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

Testing the Role of Belief Updating in Persecutory Delusions

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 16 weeks
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether talk therapy for beliefs that others want to harm you changes how people learn and update their beliefs. It also looks for changes in brain activity. It is for adults with schizophrenia or related disorders who have these beliefs.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 65.
  • Able to communicate in English.
  • An estimated IQ above 79 before the illness began, based on the WTAR test.
  • Willing to give written consent to join.
  • Medicines have stayed the same for at least 2 weeks, including an antipsychotic medicine taken by mouth or injection.
  • Have a qualifying psychotic disorder, such as schizophrenia, schizoaffective disorder, schizophreniform disorder, or delusional disorder.
  • Have a strong belief that others want to harm you, lasting at least 2 months and not directly caused by substance use. The strength of this belief must score at least 3 on the PSYRATS rating scale.

Who can't join

  • Have a serious medical or nervous system illness known to affect thinking. Examples include uncontrolled diabetes or thyroid disease, lupus, multiple sclerosis, HIV, brain or spinal cord infections, unstable heart disease, active hepatitis, or brain or spinal cord cancer.
  • Have uncorrected vision problems or tardive dyskinesia, a condition that causes unwanted movements.
  • Have had a severe head injury that caused you to pass out for more than 30 minutes.
  • Have alcohol use disorder, drug use disorder, or a personality disorder as your main diagnosis.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

TN