Effectiveness of a Peer-led Intervention for Individuals With Major Depression. (SUPEERmood)

May 6, 2024 updated by: University of the Balearic Islands

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Material and methods Type of study A two-branch randomized clinical trial will be conducted, in which one branch will receive the intervention based on a peer support program (Active Patient Program) and another branch will receive information and exercises aimed at improving their mental health through a validated App, free and in its Spanish version, called "COGITO", which consists of planning exercises based on cognitive-behavioral therapy. The App to be used can be found for free by accessing the following link: https://apps.apple.com/us/app/cogito-mct/id1557322291 (for Apple devices) https://play.google.com/store/apps/details?id=de.uke.cogitoapp&hl=en_US&pli=1 (for Android devices).

Scope of the study The consultations of the Mental Health Unit (MHU) will be the site from which the subjects will be recruited. The MHU are outpatient and community facilities of the mental health network of the Balearic Islands, where people with mental health problems are followed up. They consist of a multidisciplinary team of psychiatry, psychology, mental health nursing and social work professionals. In addition to the administrative staff of these units.

Definition of study subjects The study subjects will be those persons suffering from Major Depressive Disorder and who are currently under follow-up with one of the professionals of the MHU.

Recruitment of participants Recruitment will be done through the medical records of each nurse, psychiatrist, psychologist or social worker of the USM with current follow-up and/or active diagnostic label of Major Depressive Disorder (according to ICD or DSM criteria) in the Primary Care Information System (e-SIAP).

An initial interview will be carried out by the research staff in collaboration with the health care staff of the reference MHU to verify compliance with the inclusion criteria for the study.

Justification of sample size Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 35 subjects in the intervention group (Active Patient) and 35 in the control group are required to detect a difference equal to or greater than 6 units in the Beck Depression Inventory (BDI-II). The common standard deviation is assumed to be 8. A loss-to-follow-up rate of 20% has been estimated (Castro LS et al. Psychiatry Res. 2013;210(3):906-12). Therefore, a total of 70 participants will be needed.

Primary and secondary variables. The primary dependent variable is depressive symptomatology measured by validated BDI-II.

The secondary dependent variables are quality of life and adherence to prescribed treatment. The main independent variable is the assigned group.

Other independent or control variables taken into account in this study are sociodemographic variables (age, gender, marital status, diagnostic label, year of diagnosis, educational level, pharmacological treatment, psychotherapy treatment, USM of reference, profession, comorbidities, current employment situation).

Description of the intervention

  1. Recruitment and training of active patient trainers:

    Recruitment will be carried out by MHU professionals, through any device of the mental health network or through patients' associations and/or citizens' associations.

    The trainer patients must meet the following requirements according to the current protocol of the Active Patient Program, evaluated through the interview, the scales and questionnaires that the program stipulates in its action guide. All the information regarding this aspect can be found in detail at the following link: https://docusalut.com/handle/20.500.13003/18170.

  2. Recruitment of participants The recruitment of the study subjects will be carried out by the multidisciplinary team of the MHU (psychiatrists, psychologists, nurses and/or social workers of each center). Once the sample has been recruited, an initial interview will be conducted by the staff of the Active Patient Program team to explain the procedure and assess whether the selected persons accept their participation and meet the inclusion criteria described above.
  3. Randomization Once the necessary sample has been obtained, the participants will be randomized in a 1:1 ratio.Pseudo-anonymity of the data is guaranteed, since each participant will be identified with a numerical code that will not include any personal data.

  4. Development of the intervention- Intervention group for patients benefiting from the Active Patient Program training.

    The training will consist of a workshop of 6 sessions of 2 hours each, following the model described in the protocol of the Active Patient Program but adapted to Major Depressive Disorder.

    The adaptation of this guide will be carried out by a group of professionals, from different disciplines, experts in mental health. Once the guide has been produced, it will be sent to people of reference in the field of depressive disorders at a national level, so that they can proceed to its revision.

    The sessions that will guide us in the preparation of the Major Depressive Disorder workshop are detailed in Annex I.- Control group through the COGITO App.The control group will receive a guideline of exercises guided through the COGITO App based on cognitive-behavioral therapy (CBT). The duration of the use of this App will be the same as the intervention of the Active Patient program (6 weeks), having to comply with a pattern of use of the App of 20 minutes daily in order to match the time dedicated to the intervention. Thanks to the design of the App, its use can be counted through the history of the exercises, as well as the appearance of warnings when the use is low.Daily reminders can also be activated to incentivize it.

  5. Evaluation:

A pre-intervention evaluation will be carried out at the beginning of the intervention in both groups, another one at the end of the program sessions (6 weeks) and two post- evaluations at 6 and 12 months after completion.

The degree of depressive symptomatology, the quality of life and the degree of adherence to the prescribed treatment will be measured by means of valid instruments.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xandra González García, Ajudant professor
  • Phone Number: 2442 971172442
  • Email: xandra.gonzalez@uib.es

Study Locations

  • Spain
    • Baleares
      • Palma De Mallorca, Baleares, Spain, 07122
        • Recruiting
        • Xandra González García
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Selection and withdrawal of subjects

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Active Patient Program

The 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.
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.
Behavioral: Active Patient Program

The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of an adjuvant intervention based on a peer-leader program (Active Patient Program)
Time Frame: 12 months
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 BDI-II 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To analyze the efficacy of the proposed intervention on adherence to the prescribed treatment of people with Major Depression.
Time Frame: 12 months
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.
12 months
To evaluate the effect of intervention on the quality of life of people with Major Depression.
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Balearic Islands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Estimated)

June 20, 2024

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH2023/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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