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Feeling Safe-NL: A new recovery-oriented, transdiagnostic, modular, translational, and peer-supported treatment to achieve wellbeing and prevent the persistence of paranoia.

Projectomschrijving

Achterdocht

Veel mensen met psychische problemen hebben last van overmatige achterdocht, de angst dat anderen het op hen gemunt hebben en hen emotioneel of lichamelijk pijn zullen doen. Dit leidt tot angst, eenzaamheid en hopeloosheid. Het is dus enorm belangrijk dat er effectieve en efficiënte behandelingen voor deze doelgroep ontwikkeld worden.

Doel

In dit project wordt een nieuwe herstel- en cliëntgerichte behandeling onderzocht, Feeling Safe-NL, waarin ervaringsdeskundigen en therapeuten samenwerken om het mentaal welbevinden en de veerkracht van mensen te vergroten. Deelnemers kiezen zelf meerdere korte behandelmodules gericht op factoren die hun complexe problemen in standhouden, zoals ‘beter slapen’ en ‘trauma’s verwerken’. Op basis van hun persoonlijke doelen worden obstakels die het herstel in de weg staan aangepakt en wordt er gewerkt aan het verbeteren van het welzijn. Zo voelt men zich weer veilig en veerkrachtig en vrij om te doen wat men wil doen.

Verslagen


Samenvatting van de aanvraag

Background: Threat beliefs, also referred to as persecutory delusions or paranoia, are strong unfounded fears that people intend to harm you. Threat beliefs are highly prevalent and transdiagnostic experiences that are associated with the persistence of mental health problems and long-term treatment trajectories. Severe threat beliefs are associated with poor outcomes involving impairment in multiple functional domains and psychological well-being in the lowest 2% of the general population. Psychological mechanisms underlying threat belief formation and maintenance appear consistent across diagnoses, with traumatic stress and insomnia being two of the strongest causal factors. On the 15th of June 2020, Zorginstituut Nederland (ZIN) sent the ‘Verbetersignalement Psychose’ to the State Secretary for Health, Welfare, and Sports. The most important conclusion of this report is that only a small minority of the patients with psychosis receive the guideline intervention cognitive behaviour therapy for psychosis (CBTp). The report emphasises the necessity of implementing CBTp in routine clinical practice, and to test new (cost-)effective psychological treatments for psychosis. This is exactly the ambition of the current research project, which is a collaboration between scientists, clinicians, and experts by experience. We aim to reduce threat beliefs and improve wellbeing with a recovery-oriented intervention that is cost-effective and easy to implement. We acknowledge that recovery involves more than the absence of mental health problems and concerns a highly personal process of enhancing resilience. To this end, we build on the translational Oxford Feeling Safe Programme that involves a personalised treatment in which the causal psychological factors that drive threat beliefs are targeted one-by-one. This is done with brief CBT modules that are selected by patients from a personalised menu of treatment options. This will now be tested as the Feeling Safe-NL Programme, which aims to promote wellbeing by synergistically reducing the causal factors that hamper recovery, while concurrently addressing personal recovery with peer-support. We will test whether this new translational, recovery-oriented, transdiagnostic, modular, and peer-supported treatment is more (cost-)effective in improving wellbeing and reducing threat beliefs than CBTp. Methods/design: We will conduct a two-armed single-blind pragmatic superiority randomised controlled trial (n=190) to test whether Feeling Safe-NL helps patients improve their wellbeing and feel safer more effectively than CBTp. We will include out-patients with threat beliefs that are held with at least 60% conviction and the presence of at least two of the seven most important causal maintenance factors of threat beliefs, such as trauma-imagery and insomnia. Participants will be randomised (1:1) to Feeling Safe-NL or the gold-standard CBTp (protocolized, formulation-based), both provided over a period of 6 months. In line with the treatment protocols, participants in both conditions are offered the possibility to monitor their wellbeing, threat beliefs, maintenance factors (trauma-imagery, insomnia, self-esteem, worry, anomalous experiences, safety behaviours, reasoning biases), personal recovery goals, and resilience. Data will be visualised in a novel and patient-friendly way to enhance usability for both patients and therapists. Standard care will continue as usual and be monitored. Blinded assessments will be conducted at 0, 6- (post-treatment), 12- and 18-months follow-up. The primary outcome is wellbeing and the secondary outcome is the level of conviction of the main threat belief. We will use Linear Mixed Models (LMM) and Generalised Estimating Equations (GEE) analyses for the main outcomes. For cost-effectiveness analyses, the clinical end-terms are a clinically relevant change in wellbeing and quality-adjusted life-year gained. We will also use mediation analyses to assess mechanisms of therapeutic change. All main analyses will be intention-to-treat (ITT). The project also includes qualitative assessments of the experiences of participants, therapists, and experts by experience with the Feelings Safe-NL programme. Discussion: The Feeling Safe-NL study will provide an evaluation of a new translational, recovery-oriented, transdiagnostic, modular, and peer-supported treatment to achieve wellbeing and prevent the persistence of paranoia.

Onderwerpen

Kenmerken

Projectnummer:
636310023
Looptijd: 54%
Looptijd: 54 %
2020
2026
Onderdeel van programma:
Gerelateerde subsidieronde:
Projectleider en penvoerder:
dr. D.P.G. van den Berg PhD
Verantwoordelijke organisatie:
Vrije Universiteit Amsterdam