A trial of the Self-Help Online program for Ukrainian refugees
| ISRCTN | ISRCTN96282810 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96282810 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 4 4002 97 |
| Sponsor | University of Kassel |
| Funder | Universität Kassel |
- Submission date
- 22/06/2022
- Registration date
- 28/06/2022
- Last edited
- 31/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The study wants to test if the self-help online program helps adult people to cope with high-stress situations. The program focused on Ukrainian citizens, but do not exclude the people with other citizenship who were living in Ukraine. The program is not open to people living outside Ukraine and European Union. This program aims to help people to improve their psychological well-being and reduce stress. The results of the study will help to understand if a self-help online program can be a solution to help a large number of people across borders cope with high-stress situations.
Who can participate?
Adults (18+ years) residing in Ukraine or adults who resided in Ukraine before February 24 2022 and had to move to one of the countries in the European Union.
What does the study involve?
If you agree to participate in this study, you will be offered a chance to attend a full online self-help program for free. The full program will take you about 1.5 hours of study time on the educational platform and about 30 minutes to learn recent information about opportunities provided to Ukrainians by different countries. The computer randomly decides who will be offered participation in the full online program and who will get only the information about opportunities provided to Ukrainians by different countries.
Everyone in the study will be asked to take two brief surveys: one survey at the beginning and one survey at the end. We will use the information collected from the surveys and learning activities on the platform to analyze the effectiveness of this course for research purposes. Your participation in this study will end with an endline survey. We might contact you after the endline survey to better evaluate the results of the course and your experience.
What are the possible benefits and risks of participating?
If you are selected to complete the course, it can help you to improve your psychological well-being and reduce stress. All participants of the program will receive information about opportunities provided to Ukrainians by different countries. All participants of the program will get a certificate of completion of the program after the final survey. All participants who completed the endline survey will participate in a random draw to get 1 of 250 gift cards of 10 Euro (~320 hryvnia) value.
We will use content and materials that do not pose any risk to your mental, physical health, or socioeconomic risks.
Where is the study run from?
University of Kassel International Center for Higher Education Research (Germany)
When is the study starting and how long is it expected to run for?
May 2022 to December 2022
Who is funding the study?
University of Kassel International Center for Higher Education Research (Germany)
Who is the main contact?
Dr. Igor Asanov, igor.asanov@uni-kassel.de
Contact information
Principal investigator
Mönchebergstraße 17
Kassel
34125
Germany
 ORCID ID |
0000-0002-8091-4130 |
|---|---|
| Phone | +49 17621637014 |
| igor.asanov@uni-kassel.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The psychological online self-help program: a randomized controlled trial |
| Study acronym | SHO |
| Study objectives | Hypothesis 1: Participants who receive the self-help online course show a lower level of stress compared to the control group participants. Hypothesis 2: Participants who receive the online self-help course show a higher level of psychological well-being compared to the control group participants. Hypothesis 3: Participants who receive the online self-help course show better results on the life-related outcome, variables compared to the control group participants. |
| Ethics approval(s) | Approved 25/05/2022, Kassel University Central Ethics Committee (Geschäftsstelle der zentralen Ethikkommission der Universität Kassel Mönchebergstr. 19 34125 Kassel, Germany; no telephone number provided; ethikkommission@uni-kassel.de), ref: zEK-33 |
| Health condition(s) or problem(s) studied | High levels of stress in refugees |
| Intervention | We use simple individual-level randomization. The randomization takes place automatically via the online platform. Participants who are assigned to the treatment group receive the complete course materials: 90-minute self-help course and extensive information material about the support offered to Ukrainians in Ukraine and other countries. Participants in the control group only have access to the information material. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Kessler-6 distress will be measured online through self-assessment. It will be measured at the baseline before the intervention and 3 weeks after the beginning of the intervention. |
| Key secondary outcome measure(s) |
1. The WHO-5 Well-Being Index. It will be measured at the baseline before the intervention and 3 weeks after the beginning of the intervention. |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30000 |
| Total final enrolment | 645 |
| Key inclusion criteria | Participation in the project is open to adults (18+ years) residing in Ukraine or adults who resided in Ukraine before February 24 2022 and had to move to one of the countries in the European Union. |
| Key exclusion criteria | 1. Age under 18 years |
| Date of first enrolment | 22/06/2022 |
| Date of final enrolment | 06/07/2022 |
Locations
Countries of recruitment
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czech Republic
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Moldova
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Ukraine
Study participating centre
Kassel
34125
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | We plan to make the anonymized data available on open access repositories after the publication. No further information available at time of registration. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/10/2024 | 31/10/2024 | Yes | No | |
| Interim results article | 04/11/2023 | 18/12/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Statistical Analysis Plan | 18/07/2022 | 20/07/2022 | No | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN96282810_SAP_18Jul22.pdf
- Statistical Analysis Plan
Editorial Notes
31/10/2024: Publication reference added.
18/12/2023: Study website, publication reference and total final enrolment added. The intention to publish date was changed from 31/12/2023 to 31/12/2024.
20/07/2022: Uploaded statistical analysis plan.
24/06/2022: Trial's existence confirmed by University of Kassel.
