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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03285659
Other study ID # P17/077
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 12, 2017
Last updated September 14, 2017
Start date January 1, 2018
Est. completion date December 31, 2019

Study information

Verified date September 2017
Source Jordi Gol i Gurina Foundation
Contact Catarina Pires, PhD
Phone 0034 652957478
Email jamnista@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Depression is one of the most common conditions among primary care patients. Nevertheless, there are several problems in depression diagnosis, clinical management and outcomes. The INDI study, which is based in a collaborative care model, aims to improve the management of depression in primary care patients. It is intended to be implemented in clinical practice within the context of primary care.


Description:

BACKGROUND Depression is one of the most common conditions among primary care patients. Nevertheless, there are several problems in its diagnosis, clinical management and outcomes. The INDI study, which is based in a collaborative care model, aims to improve the management of depression in primary care patients. INDI has been proved previously to be an efficient intervention showing clinical and socio-economic benefits. INDI is intended to be implemented in the clinical practice within the context of primary care.

METHOD Aim: Test the feasibility and the impact of an implementation strategy of the INDI model for the management of depression in primary care.

Design: This is a casi-experimental study within the context of primary care. Specific geographic areas will be identified to implement the INDI program (intervention group) and other areas with similar features will to be compared (control group.

Participants: Patients diagnosed with depression will be invited to voluntarily participate in this study. Additionally, the investigators will also consider as participants the health professionals, the centres of primary care, as well as the health organizations of the geographic areas where the study will take place: Camp de Tarragona and Valles Occidental (Catalonia, Spain).

Intervention: The INDI model is a health care program for improving the management of depression. INDI includes clinical, training and organizational interventions with the participation of nurses as care managers. An active strategy based on the Promoting Action on Research Implementation in Health Services's model (PARIHS) will be designed for the implementation.

Evaluation: This study will use qualitative and quantitative methods to obtain data on the variables related to a successful implementation: feasibility, acceptability, and impact.

Discussion: In this study, the investigators aim to test the feasibility of a clinical intervention INDI, based on a collaborative care model, in the management of depression in primary care setting. If the implementation of such intervention is successful, then the achieved data and experience will help to plan a strategy to generalize the INDI model to the Catalan health system. The investigators expect significant clinical benefits to the patients, the health system and to the society.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 44
Est. completion date December 31, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients: adult patients with a new diagnosis of depression or a new episode of antidepressant treatment. The comorbidity of depression with other common mental disorders such as anxiety disorders or somatization disorders is not an exclusion criterion.

- Organization: Health centres (i.e. Primary care centres) of Catalonia, which are comparable in terms of their sociodemographic, healthy and organizational features

Exclusion Criteria:

- Patients: adult patients with a diagnosis of psychotic or bipolar disorder, drug or alcohol use disorder, dementia, intellectual disability, postpartum depression, and patients included in the home care program

- Organization: no exclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intervention: INDI Implementation
Implementation of a collaborative care model in the context of primary care to manage depression

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jordi Gol i Gurina Foundation

References & Publications (32)

Aragonès E, Caballero A, Piñol JL, López-Cortacans G, Badia W, Hernández JM, Casaus P, Folch S, Basora J, Labad A; INDI research group. Assessment of an enhanced program for depression management in primary care: a cluster randomized controlled trial. The INDI project (Interventions for Depression Improvement). BMC Public Health. 2007 Sep 20;7:253. — View Citation

Aragonès E, Caballero A, Piñol JL, López-Cortacans G. Persistence in the long term of the effects of a collaborative care programme for depression in primary care. J Affect Disord. 2014 Sep;166:36-40. doi: 10.1016/j.jad.2014.05.003. Epub 2014 May 11. — View Citation

Aragonès E, Comín E, Cavero M, Pérez V, Molina C, Palao D. [A computerised clinical decision-support system for the management of depression in Primary Care]. Aten Primaria. 2017 Jun - Jul;49(6):359-367. doi: 10.1016/j.aprim.2016.09.011. Epub 2017 Jan 9. Spanish. — View Citation

Aragonès E, López-Cortacans G, Sánchez-Iriso E, Piñol JL, Caballero A, Salvador-Carulla L, Cabasés J. Cost-effectiveness analysis of a collaborative care programme for depression in primary care. J Affect Disord. 2014 Apr;159:85-93. doi: 10.1016/j.jad.2014.01.021. Epub 2014 Feb 13. — View Citation

Aragonès E, Piñol JL, Caballero A, López-Cortacans G, Casaus P, Hernández JM, Badia W, Folch S. Effectiveness of a multi-component programme for managing depression in primary care: a cluster randomized trial. The INDI project. J Affect Disord. 2012 Dec 15;142(1-3):297-305. doi: 10.1016/j.jad.2012.05.020. Epub 2012 Oct 11. — View Citation

