Psychoeducation Programmes - Patients With Bipolar Disorder
Psychoeducation Programmes - Patients With Bipolar Disorder
This is a controlled, randomized, prospective, open-label, non-inferiority trial lasting 12
 months. The effectiveness of using a psychoeducational smartphone application (SIMPLe) will
 be compared to the effectiveness of face-to-face group psychoeducation.
Bipolar disorder (affecting 3 to 5% of French population) is characterized by the recurrence
 of severe symptomatic periods (depression, mania, hypomania) and interepisodic periods
 characterized by the persistence of residual symptoms, impaired psychosocial functioning and
 quality of life. The combination of psychosocial strategies with drug treatment is associated
 with an improvement in the prognosis of the disease. Among these complementary strategies,
 psychoeducation has been shown to be effective in reducing the risk of recurrence, the length
 of hospital stays and improving compliance. It improves an individual's understanding and
 knowledge of their disorder and its various treatments. Despite its effectiveness,
 psychoeducation for bipolar disorder remains relatively scarcely applied in France due to a
 limited healthcare offer (44 available programmes labeled by the Regional Health Agencies in
 2017).

 In recent years, a significant number of smartphone applications have been developed in the
 field of mental health. To date, none of these applications has proven effective in patients
 with bipolar disorder. In this context, the Institute of Neuroscience of Barcelona has
 developed a "SIMPLe" application to assess and record a subject's symptoms and deliver
 personalized psychoeducation. In terms of efficacy, a study has shown the interest of this
 application in improving biological rhythms, thereby reducing the risk of relapse and
 improving psychosocial functioning and the quality of life of patients suffering from bipolar
 disorder in remission phase. This application has been translated and adapted into French as
 part of a partnership with the Barcelona Institute of Neuroscience. However, the benefits of
 this type of application in terms of effectiveness, accessibility or reduction of health
 costs have never been studied in comparison to face-to-face psychoeducation programmes. This
 research project therefore represents a real opportunity to evaluate for the first time the
 effectiveness of an application allowing the delivery of personalized psychoeducation in
 comparison to a face-to-face group psychoeducation program (reference treatment for relapse
 prevention).

 The SIMPLe app includes 5 daily questions (mood, energy, sleep, irritability, medication
 adherence) that will assess different areas associated with bipolar disorder. The user will
 also receive a weekly test to determine the presence and intensity of depressive or manic
 symptoms. Daily and personalized psychoeducation messages (adapted to the answers to the
 tests carried out) will be sent to the user by notifications. The app contains a bank of
 around 400 psychoeducational messages, based on Prof. Vieta and Dr Colom's Psychoeducation
 Manual for Bipolar Disorders.

 Eligible patients, after obtaining their consent, will be randomized (i) either in the
 face-to-face psychoeducation group which will consist of the participation by the patients in
 all the sessions of a therapeutic education program (labeled and controlled by their Regional
 Health Agency) of the investigator center, (ii) or in the SIMPLe application group and will
 benefit from access to the application via a code that will be sent to them.

 Three additional visits to the usual care are planned (assessment visit, 6 months and 12
 months). At each visit, patients must complete questionnaires (CSRI, YMRS, MADRS, FAST, MARS,
 WHOQOL-BREF and EQ-5D).

 The hypothesis formulated by the investigator is that a psychoeducational strategy using the
 SIMPLe smartphone application has an effect comparable to participation in a face-to-face
 psychoeducation group, in term of the recurrence prevention in a sample of stabilized
 patients with bipolar disorder (at 12 months). The recurrence rate is defined by the
 percentage of patients having presented a mood episode of bipolar disorder, namely a major
 depressive episode, manic or hypomanic episode, according to the criteria of DSM-5 and on the
 basis of the judgment of the clinician since the beginning of the intervention.
Inclusion Criteria:

 -  Suffering from bipolar disorder (type 1 or 2) according to DSM-5 criteria

 -  Not presenting a mood episode according to DSM-5 criteria

 -  Stable for at least 1 month with scores on YMRS < 8 and MADRS < 8

 -  Owning a smartphone

 -  Agreeing to attend group psychoeducation sessions

 -  Having no problem understanding fluent French

 -  Having given free and informed consent and signed the consent to participate in the
 study

 -  Available for 12 onth follow-up

 Exclusion Criteria:

 -  Not having a smartphone compatible with the SIMPLe application

 -  Cannot attend psychoeducation group sessions on a regular basis

 -  Not having given their consent to participate in the study or unable to give their
 informed consent

 -  Not affiliation with a social security scheme

 -  Having a legal protection measure (safeguard of justice or guardianship)