Evidence map›Paper›PMID 37798792›Full record

ArticleTrials2023

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).

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 and 5 more

Erratum issuedOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 8 institutions in 2 countries.

Eva TolmeijerDepartment of Clinical Psychology, VU University and Amsterdam Public Health Research, Amsterdam, The Netherlands. eva.tolmeijer@vu.nl.ORCID http://orcid.org/0000-0003-4067-6155
Felicity WaiteDepartment of Experimental Psychology, University of Oxford and Oxford Health NHS Foundation Trust, Oxford, UK.
Louise IshamDepartment of Experimental Psychology, University of Oxford and Oxford Health NHS Foundation Trust, Oxford, UK.
Laura BringmannDepartment of Psychometrics and Statistics, University of Groningen, Groningen, The Netherlands.
Robin TimmersVoice-Hearing Support and Recovery-Team, RIBW Nijmegen and Rivierenland, Nijmegen, The Netherlands.
Arjan van den BergDepartment of Health, Wellbeing and Sport, Zadkine College Rotterdam, Rotterdam, The Netherlands.
Hanneke SchuurmansMental Health Organizations Oost Brabant, Boekel, The Netherlands.
Anton B P StaringABC Department for First Episode Psychosis, Altrecht Psychiatric Institute, Utrecht, The Netherlands.
Paul de BontMental Health Organizations Oost Brabant, Boekel, The Netherlands.
Rob van GrunsvenDepartment of Psychosis, Parnassia Psychiatric Institute, The Hague, The Netherlands.
Gert StulpDepartment of Sociology, University of Groningen, Groningen, The Netherlands.
Ben WijnenCentre of Economic Evaluation and Machine Learning, Trimbos Institute (Netherlands Institute of Mental Health and Addiction), Utrecht, The Netherlands.
Mark van der GaagDepartment of Clinical Psychology, VU University and Amsterdam Public Health Research, Amsterdam, The Netherlands.
Daniel FreemanDepartment of Experimental Psychology, University of Oxford and Oxford Health NHS Foundation Trust, Oxford, UK.
David van den BergDepartment of Clinical Psychology, VU University and Amsterdam Public Health Research, Amsterdam, The Netherlands.
Oxford Health NHS Foundation Trust · GBParnassia Groep · NLGGZ Oost Brabant · NLUniversity of Groningen · NLAltrecht GGZ · NLHAN University of Applied Sciences · NLRotterdam University of Applied Sciences · NLTrimbos Institute · NL

Funding

ZonMw 636310023
6 · The paper itself

Abstract

backgroundPersecutory 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).

methodsA 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 registrationCurrent Controlled Trials ISRCTN25766661 (retrospectively registered 7 July 2022).

Indexed as

Cognitive Behavioral TherapyPsychotic DisordersCounselingDelusionsHumansPsychiatric Status Rating ScalesQuality of LifeRandomized Controlled Trials as TopicSingle-Blind MethodCognitive behaviour therapyParanoiaPeer counsellingPersecutory delusionsPsychosisRandomized controlled trial

Identifiers

PMID37798792
PMCPMC10557156
OpenAlexW4387379715

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.