Schizophrenia Mental and Behavioural Disorders Schizophrenia
Conditions
Interventions
Participants are randomly allocated to receive one of two interventions: the Feeling Safe Programme (a new targeted psychological intervention for persecutory delusions) or Befriending. Both intervent
non-confrontation
empathy
and supportiveness.
Assessments, by a rater-blind to allocation, will be conducted at 0, 6 (post-treatment) and 12 months. All main analyses will be intention to treat. (A small numbe
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or above 2. Participant is willing and able to give informed consent for participation in the trial 3. Persistent (at least 3 months) persecutory delusion (as defined by Freeman & Garety, 2000), held with at least 60% conviction 4. Primary diagnosis of schizophrenia spectrum psychosis (nonaffective psychosis)
Exclusion criteria
Exclusion criteria: 1. Current receipt of another psychological therapy 2. Insufficient comprehension of English 3. Primary diagnosis of alcohol, drug, or personality disorder 4. In forensic settings 5. Organic syndrome 6. Learning disability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conviction in persecutory delusion will be assessed on a 0% to 100% rating scale within the Psychotic Symptoms Rating Scale - Delusions at baseline, 6 months (post-treatment) and 12 months. Both rates of recovery in the delusion (defined as conviction falling below 50%) and dimensional change in the conviction levels (0%-100%) will be tested. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Psychological well-being will be assessed by the Warwick-Edinburgh Mental Well-being Scale at baseline, 6 months and 12 months 2. Patient satisfaction will be assessed using the CHOICE (a service user-led outcome measure) at baseline, 6 months and 12 months 3. Activity levels will be assessed using actigraphy and a time-budget measure at baseline, 6 months and 12 months 4. Overall paranoia will be measured on the Green Paranoid Thoughts Scale (GPTS) at baseline, 6 months and 12 months 5. Overall delusion severity will be assessed by the Psychotic Symptoms Rating Scale – Delusions at baseline, 6 months and 12 months 6. Suicidal Ideation will be measured using the Columbia-Suicide Severity Rating Scale at baseline, 6 months and 12 months Added 05/03/2021: 7. Depression will be measured using the Beck Depression Inventory at baseline, 6 months and 12 months 8. Anger will be measured using the Dimensions of Anger Reactions at baseline, 6 months and 12 months 9. Verbal auditory hallucinations will be measured using items from the Specific Psychotic Experiences Questionnaire at baseline, 6 months and 12 months 10. Anhedonia will be measured using the Temporal Experience of Pleasure Scale - Anticipatory Pleasure at baseline, 6 months and 12 months 11. Quality of life will be measured using the EQ-5D-5L and Long Term Conditions Questionnaire at baseline, 6 months and 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactFelicity Waite
Outcome results
None listed