Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2020

01-12-2020 | Mood Disorders | Study protocol

A collaborative care psychosocial intervention to improve late life depression in socioeconomically deprived areas of Guarulhos, Brazil: the PROACTIVE cluster randomised controlled trial protocol

Authors: Marcia Scazufca, Carina Akemi Nakamura, Tim J. Peters, Maiara Garcia Henrique, Antônio Seabra, Ehidee Gomez La Rotta, Renato M. Franzin, Daniele Ferreira Martins, Pepijn Van de Ven, William Hollingworth, Ricardo Araya

Published in: Trials | Issue 1/2020

Login to get access

Abstract

Background

The elderly population has been growing in most low- and middle-income countries (LMIC), and depression is a common condition among these populations. The lack of integration between mental health and primary healthcare services and the shortage of mental health specialists in the public health system contribute to underdiagnosis and undertreatment of depression. One of the strategies to reduce this gap is task shifting and collaborative care treatments. This study therefore aims to evaluate the effectiveness and cost-effectiveness of a collaborative care psychosocial intervention to improve the clinical management of depression among elderly people in poor neighbourhoods in Guarulhos, Brazil.

Methods

Two-arm, cluster randomised controlled trial with Basic Health Units as the clusters and a 1:1 allocation ratio. Twenty Basic Health Units have been randomly selected and randomised to control or intervention arms. We aim to recruit 1440 adults (72 per cluster) aged 60 years or over identified with depression (9-item Patient Health Questionnaire (PHQ-9) score ≥ 10). The control arm participants will receive an enhanced usual care, while the intervention arm participants will receive an enhanced usual care and a 17-week psychosocial intervention programme delivered at home by community health workers with the help of an application installed on tablet computers. The primary outcome is the proportion with depression recovery (PHQ-9 < 10) at 8 months’ follow-up. We will also assess the maintenance of any earlier clinical gains and the cost-effectiveness of the intervention at 12 months.

Discussion

This is the first randomised trial to investigate a collaborative care intervention to treat depression among poor elderly in LMIC/Latin America. This is a major public health problem worldwide, but in these countries, there are no locally tested, evidence-based interventions available to date.

