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Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial
Open accessAbstract
BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT03720769.
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“Initial studies on a guided self-help version of SbS with weekly phone contacts in Lebanon found positive treatment effects on indicators of psychological distress and functioning in Syrian refugees and Lebanese local populations [23,37,38].”
From Effects of a self-guided digital mental health self-help intervention for Syrian refugees in Egypt: A pragmatic randomized controlled trial (2024) · cites this paper as [23]
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“Our trial is the first to implement SbS using a COD guidance model, as opposed to the regular (typically weekly) guidance of previous trials via phone or messaging [23].”
From Effects of a self-guided digital mental health self-help intervention for Syrian refugees in Egypt: A pragmatic randomized controlled trial (2024) · cites this paper as [23]
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“For Syrian refugees, there is only a small number of studies on digital interventions that find a range from small, nonsignificant effects [21,22] to medium effects [23] on mental health outcomes.”
From Effects of a self-guided digital mental health self-help intervention for Syrian refugees in Egypt: A pragmatic randomized controlled trial (2024) · cites this paper as [23]
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“In a previous trial using SbS among Syrian refugees, which used the same version of the SbS digital app [23], significant effects were found on symptoms of depression (g = 0.61), anxiety (g = 0.41), and PTSD (g = 0.39) as well as on functioning (g = 0.45), well-being (g = 0.51), and self-defined problems (g = 0.40).”
From Effects of a self-guided digital mental health self-help intervention for Syrian refugees in Egypt: A pragmatic randomized controlled trial (2024) · cites this paper as [23]
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“Recently published data on guided versions are promising (Cuijpers et al., 2022).”
From Smartphone-delivered mental health care interventions for refugees: A systematic review of the literature (2023) · cites this paper as Cuijpers et al., 2022
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Cites
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“A recent randomized controlled trial found that a WHO non-clinically guided digital mental health intervention (i.e., “Step-by-Step”) was clinically effective at reducing depression, anxiety, post-traumatic stress, and functional impairment in displaced Syrian refugees in Lebanon (see Table 1) [36].”
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“Similarly, 67% (2/3) of the articles that reported more than one delivery platform mentioned cultural adaptation but did not describe the process in detail [71,72].”
InfluentialLi, G., Sit, H. F., Chen, W. L., Wu, K., Sou, E. K. L., Wong, M., Chen, Z., Burchert, S., Hong, I. W., Sit, H. Y., et al. (2024) · Translational Psychiatry · doi:10.1038/s41398-024-02812-3 · Cited by 23
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“…with culturally and linguistically appropriate program content, led by non-specialist instructors with similar culture or refugee background, same language, and gender as the participants, in safe gender-segregated groups [57, 58, 72, 75–78, 82, 83, 85–87, 93, 95, 97–101, 103, 104, 107, 108].”
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“Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.”
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“These findings are in line with meta-analytic evidence on adherence rates in smartphone-delivered interventions for mental health problems [45] and comparable to what has been found for the Step-by-Step intervention studies in Lebanon, where 19% [14] and 32% [13] completed the intervention.”
Papola, D., Prina, E., Ceccarelli, C., Cadorin, C., Gastaldon, C., Ferreira, M. C., Tol, W. A., van Ommeren, M., Barbui, C., & Purgato, M. (2024) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd014300.pub2 · Cited by 18
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“Finally, digital interventions, which may be effective in reducing mental health symptoms and less resource-intensive than face-to-face interventions (Abtahi et al., 2023; Cuijpers et al., 2022; Röhr et al., 2021), were excluded.”
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Cultural adaptation of an internet-based self-help app for grieving Syrian refugees in Switzerland
Aeschlimann, A., Heim, E., Hoxha, A., Triantafyllidou, V., Killikelly, C., Haji, F., Stoeckli, R. T., Aebersold, M., & Maercker, A. R. A. (2024) · BMC Public Health · doi:10.1186/s12889-024-20507-8 · Cited by 12
“A guided and scalable IBI for depression was evaluated for Syrian refugees in Lebanon with results showing a significant reduction in depression and anxiety symptoms [33].”
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“…recruitment has proven to be an effective recruitment strategy in e-mental health research (Kayrouz et al., 2016; Whitaker et al., 2017), and was used in an RCT with the Arabic and English version of Hap-pas-Hapi, called Step-by-Step, in Lebanon (Cuijpers et al., 2022a; Cuijpers et al., 2022b).”
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Why did our trial not work out? A qualitative analysis
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“In addition, the online self-help intervention has shown to be acceptable and efficacious in two large-scale RCTs in Lebanon among Syrian displaced people and the Lebanese population (Cuijpers et al., 2022a; Cuijpers et al., 2022b).”
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Putting psychological interventions first in primary health care
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“This sample size calculation was based on the results of prior trials exploring the effectiveness of comparable digital interventions which report effect sizes (Cohen d ) ranging from 0.48 to 0.56 [17,18,59].”
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“Research by Cuijpers et al. (2022) also demonstrates a causal relationship between relational needs satisfaction and subjective well-being.”
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“There is, however, strong evidence for the efficacy of similar DID in Arabic language 26 and for the iFD tool itself 37 including an assessment of possible negative effects 48 .”
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“The World Health Organization’s culturally adapted digital intervention Step-by-Step for treating depression trained nonspecialists to guide participants with weekly contact and demonstrated moderate effects in an RCT with Syrian refugees in Lebanon [60,61].”
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“Another randomized controlled trial (RCT) found that a digital intervention based on CBT delivered via a mobile application significantly reduced symptoms of depression and functional impairment among Syrian refugees in Lebanon (Cuijpers et al., 2022).”
Mediavilla, R., García-Vázquez, B., McGreevy, K. R., Underhill, J., Bayón, C., Bravo‐Ortiz, M. F., Muñoz‐Sanjosé, A., Haro, J. M., Monistrol-Mula, A., Nicaise, P., et al. (2024) · Digital Health · doi:10.1177/20552076241287678 · Cited by 4
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“Cuijpers et al. (2022) demonstrated that a guided digital intervention was effective in reducing depression among Syrian refugees in Lebanon (Cuijpers et al., 2022).”
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Kurath, J., Akhtar, A., Karyotaki, E., Sijbrandij, M., Cuijpers, P. J., Bryant, R. A., & Morina, N. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-078473 · Cited by 2
“…have been taken to treat FDP including therapies delivered by specialists (eg, cognitive–behavioural therapy (CBT) 8 ), low-intensity interventions delivered by non-specialists (eg, Problem Management Plus (PM+) 9 ), and guided (eg, Step- by-Step (SbS) 10 ) or unguided self-help programmes.”
BackgroundSelf-citationInterpersonal Psychotherapy for Depression in Low- and Middle-Income Countries
Cuijpers, P. J. (2024) · Oxford University Press eBooks · doi:10.1093/oso/9780197652084.003.0004 · Cited by 2
Self-citationRajkumar, E., Lipsa, J. M., Harshit, S., & Gopi, A. (2025) · Psychiatry Research · doi:10.1016/j.psychres.2025.116432 · Cited by 4
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Zohar, S., Yuval, K., Gebremariam, S. G., Goldberg, S. B., Aviad, N., Baldwin, S. A., & Bernstein, A. (2025) · Mindfulness · doi:10.1007/s12671-025-02675-9 · Cited by 1
“In a randomized controlled trial in Lebanon among Syrian FDP, minimally guided Step-by-Step demonstrated promising efficacy post-intervention for stress-and trauma-related mental health conditions, impaired functioning, and well-being, relative to usual care (Cuijpers et al., 2022).”
InfluentialRamia, J. A., Khoury, S., Armani, N., Cuijpers, P. J., Carswell, K., Hof, E. V., Zoghbi, E., Sijbrandij, M., & Chammay, R. E. (2025) · Frontiers in Public Health · doi:10.3389/fpubh.2025.1665093 · Cited by 1
Self-citationUse of Digital Health Interventions Among Forcibly Displaced People
Virk, S., Poovathoor, R. A., Ravi, S., Ercanli, N., Vetter, I., Milewski, A., & Kaur, G. (2025) · JAMA Network Open · doi:10.1001/jamanetworkopen.2025.42379 · Cited by 3
Rangel, R., Brown, A. D., Galea, J. T., Rai, S., Ross, N., Raji, M., Shrestha, P., Cheng, B., Akellot, J., & Kohrt, B. A. (2025) · PLOS Global Public Health · doi:10.1371/journal.pgph.0005123 · Cited by 1
“Inclusion criteria on mental health instruments were moderate to severe depression, measured on the PHQ-9 ≥ 10 [57] and PHQ-9 > 10 [58], functional impairment (WHODAS > 16) in Lebanon [57,58], mild depression symptoms in China (PHQ-9 ≥ 5) [59], psychological distress, (K10 > 15) and functional…”
InfluentialVentevogel, P. (2026) · Springer eBooks · doi:10.1007/978-981-95-5871-1_2 · Cited by 1
Patel, A., Ramirez, G., Fernandes, L., Bariya-Sousa, A., McGuinness, E., Taha, S., Biswal, B., Awasthi, A., Wilson, D., Dixon, K. E., et al. (2026) · The Lancet Psychiatry · doi:10.1016/s2215-0366(26)00123-9 · Cited by 1
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van Lent, L. G. G., Hodáková, S., Hanft-Robert, S., Mösko, M., Rao, C., Kerremans, K., Cox, A., Gutiérrez, R. L., Temizöz, Ö., Mankauskienė, D., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-095868 · Cited by 3
“26 31 Building on these successes, our platform is designed to address the unique challenges faced by LLP refugees and migrants who suffer from mental health problems.”
Karyotaki, E. (2023) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2023.50.pr6 · Cited by 1
Lau, N., Kola, L., Zhao, X., Asafo, S. M., Attah, D. A., & Ben‐Zeev, D. (2025) · Wiley eBooks · doi:10.1002/9781394179909.ch14 · Cited by 2
El-Haj-Mohamad, R., Nohr, L., Niemeyer, H., et al. (2022) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2022.61.pr8
El-Haj-Mohamad, R., Nohr, L., Niemeyer, H., et al. (2022) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2022.61.pr4
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El-Haj-Mohamad, R., Nohr, L., Niemeyer, H., et al. (2022) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2022.61.pr6
El-Haj-Mohamad, R., Nohr, L., Niemeyer, H., et al. (2022) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2022.61.pr2
Nohr, L. (2022) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2022.61.pr1
Nohr, L. (2022) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2022.61.pr7
El-Haj-Mohamad, R., Nohr, L., Niemeyer, H., et al. (2022) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2022.61.pr3
Reich, H., Hegerl, U., Rosenthal, A., & Oehler, C. (2023) · doi:10.31234/osf.io/fsxbd
Mental Health and Social Support Interventions
Emmelkamp, P. M. G. (2023) · Springer eBooks · doi:10.1007/978-3-031-34078-9_6
Karyotaki, E., Miguel, C., Panagiotopoulou, O. M., et al. (2023) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2023.50.pr2
Karyotaki, E., Miguel, C., Panagiotopoulou, O. M., et al. (2023) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2023.50.pr8
Karyotaki, E., Miguel, C., Panagiotopoulou, O. M., et al. (2023) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2023.50.pr5
Karyotaki, E., Miguel, C., Panagiotopoulou, O. M., et al. (2023) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2023.50.pr3
Karyotaki, E., Miguel, C., Panagiotopoulou, O. M., et al. (2023) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2023.50.pr9
Karyotaki, E., Miguel, C., Panagiotopoulou, O. M., et al. (2023) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2023.50.pr10
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Karyotaki, E. (2023) · Cambridge Prisms Global Mental Health · doi:10.1017/gmh.2023.50.pr1
Spanhel, K., & Heim, E. (2024) · PPmP - Psychotherapie · Psychosomatik · Medizinische Psychologie · doi:10.1055/a-2305-8780
Cultural adaptation of an internet-based self-help app for grieving Syrian refugees in SwitzerlandPreprint
Aeschlimann, A., Heim, E., Hoxha, A., Triantafyllidou, V., Killikelly, C., Haji, F., Stoeckli, R. T., Aebersold, M., & Maercker, A. R. A. (2024) · Research Square · doi:10.21203/rs.3.rs-4804166/v1
Media and Mental Health Interventions Among Migrants
Ahmed, R., & Park, S. (2024) · Oxford University Press eBooks · doi:10.1093/oxfordhb/9780197744345.013.23
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“Indeed, the World Health Organization (WHO) has implemented a comprehensive mental health strategy grounded in principles of inclusivity and scalability, which also incorporates the use of digital technologies [12,13].”
