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

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.

Study Overview

• Status: Terminated
• Conditions: Bipolar Disorders; Euthymic Status
• Intervention / Treatment: Behavioral: Bipolife® 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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Montpellier hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; Bipolife group	Behavioral: 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.
No Intervention: Control group; No specific intervention, treatment as usual

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2014
• Primary Completion (Actual): May 12, 2017
• Study Completion (Actual): May 12, 2017

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimated): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Psychiatry; Compliance; Psychoeducation; Bipolar disorder; Serious game
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Bipolar Disorder; Patient Compliance
• Other Study ID Numbers: UF 9238; 2013-A01481-44 (Other Identifier: Agence Nationale de Sécurité des Médicaments)