Evidence map›Paper›PMID 42216127›Full record

Trial reportBMC psychiatry2026

A self-guided digital mental health intervention for Syrian refugees in Germany and Sweden: effects from two pragmatic randomized controlled trials.

Sebastian Burchert, Mhd Salem Alkneme, Ammar Alsaod, Kenneth Carswell, Pim Cuijpers, Anne M de Graaff, Eva Heim, Jonas Hessling, Tomas Lindegaard, Shervin Shahnavaz and 5 more

Abstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Publisher
In one paragraph

Trial report in BMC psychiatry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Sebastian BurchertDepartment of Education and Psychology, Division of Clinical Psychological Intervention, Freie Universität Berlin, Berlin, Germany. s.burchert@fu-berlin.de.
Mhd Salem AlknemeDepartment of Education and Psychology, Division of Clinical Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
Ammar AlsaodDepartment of Education and Psychology, Division of Clinical Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
Kenneth CarswellDepartment of Noncommunicable Diseases and Mental Health, World Health Organization, Geneva, Switzerland.
Pim CuijpersDepartment of Clinical, Neuro and Developmental Psychology, WHO Collaborating Center for Research and Dissemination of Psychological Interventions, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Anne M de GraaffDepartment of Noncommunicable Diseases and Mental Health, World Health Organization, Geneva, Switzerland.
Eva HeimInstitute of Psychology, University of Lausanne, Lausanne, Switzerland.
Jonas HesslingDepartment of Education and Psychology, Division of Clinical Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
Tomas LindegaardDepartment of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.
Shervin ShahnavazCentre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.
Marit SijbrandijDepartment of Clinical, Neuro and Developmental Psychology, WHO Collaborating Center for Research and Dissemination of Psychological Interventions, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Edith Van't HofDepartment of Noncommunicable Diseases and Mental Health, World Health Organization, Geneva, Switzerland.
Mark van OmmerenDepartment of Noncommunicable Diseases and Mental Health, World Health Organization, Geneva, Switzerland.
Christine KnaevelsrudDepartment of Education and Psychology, Division of Clinical Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
STRENGTHS Consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSyrian refugees across diverse host countries, including high-income European countries, face increased mental health needs. Digital interventions can scale support, but global scalability limits human guidance and contextual adaptations. We evaluated the effectiveness of a potentially scalable digital intervention (Step-by-Step; SbS) with minimal contact-on-demand (COD) in reducing psychological distress and functional impairment among Syrian refugees in Germany and Sweden. These trials were conducted in parallel with SbS studies in Egypt and Lebanon, using the same content to test broader contextual applicability without further adaptations.

methodsSeparate two-arm pragmatic RCTs were conducted in Germany (N = 559) and Sweden (N = 184) with Syrians screening positive for elevated distress (K10 > 15) and impaired functioning (WHODAS 2.0 > 16). Participants were randomized to SbS (five sessions) + care-as-usual (CAU) or CAU-only. Primary outcomes were psychological distress (HSCL-25) and functioning (WHODAS 2.0) at 3-month follow-up. Secondary outcomes were PTSD symptoms (PCL-5 short) and self-defined problems (PSYCHLOPS). Intention-to-treat (ITT) analyses were run separately by trial. Exploratory per-protocol analyses combined datasets.

resultsITT analyses showed no statistically significant time × condition effects for any primary or secondary outcome in both trials. Dropout was high (Germany: 86.3%; Sweden: 82.1%). In per-protocol analyses (participants completing ≥ 4 of 5 sessions), the SbS + CAU arm showed significantly lower standardized mean scores at 3 months for psychological distress (HSCL-25; Hedges' g = 0.31; p = .03) and PTSD symptoms (PCL-5 short; Hedges' g = 0.27; p < .05). COD use was low (Germany: 15.1%; Sweden: 8.4%), leaving the intervention effectively unguided for most participants.

conclusionsWhile limiting guidance and contextual tailoring can enhance scalability across borders, digital interventions may struggle with engagement, adherence, and contextual relevance. In high-income settings, an unguided approach for refugees may not work, showing that prioritizing scalability could potentially compromise clinical impact in this population. Some level of human guidance may be necessary to balance scalability and effectiveness, and it remains unclear how minimal that guidance can be without compromising outcomes.

trial registrationGerman Register for Clinical Studies (Germany: DRKS00022143-registered June 29th, 2020, and Sweden: DRKS00022144-registered July 1st, 2020).

Indexed as

RefugeesStress Disorders, Post-TraumaticAdultDigital HealthFemaleGermanyHumansMaleMiddle AgedPsychological DistressSwedenSyriaDigital mental healthe-mental healthScalable interventionsSelf-helpSmartphone-basedSyriaSyrian refugees

Identifiers

PMID42216127

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.