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TerminatedNCT02936466BipolifeUpdated May 14, 2026

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

An interventional study of Bipolife® group in Bipolar Disorders and Euthymic Status, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Treatment

Why this study was terminated
difficulties encountered in recruiting and stop of funding

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Dec 2014, registered Jul 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bipolar Disorders
  • Euthymic Status

Keywords

  • Psychiatry
  • Randomized controlled trial
  • Bipolar disorder
  • Serious game
  • Compliance
  • Psychoeducation
03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 42 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria:

  • decline of participation
  • patient on protective measures (guardianship or trusteeship)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Interventional group

    Bipolife group

    Behavioral: Bipolife® group

  • No intervention
    Control group

    No specific intervention, treatment as usual

Interventions

  • BehavioralBipolife® 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.

06

What researchers measure

Primary outcomes

  1. Compliance rate

    Evaluation of patient compliance by Medication Adherence Rating Scale (MARS) score.

    Time frame: At 4 months after the inclusion

Secondary outcomes

  1. 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)

    Time frame: Between 1 and 4 months after the inclusion

  2. Evolution of sleep disturbance

    evaluation of sleep disturbance (by Pittsburgh Sleep Quality Index PSQI)

    Time frame: Between 1 and 4 months after the inclusion

  3. Evolution of the alimentation

    evaluation of alimentation (patient will be asked about his alimentation)

    Time frame: Between 1 and 4 months after the inclusion

  4. Global functioning

    evaluation of global functioning is realized by the Functioning Assessment Short Test (FAST) scale.

    Time frame: At 1 and 4 months after the inclusion

  5. 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

    Time frame: At 1 and 4 months after the inclusion

  6. acceptability and satisfaction

    only on the "interventional group" : evaluation of the acceptability and satisfaction by a home made acceptability scale.

    Time frame: At 1 and 4 months after the inclusion

07

Study locations

1 site
  • University Montpellier Hospital
    Montpellier, 34295, France
08

References and documents

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. PubMed 31668996 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02936466
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Oct 18, 2016
Start date
Dec 9, 2014
Primary completion
May 12, 2017
Completion
May 12, 2017
Last update
May 14, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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