Peer-led Intervention for Individuals With Major Depression.

NCT06398561 | Recruiting

• 1 other identifier: GH2023/07
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder, Major

Keywords

peer-leader; promotion; mental health; depression; peer to peer; health education

Outcome Measures

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.

  12 months

Secondary Outcomes (2)

• To analyze the efficacy of the proposed intervention on adherence to the prescribed treatment of people with Major Depression.

  12 months

• To evaluate the effect of intervention on the quality of life of people with Major Depression.

  12 months

Study Arms (2)

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 after the end of the sessions.

Behavioral: Active Patient Program

Control: Use App COGITO

ACTIVE COMPARATOR

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

Interventions

Active Patient Program BEHAVIORAL

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.

Control: Use App COGITO; Experimental: Active Patient Program intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Balearic Islands: lead

Study Sites (1)

Xandra González García

Palma de Mallorca, Balearic Islands, 07122, Spain

RECRUITING

Related Publications (25)

• World Health Organization. Depression 2021. Available from: https://www.who.int/es/news-room/fact-sheets/detail/depression.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 37812418 RESULT

• Garcia 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.

  PMID: 36442318 RESULT

• Grupo 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.

  RESULT

• 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.

  PMID: 26859236 RESULT

• Wong 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.

  PMID: 33609955 RESULT

• Eiroa-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.

  PMID: 37311138 RESULT

• Davidson 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.

  PMID: 22654945 RESULT

• Smit 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.

  PMID: 36066104 RESULT

• Naslund 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.

  PMID: 26744309 RESULT

• Sastre 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.

  RESULT

• 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

  RESULT

• 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.

  PMID: 30373734 RESULT

• Prevatt 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.

  PMID: 29908406 RESULT

• Liu T, Leung DKY, Lu S, Kwok WW, Sze LCY, Tse SSK, Ng SM, Wong PWC, Lou VWQ, Tang JYM, Wong DFK, Chan WC, Kwok RYK, Lum TYS, Wong GHY. Collaborative community mental health and aged care services with peer support to prevent late-life depression: study protocol for a non-randomised controlled trial. Trials. 2022 Apr 11;23(1):280. doi: 10.1186/s13063-022-06122-1.

  PMID: 35410292 RESULT

• Simmons MB, Cartner S, MacDonald R, Whitson S, Bailey A, Brown E. The effectiveness of peer support from a person with lived experience of mental health challenges for young people with anxiety and depression: a systematic review. BMC Psychiatry. 2023 Mar 24;23(1):194. doi: 10.1186/s12888-023-04578-2.

  PMID: 36964523 RESULT

• Byrom N. An evaluation of a peer support intervention for student mental health. J Ment Health. 2018 Jun;27(3):240-246. doi: 10.1080/09638237.2018.1437605. Epub 2018 Feb 16.

  PMID: 29451411 RESULT

• Mahlke CI, Priebe S, Heumann K, Daubmann A, Wegscheider K, Bock T. Effectiveness of one-to-one peer support for patients with severe mental illness - a randomised controlled trial. Eur Psychiatry. 2017 May;42:103-110. doi: 10.1016/j.eurpsy.2016.12.007. Epub 2016 Dec 28.

  PMID: 28364685 RESULT

• Lauridsen S, Nielsen MBD, Kusier AO, Cloos CO, Jensen MP, Andersen S, Thygesen LC, Folker AP. Implementing a peer-to-peer, self-management intervention for young people with depression and anxiety in Denmark. BMC Psychol. 2022 Mar 16;10(1):70. doi: 10.1186/s40359-022-00777-w.

  PMID: 35296363 RESULT

• Richard J, Rebinsky R, Suresh R, Kubic S, Carter A, Cunningham JEA, Ker A, Williams K, Sorin M. Scoping review to evaluate the effects of peer support on the mental health of young adults. BMJ Open. 2022 Aug 4;12(8):e061336. doi: 10.1136/bmjopen-2022-061336.

  PMID: 35926986 RESULT

• Thomas EC, Simmons MB, Mathai C, Salzer MS. Peer-Facilitated Decision Making in Mental Health: Promises, Pitfalls, and Recommendations for Research and Practice. Psychiatr Serv. 2023 Apr 1;74(4):401-406. doi: 10.1176/appi.ps.20220086. Epub 2022 Sep 27.

  PMID: 36164774 RESULT

• Valenstein M, Pfeiffer PN, Brandfon S, Walters H, Ganoczy D, Kim HM, Cohen JL, Benn-Burton W, Carroll E, Henry J, Garcia E, Risk B, Kales HC, Piette JD, Heisler M. Augmenting Ongoing Depression Care With a Mutual Peer Support Intervention Versus Self-Help Materials Alone: A Randomized Trial. Psychiatr Serv. 2016 Feb;67(2):236-9. doi: 10.1176/appi.ps.201400454. Epub 2015 Sep 15.

  PMID: 26369884 RESULT

• Mantani A, Kato T, Furukawa TA, Horikoshi M, Imai H, Hiroe T, Chino B, Funayama T, Yonemoto N, Zhou Q, Kawanishi N. Smartphone Cognitive Behavioral Therapy as an Adjunct to Pharmacotherapy for Refractory Depression: Randomized Controlled Trial. J Med Internet Res. 2017 Nov 3;19(11):e373. doi: 10.2196/jmir.8602.

  PMID: 29101095 RESULT

• Gonzalez-Garcia X, Moreno-Sancho ML, Roa-Diez P, Caceres-Tejeiro Y, Flowers SA, de Montes CG, Bennasar-Veny M, Garcia-Toro M, Yanez AM. Peer-led intervention for individuals with major depression: study protocol for a randomized controlled trial (SUPEERMood). BMC Psychiatry. 2024 Sep 30;24(1):639. doi: 10.1186/s12888-024-06094-3.

  PMID: 39350120 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Psychological Well-Being; Depression; Health Education

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Central Study Contacts

Xandra González García, Ajudant Professor

CONTACT

971172442; xandra.gonzalez@uib.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: We randomized the participants across the informatic program named RedCap. Only was masking the outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 after the last session.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 3, 2024
• Study Start: May 10, 2024
• Primary Completion: May 20, 2025
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)