, treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bipolife® group

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Montpellier Hospital

Montpellier, , France

Countries

France

Other Identifiers

2013-A01481-44

Identifier Type: OTHER

Identifier Source: secondary_id

UF 9238

Identifier Type: -

Identifier Source: org_study_id