NCT06835556

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

Testing the Role of Belief Updating in Persecutory Delusions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Schizophrenia Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	Individuals will be assessed for which psychological factors are maintaining paranoia in their daily lives. They will collaboratively identify one maintenance factor to focus on (e.g. worry, anomalous experience, self-confidence, PTSD) for 8 weeks of individual therapy. Then, all participants will transition to 8 weeks of individual therapy focused on dropping safety behaviors and re-engaging in everyday life.
BEHAVIORAL	TAU	Individuals will continue treatment as usual (TAU). In addition they will have contact with a study therapist weekly via phone to provide information on what treatment they received. Phone check-ins will last approximately 5-10 minutes.

Timeline

• Start date: 2025-01-15
• Primary completion: 2029-09-03
• Completion: 2030-02-01
• First posted: 2025-02-19
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States