Personality disorder - paranoia Mental and Behavioural Disorders Paranoid personality disorder
Conditions
Interventions
Current intervention as of 24/08/2022:
This study proposes to develop and test a mobile app version (STOP) of a new intervention for paranoia called CBM-pa. CBM-pa is a self-administered psychological
Sponsors
King's College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 24/08/2022: 1. Any clinical diagnosis featuring clinically significant persecutory or paranoid symptoms, present for at least the preceding month. This will be operationalised as a score of 3 (“mild”) or more on the paranoia item (item 6) of the Positive and Negative Syndrome Scale (PANSS). 2. Displaying an interpretation bias =2 on the 8-item screening version of the Similarity Ratings Task (SRT). The screening score has a range of +3 (strong positive bias) to -3 (strong paranoid bias). 3. If on psychotropic medication, then stable on medication for at least the last 3 months and expected to be so for the study duration 4. Aged =18 years 5. Capacity to consent Previous participant inclusion criteria: 1. Any clinical diagnosis featuring clinically significant persecutory or paranoid symptoms, present for at least the preceding month 2. Showing paranoid symptoms >/=3 on the paranoia item (item 6) of the Positive and Negative Symptoms Scale (PANSS) 3. Displaying an interpretation bias >/= 1 on the 8-item screening version of the Similarity Ratings Task (SRT). The screening score has a range of +3 (strong positive bias) to -3 (strong paranoid bias) 4. If on psychotropic medication, then stable on medication for at least the last 3 months and expected to be so for the study duration 5. Age 18 - 65 years 6. Capacity to consent, assessed by clinician using the South London and Maudsley NHS Trust required standard protocol
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 24/08/2022: 1. Severe cognitive impairment 2. Illiteracy or inability to understand written and spoken English for any other reason 3. Major physical illness (cancer, heart disease, stroke) 4. Major substance or alcohol misuse, assessed by the SCID-V screen 5. Currently receiving, or soon due to receive, a psychological intervention targeting the same psychological mechanism as STOP (i.e., paranoid belief change) or having done so in the last 3 months 6. Currently taking part in any other interventional research study 7. Scoring 7 (defined as ‘Extreme’) on item 6 of the PANSS 8. At high risk of suicide as indicated by the Columbia Suicide Severity Rating Scale (C-SSRS) -Screen Version Previous participant exclusion criteria: 1. Severe cognitive impairment 2. Illiteracy 3. Major physical illness (cancer, heart disease, stroke) 4. Major substance or alcohol misuse, assessed by the SCID-V screen 5. Currently receiving, or soon due to receive, a psychological intervention targeting the same psychological mechanism as CBM-pa (paranoid beliefs) or having done so in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 24/08/2022: Paranoid symptoms are measured using the Paranoia Scale (PS) at 24 weeks (T4) post-randomisation follow-up. Previous primary outcome measure: Paranoid symptoms are measured using the Paranoia Scale (PS) at baseline (T0), 6 (T1), 12 (T2), 18 (T3) and 24 weeks (T4) post-randomisation follow ups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/08/2022: 1. Target mechanism (interpretation bias) is measured at baseline (T0), 6 (T1), 12 (T2), 18 (T3), and 24 weeks (T4) post-randomisation using: 1.1. Similarity Rating Test (SRT) 1.2. Scrambled Sentences Task (SST) 2. Clinical symptoms are measured using: 2.1. Paranoia Scale (PS) at baseline (T0), 6 (T1), 12 (T2), and 18 weeks (T3) post-randomisation 2.2. Green Paranoid Thoughts Scale - Revised (R-GPTS) at baseline (T0), 6 (T1), 12 (T2), 18 (T3), and 24 weeks (T4) post-randomisation 2.3. Positive and Negative Symptom Schedule (PANSS) item 6 only at baseline (T0), 6 (T1), 12 (T2), 18 (T3), and 24 weeks (T4) post-randomisation 3. Other symptoms are measured at baseline (T0), 6 (T1), 12 (T2), 18 (T3), and 24 weeks (T4) post-randomisation using: 3.1. Hospital Anxiety and Depression Scale (HADS) 3.2. Paranoia Worries Questionnaire (PWQ) 4. Recovery is measured at baseline (T0), 6 (T1), 12 (T2), 18 (T3), and 24 weeks (T4) post-randomisation using: 4.1. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) 4.2. Questionnaire about the Process of Recovery (QPR) 4.3. Recovering Quality of Life (ReQoL) Previous secondary outcome measures: 1. Target mechanism (interpretation bias) is measured at baseline (T0), 6 (T1), 12 (T2), 18 (T3) and 24 weeks (T4) post-randomisation using: 1.1. Similarity Rating Test (SRT) 1.2. Scrambled Sentences Task (SST) 2. Paranoid symptoms are measured at baseline (T0), 6 (T1), 12 (T2), 18 (T3) and 24 weeks (T4) post-randomisation using: 2.1. Green Paranoid Thoughts Scale (GPTS) 2.2. Peter’s Delusions Inventory (PDI) 2.3. Positive and Negative Symptom Schedule (PANSS) - item 6 only 3. Other symptoms are measured using the Hospital Anxiety and Depression Scale (HADS) and Paranoia Worries Questionnaire (PWQ) at baseline (T0), 6 (T1), 12 (T2), 18 (T3) and 24 weeks (T4) post-randomisation 4. Recovery is measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) and Questionnaire about t | — |
Countries
England, United Kingdom
Contacts
Public ContactTanya Ricci
Outcome results
None listed