Depressive Disorder, MajorSUPEERmoodNCT06398561
Peer-led Intervention for Individuals With Major Depression.
A study testing Active Patient Program in people with Depressive Disorder, Major, run by University of the Balearic Islands at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Active Patient Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2024to 28 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- 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.
- 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.
- 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.
- 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.
- Evaluation:
The evaluations will be carry out at baseline, post-intervention and 6 and 12 months.
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.
- Conditions
- Depressive Disorder, Major
- Being tested
- Active Patient Program, Active Control
- Keywords
- peer-leader, promotion, mental health, depression, peer to peer, health education
- Medical subject headings
- Depressive Disorder, Major, Psychological Well-Being, Depression, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Patient ProgramBehavioural
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 ControlBehavioural
Participants allocated to the control group received access to COGITO, a fully self-guided CBT-based mHealth application developed by the University Medical Centre Hamburg-Eppendorf and used as an adjunct to CAU. Over six weeks, participants were instructed to complete approximately 20 minutes of app-based activities per day using the Mood and Self-Esteem module, which included psychoeducation, cognitive restructuring, behavioural activation, emotional self-monitoring, and coping and self-management exercises. The app was fully automated and asynchronous, with no therapist support or personalized feedback, although participants received an initial face-to-face explanation and automated notifications and gamification features to support engagement. Only anonymized usage data were recorded for adherence monitoring, and all participants continued their usual psychiatric and psychological care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Active Patient Program intervention | Experimental | 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. Receives: Behavioral: Active Patient Program |
| Control: Use App COGITO | Active comparator | the control consists of the regular use (20 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. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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 in a sample of 70 people with Major Depression.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start10 May 2024
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-branch randomized clinical trial will be carried out, in which one branch will receive the intervention based on a peer support program (Active Patient Program) and the other 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). A measurement of the study variables will be carried out through validated instruments at the beginning of the program, another one at the end of the six sessions (6 weeks), 6 and 12 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398561
- Sponsor's protocol ID
- GH2023/07
- Acronym
- SUPEERmood
- Status last verified
- Jul 2024
- First submitted
- 1 May 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization. Depression 2021. Available from: https://www.who.int/es/news-room/fact-sheets/detail/depression.
Global Health Data Exchange. Global Health Data Exchange (GHDx) 2021. Available from:http://ghdx.healthdata.org/gbd-results-tool?params=gbd-api-2019-permalink/442c335139ab11cec605591fd4141f0d.
Zhang Z, Jackson SL, Gillespie C, Merritt R, Yang Q. Depressive Symptoms and Mortality Among US Adults. JAMA Netw Open. 2023 Oct 2;6(10):e2337011. doi: 10.1001/jamanetworkopen.2023.37011.
PubMed 37812418Garcia A, Yanez AM, Bennasar-Veny M, Navarro C, Salva J, Ibarra O, Gomez-Juanes R, Serrano-Ripoll MJ, Olivan B, Gili M, Roca M, Riera-Serra P, Aguilar-Latorre A, Montero-Marin J, Garcia-Toro M. Efficacy of an adjuvant non-face-to-face multimodal lifestyle modification program for patients with treatment-resistant major depression: A randomized controlled trial. Psychiatry Res. 2023 Jan;319:114975. doi: 10.1016/j.psychres.2022.114975. Epub 2022 Nov 22.
PubMed 36442318Grupo de trabajo de la Guía de Práctica Clínica sobre el Manejo de la Depresión en el Adulto. Guía de Práctica Clínica sobre el Manejo de la Depresión en el Adulto.: Ministerio de Sanidad, servicios Sociales e Igualdad. Agencia de Evaluación de Tecnnologías Sanitarias de Galicia (avalia-t); 2014.
Salehi I, Hosseini SM, Haghighi M, Jahangard L, Bajoghli H, Gerber M, Puhse U, Holsboer-Trachsler E, Brand S. Electroconvulsive therapy (ECT) and aerobic exercise training (AET) increased plasma BDNF and ameliorated depressive symptoms in patients suffering from major depressive disorder. J Psychiatr Res. 2016 May;76:1-8. doi: 10.1016/j.jpsychires.2016.01.012. Epub 2016 Jan 25.
PubMed 26859236Wong VW, Ho FY, Shi NK, Sarris J, Chung KF, Yeung WF. Lifestyle medicine for depression: A meta-analysis of randomized controlled trials. J Affect Disord. 2021 Apr 1;284:203-216. doi: 10.1016/j.jad.2021.02.012. Epub 2021 Feb 5.
