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Completed

NCT Number: NCT04748679

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

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 diagnosis who endorse both a current persecutory delusion with strong conviction and significant worry will be recruited and randomized to receive either a CBT-based worry intervention for persecutory delusions or an active control condition (befriending therapy). The investigators will examine: 1) whether belief updating parameters change as delusion severity changes, 2) whether CBT contributes to greater change in belief updating parameters than befriending therapy, and 3) whether neural correlates of belief updating parameters, as measured using functional magnetic resonance imaging (fMRI), predict treatment response.

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Key information

Conditions

Schizophrenia; Psychosis Mental Disorders Persecutory Delusion 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

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 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 criteria

  • 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)

Treatment and study plan

Worry Intervention

Behavioral

The worry intervention is weekly individual therapy with a trained therapist

Befriending

Behavioral

The worry intervention is weekly individual therapy with a trained therapist

Primary outcomes

  1. Computational Parameters of Belief Updating as Measured During a Probabilistic Reversal Learning Task

    Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks

    change in computational parameters after intervention

  2. Change in Delusion Severity Utilizing the Change in Psychotic Symptoms Rating Scale (PSYRATS)

    Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks

    The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 24. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24.

  3. Change in Neural Correlates of Belief Updating Parameters

    Time frame: Baseline, 8 weeks

    Change in blood oxygen dependent level (BOLD) signal after intervention

Secondary outcomes

  1. Baseline Neural Predictors of Treatment Response

    Time frame: Baseline

    BOLD signal during belief updating task at baseline predicting treatment response

  2. Resting-State Predictors of Treatment Response

    Time frame: Baseline

    resting-state connectivity of functional networks predicting treatment response

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2021
Registry last updated
Aug 15, 2024

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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