Top

Published in:

01-12-2021 | Affective Disorder | Study protocol

A collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care: protocol for a cluster randomized controlled trial

Authors: Graciela Rojas, Pablo Martínez, Viviana Guajardo, Solange Campos, Pablo Herrera, Paul A. Vöhringer, Víctor Gómez, Wilsa Szabo, Ricardo Araya

Published in: BMC Psychiatry | Issue 1/2021

Abstract

Background

Depression and chronic diseases are frequently comorbid public health problems. However, clinical guidelines often fail to consider comorbidities. This study protocol describes a cluster randomized trial (CRT) aimed to compare the effectiveness of a collaborative, computer-assisted, psycho-educational intervention versus enhanced usual care (EUC) in the treatment of depressed patients with hypertension and/or diabetes in primary care clinics (PCC) in Santiago, Chile.

Methods

Two-arm, single-blind, CRT carried out at two municipalities in Santiago, Chile. Eight PCC will be randomly assigned (1:1 ratio within each municipality, 4 PCC in each municipality) to the INTERVENTION or EUC. A total of 360 depressed patients, aged at least 18 years, with Patient Health Questionnaire-9 Item [PHQ-9] scores ≥15, and enrolled in the Cardiovascular Health Program at the participating PCC. Patients with alcohol/substance abuse; current treatment for depression, bipolar disorder, or psychosis; illiteracy; severe impairment; and resident in long-term care facilities, will be excluded. Patients in both arms will be invited to use the Web page of the project, which includes basic health education information. Patients in the INTERVENTION will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists, a structured telephone calls to monitor progress, and usual medical care for chronic diseases. Therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care. Patients in EUC will receive depression treatment according to clinical guidelines and usual medical care for chronic diseases. Outcome assessments will be conducted at 3, 6, and 12 months after enrollment. The primary outcome will be depression improvement at 6 months, defined as ≥50% reduction in baseline PHQ-9 scores. Intention-to-treat analyses will be performed.

Discussion

This study will be one of the first to provide evidence for the effectiveness of a collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care in a Latin American country.

Trial registration

retrospectively registered in ClinicalTrials.gov, first posted: November 3, 2020, under identifier: NCT04613076.

Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;3(11):e442. https://doi.org/10.1371/journal.pmed.0030442.CrossRefPubMedPubMedCentral

Depression and Other Common Mental Disorders: Global Health Estimates. Geneva: World Health Organization; 2017.

Disease GBD, Injury I, Prevalence C. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the global burden of Disease study 2015. Lancet. 2016;388(10053):1545–602.CrossRef

DALYs GBD, Collaborators H. Global, regional, and national disability-adjusted life-years (DALYs) for 315 diseases and injuries and healthy life expectancy (HALE), 1990-2015: a systematic analysis for the global burden of Disease study 2015. Lancet. 2016;388(10053):1603–58.CrossRef

Smith DJ, Court H, McLean G, Martin D, Langan Martin J, Guthrie B, et al. Depression and multimorbidity: a cross-sectional study of 1,751,841 patients in primary care. J Clin Psychiatry. 2014;75(11):1202–8; quiz 8. https://doi.org/10.4088/JCP.14m09147.CrossRefPubMed

Prados-Torres A, Calderon-Larranaga A, Hancco-Saavedra J, Poblador-Plou B, van den Akker M. Multimorbidity patterns: a systematic review. J Clin Epidemiol. 2014;67(3):254–66. https://doi.org/10.1016/j.jclinepi.2013.09.021.CrossRefPubMed

Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the world health surveys. Lancet. 2007;370(9590):851–8. https://doi.org/10.1016/S0140-6736(07)61415-9.CrossRefPubMed

Jansen L, van Schijndel M, van Waarde J, van Busschbach J. Health-economic outcomes in hospital patients with medical-psychiatric comorbidity: a systematic review and meta-analysis. PLoS One. 2018;13(3):e0194029. https://doi.org/10.1371/journal.pone.0194029.CrossRefPubMedPubMedCentral

Grenard JL, Munjas BA, Adams JL, Suttorp M, Maglione M, McGlynn EA, et al. Depression and medication adherence in the treatment of chronic diseases in the United States: a meta-analysis. J Gen Intern Med. 2011;26(10):1175–82. https://doi.org/10.1007/s11606-011-1704-y.CrossRefPubMedPubMedCentral

10.

van Dooren FE, Nefs G, Schram MT, Verhey FR, Denollet J, Pouwer F. Depression and risk of mortality in people with diabetes mellitus: a systematic review and meta-analysis. PLoS One. 2013;8(3):e57058. https://doi.org/10.1371/journal.pone.0057058.CrossRefPubMedPubMedCentral

11.