PubMed 33609955Eiroa-Orosa FJ, Sanchez-Moscona C. Implementing the figure of peer support workers in mental health: an international perspective from the context of its implementation in Catalonia. Salud Colect. 2023 Jan 23;19:e4252. doi: 10.18294/sc.2023.4252. English, Spanish.
PubMed 37311138Davidson L, Bellamy C, Guy K, Miller R. Peer support among persons with severe mental illnesses: a review of evidence and experience. World Psychiatry. 2012 Jun;11(2):123-8. doi: 10.1016/j.wpsyc.2012.05.009.
PubMed 22654945Smit D, Miguel C, Vrijsen JN, Groeneweg B, Spijker J, Cuijpers P. The effectiveness of peer support for individuals with mental illness: systematic review and meta-analysis. Psychol Med. 2023 Aug;53(11):5332-5341. doi: 10.1017/S0033291722002422. Epub 2022 Sep 6.
PubMed 36066104Naslund JA, Aschbrenner KA, Marsch LA, Bartels SJ. The future of mental health care: peer-to-peer support and social media. Epidemiol Psychiatr Sci. 2016 Apr;25(2):113-22. doi: 10.1017/S2045796015001067. Epub 2016 Jan 8.
PubMed 26744309Sastre Perea MJ, Vidal Thomàs MC, Cáceres Teijeiro Y, Moreno Sancho ML, Miguelez Chamorro A, Font Oliver MA, et al. Programa Pacient Actiu de les Illes Balears. Palma: Servei de Salut de les Illes Balears; 2018.
Peer Support Canada. Guiding connection Strategic Plan 2022-2027. Canada; 2022. Available from: https://peersupportcanada.ca/wp-content/uploads/2022/11/Peer-Support-Canada-Strategic-Plan-1.pdf
Cherrington AL, Khodneva Y, Richman JS, Andreae SJ, Gamboa C, Safford MM. Impact of Peer Support on Acute Care Visits and Hospitalizations for Individuals With Diabetes and Depressive Symptoms: A Cluster-Randomized Controlled Trial. Diabetes Care. 2018 Dec;41(12):2463-2470. doi: 10.2337/dc18-0550. Epub 2018 Oct 29.
PubMed 30373734Prevatt BS, Lowder EM, Desmarais SL. Peer-support intervention for postpartum depression: Participant satisfaction and program effectiveness. Midwifery. 2018 Sep;64:38-47. doi: 10.1016/j.midw.2018.05.009. Epub 2018 May 31.
PubMed 29908406
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-led Intervention for Individuals With Major Depression.
- ClinicalTrials.gov ID
- NCT06398561
- Acronym / sponsor ID
- SUPEERmood / GH2023/07
- Conditions
- Depressive Disorder, Major
- Keywords
- peer-leader, promotion, mental health, depression, peer to peer, health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- 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.
- 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.
- 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.
- Evaluation:
The evaluations will be carry out at baseline, post-intervention and 6 and 12 months.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A two-branch randomized clinical trial will be carried out, in which one branch will receive the intervention based on a peer support program (Active Patient Program) and the other 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). A measurement of the study variables will be carried out through validated instruments at the beginning of the program, another one at the end of the six sessions (6 weeks), 6 and 12 months.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Active Patient Program intervention | Experimental | Behavioral: Active Patient ProgramThe 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. |
| Control: Use App COGITO | Active comparator | Behavioral: Active Controlthe control consists of the regular use (20 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Patient ProgramThe 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. | Behavioural | Experimental: Active Patient Program intervention |
| Active ControlParticipants allocated to the control group received access to COGITO, a fully self-guided CBT-based mHealth application developed by the University Medical Centre Hamburg-Eppendorf and used as an adjunct to CAU. Over six weeks, participants were instructed to complete approximately 20 minutes of app-based activities per day using the Mood and Self-Esteem module, which included psychoeducation, cognitive restructuring, behavioural activation, emotional self-monitoring, and coping and self-management exercises. The app was fully automated and asynchronous, with no therapist support or personalized feedback, although participants received an initial face-to-face explanation and automated notifications and gamification features to support engagement. Only anonymized usage data were recorded for adherence monitoring, and all participants continued their usual psychiatric and psychological care. | Behavioural | Control: Use App COGITO |
Primary outcome
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 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.
2 secondary outcomes
To analyze the efficacy of the proposed intervention on adherence to the prescribed treatment of people with Major Depression.
