Peer-led Intervention for Individuals With Major Depression.
Recruiting · NCT06398561 · Interventional (participants receive a specific treatment) · Lead sponsor: University of the Balearic Islands
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Xandra González García - Palma de Mallorca, Balearic Islands, Spain