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NCT Number: NCT06835556

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

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

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Key information

Conditions

Schizophrenia Disorders Behavior Behavioral Symptoms Delusions Mental Disorders Paranoid Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location status: Recruiting

Location contact

Julia Sheffield, PhD

CONTACT

[email protected]

615-343-3839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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.

TAU

Behavioral

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 outcomes

  1. Change in prior expectations of volatility (mu3)

    Time frame: Baseline to 16 weeks

    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.

  2. Change in unexpected uncertainty (kappa)

    Time frame: Baseline to 16 weeks

    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.

  3. Change in psychotic Symptom Rating Scale (PSYRATS)- Belief Subscale Total

    Time frame: Baseline to 16 weeks

    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

  4. Change in PANSS Positive Symptoms - Total

    Time frame: Baseline to 16 weeks

    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

  5. BOLD activation change during PRL task, pre/post treatment - prefrontal cortex

    Time frame: Baseline to 16 weeks

    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

  6. BOLD activation change pre/post treatment - striatum

    Time frame: Baseline to 16 weeks

    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

  7. BOLD activation change during PRL task, pre/post treatment - locus coeruleus

    Time frame: Baseline to 16 weeks

    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

  8. Task-based functional connectivity changes during PRL task, pre/post treatment - prefrontal cortex to striatum

    Time frame: Baseline to 16 weeks

    Functional connectivity during the PRL task will be quantified between the dlPFC and striatum

Secondary outcomes

  1. Change in PANSS P1 Item

    Time frame: Baseline to 16 weeks

    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

  2. Change in PANSS P6 Item

    Time frame: Baseline to 16 weeks

    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

  3. Change in meta-volatility learning rate (omega3)

    Time frame: Baseline to 16 weeks

    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.

  4. BOLD activation changes during PRL task, pre/post treatment - whole brain analysis

    Time frame: Baseline to 16 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Julia Sheffield, PhD

CONTACT

[email protected]

615-343-3839

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Testing the Role of Belief Updating in Persecutory Delusions

Acronym: VIP

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Feb 19, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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