STOP - Successful treatment of paranoia

Not Applicable

• Conditions: Personality disorder - paranoia; Mental and Behavioural Disorders; Paranoid personality disorder

• Registration Number: ISRCTN17754650
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-03
• Last Update Posted: 9 September 2024
• Study Completion: 2024-12-16

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 274

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 24/08/2022:<br>Paranoid symptoms are measured using the Paranoia Scale (PS) at 24 weeks (T4) post-randomisation follow-up.<br><br><br>Previous primary outcome measure:<br>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.