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

Официальное название

Testing the Role of Belief Updating in Persecutory Delusions

Обзор

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

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change in prior expectations of volatility (mu3) [Срок оценки: Baseline to 16 weeks]
• Change in unexpected uncertainty (kappa) [Срок оценки: Baseline to 16 weeks]
• Change in psychotic Symptom Rating Scale (PSYRATS)- Belief Subscale Total [Срок оценки: Baseline to 16 weeks]
• Change in PANSS Positive Symptoms - Total [Срок оценки: Baseline to 16 weeks]
• BOLD activation change during PRL task, pre/post treatment - prefrontal cortex [Срок оценки: Baseline to 16 weeks]
• BOLD activation change pre/post treatment - striatum [Срок оценки: Baseline to 16 weeks]
• BOLD activation change during PRL task, pre/post treatment - locus coeruleus [Срок оценки: Baseline to 16 weeks]
• Task-based functional connectivity changes during PRL task, pre/post treatment - prefrontal cortex to striatum [Срок оценки: Baseline to 16 weeks]

Вторичные конечные точки (4)

• Change in PANSS P1 Item [Срок оценки: Baseline to 16 weeks]
• Change in PANSS P6 Item [Срок оценки: Baseline to 16 weeks]
• Change in meta-volatility learning rate (omega3) [Срок оценки: Baseline to 16 weeks]
• BOLD activation changes during PRL task, pre/post treatment - whole brain analysis [Срок оценки: Baseline to 16 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT06835556 · 240788 · R01MH137024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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