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Effect of a Digital Intervention on Depressive Symptoms in Patients With Comorbid Hypertension or Diabetes in Brazil and PeruTwo Randomized Clinical Trials

Educational Objective
To learn the effect of a behavioral activation digital intervention on depressive symptoms in patients with comorbid hypertension or diabetes in Brazil and Peru.
1 Credit CME
Key Points

Question  What is the effect of a behavioral activation digital intervention delivered over a 6-week period on depressive symptoms among patients with comorbid hypertension or diabetes in Brazil and Peru?

Findings  In 2 randomized clinical trials conducted separately in São Paulo, Brazil (880 participants), and Lima, Peru (432 participants), a significantly greater proportion of participants who received the digital intervention, compared with enhanced usual care, experienced at least a 50% reduction in depressive symptoms at 3 months (40.7% vs 28.6% in Brazil; [odds ratio, 1.6]; 52.7% vs 34.1% in Peru [odds ratio, 2.1]), although the differences were no longer statistically significant at 6 months.

Meaning  A digital intervention for patients with depressive symptoms and comorbid hypertension or diabetes significantly improved depressive symptoms at 3 months compared with enhanced usual care in Peru and Brazil, but the effects were not sustained at 6 months in either of the 2 trials.

Abstract

Importance  Depression is a leading contributor to disease burden globally. Digital mental health interventions can address the treatment gap in low- and middle-income countries, but the effectiveness in these countries is unknown.

Objective  To investigate the effectiveness of a digital intervention in reducing depressive symptoms among people with diabetes and/or hypertension.

Design, Setting, and Participants  Participants with clinically significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score ≥10) who were being treated for hypertension and/or diabetes were enrolled in a cluster randomized clinical trial (RCT) at 20 sites in São Paulo, Brazil (N=880; from September 2016 to September 2017; final follow-up, April 2018), and in an individual-level RCT at 7 sites in Lima, Peru (N=432; from January 2017 to September 2017; final follow-up, March 2018).

Interventions  An 18-session, low-intensity, digital intervention was delivered over 6 weeks via a provided smartphone, based on behavioral activation principles, and supported by nurse assistants (n = 440 participants in 10 clusters in São Paulo; n = 217 participants in Lima) vs enhanced usual care (n = 440 participants in 10 clusters in São Paulo; n = 215 participants in Lima).

Main Outcomes and Measures  The primary outcome was a reduction of at least 50% from baseline in PHQ-9 scores (range, 0-27; higher score indicates more severe depression) at 3 months. Secondary outcomes included a reduction of at least 50% from baseline PHQ-9 scores at 6 months.

Results  Among 880 patients cluster randomized in Brazil (mean age, 56.0 years; 761 [86.5%] women) and 432 patients individually randomized in Peru (mean age, 59.7 years; 352 [81.5%] women), 807 (91.7%) in Brazil and 426 (98.6%) in Peru completed at least 1 follow-up assessment. The proportion of participants in São Paulo with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 40.7% (159/391 participants) in the digital intervention group vs 28.6% (114/399 participants) in the enhanced usual care group (difference, 12.1 percentage points [95% CI, 5.5 to 18.7]; adjusted odds ratio [OR], 1.6 [95% CI, 1.2 to 2.2]; P = .001). In Lima, the proportion of participants with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 52.7% (108/205 participants) in the digital intervention group vs 34.1% (70/205 participants) in the enhanced usual care group (difference, 18.6 percentage points [95% CI, 9.1 to 28.0]; adjusted OR, 2.1 [95% CI, 1.4 to 3.2]; P < .001). At 6-month follow-up, differences across groups were no longer statistically significant.

Conclusions and Relevance  In 2 RCTs of patients with hypertension or diabetes and depressive symptoms in Brazil and Peru, a digital intervention delivered over a 6-week period significantly improved depressive symptoms at 3 months when compared with enhanced usual care. However, the magnitude of the effect was small in the trial from Brazil and the effects were not sustained at 6 months.

