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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVanderbilt University Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women age 18 - 65.

Communicative in English.

Premorbid IQ >79 (WTAR)

Provide voluntary, written informed consent.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: CBTpExperimental treatment 1 intervention
Group B: TAU + Phone Check-InActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Time frame
Baseline to 16 weeks

Other outcomes

Sponsors and contacts

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Vanderbilt University Medical Center

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator