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Psychoeducational Intervention for Families With a Member Affected by Major Depression

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 19, 2024 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Apr 2024); last known: Recruiting
  2. Start date changed from estimate of Sep 2023 to Sep 27, 2023v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Major depressive disorder (MDD) is the most common mental disorder. It can be a huge burden not only for the person affected by it, but also for his/her whole family. The goal of this clinical trial is to test the efficacy of a family supportive intervention called psychoeducational family intervention (PFI) compared to a brief informative intervention in families with a member affected by MDD. Families will participate in one of the two interventions for a period of 6 months more or less, and they will be asked to answer some questionnaires about how much MDD impacts on their everyday life and the patient's symptoms, in order to understand whether a more structured intervention such as PFI can be useful for families in order to better deal with this complicated illness.
Trial Details
NCT Number NCT05988333
Lead Sponsor University of Campania Luigi Vanvitelli
Collaborators: Università degli Studi di Brescia, University of Bologna, University of Catanzaro, Università degli Studi 'G. d'Annunzio' Chieti e Pescara, University of Cagliari, University of Florence, Università degli Studi di Ferrara, University of Foggia, Universita degli Studi di Genova, University of Milan, University of Modena and Reggio Emilia, Università degli Studi del Piemonte Orientale Amedeo Avogadro, University of Parma, University Of Perugia, University of Pisa, Università Politecnica delle Marche, University of Roma La Sapienza, University of Rome Tor Vergata, Catholic University of the Sacred Heart, Università degli Studi di Sassari, University of Siena, Università degli studi di Trieste, Universita di Verona
Conditions
(from sponsor)		 Depressive Disorder, Major
Related terms Depression, Major Depressive Disorder
Enrollment 384 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov