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.
“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]
The Methods (Study arms) describe weekly phone or message-based support, and the Results (Primary outcome) report significant improvements in depression and functioning. The Methods (Procedures) restrict participants to Syrian displaced people living in Lebanon; this trial does not establish treatment effects in Lebanese local populations. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe trial is the first to implement SbS using a COD guidance model, as opposed to the regular weekly guidance of previous trials.
“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]
For Syrian refugees, studies on digital interventions find effects ranging from small, nonsignificant to medium on mental health outcomes.
“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]
A previous trial using the same version of the SbS digital app among Syrian refugees found significant effects on depression, anxiety, PTSD, functioning, well-being, and self-defined problems.
“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]
Recently published data on guided versions are promising.
“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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“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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“Digital mental health interventions offer promising alternatives to address this issue, particularly for vulnerable populations like displaced people and those affected by conflict [11].”
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Putting psychological interventions first in primary health care
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“…psychotherapeutic intervention was compared to a control group (Acarturk et al., 2015, 2016; Alkhazaleh et al., 2023; Banoglu & Korkmazlar, 2022; Cuijpers et al., 2022; de Graaff et al., 2023; Eskici et al., 2021) while some others used a one-group pre-post research design (Bunn et al., 2022;…”
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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].”
Trust in higher guidance and suicidality in Afghan students under the Taliban regime
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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).”
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“Overall, these trials showed minimal protocol deviations 38,39 and good adherence to the duration of the 15-minutes weekly calls, 40 in line with our results.”
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“Few studies so far have examined digital solutions tailored to the specific needs of refugees and migrants [32-34], even though there exist specific frameworks for the cultural adaptation process [35], studies describing the adaptation process [36], and research suggesting that culturally adapting…”
Staples, L., Fisher, A. C., Dear, B. F., Nielssen, O. B., & Titov, N. (2026) · Frontiers in Digital Health · doi:10.3389/fdgth.2026.1761107 · Cited by 2 · see citing works
Readiness for mHealth interventions in Jordan: Refugee camp and urban community survey
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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).”
BackgroundAeschlimann, A., Heim, E., Killikelly, C., Mahmoud, N., Haji, F., Stoeckli, R. T., Aebersold, M., Thoma, M. V., & Maercker, A. R. A. (2025) · Internet Interventions · doi:10.1016/j.invent.2025.100800 · Cited by 2 · see citing works
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Refugees’ experiences with online higher education: Impact and implications through the pandemic
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“…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 1 · see citing works
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“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 · see citing works
Self-citationUse of Digital Health Interventions Among Forcibly Displaced People
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“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…”
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“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.”
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Mental Health and Social Support Interventions
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Cultural adaptation of an internet-based self-help app for grieving Syrian refugees in SwitzerlandPreprint
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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
- 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
- Social Sciences › Psychology › Social Psychology › 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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