NCT02936466

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2017

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

2.4 years

First QC Date

July 15, 2016

Last Update Submit

August 23, 2022

Conditions

Bipolar DisordersEuthymic Status

Keywords

PsychiatryRandomized controlled trialBipolar disorderSerious gameCompliancePsychoeducation

Outcome Measures

Primary Outcomes (1)

  • Compliance rate

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

    At 4 months after the inclusion

Secondary Outcomes (6)

  • Evolution of toxic consumption

    Between 1 and 4 months after the inclusion

  • Evolution of sleep disturbance

    Between 1 and 4 months after the inclusion

  • Evolution of the alimentation

    Between 1 and 4 months after the inclusion

  • Global functioning

    At 1 and 4 months after the inclusion

  • Ability to access health care in emergency description : number of emergency consultation for psychiatric reason

    At 1 and 4 months after the inclusion

  • +1 more secondary outcomes

Study Arms (2)

Interventional group

EXPERIMENTAL

Bipolife group

Behavioral: Bipolife® group

Control group

NO INTERVENTION

No specific intervention, treatment as usual

Interventions

Bipolife® groupBEHAVIORAL

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.

Interventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Montpellier Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Bipolar DisorderPatient Compliance

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

October 18, 2016

Study Start

December 9, 2014

Primary Completion

May 12, 2017

Study Completion

May 12, 2017

Last Updated

August 26, 2022

Record last verified: 2022-08

Locations

FR(1)