Examining how psychotherapy affects paranoia in schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of psychotherapy on individuals with schizophrenia-spectrum disorders, specifically focusing on changes in belief updating and environmental volatility related to persecutory delusions. Participants will receive either Cognitive Behavioral Therapy for psychosis (CBTp) or treatment as usual (TAU) along with phone check-ins over a 16-week period. Assessments will be conducted at four different time points over six months, and MRI scans may be performed to observe corresponding brain activity changes. The study aims to determine if effective treatment can reduce prior expectations about environmental volatility and alter brain activity.

Why it matters

Who can join: the full rules

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's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Julia Sheffield, PhD
• Email: julia.sheffield@vumc.org
• Phone: 615-343-3839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.