Bipolar DisordersBipolifeNCT02936466
Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group
A study testing Bipolife® group in people with Bipolar Disorders and Euthymic Status, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorders, Euthymic Status
- What is being tested?
- Bipolife® group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2014to 12 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- decline of participation
- patient on protective measures (guardianship or trusteeship)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Bipolar Disorders, Euthymic Status
- Being tested
- Bipolife® group
- Keywords
- Psychiatry, Randomized controlled trial, Bipolar disorder, Serious game, Compliance, Psychoeducation
- Medical subject headings
- Bipolar Disorder, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolife® groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Bipolife group Receives: Behavioral: Bipolife® group |
| Control group | No intervention | No specific intervention, treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate
Evaluation of patient compliance by Medication Adherence Rating Scale (MARS) score.
Measured: At 4 months after the inclusion
Secondary outcomes (6)
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)
Measured: Between 1 and 4 months after the inclusion
Evolution of sleep disturbance
evaluation of sleep disturbance (by Pittsburgh Sleep Quality Index PSQI)
Measured: Between 1 and 4 months after the inclusion
Evolution of the alimentation
evaluation of alimentation (patient will be asked about his alimentation)
Measured: Between 1 and 4 months after the inclusion
Global functioning
evaluation of global functioning is realized by the Functioning Assessment Short Test (FAST) scale.
Measured: 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
Measured: 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.
Measured: At 1 and 4 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start9 Dec 2014
- Primary completion12 May 2017
- Study completion12 May 2017
Why it stopped: difficulties encountered in recruiting and stop of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936466
- Sponsor's protocol ID
- UF 9238
- Other IDs
- 2013-A01481-44
- Acronym
- Bipolife
- Status last verified
- Aug 2022
- First submitted
- 15 Jul 2016
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group
- ClinicalTrials.gov ID
- NCT02936466
- Acronym / sponsor ID
- Bipolife / UF 9238
- Conditions
- Bipolar Disorders, Euthymic Status
- Keywords
- Psychiatry, Randomized controlled trial, Bipolar disorder, Serious game, Compliance, Psychoeducation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties encountered in recruiting and stop of funding
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 9 Dec 2014 (actual)
- Primary completion
- 12 May 2017 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: Bipolife® groupBipolife group |
| Control group | No intervention | –No specific intervention, treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- decline of participation
- patient on protective measures (guardianship or trusteeship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bipolife® groupThe 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. | Behavioural | Interventional group |
Primary outcome
Compliance rate
Time frame: At 4 months after the inclusion
Evaluation of patient compliance by Medication Adherence Rating Scale (MARS) score.
6 secondary outcomes
Evolution of toxic consumption
Time frame: Between 1 and 4 months after the inclusion
Evolution of sleep disturbance
Time frame: Between 1 and 4 months after the inclusion
Evolution of the alimentation
Time frame: Between 1 and 4 months after the inclusion
Global functioning
Time frame: At 1 and 4 months after the inclusion
Ability to access health care in emergency description : number of emergency consultation for psychiatric reason
Time frame: At 1 and 4 months after the inclusion
acceptability and satisfaction
Time frame: At 1 and 4 months after the inclusion
Results and safety
The study was stopped early (reason given: difficulties encountered in recruiting and stop of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 31668996Maurin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolife® group in people with Bipolar Disorders and Euthymic Status, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulties encountered in recruiting and stop of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate (time frame: At 4 months after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02936466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.