Gathright EC, Goldstein CM, Josephson RA, Hughes JW. Depression increases the risk of mortality in patients with heart failure: a meta-analysis. J Psychosom Res. 2017;94:82–9. https://doi.org/10.1016/j.jpsychores.2017.01.010.CrossRefPubMedPubMedCentral

12.

Kazakovtsev BA, Krasnov VN, Levina NB, Nemtsov AV. WHO European ministerial conference on mental health, “facing the challenges, building solutions” (Helsinki, Finland, 12-15 January 2005). Zh Nevrol Psikhiatr Im S S Korsakova. 2005;105(9):78–80.PubMed

13.

Vanderlip ER, Rundell J, Avery M, Alter C, Engel C, Fortney J, et al. Dissemination of integrated care within adult primary care settings: the collaborative care model. 2016.

14.

Woltmann E, Grogan-Kaylor A, Perron B, Georges H, Kilbourne AM, Bauer MS. Comparative effectiveness of collaborative chronic care models for mental health conditions across primary, specialty, and behavioral health care settings: systematic review and meta-analysis. Am J Psychiatry. 2012;169(8):790–804. https://doi.org/10.1176/appi.ajp.2012.11111616.CrossRefPubMed

15.

Panagioti M, Bower P, Kontopantelis E, Lovell K, Gilbody S, Waheed W, et al. Association between chronic physical conditions and the effectiveness of collaborative Care for Depression: an individual participant data meta-analysis. JAMA Psychiatry. 2016;73(9):978–89. https://doi.org/10.1001/jamapsychiatry.2016.1794.CrossRefPubMed

16.

Rossom RC, Solberg LI, Magnan S, Crain AL, Beck A, Coleman KJ, et al. Impact of a national collaborative care initiative for patients with depression and diabetes or cardiovascular disease. Gen Hosp Psychiatry. 2017;44:77–85. https://doi.org/10.1016/j.genhosppsych.2016.05.006.CrossRefPubMed

17.

Dickens C, Cherrington A, Adeyemi I, Roughley K, Bower P, Garrett C, et al. Characteristics of psychological interventions that improve depression in people with coronary heart disease: a systematic review and meta-regression. Psychosom Med. 2013;75(2):211–21. https://doi.org/10.1097/PSY.0b013e31827ac009.CrossRefPubMed

18.

Zomahoun HTV, Guenette L, Gregoire JP, Lauzier S, Lawani AM, Ferdynus C, et al. Effectiveness of motivational interviewing interventions on medication adherence in adults with chronic diseases: a systematic review and meta-analysis. Int J Epidemiol. 2017;46(2):589–602. https://doi.org/10.1093/ije/dyw273.CrossRefPubMed

19.

Pal K, Eastwood SV, Michie S, Farmer A, Barnard ML, Peacock R, et al. Computer-based interventions to improve self-management in adults with type 2 diabetes: a systematic review and meta-analysis. Diabetes Care. 2014;37(6):1759–66. https://doi.org/10.2337/dc13-1386.CrossRefPubMed

20.

Kroenke K, Unutzer J. Closing the false divide: sustainable approaches to integrating mental health services into primary care. J Gen Intern Med. 2017;32(4):404–10. https://doi.org/10.1007/s11606-016-3967-9.CrossRefPubMedPubMedCentral

21.

Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014;13(3):288–95. https://doi.org/10.1002/wps.20151.CrossRefPubMedPubMedCentral

22.

