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

Primary Purpose

Schizophrenia; Psychosis, Persecutory Delusion

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Worry Intervention

Befriending

About this trial

This is an interventional treatment trial for Schizophrenia; Psychosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Worry Intervention

Befriending

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

change in computational parameters after intervention

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.

Change in Neural Correlates of Belief Updating Parameters

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

Secondary Outcome Measures

Baseline Neural Predictors of Treatment Response

BOLD signal during belief updating task at baseline predicting treatment response

Resting-State Predictors of Treatment Response

resting-state connectivity of functional networks predicting treatment response

Full Information

NCT ID

NCT04748679

First Posted

February 5, 2021

Last Updated

September 23, 2023

Sponsor

Vanderbilt University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04748679

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2021 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia; Psychosis, Persecutory Delusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Worry Intervention

Arm Type

Experimental

Arm Description

Arm Title

Befriending

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Worry Intervention

Intervention Description

The worry intervention is weekly individual therapy with a trained therapist

Intervention Type

Behavioral

Intervention Name(s)

Befriending

Intervention Description

The worry intervention is weekly individual therapy with a trained therapist

Primary Outcome Measure Information:

Title

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

Description

change in computational parameters after intervention

Time Frame

Baseline, 4 weeks, 8 weeks, 24 weeks

Title

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

Description

Time Frame

Baseline, 4 weeks, 8 weeks, 24 weeks

Title

Change in Neural Correlates of Belief Updating Parameters

Description

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

Time Frame

Baseline, 8 weeks

Secondary Outcome Measure Information:

Title

Baseline Neural Predictors of Treatment Response

Description

BOLD signal during belief updating task at baseline predicting treatment response

Time Frame

Baseline

Title

Resting-State Predictors of Treatment Response

Description

resting-state connectivity of functional networks predicting treatment response

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julia M Sheffield, PhD

Phone

6153433839

julia.sheffield@vumc.org

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julia Sheffield, PhD

12. IPD Sharing Statement

Plan to Share IPD

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

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