Psychoeducational Intervention for Families With a Member Affected by Major Depression

NCT05988333 | Recruiting

• 1 other identifier: 0012764/2023
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

depression; caregiver; family; psychoeducation

Outcome Measures

Primary Outcomes (4)

• 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.

  At baseline, after 6-, 12- and 24 months

• 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.

  At baseline, after 6-, 12- and 24 months

• 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).

  At baseline, after 6-, 12- and 24 months

• 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).

  At baseline, after 6-, 12- and 24 months

Study Arms (2)

Psychoeducational Family Intervention

EXPERIMENTAL

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.

Other: Psychoeducational Family Intervention

Informative intervention

ACTIVE COMPARATOR

The informative intervention consists of five sessions, administered every 7-10 days.

Other: Informative intervention

Interventions

Psychoeducational Family Intervention OTHER

Supportive intervention administered to families with a member affected by MDD

Psychoeducational Family Intervention

Informative intervention OTHER

Informative intervention administered to families with a member affected by MDD

Informative intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• 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

Study Sites (1)

University of Campania L. Vanvitelli

Napoli, 80138, Italy

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Mario Luciano, Doctor

CONTACT

+393490730150; mario.luciano@unicampania.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)