Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.

<h4>Background</h4>Most displaced people with mental disorders in low- and middle-income countries do not receive effective care, and their access to care has deteriorated during the Coronavirus Disease 2019 (COVID-19) pandemic. Digital mental health interventions are scalable when digit...

Full description

Bibliographic Details
Main Authors: Pim Cuijpers, Eva Heim, Jinane Abi Ramia, Sebastian Burchert, Kenneth Carswell, Ilja Cornelisz, Christine Knaevelsrud, Philip Noun, Chris van Klaveren, Edith Van't Hof, Edwina Zoghbi, Mark van Ommeren, Rabih El Chammay
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2022-06-01
Series:PLoS Medicine
Online Access:https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1004025&type=printable
_version_ 1826545949820846080
author Pim Cuijpers
Eva Heim
Jinane Abi Ramia
Sebastian Burchert
Kenneth Carswell
Ilja Cornelisz
Christine Knaevelsrud
Philip Noun
Chris van Klaveren
Edith Van't Hof
Edwina Zoghbi
Mark van Ommeren
Rabih El Chammay
author_facet Pim Cuijpers
Eva Heim
Jinane Abi Ramia
Sebastian Burchert
Kenneth Carswell
Ilja Cornelisz
Christine Knaevelsrud
Philip Noun
Chris van Klaveren
Edith Van't Hof
Edwina Zoghbi
Mark van Ommeren
Rabih El Chammay
author_sort Pim Cuijpers
collection DOAJ
description <h4>Background</h4>Most displaced people with mental disorders in low- and middle-income countries do not receive effective care, and their access to care has deteriorated during the Coronavirus Disease 2019 (COVID-19) pandemic. Digital mental health interventions are scalable when digital access is adequate, and they can be safely delivered during the COVID-19 pandemic. We examined whether a new WHO-guided digital mental health intervention, Step-by-Step, in which participants were supported by a nonspecialist helper, was effective in reducing depression among displaced people in Lebanon.<h4>Methods and findings</h4>We conducted a single-blind, 2-arm pragmatic randomized clinical trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among displaced Syrians suffering from depression and impaired functioning in Lebanon. Primary outcomes were depression (Patient Health Questionnaire, PHQ-9) and impaired functioning (WHO Disability Assessment Schedule-12, WHODAS) at posttreatment. Secondary outcomes included subjective well-being, anxiety, post-traumatic stress, and self-described problems. A total of 569 displaced people from Syria with depression (PHQ-9 ≥ 10) and impaired functioning (WHODAS > 16) were randomized to Step-by-Step (N = 283; lost to follow-up: N = 167) or ECAU (N = 286; lost to follow-up: 133). Participants were considered to be lost to follow-up when they did not fill in the outcome measures at posttest or follow-up. Recruitment started on December 9, 2019 and was completed on July 9, 2020. The last follow-up assessments were collected in December 2020. The study team had access to the online platform, where they could see treatment arm assignment for each participant. All questionnaires were completed by participants online. Intention-to-treat (ITT) analyses showed intervention effects on depression (standardized mean differences [SMDs]: 0.48; 95% CI: 0.26; 0.70; p < 0.001), impaired functioning (SMD: 0.35; 95% CI: 0.14; 0.56; p < 0.001), post-traumatic stress (SMD: 0.36; 95% CI: 0.16; 0.56; p < 0.001), anxiety (SMD: 0.46; 95% CI: 0.24; 0.68; p < 0.001), subjective well-being (SMD: 0.47; 95% CI: 0.26; 0.68; p < 0.001), and self-identified personal problems (SMD: 0.49; 95% CI 0.28; 0.70; p < 0.001). Significant effects on all outcomes were maintained at 3 months follow-up. During the trial, one serious adverse event occurred, unrelated to the intervention. The main limitation of the current trial is the high dropout rate.<h4>Conclusions</h4>In this study, we found that a guided, digital intervention was effective in reducing depression in displaced people in Lebanon. The guided WHO Step-by-Step intervention we examined should be made available to communities of displaced people that have digital access.<h4>Trial registration</h4>ClinicalTrials.gov NCT03720769.
first_indexed 2024-04-09T17:12:05Z
format Article
id doaj.art-f755c4daacba461e970cabd641d16644
institution Directory Open Access Journal
issn 1549-1277
1549-1676
language English
last_indexed 2025-03-14T05:26:00Z
publishDate 2022-06-01
publisher Public Library of Science (PLoS)
record_format Article
series PLoS Medicine
