NCT06835556 Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
| NCT ID | NCT06835556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Schizophrenia Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2029-09-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-01-15 with a primary completion date of 2029-09-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06835556 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06835556 currently recruiting?
Yes, NCT06835556 is actively recruiting participants. Contact the research team at julia.sheffield@vumc.org for enrollment information.
Where is the NCT06835556 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06835556 clinical trial?
NCT06835556 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 120 participants.
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