Trial registration

International Standard Randomised Controlled Trial Number ISRCTN57805470. Registered on 25 April 2019
Literature
1.
2.
3.
4.
5.
Stopa SR, Malta DC, de Oliveira MM, Lopes CES, Menezes PR, Kinoshita RT. Prevalence of self-reported depression in Brazil: 2013 National Health Survey results. Rev Bras Epidemiol. 2015;18(Suppl 2):170–80.PubMed
6.
7.
Scazufca M, Menezes P, Tabb K, Kester R, Rössler W, Huang H. Identification and treatment of depression of older adults in primary care: findings from the São Paulo Ageing and Health Study. Fam Pract. 2016;33(3):233–7.PubMed
8.
Saraceno B, van Ommeren M, Batniji R, Cohen A, Gureje O, Mahoney J, et al. Barriers to improvement of mental health services in low-income and middle-income countries. Lancet. 2007;370(9593):1164–74.PubMed
9.
Wilkinson P, Izmeth Z. Continuation and maintenance treatments for depression in older people. Cochrane Database Syst Rev. 2016;9:CD006727.PubMed
10.
Chang-Quan H, Bi-Rong D, Zhen-Chan L, Yuan Z, Yu-Sheng P, Qing-Xiu L. Collaborative care interventions for depression in the elderly: a systematic review of randomized controlled trials. J Investig Med. 2009;57(2):446–55.PubMed
11.
12.
Ekers D, Richards D, McMillan D, Bland JM, Gilbody S. Behavioural activation delivered by the non-specialist: phase II randomised controlled trial. Br J Psychiatry. 2011;198(1):66–72.PubMed
13.
Petersen I, Bhana A, Baillie K, Consortium MRP. The feasibility of adapted group-based interpersonal therapy (IPT) for the treatment of depression by community health workers within the context of task shifting in South Africa. Community Ment Health J. 2012;48(3):336–41.PubMed
14.
Unützer J, Katon W, Callahan CM, Williams JW, Hunkeler E, Harpole L, et al. Collaborative care management of late-life depression in the primary care setting: a randomized controlled trial. JAMA. 2002;288(22):2836–45.PubMed
15.
Ciechanowski P, Wagner E, Schmaling K, Schwartz S, Williams B, Diehr P, et al. Community-integrated home-based depression treatment in older adults: a randomized controlled trial. JAMA. 2004;291(13):1569–77.PubMed
16.
Hunkeler EM, Katon W, Tang L, Williams JW, Kroenke K, Lin EH, et al. Long term outcomes from the IMPACT randomised trial for depressed elderly patients in primary care. BMJ. 2006;332(7536):259–63.PubMedPubMedCentral
17.
Bosanquet K, Adamson J, Atherton K, Bailey D, Baxter C, Beresford-Dent J, et al. CollAborative care for Screen-Positive EldeRs with major depression (CASPER plus): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness. Health Technol Assess. 2017;21(67):1–252.PubMedPubMedCentral
18.
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.PubMed
19.
Rojas G, Fritsch R, Solis J, Jadresic E, Castillo C, González M, et al. Treatment of postnatal depression in low-income mothers in primary-care clinics in Santiago, Chile: a randomised controlled trial. Lancet. 2007;370(9599):1629–37.PubMed
20.
Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet. 2008;372(9642):902–9.PubMedPubMedCentral
21.
Patel V, Weiss HA, Chowdhary N, Naik S, Pednekar S, Chatterjee S, et al. Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial. Lancet. 2010;376(9758):2086–95.PubMedPubMedCentral
22.
Scazufca M, de Paula Couto MCP, Henrique MG, Mendes AV, Matijasevich A, Pereda PC, et al. Pilot study of a two-arm non-randomized controlled cluster trial of a psychosocial intervention to improve late life depression in socioeconomically deprived areas of São Paulo, Brazil (PROACTIVE): feasibility study of a psychosocial intervention for late life depression in São Paulo. BMC Public Health. 2019;19(1):1152.PubMedPubMedCentral
23.
Van de Ven P, Araya R, de Paula Couto MCP, Henrique MG, Meere D, Vilela Mendes A, et al. Investigating software requirements for systems supporting task-shifted interventions: usability study. J Med Internet Res. 2019;21(11):e11346.PubMedPubMedCentral
24.
25.
26.
27.
28.
Harzheim E, Duncan BB, Stein AT, Cunha CR, Goncalves MR, Trindade TG, et al. Quality and effectiveness of different approaches to primary care delivery in Brazil. BMC Health Serv Res. 2006;6:156.PubMedPubMedCentral
29.
30.
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.PubMedPubMedCentral
31.
Ekers D, Webster L, Van Straten A, Cuijpers P, Richards D, Gilbody S. Behavioural activation for depression; an update of meta-analysis of effectiveness and sub group analysis. PLoS One. 2014;9(6):e100100.PubMedPubMedCentral
32.
Ekers D, Richards D, Gilbody S. A meta-analysis of randomized trials of behavioural treatment of depression. Psychol Med. 2008;38(5):611–23.PubMed
33.
Ekers DM, Dawson MS, Bailey E. Dissemination of behavioural activation for depression to mental health nurses: training evaluation and benchmarked clinical outcomes. J Psychiatr Ment Health Nurs. 2013;20(2):186–92.PubMed
34.
Devlin NJ, Krabbe PF. The development of new research methods for the valuation of EQ-5D-5L. Eur J Health Econ. 2013;14(Suppl 1):S1–3.PubMed
35.
Grewal I, Lewis J, Flynn T, Brown J, Bond J, Coast J. Developing attributes for a generic quality of life measure for older people: preferences or capabilities? Soc Sci Med. 2006;62(8):1891–901.PubMed
36.
Manos RC, Kanter JW, Luo W. The behavioral activation for depression scale-short form: development and validation. Behav Ther. 2011;42(4):726–39.PubMed
37.
Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–7.CrossRefPubMed
