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Mindfulness for paranoia

Mindfulness therapy for persecutory delusions: A randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16318074
Enrollment
144
Registered
2025-02-07
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Paranoia Mental and Behavioural Disorders

Interventions

Design Randomised Controlled trial, randomising 144 participants to either a 10-week group mindfulness therapy alongside their usual treatment (n=72) or treatment as usual alone (n=72). Measures Part

Sponsors

University of Southampton
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Have a diagnosis of a Schizophrenia Spectrum Disorder, or attending an Early intervention in Psychosis Service, and be experiencing current distressing persecutory delusions (confirmed by clinical team psychiatrist). 2. Be aged over 18 years of age. 3. Be able to provide informed consent to take part.

Exclusion criteria

Exclusion criteria: 1. Participants will not have an identified organic cause for their symptoms 2. Diagnosis of a learning disability. 3. Participants with a significant risk of violence to others

Design outcomes

Primary

MeasureTime frame
Depression – measured by the PHQ9 at baseline, after the therapy (4 months post-randomisation), and at follow-up (8 months post-randomisation)

Secondary

MeasureTime frame
At baseline, post therapy (approx. 4 months post randomisation) and follow up (approx. 8 months post randomisation): 1. Recovery – measured by the Recovery Assessment Scale 2. Anxiety – measured by the GAD-7 3. Psychotic symptoms – measured by the PSYRATS 4. Forgiveness – measured by the Trait Forgivingness Scale 5. Loneliness – measured using the UCLA Loneliness Scale (3-item version) 6. Mindfulness – measured by the Southampton Mindfulness Questionnaire 7. Health economic measures – including CRSI, EQ-5D-5L, and ReQOL-10

Countries

England, United Kingdom

Contacts

Public ContactLyn Ellett
l.a.ellett@soton.ac.uk+44 2380 599599

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026