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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVanderbilt University Medical Center

About this trial

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

Qualifiers

Men and women age 18 - 65.

Communicative in English.

Premorbid IQ >79 (WTAR)

Provide voluntary, written informed consent.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cognitive Behavioral Therapy
  • TAU

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Vanderbilt University Medical Center

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator