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

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

Recruiting
18-65 years
All
Phase N/A

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Overview

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

Eligibility

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study details
    Schizophrenia Disorders

NCT06835556

Vanderbilt University Medical Center

13 May 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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