Randomized controlled trial to test the (cost-)effectiveness of Step-by-Step, a smartphone-based self-help program for Syrian refugees in Germany.

Randomized controlled trial to test the (cost-)effectiveness of Step-by-Step, a smartphone-based self-help program for Syrian refugees in Germany. - STRENGTHS SBS RCT GERMANY

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00022143

Enrollment

532

Registered

2020-06-29

Start date

2020-08-09

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychological distress functional impairment

Interventions

Group 1: Intervention group: Participants receive access to Step-by-Step, a smartphone- and internet-based self-help program with an introduction session (15 minutes) and 5 weekly sessions (each 30 mi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Syrian displaced person living in Germany; Arabic-speaking; minimum age 18 years; K10 score > 15 and WHODAS 2.0 score > 16; access to a smartphone (iOS or Android) or web-browser; internet access

Exclusion criteria

Exclusion criteria: Serious suicidal thoughts or plan

Design outcomes

Primary

Measure	Time frame
Primary outcomes are the change in psychological distress, measured by the Hopkins Symptom Checklist (HSCL-25), and the change in functional impairment, measured by the WHO Disability Assessment Schedule 2.0 (WHODAS), between baseline (T1) and follow-up (T3).	—

Secondary

Measure	Time frame
1) The severity of PTSD symptoms, measured by the PTSD Checklist (short version) for DSM-5 (PCL-5) 2) Self-defined problems, measured by the Psychological Outcome Profiles Instrument (PSYCHLOPS) 3) Access to health services, measured by a new questionnaire developed for this study by the London School of Hygiene and Tropical medicine 4) Costs of care, measured by an adapted version of the Service Receipt Inventory (SRI) 5) User satisfaction, measured by the Client Satisfaction Questionnaire (CSQ-I) In addition, the following potential moderators will be assessed: 1) Demographic variables, measured by an adapted version of the WHODAS 2.0 demographic questions 2) Exposure to COVID-19 related stressors, measured by a newly developed questionnaire 3) Post-migration stressors, measured by the Post-Migration Living Difficulties Checklist (PMLDC) Finally, the following process variables will be assessed: 1) Weekly psychological distress, measured by the Kessler-10 Psychological Distress Scale (K10) this questionnaire is also used as the screening instrument for psychological distress 2) Momentary mood ratings, measured by a 5-item smiley-scale 3) Indicators of app usage, measured by automatically tracked usage variables, e.g. the number of completed sessions, the number of planned and completed activities or the number of messages sent to an e-helper Participants in the control group will be asked to answer an additional contamination questionnaire. A sub-sample of 15 to 20 participants will be invited to an in-depth interview in which they will be asked for their views on Step-by-Step, barriers and facilitators to engagement and adherence, usability dimensions as well as how this intervention can potentially be scaled up in Germany. Questions on usability dimensions are based on the Mobile App Rating Scale user version (uMARS).	—

Measure

Time frame

1) The severity of PTSD symptoms, measured by the PTSD Checklist (short version) for DSM-5 (PCL-5) 2) Self-defined problems, measured by the Psychological Outcome Profiles Instrument (PSYCHLOPS) 3) Access to health services, measured by a new questionnaire developed for this study by the London School of Hygiene and Tropical medicine 4) Costs of care, measured by an adapted version of the Service Receipt Inventory (SRI) 5) User satisfaction, measured by the Client Satisfaction Questionnaire (CSQ-I) In addition, the following potential moderators will be assessed: 1) Demographic variables, measured by an adapted version of the WHODAS 2.0 demographic questions 2) Exposure to COVID-19 related stressors, measured by a newly developed questionnaire 3) Post-migration stressors, measured by the Post-Migration Living Difficulties Checklist (PMLDC) Finally, the following process variables will be assessed: 1) Weekly psychological distress, measured by the Kessler-10 Psychological Distress Scale (K10) this questionnaire is also used as the screening instrument for psychological distress 2) Momentary mood ratings, measured by a 5-item smiley-scale 3) Indicators of app usage, measured by automatically tracked usage variables, e.g. the number of completed sessions, the number of planned and completed activities or the number of messages sent to an e-helper Participants in the control group will be asked to answer an additional contamination questionnaire. A sub-sample of 15 to 20 participants will be invited to an in-depth interview in which they will be asked for their views on Step-by-Step, barriers and facilitators to engagement and adherence, usability dimensions as well as how this intervention can potentially be scaled up in Germany. Questions on usability dimensions are based on the Mobile App Rating Scale user version (uMARS).

—

Countries

Germany

Contacts

Public ContactSebastian Burchert

Freie Universität Berlin

s.burchert@fu-berlin.de+49 30 838 57523

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 31, 2026