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Recruiting NCT06835556

Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy

No phase Interventional Schizophrenia Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavioral Therapy, TAU.
Who it may be relevant to
Registry conditions: Schizophrenia Disorders. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Testing the Role of Belief Updating in Persecutory Delusions

Overview

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

Interventions

  • Behavioral Cognitive Behavioral Therapy
    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.
  • Behavioral TAU
    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.

Primary outcome measures

  • Change in prior expectations of volatility (mu3) [Time frame: Baseline to 16 weeks]
  • Change in unexpected uncertainty (kappa) [Time frame: Baseline to 16 weeks]
  • Change in psychotic Symptom Rating Scale (PSYRATS)- Belief Subscale Total [Time frame: Baseline to 16 weeks]
  • Change in PANSS Positive Symptoms - Total [Time frame: Baseline to 16 weeks]
  • BOLD activation change during PRL task, pre/post treatment - prefrontal cortex [Time frame: Baseline to 16 weeks]
  • BOLD activation change pre/post treatment - striatum [Time frame: Baseline to 16 weeks]
  • BOLD activation change during PRL task, pre/post treatment - locus coeruleus [Time frame: Baseline to 16 weeks]
  • Task-based functional connectivity changes during PRL task, pre/post treatment - prefrontal cortex to striatum [Time frame: Baseline to 16 weeks]
Secondary outcome measures (4)
  • Change in PANSS P1 Item [Time frame: Baseline to 16 weeks]
  • Change in PANSS P6 Item [Time frame: Baseline to 16 weeks]
  • Change in meta-volatility learning rate (omega3) [Time frame: Baseline to 16 weeks]
  • BOLD activation changes during PRL task, pre/post treatment - whole brain analysis [Time frame: Baseline to 16 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT06835556 · 240788 · R01MH137024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