An interventional study of Cognitive Behavioral Therapy and TAU in Schizophrenia Disorders, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Basic science
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:
Participants will:
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 120 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weekly individual psychotherapy targeting specific maintenance factors of paranoia (worry, anomalous experiences, self-confidence, and safety behaviors), tailored to the participant's experience
Behavioral: Cognitive Behavioral Therapy
Participants will continue with their regular care (treatment as usual (TAU)) without interference from the study team. In addition to TAU, a study therapist will call them weekly to review what treatment the participants have engaged in. Phone calls will last approximately 5-10 minutes
Behavioral: TAU
Individuals will be assessed for which psychological factors are maintaining paranoia in their daily lives. They will collaboratively identify one maintenance factor to focus on (e.g. worry, anomalous experience, self-confidence, PTSD) for 8 weeks of individual therapy. Then, all participants will transition to 8 weeks of individual therapy focused on dropping safety behaviors and re-engaging in everyday life.
Individuals will continue treatment as usual (TAU). In addition they will have contact with a study therapist weekly via phone to provide information on what treatment they received. Phone check-ins will last approximately 5-10 minutes.
Change in prior expectations of volatility (mu3)
Reversal learning data will be collected from a 3-option probabilistic reversal learning task. This data will be analyzed using a computational model that estimates the prior expectations of environmental volatility. That parameter, in many models, is Mu3.
Time frame: Baseline to 16 weeks
Change in unexpected uncertainty (kappa)
Reversal learning data will be collected from a 3-option probabilistic reversal learning task. This data will be analyzed using a computational model that estimates the unexpected uncertainty, sometimes also referred to as sensitivity to volatility.
Time frame: Baseline to 16 weeks
Change in psychotic Symptom Rating Scale (PSYRATS)- Belief Subscale Total
The PSYRATS is a interview-assisted assessment measuring the severity of a delusional belief. Total scores range from 0-24 with high scores indicating more severe delusion; 6 questions, 0-4 scale for each item
Time frame: Baseline to 16 weeks
Change in PANSS Positive Symptoms - Total
The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The positive symptom total score is the sum of the Positive Symptom items
Time frame: Baseline to 16 weeks
BOLD activation change during PRL task, pre/post treatment - prefrontal cortex
functional MRI will be used to collect BOLD activation data during the PRL reversal learning task. The investigators expect changes in activation following treatment, particularly in the CBTp group
Time frame: Baseline to 16 weeks
BOLD activation change pre/post treatment - striatum
functional MRI will be used to collect BOLD activation data during the PRL reversal learning task. The investigators expect changes in activation following treatment, particularly in the CBTp group
Time frame: Baseline to 16 weeks
BOLD activation change during PRL task, pre/post treatment - locus coeruleus
functional MRI will be used to collect BOLD activation data during the PRL reversal learning task. The investigators expect changes in activation following treatment, particularly in the CBTp group
Time frame: Baseline to 16 weeks
Task-based functional connectivity changes during PRL task, pre/post treatment - prefrontal cortex to striatum
Functional connectivity during the PRL task will be quantified between the dlPFC and striatum
Time frame: Baseline to 16 weeks
Volatility Expectations - During Stable3 Task
Time frame: Change from baseline
Scale of Unpredictability Beliefs
Time frame: Change from baseline
Change in PANSS P1 Item
The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. P1 is the first item on the scale, representing delusion severity
Time frame: Baseline to 16 weeks
Change in PANSS P6 Item
The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. P6 is the item on the scale assessing severity of paranoia/suspiciousness
Time frame: Baseline to 16 weeks
Change in meta-volatility learning rate (omega3)
Reversal learning data will be collected from a 3-option probabilistic reversal learning task. This data will be analyzed using a computational model that estimates the meta-volatility.
Time frame: Baseline to 16 weeks
BOLD activation changes during PRL task, pre/post treatment - whole brain analysis
Time frame: Baseline to 16 weeks
PSYRATS Hallucinations
Time frame: Change from baseline
Kamin Blocking
Time frame: Change from baseline
Social Hallucinations - Chasing
Time frame: Change from baseline
Minnesota Trust Game
Time frame: Change from baseline
r-GPTS
Time frame: Change from baseline
DWQ
Time frame: Change from baseline
BDI-II
Time frame: Change from baseline
O-AS
Time frame: Change from baseline
Positive Thoughts Scale
Time frame: Change from baseline
Guilt and Shame Experiences Scale
Time frame: Change from baseline
O-CDQ
Time frame: Change from baseline
Insomnia Severity Index
Time frame: Change from baseline
PCL-5
Time frame: Change from baseline
CEFSA
Time frame: Change from baseline
DERS-16
Time frame: Change from baseline
Intolerance of Uncertainty
Time frame: Change from baseline
LSAS
Time frame: Change from baseline
LSNS-6
Time frame: Change from baseline
CHOICE
Time frame: Change from baseline
WEMWBS
Time frame: Change from baseline
MCQ-36
Time frame: Change from baseline
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Sep 2029, 55 months after the start.
Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 55 months is above that.
Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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