Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
Recruiting · NCT06835556 · Interventional (participants receive a specific treatment) · Lead sponsor: Vanderbilt University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Vanderbilt University Medical Center - Nashville, Tennessee, United States