Administrative information
Title {1} | Testing the combination of Feeling Safe and peer counselling against formulation-based cognitive behaviour therapy to promote psychological wellbeing in people with persecutory delusions: study protocol for a randomized controlled trial (the Feeling Safe-NL Trial). |
Trial registration {2a and 2b}. | ISRCTN registry (https://doi.org/10.1186/ISRCTN25766661) |
Protocol version {3} | Protocol version 2 (21–12-2022). |
Funding {4} | Funded by the independent and self-governing organization ZonMw for healthcare research. |
Author details {5a} | Eva Tolmeijer1,2 Felicity Waite3 Louise Isham3 Laura Bringmann4 Robin Timmers5,6 Arjan van den Berg7 Hanneke Schuurmans8 Anton B.P. Staring9 Paul de Bont8 Rob van Grunsven2 Gert Stulp10 Ben Wijnen11 Mark van der Gaag1 Daniel Freeman3 David van den Berg1,2 1Department of Clinical Psychology, VU University and Amsterdam Public Health Research. 2Department of Psychosis, Parnassia Psychiatric Institute, The Hague. 3Department of Experimental Psychology, University of Oxford and Oxford Health NHS Foundation Trust. 4Department of Psychometrics and Statistics, University of Groningen. 5Voice-hearing support and recovery-team, RIBW Nijmegen and Rivierenland. 6University of Applied Sciences Nijmegen. 7Department of Health, Wellbeing and Sport, Zadkine College Rotterdam. 8Mental health organizations Oost Brabant. 9ABC Department for First Episode Psychosis, Altrecht Psychiatric Institute. 10Department of Sociology, University of Groningen. 11Centre of Economic Evaluation and Machine Learning, Trimbos Institute (Netherlands Institute of Mental Health and Addiction). |
Name and contact information for the trial sponsor {5b} | VU University Amsterdam, Faculty of Behavioral and Movement Sciences, Department of Clinical Psychology Van der Boechorststraat 7 1081 BT Amsterdam. |
Role of sponsor {5c} | The sponsor and funding body have no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. |