Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-23 @ 12:42 AM
Study NCT ID:
NCT02936466
Status:
TERMINATED
Last Update Posted:
2022-08-26
First Post:
2016-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'whyStopped': 'difficulties encountered in recruiting and stop of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance rate', 'timeFrame': 'At 4 months after the inclusion', 'description': 'Evaluation of patient compliance by Medication Adherence Rating Scale (MARS) score.'}], 'secondaryOutcomes': [{'measure': 'Evolution of toxic consumption', 'timeFrame': 'Between 1 and 4 months after the inclusion', '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)'}, {'measure': 'Evolution of sleep disturbance', 'timeFrame': 'Between 1 and 4 months after the inclusion', 'description': 'evaluation of sleep disturbance (by Pittsburgh Sleep Quality Index PSQI)'}, {'measure': 'Evolution of the alimentation', 'timeFrame': 'Between 1 and 4 months after the inclusion', 'description': 'evaluation of alimentation (patient will be asked about his alimentation)'}, {'measure': 'Global functioning', 'timeFrame': 'At 1 and 4 months after the inclusion', 'description': 'evaluation of global functioning is realized by the Functioning Assessment Short Test (FAST) scale.'}, {'measure': 'Ability to access health care in emergency description : number of emergency consultation for psychiatric reason', 'timeFrame': 'At 1 and 4 months after the inclusion', 'description': 'evaluation of the ability to require to health care structures : Patients will be asked about their consultations and hospitalisations during the follow-up'}, {'measure': 'acceptability and satisfaction', 'timeFrame': 'At 1 and 4 months after the inclusion', 'description': 'only on the "interventional group" : evaluation of the acceptability and satisfaction by a home made acceptability scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psychiatry', 'Randomized controlled trial', 'Bipolar disorder', 'Serious game', 'Compliance', 'Psychoeducation'], 'conditions': ['Bipolar Disorders', 'Euthymic Status']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.', 'detailedDescription': '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.\n\nThree visits :\n\nAt 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.\n\nInstructions on interventional group are to periodically connect to BIPOLIFE until next visit.\n\nOn the first visit, one month later (V1) and on the second visit, four months later (V2), the investigator evaluate compliance, routine habits and mood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* diagnosis of bipolar disorder according to the Diagnostic and Statistical Manual (DSM) IV\n* euthymic status at least since 3 months\n* participation to a psychoeducation group ending on the 15 last days\n* realized at less 50% of the sessions of psychoeducation group\n* free access to a computer with internet connection\n* signed informed consent\n\nExclusion criteria:\n\n* decline of participation\n* patient on protective measures (guardianship or trusteeship)'}, 'identificationModule': {'nctId': 'NCT02936466', 'acronym': 'Bipolife', 'briefTitle': 'Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group', 'orgStudyIdInfo': {'id': 'UF 9238'}, 'secondaryIdInfos': [{'id': '2013-A01481-44', 'type': 'OTHER', 'domain': 'Agence Nationale de Sécurité des Médicaments'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'Bipolife group', 'interventionNames': ['Behavioral: Bipolife® group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No specific intervention, treatment as usual'}], 'interventions': [{'name': 'Bipolife® group', 'type': 'BEHAVIORAL', 'description': 'The participant is proposed to play to the serious game Bipolife® with following instructions :\n\n* At least one connection per week during 4 weeks\n* 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.\n\nAfter 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.', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'University Montpellier Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}