Peer-led Intervention for Individuals With Major Depression.
ConditionDepressive Disorder, Major
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of the Balearic Islands
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.).
Trial design
Design model
Parallel
Treatments tested in this trial
Active Patient Program
BehavioralThe Active Patient Program is a peer-leader intervention that consist of training patients with a chronic disease or mental health illness for improve the symptoms of that pathology. Training is carried out in groups of about 12-15 patients and usually has 2 patient trainers. These patients lead the sessions through the theoretical content they have integrated, motivation, group leadership, exchange of experiences and promotion of communication. In this way they favor problem-solving by the patients who attend the sessions, thus improving their self-management and self-efficacy. In the group formed by patients who are trainers and patients who benefit from the sessions, a climate of trust is created that favors the expression of emotions on both sides, empathy and assertiveness. In addition to fostering socio-affective bonds between the participants and increasing perceived social and emotional support.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Experimental: Active Patient Program interventionExperimental treatment 1 intervention
Group B: Control: Use App COGITOActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the efficacy of an adjuvant intervention based on a peer-leader program (Active Patient Program)
To measure the efficacy of an adjuvant intervention based on a peer-leader program (Active Patient Program) for the reduction on 6 points the depressive sympthoms with the Beck Depression Inventory in a sample of 70 people with Major Depression versus an online intervention in Primary Care Mental Health Units in Mallorca.Using Beck Depression Inventory (BDI-II) we want to know if the intervention can reduce the depressive symptoms.
Time frame
12 monthsSecondary outcomes
1
To analyze the efficacy of the proposed intervention on adherence to the prescribed treatment of people with Major Depression.
To measure the adherence to psychiatric treatment, we use the Drug Attitude Inventory (DAI-10) questionnaire. In a sample of 70 people with Major Depression, we want to know if the intervention can improve the treatment adherence of life of the participants.
Time frame
12 months2
To evaluate the effect of intervention on the quality of life of people with Major Depression.
To analyze the life-quality, we use the EuroQoL-5D questionnaire and measure the differences in the baseline life-quality and the following visits post intervention and post control in a sample of 70 people with Major Depression.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov