Stepped Care focused on return to work for employees with psychological distress
| ISRCTN | ISRCTN90663076 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90663076 |
| Secondary identifying numbers | 10320052010005 |
- Submission date
- 02/10/2023
- Registration date
- 05/10/2023
- Last edited
- 19/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
Psychological complaints are common, are associated with absenteeism and are the most common reason for disability. Early interventions aimed at return to work for employees with psychological complaints are needed. In this study a step-by-step approach (Stepped Care) will be evaluated on time to lasting return to work for employees with psychological distress.
Who can participate?
Employees with psychological distress and absenteeism between 2 and 8 weeks are eligible for inclusion.
What does the study involve?
First, a low-intensive E-health intervention is offered early in the absenteeism process and only in case of persistent absenteeism a high-intensity intervention in the form of a Participatory Approach will follow. Measurements in the form of questionnaires will take place at four moments, divided over 12 months.
What are the possible benefits and risks of participating?
The Stepped Care approach will be offered on top of usual care, so the participant will be offered extra guidance. By participating the participant will also contribute to (scientific) knowledge about the process of absenteeism and return to work for employees with psychological distress. The risks of participating is that it will cost time and energy from the participants to follow the interventions and filling in of the questionnaires.
Where is the study run from?
National Institute for Public Health and the Environment (Netherlands)
When is the study starting and how long is it expected to run for?
January 2022 to January 2026
Who is funding the study?
This research was funded by the Netherlands Organization for Health Research and Development. (ZonMw), grant number 50-55900-98-203 / 10320052010005. The funder was not involved in the determination of the study.
Who is the main contact?
Hanneke Lettinga, hanneke.lettinga@rivm.nl
Karin Proper, karin.proper@rivm.nl
Contact information
Principal Investigator
RIVM
Volksgezondheid en Zorg
Postbus 1
Bilthoven
3720 BA
Netherlands
 ORCID ID |
0000-0001-7016-1625 |
|---|---|
| Phone | +31 30 2743340 |
| karin.proper@rivm.nl |
Public, Scientific
RIVM
Volksgezondheid en Zorg
Postbus 1
Bilthoven
3720 BA
Netherlands
| ORCID ID |
0000-0003-2569-980X |
|---|---|
| Phone | +31 629661007 |
| hanneke.lettinga@rivm.nl |
Study information
| Study design | Single-blind interventional randomized controlled trial with a 2 x 2 factorial design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Workplace |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request participant information sheet |
| Scientific title | Return to work for Employees with distress: a STepped cARe Treatment |
| Study acronym | RESTART |
| Study hypothesis | Faster sustainable return to work for employees who receive the stepped care approach compared to care-as-usual. |
| Ethics approval(s) |
Approved 05/10/2023, Medical Ethics Review Committee of Amsterdam University Medical Centers (Van Der Boechorststraat 7, Amsterdam, 1081 BT, Netherlands; +31 20-4445585; metc@amsterdamumc.nl), ref: 2023.0474 |
| Condition | Return to work for sick-listed employees with psychological distress |
| Intervention | The stepped care approach consists of two elements, a low-intensive e-Health and a high-intensive participatory approach (PA) in the workplace. Participants will be randomized into four groups based on intention-to-treat. All participants will receive usual care. On top of that they either receive both e-Health and PA, only e-Health, only PA, or nothing (only usual care, i.e. the control group). The e-Health will be administered through an app (online) of which the duration is 6 weeks. The participatory approach consists of three meetings that are guided by a trained return-to-work (RTW) coordinator. The first meeting will be between the RTW-coordinator and employee, the second between the RTW-coordinator and the supervisor, and the third meeting will be between the employee and supervisor, guided by the RTW-coordinator. The end product will be a return-to-work plan, which the RTW-coordinator will plan an evaluation for. Duration of the period in which the three meetings will take place will be around three weeks, the evaluation will take place approximately after three months. There will be four measurement moments for all participants: at baseline (t0), after the e-Health (t6 weeks) after the PA (t6months) and a follow up at 12 months (t12 months). Randomization: A computer-based randomization list, generated by an independent researcher, will be used to allocate participants, based on their participant-ID, to one of the four groups. Before the statistical analyses are performed the condition-IDs are recoded by an independent researcher, which allows the primary researcher to be blinded for the allocation and the RCT to be single-blind. |
| Intervention type | Behavioural |
| Primary outcome measure | Time to lasting return to work (Lasting RTW is defined as RTW to the employee’s previous position, or another position with equal earnings, for a minimum of four consecutive weeks). Lasting RTW is measured using self-report of the employee on the measurement moments and absenteeism records. |
| Secondary outcome measures | 1. (Severity of) stress-related symptoms, measured using the four-dimensional symptoms questionnaire at the 4 measurement moments over 12 months. 2. Total sick-leave days measured by self-report and absenteeism record at the 4 measurement moments over 12 months. 3. Self-efficacy measured using the Work Self-Efficacy questionnaire at the 4 measurement moments over 12 months. 4. Self-reported health measured with the Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire at the 4 measurement moments over 12 months. |
| Overall study start date | 17/01/2022 |
| Overall study end date | 01/01/2026 |
Eligibility
| Participant type(s) | Employee |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 67 Years |
| Sex | Both |
| Target number of participants | 170 |
| Participant inclusion criteria | 1. Employees with absence duration of 2-8 weeks 2. Employees with psychological distress as measured with a distress screener |
| Participant exclusion criteria | 1. Severe psychiatric disorder (suicidal risk, schizophrenia, bipolar disorder) 2. Under treatment for chronic or terminal illnesses that preclude their ability to resume work in the near future (e.g. chemotherapy, cardiac surgery) 3. Labour dispute with employer involving legal action 4. Working less than 12 hours according to contract 5. Pregnancy 6. No proficiency in the Dutch language 7. No access to internet |
| Recruitment start date | 11/04/2024 |
| Recruitment end date | 30/11/2025 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Utrecht
3503 AH
Netherlands
Sponsor information
Research organisation
Antonie van Leeuwenhoeklaan 9
Bilthoven
3721 MA
Netherlands
| Phone | +31 88 689 8989 |
|---|---|
| info@rivm.nl | |
| Website | https://www.rivm.nl/en/ |
"ROR" |
https://ror.org/01cesdt21 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of at least five papers in a high-impact peer-reviewed journal. The papers will at least cover the protocol, the main and secondary outcomes and process evaluations of the intervention. |
| IPD sharing plan | The datasets generated and analyzed during the current study will be available upon request from Hanneke Lettinga, hanneke.lettinga@rivm.nl |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (preprint) | 04/10/2023 | No | No | ||
| Protocol article | 22/08/2024 | 23/08/2024 | Yes | No | |
| Other publications | Qualitative study | 16/05/2025 | 19/05/2025 | Yes | No |
Additional files
Editorial Notes
19/05/2025: Publication reference added.
11/11/2024: The following changes were made to the study record:
1. The recruitment start date was changed from 15/01/2024 to 11/04/2024.
2. The recruitment end date was changed from 30/11/2024 to 30/11/2025.
3. The overall study end date was changed from 30/11/2025 to 01/01/2026.
4. The intention to publish date was changed from 01/12/2025 to 01/02/2026.
23/08/2024: Publication reference added.
07/12/2023: Ethics approval details added. The recruitment start date was changed from 01/11/2023 to 15/01/2024.
04/10/2023: Trial's existence confirmed by ZonMw.
