Peer-led Intervention for Individuals With Major Depression.

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Xandra González García
RECRUITING
Palma De Mallorca
Contact Information
Primary
Xandra González García, Ajudant Professor
xandra.gonzalez@uib.es
971172442
Time Frame
Start Date: 2024-05-10
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 70
Treatments
Experimental: Experimental: Active Patient Program intervention
The intervention consists of carrying out the six sessions of the Active Patient Program by peers. The sessions have a duration of 2 hours/week during 6 weeks. It is aimed at patients with a diagnosis of major depression and they will undergo 4 evaluations, one before, one at the end of the sessions and two more at 6 and 12 months after the end of the sessions.
Active_comparator: Control: Use App COGITO
the control consists of the regular use (30 minutes daily) of the COGITO App that will guide the participant in the performance of exercises to improve depressive symptomatology. The time of use is equivalent to the time invested in the sessions.~The same evaluations will be carried out as in the experimental group (previous evaluation, at the end of the sessions (6 weeks) and two more at 6 and 12 months after the end of the sessions.
Related Therapeutic Areas
Sponsors
Leads: University of the Balearic Islands

This content was sourced from clinicaltrials.gov