Schizophrenia Disorders study: Cognitive Behavioral Therapy vs TAU
Official title Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
ClinicalTrials.gov ID: NCT06835556
What this study is testing
- What it's testing
- The study wants to see whether treatment reduces how people expect the world to be unpredictable and whether related brain activity changes.
- Who it's for
- Adults with schizophrenia‑spectrum disorders who experience persecutory (paranoid) delusions.
- What's involved
- Participants receive either cognitive‑behavioral therapy for psychosis (CBTp) or usual care with phone check‑ins for 16 weeks, complete several assessments, and may have an MRI scan.
- Time commitment
- The study lasts about 6 months, with therapy over 16 weeks and assessment visits at four time points.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- Serious medical or neurological illness known to interfere with cognitive functioning (uncontrolled/unstable diabetes, uncontrolled hypothyroidism...
- History of severe head trauma with loss of consciousness \>30 minutes.
- Primary diagnosis of alcohol or substance use disorder or personality disorder
See the full eligibility 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...
- 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...
- History of severe head trauma with loss of consciousness \>30 minutes.
- Primary diagnosis of alcohol or substance use disorder or personality disorder
The study team makes the final eligibility decision.
Where it is enrolling
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.