Psychosis with a current persecutory delusion Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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