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Feeling Safe-Netherlands: recovery-oriented cognitive behaviour therapy to promote wellbeing and feeling safer.

Feeling Safe-Netherlands: recovery-oriented cognitive behaviour therapy to promote wellbeing and feeling safer. - FSNL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50990
Enrollment
190
Registered
2022-02-09
Start date
2022-03-16
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

andere psychische stoornissen waarbij sprake is van overmatige achterdocht Paranoia threat beliefs

Interventions

Feeling Safe-NL 1) Rationale The aim of Feeling Safe-NL is to reduce obstacles that hamper the recovery process while concurrently addressing personal recovery to promote wellbeing. This approach e

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
16 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Help-seeking or in outpatient care. 2) Experience threat beliefs, held with at least 60% conviction (Psychotic Symptom Rating Scale - Delusions). 3) Low wellbeing, score of 43 or less (Warwick-Edinburgh Mental Wellbeing Scale). 4) Sixteen years or older.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Wellbeing ( Warwick-Edinburgh Mental Wellbeing Scale, WEMWBS; Tennant et al., 2007). The WEMWBS can detect clinically meaningful change (Collins et al., 2012; Maheswaran, Weich, Powell, & Stewart-Brown, 2012).

Secondary

MeasureTime frame
Secondary outcome: Conviction of Main Threat Belief (Psychotic Symptom Rating Scale, PSYRATS; Haddock, McCarron, Tarrier, & Faragher, 1999) Distress of Main Threat Belief (PSYRATS) Paranoid ideation (Revised-Green Paranoid Thought Scale, R-GPTS; Freeman, Loe, et al., 2019) Patient Satisfaction (Greenwood et al., 2010) Acitivty (Jolley et al., 2006) Mediators: Trauma-imagery (Trauma Screening Questionnaire, TSQ; Brewin et al., 2002; De Bont et al., 2015) Insomnia (Insomnia Severity Index, ISI; Bastien, Vallières, & Morin, 2001) Self-esteem (Brief Core Schema Scale, BCSS; Fowler et al., 2006) Worry (Dunn Worry Questionnaire, DWQ; Freeman et al., 2019) Voices (Voices Impact Scale, VIS; Strauss, 2016) Safety Behaviours (Oxford Agoraphobic Avoidance Scale, OAAS; Lambe et al., 2021; Oxford Paranoia Defence Behaviours Questionnaire, OPDBQ; under review) Reasoning Biases (Fast and Slow Thinking Questionnaire, FAST; Hardy et al., 2020; Explanations of Experiences, EoE; Freeman et al., 2004; Maudsley Assessment of Delusions Schedule-Possibility of being Mistaken, MADS-PM; Wessely et al., 1993) Personal Recovery (Questionnaire about the Process of Recovery, QPR; Neil et al., 2009) Resilience (The Brief Resilience Scale, BRS; Smith et al., 2008). Other study parameters: Therapeutic relationship (Counsellor Rating Form-Short form, CRF-S; Corrigan & Schmidt, 1983) Working alliance (Working Alliance Inventory-Short Form Revised, WAI-SR; Paap & Dijkstra, 2017) Health-economic evaluation (treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P), the standardized 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L)).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)