Status:
UNKNOWN
Psychoeducation Programmes - Patients With Bipolar Disorder
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Bipolar Disorder Type I or II (According to DSM-5)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT04775498
Start Date
February 1 2021
End Date
February 1 2025
Last Update
March 1 2021
Active Locations (10)
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1
CH Charles Perrens
Bordeau, France, 33076
2
CHU - Gabriel Montpied
Clermont-Ferrand, France, 63000
3
CHU - Hôpital Lapeyronie
Montpellier, France, 34295
4
CHU
Nantes, France, 44000