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

Last updated: May 5, 2025
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Schizotypal Personality Disorder (Spd)

Tourette's Syndrome

Psychosis

Treatment

TAU

Cognitive Behavioral Therapy

Clinical Study ID

NCT06835556
240788
R01MH137024
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 ofeither an oral or intramuscular administration of an antipsychotic medication.

  • Diagnosis of a non-affective psychotic disorder (e.g. schizophrenia, schizoaffectivedisorder, schizophreniform disorder, delusional disorder)

  • A persecutory delusion scoring at least a 3 on the conviction scale of the PsychoticSymptoms Rating Scale (PSYRATS) that had persisted for at least two months and thatwas not considered the direct result of substance use.

Exclusion

Exclusion Criteria:

  • Serious medical or neurological illness known to interfere with cognitivefunctioning (uncontrolled/unstable diabetes, uncontrolled hypothyroidism, Cushing'sdisease, Lupus, any demyelinating disease such as Multiple Sclerosis, HIV infection,CNS infection, unstable heart disease, active hepatitis, other significant endocrinecondition, 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 Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: TAU
Phase:
Study Start date:
January 15, 2025
Estimated Completion Date:
February 01, 2030

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

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