Actively Recruiting
Peer-led Intervention for Individuals With Major Depression.
Led by University of the Balearic Islands · Updated on 2024-07-03
70
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Peer-led Intervention for Individuals With Major Depression.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- People over 18 years of age
- Attending consultations with any professionals in the USM mental health network
- Having an active diagnosis of Major Depressive Disorder according to ICD or DSM criteria or meeting MINI TRAS criteria after interview for Major Depressive Episode
You will not qualify if you...
- Having mental health disorders associated with depression in the acute phase
- Not under active follow-up with any USM mental health professional
- Having mobility problems or difficulty traveling to the health center
- Having another disease affecting the central nervous system, such as organic brain pathology, severe head injury, dementia, or neurodegenerative diseases
- Having uncontrolled serious medical, infectious, or degenerative diseases that may affect mood symptoms
- Having a significant risk of suicide as assessed by medical professionals
- Having any medical, psychological, or social problems that could seriously interfere with study participation
- Being legally incapacitated to make health decisions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Xandra González García
Palma de Mallorca, Balearic Islands, Spain, 07122
Actively Recruiting
Research Team
X
Xandra González García, Ajudant Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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