RecruitingNot ApplicableNCT06835556

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

Testing the Role of Belief Updating in Persecutory Delusions


Sponsor

Vanderbilt University Medical Center

Enrollment

120 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial (VIP) tests whether a specific type of talking therapy can help reduce paranoid thinking in people with psychotic disorders (such as schizophrenia) by targeting a tendency called "volatility" — the brain's habit of overreacting to unexpected events and expecting the worst. **You may be eligible if...** - You are between 18 and 65 years old - You communicate in English - You have been diagnosed with a non-affective psychotic disorder (e.g., schizophrenia, schizoaffective disorder, or delusional disorder) - You experience ongoing paranoid beliefs that have persisted for at least 2 months - Your psychiatric medications have been stable for at least 2 weeks **You may NOT be eligible if...** - You have a serious medical or neurological illness that affects thinking - You have an active severe substance use disorder - You are acutely suicidal - You have IQ below 80 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive 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.

BEHAVIORALTAU

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.


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT06835556


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