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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Terminated

Conditions

Bipolar Disorders
Euthymic Status

Treatments

Behavioral: Bipolife® group

Study type

Interventional

Funder types

Other

Identifiers

NCT02936466
2013-A01481-44 (Other Identifier)
UF 9238

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 2 patient groups

Interventional group
Experimental group
Description:
Bipolife group
Treatment:
Behavioral: Bipolife® group
Control group
No Intervention group
Description:
No specific intervention, treatment as usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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