NCT06835556Recruiting
Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
Testing the Role of Belief Updating in Persecutory Delusions
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 12 Feb 2025
- Start date
- 15 Jan 2025
- Primary completion date
- 3 Sept 2029
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Schizophrenia
- NCT number
- NCT06835556
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 15 Jan 2025 to the primary completion date, 3 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Serious medical or neurological illness known to interfere with cognitive functioning (uncontrolled/unstable diabetes, uncontrolled hypothyroidism, Cushing's disease, Lupus, any demyelinating disease such as Multiple Sclerosis, HIV infection, CNS infection, unstable heart disease, active hepatitis, other significant endocrine condition, any cancer involving the CNS/brain, any uncorrected vision problems, tardive dyskinesia).
- History of severe head trauma with loss of consciousness \>30 minutes.
- Primary diagnosis of alcohol or substance use disorder or personality disorder
Who the study is looking for
- Men and women age 18 - 65.
- Communicative in English.
- Premorbid IQ \>79 (WTAR)
- Provide voluntary, written informed consent.
- Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
- Diagnosis of a non-affective psychotic disorder (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder)
- A persecutory delusion scoring at least a 3 on the conviction scale of the Psychotic Symptoms Rating Scale (PSYRATS) that had persisted for at least two months and that was not considered the direct result of substance use.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.