Collaborative Multidimensional Intervention for Depression in Chile

NCT05016388 | Unknown

• 1 other identifier: SA20I0031
• Study Type: interventional
• Target: 394
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study protocol aims to determine the efficacy of a collaborative multidimensional model (CMD) to improve the results of depression in primary care (PHC) in Chile. The CMD includes training of PHC teams, on the recognition of clinical, functional and psycho-biographic dimensions associated to a complex depression sub-type, difficult to treat, prevalent in PHC in Chile, for which there are no recommendations in current clinical guidelines. This model implies the implementation of a collaborative model, trauma informed care, patient- centered, that includes a case manager, the use of instruments and a close relationship between the PHC team and the specialty level. At least twelve primary care teams belonging to the Maule Region will be randomly assigned to one of the two arms of the study, the CMD group and the current standard model (SM). After the implementation of the CMD, an intentional sample of 394 participants who agreed to participate, with prior informed consent, will be evaluated by a blind research team at the beginning, at three and six months with a battery of instruments. An improvement in depressive symptoms, anxiety and functional variables is expected in participants treated in CMD versus SM. This protocol was approved by the Research Ethics Council of the University of Talca, Talca. The goal is to publish the preliminary results in December 2022.

Conditions

Depression

Keywords

Complex Depression; Collaborative Model; Primary Health Care; Trauma Informed Care; Difficult to treat Depression

Outcome Measures

Primary Outcomes (2)

• Change in Depressive symptoms at three months relative to baseline

  Depressive symptoms will be assessed by the Patient Health Questionnaire (PhQ9). The Patient Health Questionnaire is a nine-item self-report measure that assesses the presence of depressive symptoms based on the DSM-IV criteria for major depressive. The Spanish version of the Patient Health Questionnaire has been validated in Chile. The Patient Health Questionnaire measures the symptoms experienced by the patients during the two weeks prior to the interview. Total score ranges from 0 to 27 points and greater scores means worse symptoms.

  Three months after admission to depression treatment

• Change in Depressive symptoms at six months relative to baseline

  Depressive symptoms will be assessed by the Patient Health Questionnaire (PhQ9). The Patient Health Questionnaire is a nine-item self-report measure that assesses the presence of depressive symptoms based on the DSM-IV criteria for major depressive. The Spanish version of the Patient Health Questionnaire has been validated in Chile. The Patient Health Questionnaire measures the symptoms experienced by the patients during the two weeks prior to the interview. Total score ranges from 0 to 27 points and greater scores means worse symptoms.

  Six months after admission to depression treatment

Secondary Outcomes (8)

• Change in Anxiety symptoms at three months relative to baseline

  Three months after admission to depression treatment

• Change in Anxiety symptoms at six months relative to baseline

  Six months after admission to depression treatment

• Change in Interpersonal Dysfunction and Social Dysfunction at three months relative to baseline

  Three months after admission to depression treatment

• Change in Interpersonal Dysfunction and Social Dysfunction at six months relative to baseline

  Six months after admission to depression treatment

• Change in Emotion Regulation at three months relative to baseline

  Three months after admission to depression treatment

Other Outcomes (2)

• Self-efficacy of the primary care mental health team at baseline

  Baseline (at the first training session)

• Self-efficacy of the primary care mental health team after three months

  Three months after the first training session

Study Arms (2)

Collaborative Multidimensional Model (CMD)

EXPERIMENTAL

The teams in the CMD group will be composed each of at least a MD, a psychologist, and a social worker. The teams will receive the CMD training and the CMD will be installed in the primary health care (PHC) center. Then, the participants with depression who enter treatment for depression in their respective PHC center, will be enrolled and evaluated by an external team, blind to the interventions at the beginning, three and six months after.

Other: Collaborative Multidimensional Model (CMD)

Standard Model (SM)

OTHER

The teams in the SM group will be composed each of at least a MD, a psychologist, and a social worker. The teams will receive the SM training and the SM will be set in the primary health care (PHC) center. Then, the participants with depression who enter treatment for depression in their respective PHC center, will be enrolled and evaluated by an external team, blind to the interventions at the beginning, three and six months after.

Other: Standard Model (SM)

Interventions

Collaborative Multidimensional Model (CMD) OTHER

The teams enrolled in the CMD intervention will have a 22-hour training that integrates current knowledge of depression with skills for the management of functional variables, interpersonal, social, emotional regulation, and history of biographical adversity from childhood considering the trauma informed care paradigm. After the training, the PHC teams will implement the depression treatment according to a collaborative model.

Also known as: Intervention

Collaborative Multidimensional Model (CMD)

Standard Model (SM) OTHER

The teams enrolled in the SM intervention will have a 22-hour training that integrates the current national clinical guide for Depression in Chile. This guide offers a staggered treatment according to the severity of the depression. After the training, the PHC teams will implement the depression treatment according to the SM.

Also known as: Control

Standard Model (SM)

Eligibility Criteria

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

You may qualify if:

• Starting the treatment for depression in Primary Care according the Health Guarantees.
• Confirmed depression diagnosis according to the Mini International Diagnostic Interview Mini International Neuropsychiatric Interview (MINI, Sheehan et al. 1998).

You may not qualify if:

• Sensory disability
• Inability to provide the informed consent
• not having contact phone number
• Continuing treatment for depression
• High suicidal risk
• Suspected bipolar and psychosis.

Sponsors & Collaborators

• University of Talca: lead
• National Fund for Research and Development in Health, Chile: collaborator

Related Publications (13)

• Saldivia S, Aslan J, Cova F, Vicente B, Inostroza C, Rincon P. [Psychometric characteristics of the Patient Health Questionnaire (PHQ-9)]. Rev Med Chil. 2019;147(1):53-60. doi: 10.4067/S0034-98872019000100053. Spanish.

