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.
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.
moderate or severe cognitive deficits, physical illnesses preventing the participation to the sessions or if they were hospitalization in the two months prior the enrollment
Parallel
Psychoeducational Family Intervention
Other interventionSupportive intervention administered to families with a member affected by MDD
Informative intervention
Other interventionInformative intervention administered to families with a member affected by MDD
Severity of depressive symptoms
Hamilton Depression Rating Scale (HAM-D). The HAM-D includes 17 items. Of these, 8 items are scored from 0 (absent) to 4 (severe), while nine are scored from 0 to 2. The total score is performed by the sum of the items' scores, and ranges from 0 to 52 points.
Psychosocial functioning
Personal and Social Performance Scale (PSP). A total score can be attributed to score the overall patient's functioning, ranging from 0 to 100, with higher scores indicating higher functioning. Ratings are based mainly on the assessment of patient's functioning in four main areas: (1) socially useful activities; (2) personal and social relationships; (3) self-care; and (4) disturbing and aggressive behaviors.
Severity of anxiety symptoms
Hamilton Anxiety Rating Scale (HAM-A). It is a 14-items questionnaire developed to measure the severity of anxiety symptoms, both psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety). The score for each item ranges from 0 (not present) to 4 (extreme severity).
Social contacts
Columbia Suicide Severity Rating Scale (C-SSRS). The clinician-administered version of the C-SSRS (screening version) will be administered. Individual's suicidal ideation is rated on a scale from 1 (wish to be dead) to 5 (active suicidal ideation with a specific plan and intent). Social Network Questionnaire (SNQ).
Click on the lead sponsor to view all of their trials.
University of Campania Luigi Vanvitelli
Lead sponsor
Università degli Studi di Brescia
Collaborator
University of Bologna
Collaborator
University of Catanzaro
Collaborator
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Collaborator
University of Cagliari
Collaborator
University of Florence
Collaborator
Università degli Studi di Ferrara
Collaborator
University of Foggia
Collaborator
Universita degli Studi di Genova
Collaborator
University of Milan
Collaborator
University of Modena and Reggio Emilia
Collaborator
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Collaborator
University of Parma
Collaborator
University Of Perugia
Collaborator
University of Pisa
Collaborator
Università Politecnica delle Marche
Collaborator
University of Roma La Sapienza
Collaborator
University of Rome Tor Vergata
Collaborator
Catholic University of the Sacred Heart
Collaborator
Università degli Studi di Sassari
Collaborator
University of Siena
Collaborator
Università degli studi di Trieste
Collaborator
Universita di Verona
Collaborator