Bao Y, Druss BG, Jung HY, Chan YF, Unutzer J. Unpacking collaborative Care for Depression: examining two essential tasks for implementation. Psychiatr Serv. 2016;67(4):418–24. https://doi.org/10.1176/appi.ps.201400577.CrossRefPubMed

23.

Ministerio de Salud de Chile. Estrategia Nacional de Salud para el cumplimiento de los Objetivos Sanitarios de la Década 2011–2020. Santiago: Ministerio de Salud de Chile; 2011.

24.

Araya R, Alvarado R, Minoletti A. Chile: an ongoing mental health revolution. Lancet. 2009;374(9690):597–8. https://doi.org/10.1016/S0140-6736(09)61490-2.CrossRefPubMed

25.

Araya R, Rojas G, Fritsch R, Gaete J, Rojas M, Simon G, et al. Treating depression in primary care in low-income women in Santiago, Chile: a randomised controlled trial. Lancet. 2003;361(9362):995–1000. https://doi.org/10.1016/S0140-6736(03)12825-5.CrossRefPubMed

26.

Aguilera X, Castillo-Laborde C, Ferrari MN, Delgado I, Ibanez C. Monitoring and evaluating progress towards universal health coverage in Chile. PLoS Med. 2014;11(9):e1001676. https://doi.org/10.1371/journal.pmed.1001676.CrossRefPubMedPubMedCentral

27.

Ministerio de Salud de Chile. Encuesta Nacional de Salud 2016–2017: primeros resultados. Santiago: Ministerio de Salud de Chile; 2017.

28.

Ministerio de Salud de Chile. Encuesta Nacional de Salud 2016–2017: segund entrega de resultados. Santiago: Ministerio de Salud de Chile; 2018.

29.

Alvarado R, Rojas G, Minoletti A, Alvarado F, Domínguez C. Depression program in primary health care: the Chilean experience. Int J Ment Health. 2012;41(1):38–47. https://doi.org/10.2753/IMH0020-7411410103.CrossRef

30.

Minoletti A, Sepúlveda R, Horvitz-Lennon M. Twenty years of mental health policies in Chile: lessons and challenges. Int J Ment Health. 2012;41(1):21–37. https://doi.org/10.2753/IMH0020-7411410102.CrossRef

31.

Martinez P, Rojas G, Fritsch R, Martinez V, Vohringer PA, Castro A. Comorbidity in people with depression seeking help at primary health care centers in Santiago, Chile. Rev Med Chil. 2017;145(1):25–32. https://doi.org/10.4067/S0034-98872017000100004.CrossRefPubMed

32.

Dois A, Cazenave A. Pesquisa de depresión mayor en hipertensos consultantes de la Atención Primaria. Rev Med Chil. 2009;137(4):475–80.CrossRef

33.

Group WAW. The alcohol, smoking and substance involvement screening test (ASSIST): development, reliability and feasibility. Addiction. 2002;97(9):1183–94. https://doi.org/10.1046/j.1360-0443.2002.00185.x.CrossRef

34.

Ministerio de Salud de Chile. Guía Clínica Depresión en personas de 15 años y más. Santiago: MINSAL; 2013.

35.

Bastias G, Pantoja T, Leisewitz T, Zarate V. Health care reform in Chile. CMAJ. 2008;179(12):1289–92. https://doi.org/10.1503/cmaj.071843.CrossRefPubMedPubMedCentral

36.

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–13. https://doi.org/10.1046/j.1525-1497.2001.016009606.x.CrossRefPubMedPubMedCentral

37.

Ware J Jr, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–33. https://doi.org/10.1097/00005650-199603000-00003.CrossRefPubMed

38.

D’Zurilla TJ, Nezu AM, Maydeu-Olivares A. Social problem-solving inventory-revised; 2002.

39.

Huang Y, Wei X, Wu T, Chen R, Guo A. Collaborative care for patients with depression and diabetes mellitus: a systematic review and meta-analysis. BMC Psychiatry. 2013;13(1):260. https://doi.org/10.1186/1471-244X-13-260.CrossRefPubMedPubMedCentral

40.

Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004;57(8):785–94. https://doi.org/10.1016/j.jclinepi.2003.12.013.CrossRefPubMed

41.

