Feeling Safe-Netherlands: recovery-oriented cognitive behaviour therapy to promote wellbeing and feeling safer
| ISRCTN | ISRCTN25766661 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25766661 |
| Secondary identifying numbers | NL77046.029.21 |
- Submission date
- 05/07/2022
- Registration date
- 07/07/2022
- Last edited
- 23/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Many people do not feel safe around other people. This leads to fear, loneliness, hopelessness and often reduced mental wellbeing. This study investigates the (long-term) effects of two therapies on well-being and feeling safer. Additionally, the study will investigate how these therapies work:
1) Cognitive behavioural therapy (CBT) is the standard therapy for people with threat beliefs. The therapy focuses on fostering a shared understanding of what caused and maintains problems. In therapy, people can give new meaning to their experiences and find other ways of coping.
2) Feeling Safe is a proven effective psychological intervention developed in the UK. In the Feeling Safe-NL programme, people also work together with a peer counsellor. With the therapist, the factors that maintain feeling unsafe (trauma-imagery, insomnia, self-esteem, worry, anomalous experiences, safety behaviours) are assessed. After this, people choose from a personalised menu of brief CBT modules (booklets) aimed at reducing the maintenance factors one-by-one. While people work together with a therapist to reduce the factors that hamper recovery, people work together with a peer counsellor to promote personal recovery. This is done by identifying and using strengths and building experience knowledge. Additionally, experiences can be shared, and meaningful activities can be undertaken.
Both therapies consist of approximately 20 sessions of 90 minutes over 6 months.
Who can participate?
Adults (aged 16 years or older) who are help-seeking or in outpatient care who experience threat beliefs and low well-being.
What does the study involve?
Participants are randomly allocated to either CBTp or the Feeling Safe-NL Programme. Before starting therapy and after 6 (post-therapy), 12, and 18 months, they complete a set of interviews and questionnaires at the mental healthcare institution where they receive their treatment.
What are the possible benefits and risks of participating?
The two therapies aim to improve well-being and feel safer. They have been investigated in people with threat beliefs before and have been shown to be safe and effective in improving well-being and reducing threat beliefs. The medical ethical committee has judged the study as inducing "no increased risk" for participants.
Where is the study run from?
1. Parnassia, Den Haag, The Netherlands
2. Antes, Rotterdam, The Netherlands
3. GGz Oost-Brabant, Boekel, The Netherlands
4. Altrecht, Utrecht, The Netherlands
5. GGZ inGeest, Amsterdam, The Netherlands
6. Pro Persona, Arnhem, The Netherlands
7. Rivierduinen, Leiden, The Netherlands
When is the study starting and how long is it expected to run for?
February 2022 to December 2026.
Who is funding the study?
Netherlands Organisation for Health Research and Development (ZonMw).
Who is the main contact?
1. Dr David van den Berg (principal investigator). Email: david.vanden.berg@vu.nl
2. Drs Eva Tolmeijer (project leader and scientific/public contact). Email: eva.tolmeijer@vu.nl
Contact information
Principal Investigator
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
 ORCID ID |
0000-0002-8797-8217 |
|---|---|
| Phone | +31 (0)883576765 |
| david.vanden.berg@vu.nl |
Scientific
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
| ORCID ID |
0000-0003-4067-6155 |
|---|---|
| Phone | +31 (0)651014004 |
| eva.tolmeijer@vu.nl |
Public
Van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)651014004 |
|---|---|
| eva.tolmeijer@vu.nl |
Study information
| Study design | Single-blind pragmatic randomized controlled trial with two parallel groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A comparison of the effects of the combination of Feeling Safe and peer counselling (the Feeling Safe-NL Programme) and regular cognitive behaviour therapy for people with threat beliefs. |
| Study acronym | FSNL |
| Study hypothesis | The primary objective is to test whether the Feeling Safe-NL programme is more effective in improving wellbeing over time than CBTp (from baseline to 18-month follow-up). The secondary objectives are to test whether the Feeling Safe-NL programme is more effective than CBTp in reducing conviction and distress of the main threat belief and general paranoid ideation and improving patient chosen outcomes of therapy and activity levels over time (from baseline to 18-month follow-up). We also assess outcomes at the different time-points (6-, 12- and 18-month follow-up). Additionally, we investigate the mediators of improved wellbeing and reduced threat beliefs and whether the Feeling Safe-NL programme is more cost-effective than CBTp. |
| Ethics approval(s) | Approved 09/02/2022, Medical Ethics Committee of VU Medical Centre Amsterdam (METc VUmc, De Boelelaan 119, room 08A-08, PO Box 7057, 1081 HV Amsterdam, the Netherlands; +31 (0)20 44 45 58 5; metc@vumc.nl), ref: 2021.0650 - NL77046.029.21 |
