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

Vanderbilt University Medical Center120 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

120

Conditions

Schizophrenia Disorders

Interventions

Individuals will be assessed for which psychological factors are maintaining paranoia in their daily lives. They will collaboratively identify one maintenance factor to focus on (e.g. worry, anomalous experience, self-confidence, PTSD) for 8 weeks of individual therapy. Then, all participants will transition to 8 weeks of individual therapy focused on dropping safety behaviors and re-engaging in everyday life.

TAUBEHAVIORAL

Individuals will continue treatment as usual (TAU). In addition they will have contact with a study therapist weekly via phone to provide information on what treatment they received. Phone check-ins will last approximately 5-10 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in prior expectations of volatility (mu3)

Reversal learning data will be collected from a 3-option probabilistic reversal learning task. This data will be analyzed using a computational model that estimates the prior expectations of environmental volatility. That parameter, in many models, is Mu3.