  PMID: 30848765 BACKGROUND

• Clavijo M, Yevenes F, Gallardo I, Contreras AM, Santos C. [The general self-efficacy scale (GSES): Reevaluation of its reliability and validity evidence in Chile]. Rev Med Chil. 2020 Oct;148(10):1452-1460. doi: 10.4067/S0034-98872020001001452. Spanish.

  PMID: 33844715 BACKGROUND

• von Bergen, A., & de la Parra, G. (2002). OQ-45.2, Cuestionario para evaluación de resultados y evolución en psicoterapia: Adaptación, validación e indicaciones para su aplicación e interpretación [OQ-45.2, An Outcome Questionnaire for Monitoring Change In Psychotherapy: Adaptation, Validation and Indications for its Application and Interpretation]. Terapia Psicológica, 20(2), 161-176.

  BACKGROUND

• Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8.

  PMID: 20089179 BACKGROUND

• Guzman-Gonzalez M, Mendoza-Llanos R, Garrido-Rojas L, Barrientos J, Urzua A. [Cut-off points of the difficulties in Emotion Regulation Scale for the Chilean population]. Rev Med Chil. 2020 May;148(5):644-652. doi: 10.4067/S0034-98872020000500644. Spanish.

  PMID: 33399757 BACKGROUND

• Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

  PMID: 9881538 BACKGROUND

• McAllister-Williams RH, Arango C, Blier P, Demyttenaere K, Falkai P, Gorwood P, Hopwood M, Javed A, Kasper S, Malhi GS, Soares JC, Vieta E, Young AH, Papadopoulos A, Rush AJ. The identification, assessment and management of difficult-to-treat depression: An international consensus statement. J Affect Disord. 2020 Apr 15;267:264-282. doi: 10.1016/j.jad.2020.02.023. Epub 2020 Feb 7.

  PMID: 32217227 BACKGROUND

• Archer J, Bower P, Gilbody S, Lovell K, Richards D, Gask L, Dickens C, Coventry P. Collaborative care for depression and anxiety problems. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD006525. doi: 10.1002/14651858.CD006525.pub2.

  PMID: 23076925 BACKGROUND

• Raja S, Hasnain M, Hoersch M, Gove-Yin S, Rajagopalan C. Trauma informed care in medicine: current knowledge and future research directions. Fam Community Health. 2015 Jul-Sep;38(3):216-26. doi: 10.1097/FCH.0000000000000071.

  PMID: 26017000 BACKGROUND

• Vitriol V, Cancino A, Serrano C, Ballesteros S, Potthoff S. Remission in Depression and Associated Factors at Different Assessment Times in Primary Care in Chile. Clin Pract Epidemiol Ment Health. 2018 Mar 26;14:78-88. doi: 10.2174/1745017901814010078. eCollection 2018.

  PMID: 29643931 BACKGROUND

• Vitriol V, Cancino A, Serrano C, Ballesteros S, Ormazabal M, Leiva-Bianchi M, Salgado C, Caceres C, Potthoff S, Orellana F, Asenjo A. Latent Class Analysis in Depression, Including Clinical and Functional Variables: Evidence of a Complex Depressive Subtype in Primary Care in Chile. Depress Res Treat. 2021 Feb 11;2021:6629403. doi: 10.1155/2021/6629403. eCollection 2021.

  PMID: 33628499 BACKGROUND

• Salvo G L. [Magnitude, impact and recommended management strategies for depression, with reference to Chile]. Rev Med Chil. 2014 Sep;142(9):1157-64. doi: 10.4067/S0034-98872014000900010. Spanish.

  PMID: 25517056 BACKGROUND

• Vitriol V, Cancino A, Sciolla A, Guinez S, Calvo J, Ormazabal M, Kreither J, Ballesteros S, Aylwin ML. Effectiveness of a multidimensional collaborative approach versus usual care in the treatment of adult depression in primary care in Chile: study protocol for a single blinded cluster randomized controlled trial. F1000Res. 2024 Oct 11;11:203. doi: 10.12688/f1000research.75764.2. eCollection 2022.

  PMID: 39464248 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Veronica G Vitriol, MD

  University of Talca

  STUDY DIRECTOR

• Alfredo A Cancino, MD

  University of Talca

  STUDY DIRECTOR

• Maria L Aylwin, PhD

  University of Talca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria L Aylwin, PhD

CONTACT

56-98-239 1048; maaylwin@utalca.cl

Sergio G Guinez, PhD

CONTACT

56-99-619 5268; sguinez@utalca.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, Principal Investigator will not receive information about the assigned group (intervention/control). The Outcome assessor will be blinded to the assigned group (intervention/control) for data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The collaborative multidimensional model (CMD) for depression incorporates to the current knowledge for the treatment of depression in primary care (PHC) teams in Chile, competences for the management of clinical, functional, psycho-biographical dimensions. These dimensions are prevalent in patients consulting PHC in Chile, associated to a complex depression sub-type, for which the current clinical guide does not provide recommendations. The implementation of this model entails a 22-hour training consisting of lectures and workshops through a virtual platform, followed by the application of the CMD in the PHC teams. In brief, the application of the model involves the creation of a case manager that prioritizes participants according to their complexity and collaboration sessions with the participation of specialists and the PHC team every 15 days for at least 3 months after the training.

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 23, 2021
• Study Start: December 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: March 31, 2023
• Last Updated: August 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From September 2022 to March 2023 the data will be available through web platforms like Mendely Data
• Access Criteria: The data published will be shared through web platforms like Mendely Data and further data may be shared by special request to the principal researcher