| Condition | Threat beliefs held with at least 60% conviction and low wellbeing in people who are help-seeking or in outpatient care. |
| Intervention | Participants are randomly assigned to CBTp or the Feeling Safe-NL Programme using our independent randomisation bureau. In both arms, people will receive approximately 20 therapy sessions over a period of 6 months. To support the therapies in both arms, optional daily monitoring is available via brief questionnaires of which the outcomes are visualised. Therapists will be trained in both therapy protocols and will deliver both conditions. The Feeling Safe-NL Programme is delivered according to the protocols of Freeman et al. (2021). The empirically-based maintenance factors of threat beliefs (trauma-imagery, insomnia, self-esteem, worry, anomalous experiences, safety behaviours) are assessed. Brief CBT modules are used to reduce specific maintenance factors of threat beliefs while a peer counsellor concurrently addresses personal recovery to promote wellbeing. This approach enables synergy between the work of the therapist, peer counsellor, and participant. The overarching goals of the Feeling Safe-NL programme are to feel safer, happier, and get people back to doing what they want to do. CBTp is delivered according to the protocols of Van Der Gaag, Staring, Van Den Berg and Baas (2018). The participant and therapist collaboratively work on understanding the problems of the participant and on completing the case formulation, which provides relevant information concerning the origin and maintenance of the person's threat beliefs. The intervention phase starts after the case formulation is completed. The therapist and participant work together on achieving personalised treatment goals. |
| Intervention type | Behavioural |
| Primary outcome measure | Wellbeing as measured by the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). This will be measured at baseline, 6-month follow-up (post-treatment), 12-month follow-up, and 18-month follow-up. |
| Secondary outcome measures | Measured at baseline, 6-month follow-up (post-treatment), 12-month follow-up, and 18-month follow-up: 1. Conviction and distress level of the main threat belief (Psychotic Symptom Rating Scale, PSYRATS) 2. General paranoid ideation (Revised-Green et al. Paranoid Thought Scale, R-GPTS) 3. Patient chosen therapy outcomes (Choice in Outcome in Cognitive Behaviour Therapy for psychosis, CHOICE) 4. Activity (time budget). |
| Overall study start date | 09/02/2022 |
| Overall study end date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 190 |
| Participant inclusion criteria | 1. Help-seeking or in outpatient care. 2. Experience threat beliefs held with at least 60% conviction (PSYRATS-Del). 3. Wellbeing of 43 or less (WEMWBS). 4. Sixteen years or older. |
| Participant exclusion criteria | 1. Insufficient understanding of the Dutch language. 2. Currently receiving individual therapy or peer counselling with a frequency of at least once every month. 3. Unable to understand and sign the informed consent form. |
| Recruitment start date | 01/03/2022 |
| Recruitment end date | 30/06/2025 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
The Hague
2512 HN
Netherlands
Boekel
5427 EM
Netherlands
Utrecht
3512 PK
Netherlands
Rotterdam
3014 BH
Netherlands
Amsterdam
1072 JX
Netherlands
Arnhem
6815 AG
Netherlands
Leiden
2333 ZZ
Netherlands
Sponsor information
Research organisation
Boelelaan 1105
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 598 9898 |
|---|---|
| servicedesk.fco@vu.nl | |
"ROR" |
https://ror.org/008xxew50 |
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 | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results regarding all hypotheses - as described in the 'study hypothesis' section - will be published unreservedly. The researchers aim to publish in high-impact peer-reviewed journals. The sponsor will have no influence on the publication of the results. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 05/10/2023 | 06/10/2023 | Yes | No | |
| Other publications | Therapy-specific questionnaires and visual feedback were developed within the online m-Path platform as part of the Feeling Safe-NL trial | 20/03/2025 | 23/04/2025 | Yes | No |
Editorial Notes
23/04/2025: Publication reference added.
22/11/2024: The following changes were made to the trial record:
1. The scientific title was changed from "A comparison of the effects of the peer supported Feeling Safe Programme (Feeling Safe-NL) and formulation based cognitive behaviour therapy for people with threat beliefs" to "A comparison of the effects of the combination of Feeling Safe and peer counselling (the Feeling Safe-NL Programme) and regular cognitive behaviour therapy for people with threat beliefs.".
2. The recruitment end date was changed from 31/12/2024 to 30/06/2025.
3. The study participating centres GGZ inGeest, Pro Persona, Rivierduinen were added.
4. The intention to publish date was changed from 31/12/2026 to 31/12/2027.
5. The plain English summary was updated to reflect these changes.
06/10/2023: Publication reference added.
07/07/2022: Trial's existence confirmed by Amsterdam UMC.