Aragonès E, Piñol JL, Labad A, Masdéu RM, Pino M, Cervera J. Prevalence and determinants of depressive disorders in primary care practice in Spain. Int J Psychiatry Med. 2004;34(1):21-35. — View Citation

Aragonès E, Piñol JL, Labad A. Depression and physical comorbidity in primary care. J Psychosom Res. 2007 Aug;63(2):107-11. — View Citation

Bolíbar B, Fina Avilés F, Morros R, Garcia-Gil Mdel M, Hermosilla E, Ramos R, Rosell M, Rodríguez J, Medina M, Calero S, Prieto-Alhambra D; Grupo SIDIAP. [SIDIAP database: electronic clinical records in primary care as a source of information for epidemiologic research]. Med Clin (Barc). 2012 May 19;138(14):617-21. doi: 10.1016/j.medcli.2012.01.020. Epub 2012 Mar 22. Spanish. — View Citation

Community Preventive Services Task Force. Recommendation from the community preventive services task force for use of collaborative care for the management of depressive disorders. Am J Prev Med. 2012 May;42(5):521-4. doi: 10.1016/j.amepre.2012.01.010. — View Citation

Coventry PA, Hudson JL, Kontopantelis E, Archer J, Richards DA, Gilbody S, Lovell K, Dickens C, Gask L, Waheed W, Bower P. Characteristics of effective collaborative care for treatment of depression: a systematic review and meta-regression of 74 randomised controlled trials. PLoS One. 2014 Sep 29;9(9):e108114. doi: 10.1371/journal.pone.0108114. eCollection 2014. Review. — View Citation

Eccles MP, Armstrong D, Baker R, Cleary K, Davies H, Davies S, Glasziou P, Ilott I, Kinmonth AL, Leng G, Logan S, Marteau T, Michie S, Rogers H, Rycroft-Malone J, Sibbald B. An implementation research agenda. Implement Sci. 2009 Apr 7;4:18. doi: 10.1186/1748-5908-4-18. — View Citation

Fernández A, Pinto-Meza A, Bellón JA, Roura-Poch P, Haro JM, Autonell J, Palao DJ, Peñarrubia MT, Fernández R, Blanco E, Luciano JV, Serrano-Blanco A. Is major depression adequately diagnosed and treated by general practitioners? Results from an epidemiological study. Gen Hosp Psychiatry. 2010 Mar-Apr;32(2):201-9. doi: 10.1016/j.genhosppsych.2009.11.015. Epub 2010 Jan 12. — View Citation

Gabilondo A, Rojas-Farreras S, Vilagut G, Haro JM, Fernández A, Pinto-Meza A, Alonso J. Epidemiology of major depressive episode in a southern European country: results from the ESEMeD-Spain project. J Affect Disord. 2010 Jan;120(1-3):76-85. doi: 10.1016/j.jad.2009.04.016. — View Citation

Gilbody S, Bower P, Fletcher J, Richards D, Sutton AJ. Collaborative care for depression: a cumulative meta-analysis and review of longer-term outcomes. Arch Intern Med. 2006 Nov 27;166(21):2314-21. Review. — View Citation

Gili M, Comas A, García-García M, Monzón S, Antoni SB, Roca M. Comorbidity between common mental disorders and chronic somatic diseases in primary care patients. Gen Hosp Psychiatry. 2010 May-Jun;32(3):240-5. doi: 10.1016/j.genhosppsych.2010.01.013. Epub 2010 Mar 1. — View Citation

Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care. 2005 May;43(5):436-44. — View Citation

Kitzinger J. Qualitative research. Introducing focus groups. BMJ. 1995 Jul 29;311(7000):299-302. — View Citation

Kohn R, Saxena S, Levav I, Saraceno B. The treatment gap in mental health care. Bull World Health Organ. 2004 Nov;82(11):858-66. Epub 2004 Dec 14. Review. — View Citation

Mira JJ, Nuño-Solinís R, Guilabert-Mora M, Solas-Gaspar O, Fernández-Cano P, González-Mestre MA, Contel JC, Del Río-Cámara M. Development and Validation of an Instrument for Assessing Patient Experience of Chronic Illness Care. Int J Integr Care. 2016 Aug 31;16(3):13. doi: 10.5334/ijic.2443. — View Citation

Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, Finch T, Kennedy A, Mair F, O'Donnell C, Ong BN, Rapley T, Rogers A, May C. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010 Oct 20;8:63. doi: 10.1186/1741-7015-8-63. — View Citation