Trial Registration  ClinicalTrials.gov: NCT02846662 (São Paulo) and NCT03026426 (Lima)

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Article Information

Corresponding Authors: Ricardo Araya, MD, PhD, Centre for Global Mental Health, King’s College London, Five De Crespigny Park, London SE5 8AF, United Kingdom (ricardo.araya@kcl.ac.uk); Jaime Miranda, MD, PhD, Centro de Excelencia en Enfermedades Crónicas, Universidad Peruana Cayetano Heredia, Av Armendáriz 445, Miraflores, Lima 18, Perú (jaime.miranda@upch.pe).

Accepted for Publication: March 8, 2021.

Author Contributions: Dr Araya had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Joint first authors: Drs Araya and Menezes. Joint senior authors: Drs Mohr and Miranda.

Concept and design: Araya, Menezes, Garcia Claro, Diez-Canseco, Peters, Martins Castro, Begale, Mohr, Miranda.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Araya, Menezes, Garcia Claro, Daley, Quayle, Diez-Canseco, Santos, Rocha, Scotton, Fernandes, Begale, Mohr, Miranda.

Critical revision of the manuscript for important intellectual content: Araya, Menezes, Garcia Claro, Brandt, Diez-Canseco, Peters, Toyama, Aschar, Hidalgo-Padilla, Martins Castro, Cavero, Fernandes, Mohr, Miranda.

Statistical analysis: Araya, Menezes, Garcia Claro, Peters, Scotton, Fernandes.

Obtained funding: Araya, Menezes, Mohr, Miranda.

Administrative, technical, or material support: Araya, Menezes, Garcia Claro, Brandt, Quayle, Diez-Canseco, Santos, Aschar, Hidalgo-Padilla, Martins Castro, Cavero, Rocha, Scotton, Begale, Mohr, Miranda.

Supervision: Araya, Menezes, Garcia Claro, Brandt, Quayle, Diez-Canseco, Cavero, Miranda.

Other - quantitative aspects of the trial design: Peters.

Conflict of Interest Disclosures: Dr Araya reported a pending patent for CONEMO (the digital intervention used in both studies). Dr Menezes reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Brandt reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Diez-Canseco reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Hidalgo-Padilla reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Cavero reported receipt of grants from NIMH (U19MH098780) during the conduct of the study. Dr Rocha reported receipt of grants from NIMH during the conduct of the study. Dr Scotton reported receipt of grants from NIMH during the conduct of the study. Dr Mohr reported receipt of grants from NIMH during the conduct of the study; personal fees from Otsuka Pharmaceuticals, from Apple Inc, Pear Therapeutics, and One Mind Foundation; and other from Adaptive Health Inc Equity Interest outside the submitted work. Dr Miranda reported receipt of grants from NIMH during the conduct of the study. No other disclosures were reported.

Funding/Support: This project was funded by NIMH (U19MH098780).

Role of the Funder/Sponsor: NIMH researchers composed the data and safety monitoring board (DSMB) and executive committee and took part in reviewing and approving research protocols and DSMB reports. The funder did not take part in the data collection or analysis. Funders did not participate in the preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3.

Additional Contributions: We thank all of the staff, especially the nurses, and the study participants.

