NCT06398561Completed
Peer-led Intervention for Individuals With Major Depression.
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 1 May 2024
- Start date
- May 2024
- Primary completion date
- Apr 2026
- Lead sponsor
- University of the Balearic Islands
- Diseases
- Depression
- NCT number
- NCT06398561
What you commit to
- Study type: Interventional
- Participants enrolled: 81
- From May 2024 to the primary completion date, Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- People who present mental health disorders associated with a depressive disorder and who are in the acute phase of the disease.
- 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.
Other
- 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 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- Selection and withdrawal of subjects
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xandra González García Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.