spelling doaj.art-f755c4daacba461e970cabd641d166442025-03-06T05:30:45ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762022-06-01196e100402510.1371/journal.pmed.1004025Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.Pim CuijpersEva HeimJinane Abi RamiaSebastian BurchertKenneth CarswellIlja CorneliszChristine KnaevelsrudPhilip NounChris van KlaverenEdith Van't HofEdwina ZoghbiMark van OmmerenRabih El Chammay<h4>Background</h4>Most displaced people with mental disorders in low- and middle-income countries do not receive effective care, and their access to care has deteriorated during the Coronavirus Disease 2019 (COVID-19) pandemic. Digital mental health interventions are scalable when digital access is adequate, and they can be safely delivered during the COVID-19 pandemic. We examined whether a new WHO-guided digital mental health intervention, Step-by-Step, in which participants were supported by a nonspecialist helper, was effective in reducing depression among displaced people in Lebanon.<h4>Methods and findings</h4>We conducted a single-blind, 2-arm pragmatic randomized clinical trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among displaced Syrians suffering from depression and impaired functioning in Lebanon. Primary outcomes were depression (Patient Health Questionnaire, PHQ-9) and impaired functioning (WHO Disability Assessment Schedule-12, WHODAS) at posttreatment. Secondary outcomes included subjective well-being, anxiety, post-traumatic stress, and self-described problems. A total of 569 displaced people from Syria with depression (PHQ-9 ≥ 10) and impaired functioning (WHODAS > 16) were randomized to Step-by-Step (N = 283; lost to follow-up: N = 167) or ECAU (N = 286; lost to follow-up: 133). Participants were considered to be lost to follow-up when they did not fill in the outcome measures at posttest or follow-up. Recruitment started on December 9, 2019 and was completed on July 9, 2020. The last follow-up assessments were collected in December 2020. The study team had access to the online platform, where they could see treatment arm assignment for each participant. All questionnaires were completed by participants online. Intention-to-treat (ITT) analyses showed intervention effects on depression (standardized mean differences [SMDs]: 0.48; 95% CI: 0.26; 0.70; p < 0.001), impaired functioning (SMD: 0.35; 95% CI: 0.14; 0.56; p < 0.001), post-traumatic stress (SMD: 0.36; 95% CI: 0.16; 0.56; p < 0.001), anxiety (SMD: 0.46; 95% CI: 0.24; 0.68; p < 0.001), subjective well-being (SMD: 0.47; 95% CI: 0.26; 0.68; p < 0.001), and self-identified personal problems (SMD: 0.49; 95% CI 0.28; 0.70; p < 0.001). Significant effects on all outcomes were maintained at 3 months follow-up. During the trial, one serious adverse event occurred, unrelated to the intervention. The main limitation of the current trial is the high dropout rate.<h4>Conclusions</h4>In this study, we found that a guided, digital intervention was effective in reducing depression in displaced people in Lebanon. The guided WHO Step-by-Step intervention we examined should be made available to communities of displaced people that have digital access.<h4>Trial registration</h4>ClinicalTrials.gov NCT03720769.https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1004025&type=printable
spellingShingle Pim Cuijpers
Eva Heim
Jinane Abi Ramia
Sebastian Burchert
Kenneth Carswell
Ilja Cornelisz
Christine Knaevelsrud
Philip Noun
Chris van Klaveren
Edith Van't Hof
Edwina Zoghbi
Mark van Ommeren
Rabih El Chammay
Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.
PLoS Medicine
title Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.
title_full Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.
title_fullStr Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.
title_full_unstemmed Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.
title_short Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.
title_sort effects of a who guided digital health intervention for depression in syrian refugees in lebanon a randomized controlled trial
url https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1004025&type=printable
work_keys_str_mv AT pimcuijpers effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT evaheim effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT jinaneabiramia effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT sebastianburchert effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT kennethcarswell effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT iljacornelisz effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT christineknaevelsrud effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT philipnoun effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT chrisvanklaveren effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT edithvanthof effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT edwinazoghbi effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT markvanommeren effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial
AT rabihelchammay effectsofawhoguideddigitalhealthinterventionfordepressioninsyrianrefugeesinlebanonarandomizedcontrolledtrial