System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Recruiting

NCT04775498 on ClinicalTrials.gov

Psychoeducation Programmes - Patients With Bipolar Disorder

Official title: Non-inferiority Study Comparing Two Psychoeducation Programmes (Mobile Application Versus Face-to-face Psychoeducation Group) in a Population of Patients With Bipolar Disorder

  • Sponsor: Centre Hospitalier Universitaire de Clermont-Ferrand
  • Enrollment: 352 (Estimated)
  • Study start: 2021-02-01 (Actual)
  • Primary completion: 2025-02-01 (Estimated)
  • Study completion: 2025-02-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: * Standard group : patients will participate at all sessions of face-to-face psychoeducation (sessions labeled and controlled by their Regional Health Agency). * Experimental group: patients will use SIMPLe application during 12 months.
  • Masking: None
  • PrimaryPurpose: Other

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 the effectiveness of face-to-face group psychoeducation.

Conditions

  • Bipolar Disorder Type I or II (According to DSM-5)

Intervention / Treatment

  • Behavioral: Face-to-face psychoeducation group
  • Behavioral: SIMPLe mobile application

Primary Outcome Measures

  • Recurrence rate (12 months after inclusion)
    Measure the difference of recurrence rate (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 judgment of the clinician since the beginning of the intervention) between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application

Countries

France

Locations and Investigators

  • CH Charles Perrens, Bordeau, France (Not yet recruiting)
    • Sebastien Gard
  • CHU - Gabriel Montpied, Clermont-Ferrand, France (Recruiting)
  • CHU - Hôpital Lapeyronie, Montpellier, France (Not yet recruiting)
    • Emilie Olié
  • CHU, Nantes, France (Not yet recruiting)
    • Anne Sauvaget
  • CHU - Hôpital Universitaire Carémeau, Nîmes, France (Not yet recruiting)
    • Mocrane Abbar
  • APHP - Hôpital Fernand-Widal, Paris, France (Not yet recruiting)
    • Sébastien Etain
  • CH Saint-Anne, Paris, France (Not yet recruiting)
    • Philip Gorwood
  • APHP - Centre Hospitalier Henri Mondor, Paris, France (Not yet recruiting)
    • Marion Leboyer
  • CHI HC site rives du Doubs Pontarlier, Pontarlier, France (Not yet recruiting)
    • Andreea Marinescu
  • CHU - Hôpital de Psychiatrie, Toulouse, France (Not yet recruiting)
    • Antoine Yrondi

Study Officials