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Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy

Study acronym: VIP
StatusRecruiting
PhaseNot applicable
Started2025-01-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 8 → 10 primary endpoints
See other at-risk trials from Vanderbilt University Medical Center

Amendment history

2026-10-01
Primary endpoint(s) modified8 to 10 entries
WasBOLD activation change during PRL task, pre/post treatment - locus coeruleus, BOLD activation change during PRL task, pre/post treatment - prefrontal cortex, BOLD activation change pre/post treatment - striatum, Change in PANSS Positive Symptoms - Total, Change in prior expectations of volatility (mu3), Change in psychotic Symptom Rating Scale (PSYRATS)- Belief Subscale Total, Change in unexpected uncertainty (kappa), Task-based functional connectivity changes during PRL task, pre/post treatment - prefrontal cortex to striatum
NowBOLD activation change during PRL task, pre/post treatment - locus coeruleus, BOLD activation change during PRL task, pre/post treatment - prefrontal cortex, BOLD activation change pre/post treatment - striatum, Change in PANSS Positive Symptoms - Total, Change in prior expectations of volatility (mu3), Change in psychotic Symptom Rating Scale (PSYRATS)- Belief Subscale Total, Change in unexpected uncertainty (kappa), Scale of Unpredictability Beliefs, Task-based functional connectivity changes during PRL task, pre/post treatment - prefrontal cortex to striatum, Volatility Expectations - During Stable3 Task
2026-05-04
Study Status, Oversight v3
Re-verified, no change to tracked fields
2025-05-05
Study Status, Oversight v2
Primary completion date2029-04→2029-09-03
Completion date2029-10→2030-02-01
2025-02-18
Study Identification, Study Status, Arms and Interventions, Outcome Measures, IPDSharing v1
Secondary endpoints4 entries, revised
ReducedChange in PANSS P1 Item ReducedChange in PANSS P6 Item increasedChange in meta-volatility learning rate (omega3)
Primary endpoints8 entries, revised
BOLD activation reductionchange during PRL task, pre/post treatment - locus coeruleus BOLD activation reductionchange during PRL task, pre/post treatment - prefrontal cortex BOLD activation reductionchange pre/post treatment - striatum ReducedChange in PANSS Positive Symptoms - Total ReducedChange in prior expectations of volatility (mu3) ReducedChange in psychotic Symptom Rating Scale (PSYRATS)- Belief Subscale Total ReducedChange in unexpected uncertainty (kappa)
Study title+64 characters
Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
2025-02-12
Original filing
The goal of this clinical trial is to learn whether learning and belief updating change in response to the treatment of persecutory delusions, in individuals with schizophrenia-spectrum disorders. The main questions are: 1. do prior expectations about environmental volatility reduce following effective psychotherapeutic treatment of delusions? 2. does corresponding brain activity related to volatility change with effective treatment of delusions? Participants will: 1. engage in CBTp or TAU + phone check-ins for 16 weeks 2. complete assessments at 4 timepoints over the course of 6 months 3. complete an MRI when possible
Trial Details
NCT Number NCT06835556
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Institute of Mental Health (NIMH)
Conditions Schizophrenia Disorders
Enrollment 120 participants
Start Date 2025-01-15
Primary Completion 2029-09-03 (estimated)
Study Completion 2030-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-30