38.
Lopes CS. Reliability of reported stressful life events reported in a self-administered questionnaire: Pró-Saúde Study. 2001;23(3):126–33 2001 FE, 23(3):126–33.
39.
Cramer H, Salisbury C, Conrad J, Eldred J, Araya R. Group cognitive behavioural therapy for women with depression: pilot and feasibility study for a randomised controlled trial using mixed methods. BMC Psychiatry. 2011;11:82.PubMedPubMedCentral
40.
Richards DA, Hill JJ, Gask L, Lovell K, Chew-Graham C, Bower P, et al. Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial. BMJ. 2013;347:f4913.PubMedPubMedCentral
41.
Peters TJ, Eachus JI. Achieving equal probability of selection under various random sampling strategies. Paediatr Perinat Epidemiol. 1995;9(2):219–24.PubMed
42.
Scazufca M, de Paula Couto MCP, Huang H, Kester R, Braga PE, Peluso É, et al. Public stigma towards older adults with depression: findings from the São Paulo-Manaus elderly in primary care study. PLoS One. 2016;11(6):e0157719.PubMedPubMedCentral
43.
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.PubMed
44.
Löwe B, Unützer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004;42(12):1194–201.PubMed
45.
Santos IS, Tavares BF, Munhoz TN, Almeida LS, Silva NT, Tams BD, et al. Sensitivity and specificity of the Patient Health Questionnaire-9 (PHQ-9) among adults from the general population. Cad Saude Publica. 2013;29(8):1533–43.PubMed
46.
Ell K, Unützer J, Aranda M, Gibbs NE, Lee PJ, Xie B. Managing depression in home health care: a randomized clinical trial. Home Health Care Serv Q. 2007;26(3):81–104.PubMedPubMedCentral
47.
Williams A, Kind P. The present state of play about QALYs. In: Hopkins A, editor. Measures of the quality of life, and the uses to which such measures may be put. London: RCP publications; 1992. p. 21–33.
48.
Sapin C, Fantino B, Nowicki ML, Kind P. Usefulness of EQ-5D in assessing health status in primary care patients with major depressive disorder. Health Qual Life Outcomes. 2004;2:20.PubMedPubMedCentral
49.
Viegas Andrade M, Noronha K, Kind P, Maia AC. Miranda de Menezes R, De Barros Reis C, et al. Societal preferences for EQ-5D health states from a Brazilian population survey. Value Health Reg Issues. 2013;2(3):405–12.PubMed
50.
Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln KW, Beck JC, et al. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006;46(4):503–13.PubMed
51.
Ribeiro O, Teixeira L, Duarte N, Azevedo M, Araújo L, Barbosa S, et al. Versão Portuguesa da Escala Breve de Redes Sociais de Lubben (LSNS-6). Revista Temática Kairós Gerontologia. 2012;15(1):217–34.
52.
Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory cCare Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998;158(16):1789–95.PubMed
53.
Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A short scale for measuring loneliness in large surveys: results from two population-based studies. Res Aging. 2004;26(6):655–72.PubMedPubMedCentral
54.
Campbell MK, Piaggio G, Elbourne DR, Altman DG, Group C. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.PubMed
55.
Chibanda D, Weiss HA, Verhey R, Simms V, Munjoma R, Rusakaniko S, et al. Effect of a primary care-based psychological intervention on symptoms of common mental disorders in Zimbabwe: a randomized clinical trial. JAMA. 2016;316(24):2618–26.PubMed
56.
Patel V, Weobong B, Weiss HA, Anand A, Bhat B, Katti B, et al. The Healthy Activity Program (HAP), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in India: a randomised controlled trial. Lancet. 2017;389(10065):176–85.PubMedPubMedCentral
57.
Ludermir AB, Lewis G, Valongueiro SA, de Araújo TV, Araya R. Violence against women by their intimate partner during pregnancy and postnatal depression: a prospective cohort study. Lancet. 2010;376(9744):903–10.PubMed
58.
Metadata
Title
A collaborative care psychosocial intervention to improve late life depression in socioeconomically deprived areas of Guarulhos, Brazil: the PROACTIVE cluster randomised controlled trial protocol
Authors
Marcia Scazufca
Carina Akemi Nakamura
Tim J. Peters
Maiara Garcia Henrique
Antônio Seabra
Ehidee Gomez La Rotta
Renato M. Franzin
Daniele Ferreira Martins
Pepijn Van de Ven
William Hollingworth
Ricardo Araya
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04826-w

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue

Study protocol

IMPROVEjob – Participatory intervention to improve job satisfaction of general practice teams: a model for structural and behavioural prevention in small and medium-sized enterprises – a study protocol of a cluster-randomised controlled trial

Study protocol

Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting

Study protocol

Transcranial direct current stimulation (tDCS) as an intervention to improve empathic abilities and reduce violent behavior in forensic offenders: study protocol for a randomized controlled trial

Study protocol

Rationale and design of the randomised Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I)

Study protocol

Community youth teams facilitating participatory adolescent groups, youth leadership activities and livelihood promotion to improve school attendance, dietary diversity and mental health among adolescent girls in rural eastern India: protocol for a cluster-randomised controlled trial

Study protocol

Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC)