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

NCT04748679 | Completed

• 1 other identifier: 201882
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Schizophrenia; Psychosis; Persecutory Delusion

Outcome Measures

Primary Outcomes (3)

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

  change in computational parameters after intervention

  Baseline, 4 weeks, 8 weeks, 24 weeks

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

  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.

  Baseline, 4 weeks, 8 weeks, 24 weeks

• Change in Neural Correlates of Belief Updating Parameters

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

  Baseline, 8 weeks

Secondary Outcomes (2)

• Baseline Neural Predictors of Treatment Response

  Baseline

• Resting-State Predictors of Treatment Response

  Baseline

Study Arms (2)

Worry Intervention

EXPERIMENTAL

The Worry Intervention uses cognitive-behavioral therapy (CBT) techniques to support the patient in reducing the amount of time they worry throughout the week. It is an 8-week manualized treatment with 5 modules. Each session is 45-60 minutes.

Behavioral: Worry Intervention

Befriending

ACTIVE COMPARATOR

Befriending therapy controls for the general factors of therapy (warmth, engagement) without any 'active' interventions. Individuals in the befriending arm will spend sessions talking with the therapist about things that interest them. It will also be conducted over 8-weeks with 45-60 minute sessions.

Behavioral: Befriending

Interventions

Worry Intervention BEHAVIORAL

The worry intervention is weekly individual therapy with a trained therapist

Worry Intervention

Befriending BEHAVIORAL

The worry intervention is weekly individual therapy with a trained therapist

Befriending

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• Sheffield JM, Sloan AF, Corlett PR, Rogers BP, Vandekar S, Liu J, Beals KM, Hall LM, Gautier T, Moussa-Tooks AB, Torregrossa LJ, Achee M, Armstrong K, Woodward ND, Belt K, Freeman D, Isham L, Diamond R, Brinen AP, Heckers S. Prior Expectations of Volatility Following Psychotherapy for Delusions: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2517132. doi: 10.1001/jamanetworkopen.2025.17132.

  PMID: 40553472 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: March 30, 2021
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)