Giraudeau B, Ravaud P. Preventing bias in cluster randomised trials. PLoS Med. 2009;6(5):e1000065. https://doi.org/10.1371/journal.pmed.1000065.CrossRefPubMedPubMedCentral

42.

Baader MT, Molina FJL, Venezian BS, Rojas CC, Farías SR, Fierro-Freixenet C, et al. Validación y utilidad de la encuesta PHQ-9 (Patient Health Questionnaire) en el diagnóstico de depresión en pacientes usuarios de atención primaria en Chile. Revista chilena de neuro-psiquiatría. 2012;50(1):10–22. https://doi.org/10.4067/S0717-92272012000100002.CrossRef

43.

Vera-Villarroel P, Silva J, Celis-Atenas K, Pavez P. Evaluation of the SF-12: usefulness of the mental health scale. Rev Med Chil. 2014;142(10):1275–83. https://doi.org/10.4067/S0034-98872014001000007.CrossRefPubMed

44.

Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017;17(1):88. https://doi.org/10.1186/s12913-017-2031-8.CrossRefPubMedPubMedCentral

45.

Ministerio de Desarrollo Social y Familia. Casen 2017: Manual del investigador. Santiago: Guía práctica para el uso y análisis de información; 2017.

46.

Batalla ABR, Ciurana M, García M, Jordi E, Pérez A. Cumplimiento de la prescripción farmacológica en pacientes hipertensos. Aten Primaria. 1984;1:185–91.

47.

Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, Group CN. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med. 2017;167(1):40–7. https://doi.org/10.7326/M17-0046.CrossRefPubMed

48.

Campbell MK, Piaggio G, Elbourne DR, Altman DG, Group C. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345(sep04 1):e5661. https://doi.org/10.1136/bmj.e5661.CrossRefPubMed

49.

StataCorp. Stata Statistical Software (Release 14). College Station: StataCorp LP; 2015.

50.

Schafer JL, Graham JW. Missing data: our view of the state of the art. Psychol Methods. 2002;7(2):147–77. https://doi.org/10.1037/1082-989X.7.2.147.CrossRefPubMed

51.

Enders CK, Keller BT, Levy R. A fully conditional specification approach to multilevel imputation of categorical and continuous variables. Psychol Methods. 2018;23(2):298–317. https://doi.org/10.1037/met0000148.CrossRefPubMed

52.

Bartlett JW, Seaman SR, White IR, Carpenter JR. Alzheimer’s Disease neuroimaging I. multiple imputation of covariates by fully conditional specification: accommodating the substantive model. Stat Methods Med Res. 2015;24(4):462–87. https://doi.org/10.1177/0962280214521348.CrossRefPubMedPubMedCentral

53.

Keller BT, Enders CK. Blimp User’s Manual (Version 1.1). Los Angeles; 2018.

54.

Rubin D. Multiple imputation for nonresponse in surveys. New York: Wiley; 1987. https://doi.org/10.1002/9780470316696.CrossRef

Title: A collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care: protocol for a cluster randomized controlled trial
Authors: Graciela Rojas
Pablo Martínez
Viviana Guajardo
Solange Campos
Pablo Herrera
Paul A. Vöhringer
Víctor Gómez
Wilsa Szabo
Ricardo Araya
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Affective Disorder
Care
Affective Disorder
Hypertension
Hypertension
Published in: BMC Psychiatry / Issue 1/2021
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-021-03380-2

At a glance: The STEP trials

Springer Medicine

A collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care: protocol for a cluster randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2021

Trajectories of loneliness and objective social isolation and associations between persistent loneliness and self-reported personal recovery in a cohort of secondary mental health service users in the UK

Associations between developmental timing of child abuse and conduct problem trajectories in a UK birth cohort

Executive functions and insight in OCD: a comparative study

A qualitative study to investigate Swiss hospital personnel’s perceived importance of and experiences with patient’s mental–somatic multimorbidities

Assessment of violence risk in 440 psychiatric patients in China: examining the feasibility and acceptability of a novel and scalable approach (FoVOx)

Validity and reliability of a Persian version of the self- evaluation of negative symptoms (SNS)