Psychoeducational Intervention for Families With a Member Affected by Major Depression

NCT05988333 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2024-04-19

No results posted yet for this study

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.

Conditions

  • Depressive Disorder, Major

Interventions

OTHER

Psychoeducational Family Intervention

Supportive intervention administered to families with a member affected by MDD

OTHER

Informative intervention

Informative intervention administered to families with a member affected by MDD

Sponsors & Collaborators

  • Università degli Studi di Brescia

    collaborator OTHER
  • University of Bologna

    collaborator OTHER
  • University of Catanzaro

    collaborator OTHER
  • Università degli Studi 'G. d'Annunzio' Chieti e Pescara

    collaborator OTHER
  • University of Cagliari

    collaborator OTHER
  • University of Florence

    collaborator OTHER
  • Università degli Studi di Ferrara

    collaborator OTHER
  • University of Foggia

    collaborator OTHER
  • Universita degli Studi di Genova

    collaborator OTHER
  • University of Milan

    collaborator OTHER
  • University of Modena and Reggio Emilia

    collaborator OTHER
  • Università degli Studi del Piemonte Orientale Amedeo Avogadro

    collaborator OTHER
  • University of Parma

    collaborator OTHER
  • University Of Perugia

    collaborator OTHER
  • University of Pisa

    collaborator OTHER
  • Università Politecnica delle Marche

    collaborator OTHER
  • University of Roma La Sapienza

    collaborator OTHER
  • University of Rome Tor Vergata

    collaborator OTHER
  • Catholic University of the Sacred Heart

    collaborator OTHER
  • Università degli Studi di Sassari

    collaborator OTHER
  • University of Siena

    collaborator OTHER
  • Università degli studi di Trieste

    collaborator UNKNOWN
  • Universita di Verona

    collaborator OTHER
  • University of Campania Luigi Vanvitelli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-27
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05988333 on ClinicalTrials.gov