Status:

COMPLETED

Cognitive Behavioral Therapy (CBT) Study Evaluating the Updating of Persecutory Beliefs

Lead Sponsor:

Vanderbilt University Medical Center

Conditions:

Schizophrenia; Psychosis

Persecutory Delusion

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

The purpose of this study is to examine how Bayesian belief updating changes throughout psychotherapeutic treatment for persecutory delusions. Specifically, individuals with a psychotic disorder diagn...

Eligibility Criteria

Inclusion

  • Men and women age 18 - 65.
  • Communicative in English.
  • Premorbid Intelligence \>79 (WTAR)
  • Provide voluntary, written informed consent.
  • Physically healthy by medical history.
  • Weight \<300 lbs
  • 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 (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief psychotic disorder, psychosis NOS) confirmed by Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-5 (SCID) or diagnostic interview with a trained clinician.
  • 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 weeks and that was not considered the direct result of substance use
  • A clinically significant level of worry, as shown by a score of at least 44 on the Penn State Worry Questionnaire (PSWQ).

Exclusion

  • Age less than 18 or greater than 65.
  • Not communicative in English.
  • Premorbid IQ \< 79 (WTAR)
  • Unable to provide written informed consent.
  • Current medical or neurological illness.
  • History of severe head trauma.
  • Weight \>300 lbs
  • Primary diagnosis of alcohol or substance use disorder or personality disorder
  • Conditions that preclude fMRI scanning (as defined in the fMRI Screening Form)
  • Subjects who are actively involved with individual cognitive therapy (Past experience with individual therapy is not an exclusion)

Key Trial Info

Start Date :

March 30 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 29 2024

Estimated Enrollment :

62 Patients enrolled

Trial Details

Trial ID

NCT04748679

Start Date

March 30 2021

End Date

May 29 2024

Last Update

August 15 2024

Active Locations (1)

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1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212

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