The Efficacy of Psychoeducational Family Intervention for Individuals With Major Depression: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• diagnosis of major depression, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition;

• ability to provide informed consent;

• presence of at least one contact per month with the psychiatric clinic for at least six months prior to recruitment;

• cohabitation with at least one family member.

Locations
Other Locations
Italy
University of Campania L. Vanvitelli
RECRUITING
Napoli
Contact Information
Primary
Mario Luciano, Doctor
mario.luciano@unicampania.it
+393490730150
Time Frame
Start Date: 2023-09-27
Estimated Completion Date: 2026-09
Participants
Target number of participants: 384
Treatments
Experimental: Psychoeducational Family Intervention
The experimental intervention will be administered individually to each recruited family. Sessions will take place three times a month for a period ranging from 4 to 6 months (about 18 sessions in total). The number of sessions, as well as the frequency, may vary depending on the patient's clinical situation. Sessions will have an average duration of 60-90 minutes.
Active_comparator: Informative intervention
The informative intervention consists of five sessions, administered every 7-10 days.
Related Therapeutic Areas
Sponsors
Collaborators: Catholic University of the Sacred Heart, University of Rome Tor Vergata, University of Pisa, Università degli studi di Trieste, University of Siena, University Of Perugia, University of Parma, University of Bologna, Universita di Verona, Università degli Studi 'G. d'Annunzio' Chieti e Pescara, University of Modena and Reggio Emilia, Università Politecnica delle Marche, University of Milan, Università degli Studi del Piemonte Orientale Amedeo Avogadro, University of Catanzaro, Università degli Studi di Sassari, University of Cagliari, University of Roma La Sapienza, Università degli Studi di Brescia, Università degli Studi di Ferrara, University of Foggia, University of Florence, Universita degli Studi di Genova
Leads: University of Campania Luigi Vanvitelli

This content was sourced from clinicaltrials.gov