References
1.
World Health Organization.  Depression and Other Common Mental Disorders: Global Health Estimates. World Health Organization; 2017.
2.
Pan American Health Organization.  The Burden of Mental Disorders in the Region of the Americas, 2018. Pan American Health Organization; 2018.
3.
Gold  SM , Köhler-Forsberg  O , Moss-Morris  R ,  et al.  Comorbid depression in medical diseases.   Nat Rev Dis Primers. 2020;6(1):69. doi:10.1038/s41572-020-0200-2PubMedGoogle ScholarCrossref
4.
Macinko  J , Andrade  FCD , Nunes  BP , Guanais  FC .  Primary care and multimorbidity in six Latin American and Caribbean countries.   Rev Panam Salud Publica. 2019;43:e8-e8. doi:10.26633/RPSP.2019.8PubMedGoogle ScholarCrossref
5.
Chibanda  D , Weiss  HA , Verhey  R ,  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):2618-2626. doi:10.1001/jama.2016.19102PubMedGoogle ScholarCrossref
6.
Patel  V , Weobong  B , Weiss  HA ,  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):176-185. doi:10.1016/S0140-6736(16)31589-6PubMedGoogle ScholarCrossref
7.
Araya  R , Rojas  G , Fritsch  R ,  et al.  Treating depression in primary care in low-income women in Santiago, Chile: a randomised controlled trial.   Lancet. 2003;361(9362):995-1000. doi:10.1016/S0140-6736(03)12825-5PubMedGoogle ScholarCrossref
8.
Torous  J , Cerrato  P , Halamka  J .  Targeting depressive symptoms with technology.   Mhealth. 2019;5:19. doi:10.21037/mhealth.2019.06.04PubMedGoogle ScholarCrossref
9.
Firth  J , Torous  J , Nicholas  J ,  et al.  The efficacy of smartphone-based mental health interventions for depressive symptoms: a meta-analysis of randomized controlled trials.   World Psychiatry. 2017;16(3):287-298. doi:10.1002/wps.20472PubMedGoogle ScholarCrossref
10.
Kuehn  BM .  Global mental health services are collapsing as demand grows.   JAMA. 2020;324(19):1933-1933. doi:10.1001/jama.2020.22085PubMedGoogle Scholar
11.
Shariful Islam  SM , Chow  CK , Redfern  J ,  et al.  Effect of text messaging on depression in patients with coronary heart disease: a substudy analysis from the TEXT ME randomised controlled trial.   BMJ Open. 2019;9(2):e022637. doi:10.1136/bmjopen-2018-022637PubMedGoogle Scholar
12.
Prabhakaran  D , Jha  D , Prieto-Merino  D ,  et al.  Effectiveness of an mHealth-based electronic decision support system for integrated management of chronic conditions in primary care: the mWellcare cluster-randomized controlled trial.   Circulation. 2019;139(3):380-391. doi:10.1161/CIRCULATIONAHA.118.038192PubMedGoogle ScholarCrossref
13.
Mohr  DC , Lyon  AR , Lattie  EG , Reddy  M , Schueller  SM .  Accelerating digital mental health research from early design and creation to successful implementation and sustainment.   J Med Internet Res. 2017;19(5):e153. doi:10.2196/jmir.7725PubMedGoogle Scholar
14.
Brandt  LR , Hidalgo  L , Diez-Canseco  F ,  et al.  Addressing depression comorbid with diabetes or hypertension in resource-poor settings: a qualitative study about user perception of a nurse-supported smartphone app in Peru.   JMIR Ment Health. 2019;6(6):e11701. doi:10.2196/11701PubMedGoogle Scholar
15.
Menezes  P , Quayle  J , Garcia Claro  H ,  et al.  Use of a mobile phone app to treat depression comorbid with hypertension or diabetes: a pilot study in Brazil and Peru.   JMIR Ment Health. 2019;6(4):e11698. doi:10.2196/11698PubMedGoogle Scholar
16.
Kroenke  K , Spitzer  RL , Williams  JB .  The PHQ-9: validity of a brief depression severity measure.   J Gen Intern Med. 2001;16(9):606-613. doi:10.1046/j.1525-1497.2001.016009606.xPubMedGoogle ScholarCrossref
17.
Sealed Envelope.  Randomisation and online databases for clinical trials. Access verified April 22, 2021. https://www.sealedenvelope.com/
18.
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. doi:10.1371/journal.pone.0100100PubMedGoogle Scholar
19.
Mohr  DC , Cuijpers  P , Lehman  K .  Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions.   J Med Internet Res. 2011;13(1):e30. doi:10.2196/jmir.1602PubMedGoogle Scholar