Lakis, C., Sherally, J., Braakman, A., Ramiah, S. A., van Herpen, M. M. J. W., Khammash, S., Tarazi, L., Khammash, U. M., Dabis, J., Rabello, E., et al. (2025) · doi:10.2196/preprints.77507
Public Mental Health Aspects of Geriatric Psychiatry in South Asia
Tewari, A., Agrawal, A., & Vishwakarma, A. (2025) · Springer eBooks · doi:10.1007/978-981-96-7469-5_10
Karyotaki, E., Tong, L., Miguel, C., Panagiotopoulou, O. M., Harrer, M., Papola, D., Sijbrandij, M., Araaya, R., Patel, V., & Cuijpers, P. J. (2025) · SSRN Electronic Journal · doi:10.2139/ssrn.5378181
Self-citation
Metadata
- Authors
- Cuijpers, P., Heim, E., Abi Ramia, J., Burchert, S., Carswell, K., Cornelisz, I., Knaevelsrud, C., Noun, P., van Klaveren, C., van’t Hof, E., Zoghbi, E., van Ommeren, M., & El Chammay, R.
- Affiliations
- Babeș-Bolyai University (RO)
- University of Zurich (CH)
- Freie Universität Berlin (DE)
- World Health Organization (CH)
- Vrije Universiteit Amsterdam (NL)
- University of Lausanne (CH)
- Corresponding author
- Cuijpers, Pim
- ORCID
- Venue
- PLoS Medicine
- Publisher
- Public Library of Science (PLoS)
- Published
- 2022-06-23
- Volume
- 19
- Issue
- 6
- Pages
- e1004025
- ISSN
- 1549-1277 (ISSN-L)
- 1549-1676
- PMC
- PMC9223343
- OpenAlex
- W4283376471
- Cited by
- 118
- References
- 38
- Citations by year
- 2026: 20 · 2025: 32 · 2024: 28 · 2023: 26 · 2022: 12
- FWCI
- 21.64
- Type
- journal article
- Language
- en
- Update notices
- correction (2023-04-14)
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, cc-by)
- IRIS (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Refubium (Universitätsbibliothek der Freien Universität Berlin) (submittedVersion, cc-by)
- VU Research Portal (submittedVersion, other-oa)
- SERVAL (Université de Lausanne) (submittedVersion, other-oa)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Universitätsbibliothek der FU Berlin Hochschulschriftenstelle u. Dokumentenserver (cc-by)
- Funders
- Research for Health in Humanitarian Crises
- Horizon 2020 Framework Programme (733337)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Social Sciences › Psychology › Clinical Psychology › Migration, Health and Trauma
- Health Sciences › Medicine › Psychiatry and Mental health › Mental Health Treatment and Access
- Keywords
- depression, Syrian refugees, digital mental health interventions, WHO STEPwise approach, impaired functioning, post-traumatic stress, anxiety, subjective well-being, COVID-19 pandemic, displaced persons, Lebanon, access to mental health care, WHODAS, PHQ-9
- MeSH terms
- Internet-Based Intervention, COVID-19, Depression, Humans, Lebanon, Refugees, Syria, World Health Organization, Single-Blind Method, Treatment Outcome, Pandemics
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