Support for families dealing with major depression
The Efficacy of Psychoeducational Family Intervention for Individuals With Major Depression: a Randomized Controlled Trial
NA · University of Campania Luigi Vanvitelli · NCT05988333
This study is testing whether a new family support program can help families dealing with major depression feel better and cope with the challenges it brings.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 384 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Campania Luigi Vanvitelli (other) |
| Locations | 1 site (Naples) |
| Trial ID | NCT05988333 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a psychoeducational family intervention (PFI) compared to a brief informative intervention for families affected by major depressive disorder (MDD). Conducted across 24 Italian university outpatient units, the study will involve 384 families, assessing their experiences and outcomes over a period of 24 months. Participants will complete questionnaires to measure the impact of MDD on their daily lives and the patient's symptoms, with the goal of determining if PFI can help families manage the challenges associated with this mental illness.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with major depression who live with at least one family member and have regular contact with a psychiatric clinic.
Not a fit: Patients with moderate to severe cognitive deficits or those who have been hospitalized in the two months prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for both patients with major depression and their family members.
How similar studies have performed: Previous studies have shown promising results for psychoeducational interventions in mental health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Naples
- University of Campania L. Vanvitelli — Naples, Italy (RECRUITING)
Study contacts
- Study coordinator: Mario Luciano, Doctor
- Email: mario.luciano@unicampania.it
- Phone: +393490730150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depressive Disorder, Major, depression, caregiver, family, psychoeducation