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)
Abstract Background Persecutory delusions are strong threat beliefs about others’ negative intentions. They can have a major impact on patients’ day-to-day life. The Feeling Safe Programme is a new translational cognitive-behaviour therapy that helps patients modify threat beliefs and relearn safety...
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07661-x |
| _version_ | 1827399338155835392 |
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| author | Eva Tolmeijer Felicity Waite Louise Isham Laura Bringmann Robin Timmers Arjan van den Berg Hanneke Schuurmans Anton B. P. Staring Paul de Bont Rob van Grunsven Gert Stulp Ben Wijnen Mark van der Gaag Daniel Freeman David van den Berg |
| author_facet | Eva Tolmeijer Felicity Waite Louise Isham Laura Bringmann Robin Timmers Arjan van den Berg Hanneke Schuurmans Anton B. P. Staring Paul de Bont Rob van Grunsven Gert Stulp Ben Wijnen Mark van der Gaag Daniel Freeman David van den Berg |
| author_sort | Eva Tolmeijer |
| collection | DOAJ |
| description | Abstract Background Persecutory delusions are strong threat beliefs about others’ negative intentions. They can have a major impact on patients’ day-to-day life. The Feeling Safe Programme is a new translational cognitive-behaviour therapy that helps patients modify threat beliefs and relearn safety by targeting key psychological causal factors. A different intervention approach, with growing international interest, is peer counselling to facilitate personal recovery. Combining these two approaches is a potential avenue to maximize patient outcomes. This combination of two different treatments will be tested as the Feeling Safe-NL Programme, which aims to promote psychological wellbeing. We will test whether Feeling Safe-NL is more effective and more cost-effective in improving mental wellbeing and reducing persecutory delusions than the current guideline intervention of formulation-based CBT for psychosis (CBTp). Methods A single-blind parallel-group randomized controlled trial for 190 out-patients who experience persecutory delusions and low mental wellbeing. Patients will be randomized (1:1) to Feeling Safe-NL (Feeling Safe and peer counselling) or to formulation-based CBTp, both provided over a period of 6 months. Participants in both conditions are offered the possibility to self-monitor their recovery process. Blinded assessments will be conducted at 0, 6 (post-treatment), 12, and 18 months. The primary outcome is mental wellbeing. The overall effect over time (baseline to 18-month follow-up) and the effects at each timepoint will be determined. Secondary outcomes include the severity of the persecutory delusion, general paranoid ideation, patient-chosen therapy outcomes, and activity. Service use data and quality of life data will be collected for the health-economic evaluation. Discussion The Feeling Safe-NL Trial is the first to evaluate a treatment for people with persecutory delusions, while using mental wellbeing as the primary outcome. It will also provide the first evaluation of the combination of a peer counselling intervention and a CBT-based program for recovery from persecutory delusions. Trial registration Current Controlled Trials ISRCTN25766661 (retrospectively registered 7 July 2022). |
| first_indexed | 2024-03-08T19:44:30Z |
| format | Article |
| id | doaj.art-7a6000ad82aa486ca33d804c34fe655f |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-08T19:44:30Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-7a6000ad82aa486ca33d804c34fe655f2023-12-24T12:28:32ZengBMCTrials1745-62152023-10-0124111610.1186/s13063-023-07661-xTesting 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)Eva Tolmeijer0Felicity Waite1Louise Isham2Laura Bringmann3Robin Timmers4Arjan van den Berg5Hanneke Schuurmans6Anton B. P. Staring7Paul de Bont8Rob van Grunsven9Gert Stulp10Ben Wijnen11Mark van der Gaag12Daniel Freeman13David van den Berg14Department of Clinical Psychology, VU University and Amsterdam Public Health ResearchDepartment of Experimental Psychology, University of Oxford and Oxford Health NHS Foundation TrustDepartment of Experimental Psychology, University of Oxford and Oxford Health NHS Foundation TrustDepartment of Psychometrics and Statistics, University of GroningenVoice-Hearing Support and Recovery-Team, RIBW Nijmegen and RivierenlandDepartment of Health, Wellbeing and Sport, Zadkine College RotterdamMental Health Organizations Oost BrabantABC Department for First Episode Psychosis, Altrecht Psychiatric InstituteMental Health Organizations Oost BrabantDepartment of Psychosis, Parnassia Psychiatric InstituteDepartment of Sociology, University of GroningenCentre of Economic Evaluation and Machine Learning, Trimbos Institute (Netherlands Institute of Mental Health and Addiction)Department of Clinical Psychology, VU University and Amsterdam Public Health ResearchDepartment of Experimental Psychology, University of Oxford and Oxford Health NHS Foundation TrustDepartment of Clinical Psychology, VU University and Amsterdam Public Health ResearchAbstract Background Persecutory delusions are strong threat beliefs about others’ negative intentions. They can have a major impact on patients’ day-to-day life. The Feeling Safe Programme is a new translational cognitive-behaviour therapy that helps patients modify threat beliefs and relearn safety by targeting key psychological causal factors. A different intervention approach, with growing international interest, is peer counselling to facilitate personal recovery. Combining these two approaches is a potential avenue to maximize patient outcomes. This combination of two different treatments will be tested as the Feeling Safe-NL Programme, which aims to promote psychological wellbeing. We will test whether Feeling Safe-NL is more effective and more cost-effective in improving mental wellbeing and reducing persecutory delusions than the current guideline intervention of formulation-based CBT for psychosis (CBTp). Methods A single-blind parallel-group randomized controlled trial for 190 out-patients who experience persecutory delusions and low mental wellbeing. Patients will be randomized (1:1) to Feeling Safe-NL (Feeling Safe and peer counselling) or to formulation-based CBTp, both provided over a period of 6 months. Participants in both conditions are offered the possibility to self-monitor their recovery process. Blinded assessments will be conducted at 0, 6 (post-treatment), 12, and 18 months. The primary outcome is mental wellbeing. The overall effect over time (baseline to 18-month follow-up) and the effects at each timepoint will be determined. Secondary outcomes include the severity of the persecutory delusion, general paranoid ideation, patient-chosen therapy outcomes, and activity. Service use data and quality of life data will be collected for the health-economic evaluation. Discussion The Feeling Safe-NL Trial is the first to evaluate a treatment for people with persecutory delusions, while using mental wellbeing as the primary outcome. It will also provide the first evaluation of the combination of a peer counselling intervention and a CBT-based program for recovery from persecutory delusions. Trial registration Current Controlled Trials ISRCTN25766661 (retrospectively registered 7 July 2022).https://doi.org/10.1186/s13063-023-07661-xParanoiaPersecutory delusionsPsychosisPeer counsellingCognitive behaviour therapyRandomized controlled trial |
| spellingShingle | Eva Tolmeijer Felicity Waite Louise Isham Laura Bringmann Robin Timmers Arjan van den Berg Hanneke Schuurmans Anton B. P. Staring Paul de Bont Rob van Grunsven Gert Stulp Ben Wijnen Mark van der Gaag Daniel Freeman David van den Berg 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) Trials Paranoia Persecutory delusions Psychosis Peer counselling Cognitive behaviour therapy Randomized controlled trial |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Paranoia Persecutory delusions Psychosis Peer counselling Cognitive behaviour therapy Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-023-07661-x |
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