NCT05988333 Psychoeducational Intervention for Families With a Member Affected by Major Depression
| NCT ID | NCT05988333 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Campania Luigi Vanvitelli |
| Condition | Depressive Disorder, Major |
| Study Type | INTERVENTIONAL |
| Enrollment | 384 participants |
| Start Date | 2023-09-27 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 384 participants in total. It began in 2023-09-27 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05988333 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Depressive Disorder, Major. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05988333 currently recruiting?
Yes, NCT05988333 is actively recruiting participants. Contact the research team at mario.luciano@unicampania.it for enrollment information.
Where is the NCT05988333 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT05988333 clinical trial?
NCT05988333 is sponsored by University of Campania Luigi Vanvitelli. The trial plans to enroll 384 participants.