Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group (Bipolife)
Primary Purpose
Bipolar Disorders, Euthymic Status
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bipolife® group
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorders focused on measuring Psychiatry, Randomized controlled trial, Bipolar disorder, Serious game, Compliance, Psychoeducation
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)
Sites / Locations
- University Montpellier Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional group
Control group
Arm Description
Bipolife group
No specific intervention, treatment as usual
Outcomes
Primary Outcome Measures
Compliance rate
Evaluation of patient compliance by Medication Adherence Rating Scale (MARS) score.
Secondary Outcome Measures
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)
Evolution of sleep disturbance
evaluation of sleep disturbance (by Pittsburgh Sleep Quality Index PSQI)
Evolution of the alimentation
evaluation of alimentation (patient will be asked about his alimentation)
Global functioning
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
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
only on the "interventional group" : evaluation of the acceptability and satisfaction by a home made acceptability scale.
Full Information
NCT ID
NCT02936466
First Posted
July 15, 2016
Last Updated
August 23, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02936466
Brief Title
Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group
Acronym
Bipolife
Official Title
Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
difficulties encountered in recruiting and stop of funding
Study Start Date
December 9, 2014 (Actual)
Primary Completion Date
May 12, 2017 (Actual)
Study Completion Date
May 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorders, Euthymic Status
Keywords
Psychiatry, Randomized controlled trial, Bipolar disorder, Serious game, Compliance, Psychoeducation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Bipolife group
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No specific intervention, treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Bipolife® group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compliance rate
Description
Evaluation of patient compliance by Medication Adherence Rating Scale (MARS) score.
Time Frame
At 4 months after the inclusion
Secondary Outcome Measure Information:
Title
Evolution of toxic consumption
Description
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
Title
Evolution of sleep disturbance
Description
evaluation of sleep disturbance (by Pittsburgh Sleep Quality Index PSQI)
Time Frame
Between 1 and 4 months after the inclusion
Title
Evolution of the alimentation
Description
evaluation of alimentation (patient will be asked about his alimentation)
Time Frame
Between 1 and 4 months after the inclusion
Title
Global functioning
Description
evaluation of global functioning is realized by the Functioning Assessment Short Test (FAST) scale.
Time Frame
At 1 and 4 months after the inclusion
Title
Ability to access health care in emergency description : number of emergency consultation for psychiatric reason
Description
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
Title
acceptability and satisfaction
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University Montpellier Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
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Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group
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