Nuño-Solinís R, Fernández-Cano P, Mira-Solves JJ, Toro-Polanco N, Carlos Contel J, Guilabert Mora M, Solas O. [Development of an instrument for the assessment of chronic care models]. Gac Sanit. 2013 Mar-Apr;27(2):128-34. doi: 10.1016/j.gaceta.2012.05.012. Epub 2012 Jul 24. Spanish. — View Citation

Pinto-Meza A, Fernandez A, Serrano-Blanco A, Haro JM. Adequacy of antidepressant treatment in Spanish primary care: a naturalistic six-month follow-up study. Psychiatr Serv. 2008 Jan;59(1):78-83. doi: 10.1176/ps.2008.59.1.78. — View Citation

Rossom RC, Solberg LI, Vazquez-Benitez G, Crain AL, Beck A, Whitebird R, Glasgow RE. The effects of patient-centered depression care on patient satisfaction and depression remission. Fam Pract. 2016 Dec;33(6):649-655. Epub 2016 Aug 17. — View Citation

Sabes-Figuera R, Knapp M, Bendeck M, Mompart-Penina A, Salvador-Carulla L. The local burden of emotional disorders. An analysis based on a large health survey in Catalonia (Spain). Gac Sanit. 2012 Jan-Feb;26(1):24-9. doi: 10.1016/j.gaceta.2011.05.019. Epub 2011 Nov 9. — View Citation

Salvador-Carulla L, Bendeck M, Fernández A, Alberti C, Sabes-Figuera R, Molina C, Knapp M. Costs of depression in Catalonia (Spain). J Affect Disord. 2011 Jul;132(1-2):130-8. doi: 10.1016/j.jad.2011.02.019. Epub 2011 Mar 12. — View Citation

Serrano-Blanco A, Palao DJ, Luciano JV, Pinto-Meza A, Luján L, Fernández A, Roura P, Bertsch J, Mercader M, Haro JM. Prevalence of mental disorders in primary care: results from the diagnosis and treatment of mental disorders in primary care study (DASMAP). Soc Psychiatry Psychiatr Epidemiol. 2010 Feb;45(2):201-10. doi: 10.1007/s00127-009-0056-y. Epub 2009 May 19. — View Citation

Sighinolfi C, Nespeca C, Menchetti M, Levantesi P, Belvederi Murri M, Berardi D. Collaborative care for depression in European countries: a systematic review and meta-analysis. J Psychosom Res. 2014 Oct;77(4):247-63. doi: 10.1016/j.jpsychores.2014.08.006. Epub 2014 Aug 27. Review. — View Citation

Solberg LI, Asche SE, Margolis KL, Whitebird RR. Measuring an organization's ability to manage change: the change process capability questionnaire and its use for improving depression care. Am J Med Qual. 2008 May-Jun;23(3):193-200. doi: 10.1177/1062860608314942. — View Citation

Solberg LI, Crain AL, Jaeckels N, Ohnsorg KA, Margolis KL, Beck A, Whitebird RR, Rossom RC, Crabtree BF, Van de Ven AH. The DIAMOND initiative: implementing collaborative care for depression in 75 primary care clinics. Implement Sci. 2013 Nov 16;8:135. doi: 10.1186/1748-5908-8-135. — View Citation

Stetler CB, Damschroder LJ, Helfrich CD, Hagedorn HJ. A Guide for applying a revised version of the PARIHS framework for implementation. Implement Sci. 2011 Aug 30;6:99. doi: 10.1186/1748-5908-6-99. — View Citation

Thota AB, Sipe TA, Byard GJ, Zometa CS, Hahn RA, McKnight-Eily LR, Chapman DP, Abraido-Lanza AF, Pearson JL, Anderson CW, Gelenberg AJ, Hennessy KD, Duffy FF, Vernon-Smiley ME, Nease DE Jr, Williams SP; Community Preventive Services Task Force. Collaborative care to improve the management of depressive disorders: a community guide systematic review and meta-analysis. Am J Prev Med. 2012 May;42(5):525-38. doi: 10.1016/j.amepre.2012.01.019. Review. — View Citation

Wittchen HU, Holsboer F, Jacobi F. Met and unmet needs in the management of depressive disorder in the community and primary care: the size and breadth of the problem. J Clin Psychiatry. 2001;62 Suppl 26:23-8. Review. — View Citation

* Note: There are 32 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary degree of implementation and capacity for change of the collaborative care model (INDI) degree of implementation of the collaborative care model (INDI) in health organization and professionals using the Assessment of Readiness for Chronicity in Health Care Organizations (ARCHO) 12 months
Primary patient experience about the collaborative care model (INDI) how patients experience depression care according to the collaborative care model (INDI) using the Instrument for Evaluating Patient Experience of Chronic Illness Care (IEXPAC) scale 12 months
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