Skip to content

Feeling Safer: a guided online programme for the treatment of severe paranoia

Feeling Safer: a cohort study and a randomised controlled trial of a guided online programme for the treatment of persecutory delusions

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN93974770
Enrollment
484
Registered
2024-02-28
Start date
2024-11-25
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Psychosis with a current persecutory delusion Mental and Behavioural Disorders

Interventions

Participants will be patients (aged 16 years or older) with persecutory delusions in the context of a diagnosis of psychosis attending NHS mental health services. Participants will be randomised to on

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial 2. Aged 16 years or older 3. Attending NHS mental health services for the treatment of psychosis 4. Persistent (at least 3 months) persecutory delusion (as defined by Freeman & Garety, 2000), held with at least 50% conviction 5. No planned significant medication changes at the outset of participation

Exclusion criteria

Exclusion criteria: 1. A primary diagnosis of another mental health condition (e.g. substance use disorder) that would be the first clinical priority to treat 2. Current engagement in any other intensive individual psychological therapy or a significant change in medication. 3. In forensic settings or Psychiatric Intensive Care Unit (PICU) 4. Command of spoken English inadequate for engaging in the therapy 5. Significant learning difficulties that would prevent the completion of assessments or the therapy 6. A participant may also not enter the trial if there is another factor (for example, current active suicidal plans that need to the focus of intervention), which, in the judgement of the investigator, would preclude the participant from providing informed consent or from safely engaging with the trial procedures

Design outcomes

Primary

MeasureTime frame
Severity of persecutory delusion measured by the Psychotic Symptoms Rating Scale (PSYRATS) at baseline, 3, 6, and 9 months. The primary endpoint is 6 months.

Secondary

MeasureTime frame
1. Depression measured using Patient Health Questionnaire-9 (PHQ-9) at baseline, 6 and 9 months 2. Anxiety measured using Generalised Anxiety Disorder Assessment (GAD-7) at baseline, 6 and 9 months 3. Insomnia measured using the Insomnia Severity Index at baseline, 6 and 9 months 4. Agoraphobia measured using the Oxford Agoraphobic Avoidance Scale at baseline, 6 and 9 months 5. Paranoia measured using the Revised Green et al Paranoid Thoughts Scale at baseline, 6 and 9 months 6. Psychological well-being measured using the Warwick-Edinburgh Mental Well-being Scale at baseline, 6 and 9 months 7. Personal recovery measured using the Process of Recovery Questionnaire at baseline, 6 and 9 months 8. Meaningful activity measured using time budget at baseline, 6 and 9 months 9. Quality of life measured using EQ-5D-L and ReQol at baseline, 6 and 9 months

Countries

England, United Kingdom

Contacts

Public ContactAriane Beckley
ariane.beckley@psy.ox.ac.uk+44 (0)7817236236

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026