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Original research
Guided digital health intervention for depression in Lebanon: randomised trial
  1. Pim Cuijpers1,2,
  2. Eva Heim3,4,
  3. Jinane Abi Ramia1,5,
  4. Sebastian Burchert6,
  5. Kenneth Carswell7,
  6. Ilja Cornelisz8,
  7. Christine Knaevelsrud6,
  8. Philip Noun4,
  9. Chris van Klaveren8,
  10. Edith van’t Hof9,
  11. Edwina Zoghbi7,
  12. Mark van Ommeren7,
  13. Rabih El Chammay5,10
  1. 1Department of Clinical, Neuro and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
  2. 2Babeș-Bolyai University, International Institute for Psychotherapy, Cluj-Napoca, Romania
  3. 3Institute of Psychology, University of Lausanne, Lausanne, Switzerland
  4. 4Department of Psychology, University of Zurich, Zurich, Switzerland
  5. 5National Mental Health Programme, Ministry of Public Health of Lebanon, Beirut, Lebanon
  6. 6Department of Education and Psychology, Freie Universität Berlin, Berlin, Germany
  7. 7World Health Organization, Geneva, Switzerland
  8. 8Department of Educational, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
  9. 9Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland
  10. 10Psychiatry Department, Saint Joseph University, Beirut, Lebanon
  1. Correspondence to Professor Pim Cuijpers, Department of Clinical, Neuro and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands; p.cuijpers{at}vu.nl

Abstract

Background Most people with mental disorders in communities exposed to adversity in low-income and middle-income countries (LMICs) do not receive effective care. Digital mental health interventions are scalable when digital access is adequate, and can be safely delivered during the COVID-19 pandemic.

Objective To examine the effects of a new WHO-guided digital mental health intervention, Step-by-Step, supported by a non-specialist helper in Lebanon, in the context of concurring economic, humanitarian and political crises, a large industrial disaster and the COVID-19 pandemic.

Methods We conducted a single-blind, two-arm pragmatic randomised trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among people suffering from depression and impaired functioning. Primary outcomes were depression (Patient Health Questionnaire 9 (PHQ-9)) and impaired functioning (WHO Disability Assessment Schedule-12 (WHODAS)) at post-treatment.

Findings 680 people with depression (PHQ-9>10) and impaired functioning (WHODAS>16) were randomised to Step-by-Step or ECAU. Intention-to-treat analyses showed effects on depression (standardised mean differences, SMD: 0.71; 95% CI: 0.45 to 0.97), impaired functioning (SMD: 0.43; 95% CI: 0.21 to 0.65), post-traumatic stress (SMD: 0.53; 95% CI: 0.27 to 0.79), anxiety (SMD: 0.74; 95% CI: 0.49 to 0.99), subjective well-being (SMD: 0.37; 95% CI: 0.12 to 0.62) and self-identified personal problems (SMD: 0.56; 95% CI 0.29 to 0.83). Significant effects on all outcomes were retained at 3-month follow-up.

Conclusions Guided digital mental health interventions can be effective in the treatment of depression in communities exposed to adversities in LMICs, although some uncertainty remains because of high attrition.

Clinical implications Guided digital mental health interventions should be considered for implementation in LMICs.

Trial registration number ClinicalTrials.gov NCT03720769.

  • Depression & mood disorders

Data availability statement

Data are available in a public, open access repository. In line with the WHO open-access policy, deidentified data collected for this study are being made available at the DANS repository (https://dans.knaw.nl/en/) at the date of publication. Application of the CC BY V.4.0 licence requires interested users of the data to attribute the original source.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Data availability statement

Data are available in a public, open access repository. In line with the WHO open-access policy, deidentified data collected for this study are being made available at the DANS repository (https://dans.knaw.nl/en/) at the date of publication. Application of the CC BY V.4.0 licence requires interested users of the data to attribute the original source.

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Footnotes

  • Contributors MvO, REC, KC, EvH, EH, SB, CK and PC made substantial contributions to the design of the study. EvH, JAR, PN and EZ contributed to the data aquisitation. IC and CvK were responsible for the analyses of the data. PC wrote the first draft of the paper and responsible for the overall content as the guarantor. All authors revised the text critically for important intellectual content and gave final approval for submission of the text. MvO and REC are joined last authors.

  • Funding This study was funded by the Fondation d’Harcourt (no grant number available). The study used an open source research infrastructure developed by Freie Universität Berlin as part of STRENGTHS project (funded by the European Union’s Horizon 2020 Research and Innovation Program Societal Challenges; agreement 733337). The funder of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.