Examining how psychotherapy affects paranoia in schizophrenia
Testing the Role of Belief Updating in Persecutory Delusions
This study is testing whether psychotherapy can help people with schizophrenia feel less paranoid and change how they think about their surroundings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06835556 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 to 65 with a diagnosis of a non-affective psychotic disorder and persistent persecutory delusions.
Not a fit: Patients with serious medical or neurological illnesses that interfere with cognitive functioning may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved therapeutic strategies for managing paranoia in patients with schizophrenia.
How similar studies have performed: Previous studies have shown promise in using psychotherapy to address delusions in schizophrenia, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.