Time frame: 12 months
To evaluate the effect of intervention on the quality of life of people with Major Depression.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publicationWorld Health Organization. Depression 2021. Available from: https://www.who.int/es/news-room/fact-sheets/detail/depression.
- Results publicationGlobal Health Data Exchange. Global Health Data Exchange (GHDx) 2021. Available from:http://ghdx.healthdata.org/gbd-results-tool?params=gbd-api-2019-permalink/442c335139ab11cec605591fd4141f0d.
- Results publication: PubMed 37812418Zhang Z, Jackson SL, Gillespie C, Merritt R, Yang Q. Depressive Symptoms and Mortality Among US Adults. JAMA Netw Open. 2023 Oct 2;6(10):e2337011. doi: 10.1001/jamanetworkopen.2023.37011.
- Results publication: PubMed 36442318Garcia A, Yanez AM, Bennasar-Veny M, Navarro C, Salva J, Ibarra O, Gomez-Juanes R, Serrano-Ripoll MJ, Olivan B, Gili M, Roca M, Riera-Serra P, Aguilar-Latorre A, Montero-Marin J, Garcia-Toro M. Efficacy of an adjuvant non-face-to-face multimodal lifestyle modification program for patients with treatment-resistant major depression: A randomized controlled trial. Psychiatry Res. 2023 Jan;319:114975. doi: 10.1016/j.psychres.2022.114975. Epub 2022 Nov 22.
- Results publicationGrupo de trabajo de la Guía de Práctica Clínica sobre el Manejo de la Depresión en el Adulto. Guía de Práctica Clínica sobre el Manejo de la Depresión en el Adulto.: Ministerio de Sanidad, servicios Sociales e Igualdad. Agencia de Evaluación de Tecnnologías Sanitarias de Galicia (avalia-t); 2014.
- Results publication: PubMed 26859236Salehi I, Hosseini SM, Haghighi M, Jahangard L, Bajoghli H, Gerber M, Puhse U, Holsboer-Trachsler E, Brand S. Electroconvulsive therapy (ECT) and aerobic exercise training (AET) increased plasma BDNF and ameliorated depressive symptoms in patients suffering from major depressive disorder. J Psychiatr Res. 2016 May;76:1-8. doi: 10.1016/j.jpsychires.2016.01.012. Epub 2016 Jan 25.
- Results publication: PubMed 33609955Wong VW, Ho FY, Shi NK, Sarris J, Chung KF, Yeung WF. Lifestyle medicine for depression: A meta-analysis of randomized controlled trials. J Affect Disord. 2021 Apr 1;284:203-216. doi: 10.1016/j.jad.2021.02.012. Epub 2021 Feb 5.
- Results publication: PubMed 37311138Eiroa-Orosa FJ, Sanchez-Moscona C. Implementing the figure of peer support workers in mental health: an international perspective from the context of its implementation in Catalonia. Salud Colect. 2023 Jan 23;19:e4252. doi: 10.18294/sc.2023.4252. English, Spanish.
- Results publication: PubMed 22654945Davidson L, Bellamy C, Guy K, Miller R. Peer support among persons with severe mental illnesses: a review of evidence and experience. World Psychiatry. 2012 Jun;11(2):123-8. doi: 10.1016/j.wpsyc.2012.05.009.
- Results publication: PubMed 36066104Smit D, Miguel C, Vrijsen JN, Groeneweg B, Spijker J, Cuijpers P. The effectiveness of peer support for individuals with mental illness: systematic review and meta-analysis. Psychol Med. 2023 Aug;53(11):5332-5341. doi: 10.1017/S0033291722002422. Epub 2022 Sep 6.
- Results publication: PubMed 26744309Naslund JA, Aschbrenner KA, Marsch LA, Bartels SJ. The future of mental health care: peer-to-peer support and social media. Epidemiol Psychiatr Sci. 2016 Apr;25(2):113-22. doi: 10.1017/S2045796015001067. Epub 2016 Jan 8.
- Results publicationSastre Perea MJ, Vidal Thomàs MC, Cáceres Teijeiro Y, Moreno Sancho ML, Miguelez Chamorro A, Font Oliver MA, et al. Programa Pacient Actiu de les Illes Balears. Palma: Servei de Salut de les Illes Balears; 2018.
- Individual participant dataSharing planned: No
Related trials for Depressive Disorder, Major
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Patient Program in people with Depressive Disorder, Major, run by University of the Balearic Islands at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of an adjuvant intervention based on a peer-leader program (Active Patient Program) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06398561, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.