20.
Coley  RY , Boggs  JM , Beck  A , Hartzler  AL , Simon  GE .  Defining success in measurement-based care for depression: a comparison of common metrics.   Psychiatr Serv. 2020;71(4):312-318. doi:10.1176/appi.ps.201900295PubMedGoogle ScholarCrossref
21.
Cuijpers  P , Stringaris  A , Wolpert  M .  Treatment outcomes for depression: challenges and opportunities.   Lancet Psychiatry. 2020;7(11):925-927. doi:10.1016/S2215-0366(20)30036-5PubMedGoogle ScholarCrossref
22.
McMillan  D , Gilbody  S , Richards  D .  Defining successful treatment outcome in depression using the PHQ-9: a comparison of methods.   J Affect Disord. 2010;127(1-3):122-129. doi:10.1016/j.jad.2010.04.030PubMedGoogle ScholarCrossref
23.
Rabin  R , de Charro  F .  EQ-5D: a measure of health status from the EuroQol Group.   Ann Med. 2001;33(5):337-343. doi:10.3109/07853890109002087PubMedGoogle ScholarCrossref
24.
World Health Organization.  World Health Organization Disability Assessment Schedule: WHODAS II. World Health Organization; 2000.
25.
Rojas  G , Fritsch  R , Solis  J ,  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):1629-1637. doi:10.1016/S0140-6736(07)61685-7PubMedGoogle ScholarCrossref
26.
Patel  V , Weiss  HA , Chowdhary  N ,  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):2086-2095. doi:10.1016/S0140-6736(10)61508-5PubMedGoogle ScholarCrossref
27.
Singla  DR , Waqas  A , Hamdani  SU ,  et al.  Implementation and effectiveness of adolescent life skills programs on low- and middle-income countries: a critical review and meta-analysis.   Behav Res Ther. 2020;130:103402. doi:10.1016/j.brat.2019.04.010PubMedGoogle Scholar
28.
Kounali  D , Button  KS , Lewis  G ,  et al.  How much change is enough? evidence from a longitudinal study on depression in UK primary care.   Psychol Med. 2020;1-8. doi:10.1017/S0033291720003700PubMedGoogle Scholar
29.
White  IR , Royston  P , Wood  AM .  Multiple imputation using chained equations: issues and guidance for practice.   Stat Med. 2011;30(4):377-399. doi:10.1002/sim.4067PubMedGoogle ScholarCrossref
30.
Sawyer  A , Kaim  A , Le  H-N ,  et al.  The effectiveness of an app-based nurse-moderated program for new mothers with depression and parenting problems (eMums Plus): pragmatic randomized controlled trial.   J Med Internet Res. 2019;21(6):e13689. doi:10.2196/13689PubMedGoogle Scholar
31.
Arjadi  R , Nauta  MH , Scholte  WF ,  et al.  Internet-based behavioural activation with lay counsellor support versus online minimal psychoeducation without support for treatment of depression: a randomised controlled trial in Indonesia.   Lancet Psychiatry. 2018;5(9):707-716. doi:10.1016/S2215-0366(18)30223-2PubMedGoogle ScholarCrossref
32.
Graham  AK , Lattie  EG , Mohr  DC .  Experimental therapeutics for digital mental health.   JAMA Psychiatry. 2019;76(12):1223-1224. doi:10.1001/jamapsychiatry.2019.2075PubMedGoogle ScholarCrossref
33.
Naslund  JA , Aschbrenner  KA , Araya  R ,  et al.  Digital technology for treating and preventing mental disorders in low-income and middle-income countries: a narrative review of the literature.   Lancet Psychiatry. 2017;4(6):486-500. doi:10.1016/S2215-0366(17)30096-2PubMedGoogle ScholarCrossref
34.
Jiménez-Molina  Á , Franco  P , Martínez  V , Martínez  P , Rojas  G , Araya  R .  Internet-based interventions for the prevention and treatment of mental disorders in Latin America: a scoping review.   Front Psychiatry. 2019;10:664. doi:10.3389/fpsyt.2019.00664PubMedGoogle ScholarCrossref
35.
Carter  H , Araya  R , Anjur  K , Deng  D , Naslund  JA .  The emergence of digital mental health in low-income and middle-income countries: a review of recent advances and implications for the treatment and prevention of mental disorders.   J Psychiatr Res. 2021;133:223-246. doi:10.1016/j.jpsychires.2020.12.016PubMedGoogle ScholarCrossref
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