NCT06398561 Peer-led Intervention for Individuals With Major Depression.
| NCT ID | NCT06398561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of the Balearic Islands |
| Condition | Depressive Disorder, Major |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-05-10 |
| Primary Completion | 2025-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 70 participants in total. It began in 2024-05-10 with a primary completion date of 2025-05-20.
⚠ 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
Objective: To evaluate the efficacy of an adjuvant intervention based on a peer support program in the reduction of depressive symptomatology versus an online intervention in people with major depression in Primary Care Mental Health Units in Mallorca. Design: Randomized clinical trial of two branches in a Mental Health Unit of Mallorca, where one branch will receive an adjuvant intervention based on a peer support program (Active Patient Program) and another branch (control) will receive information and exercises aimed at improving their mental health through the COGITO App, designed and validated for this purpose. Scope and study subjects: The scope of the study will be the consultations of the Mental Health Unit (MHU) of Primary Care in Mallorca. The study subjects will be patients of these units who meet the criteria for Major Depression. The mental health professionals of the MHU will be in charge of recruiting participants who meet the inclusion and exclusion criteria. The required sample will be 70 subjects, 35 in each branch. Variables: The main dependent variable is depressive symptomatology, measured through the Beck Depression Inventory (BDI-II). As secondary variables, quality of life and adherence to treatment will be included. Data analysis: All analyses will be carried out using the SPSS statistical program. An intention-to-treat (ITT) analysis will be performed. The efficacy of the intervention (reduction of depressive symptoms (BDI-II)) will be assessed by a general linear model (ANOVA) at 6 weeks, 6 and 12 months, adjusted for baseline values.
Eligibility Criteria
Selection and withdrawal of subjects Inclusion criteria: * People over 18 years of age. * Attending consultations with any of the professionals in the USM mental health network. * Having an active diagnostic label of Major Depressive Disorder, according to ICD or DSM criteria in the Primary Care e-SIAP program or meeting MINI TRAS criteria after individual interview for Major Depressive Episode. Exclusion criteria * People who present mental health disorders associated with a depressive disorder and who are in the acute phase of the disease. * People who are not under active follow-up with any of the professionals of the USM. * People with mobility problems and / or displacement to the health center. * People suffering from another disease affecting the CNS (organic brain pathology or who have suffered a severe head injury, onset dementia or any other neurodegenerative disease, etc.). * People with presence of uncontrolled serious medical, infectious or degenerative disease, which may interfere with affective symptomatology. * People with significant risk of suicide according to medical criteria, assessed through follow-up interviews conducted by mental health professionals of reference. * People with any medical, psychological and/or social problem that could seriously interfere with the patient's participation in the study. * People who are legally incapacitated to make health decisions.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06398561 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 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 NCT06398561 currently recruiting?
Yes, NCT06398561 is actively recruiting participants. Contact the research team at xandra.gonzalez@uib.es for enrollment information.
Where is the NCT06398561 trial being conducted?
This trial is being conducted at Palma de Mallorca, Spain.
Who is sponsoring the NCT06398561 clinical trial?
NCT06398561 is sponsored by University of the Balearic Islands. The trial plans to enroll 70 participants.