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

Schizophrenia; Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04748679
• Other study ID #: 201882
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: December 1, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Men and women age 18 - 65.

2. Communicative in English.

3. Premorbid Intelligence >79 (WTAR)

4. Provide voluntary, written informed consent.

5. Physically healthy by medical history.

6. Weight <300 lbs

7. Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.

8. 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.

9. 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

10. A clinically significant level of worry, as shown by a score of at least 44 on the Penn State Worry Questionnaire (PSWQ).

Exclusion Criteria:

1. Age less than 18 or greater than 65.

2. Not communicative in English.

3. Premorbid IQ < 79 (WTAR)

4. Unable to provide written informed consent.

5. Current medical or neurological illness.

6. History of severe head trauma.

7. Weight >300 lbs

8. Primary diagnosis of alcohol or substance use disorder or personality disorder

9. Conditions that preclude fMRI scanning (as defined in the fMRI Screening Form)

10. Subjects who are actively involved with individual cognitive therapy (Past experience with individual therapy is not an exclusion)

Related Conditions & MeSH terms

• Delusions
• Persecutory Delusion
• Schizophrenia
• Schizophrenia; Psychosis

Intervention

Behavioral:
• Worry Intervention
The worry intervention is weekly individual therapy with a trained therapist
• Befriending
The worry intervention is weekly individual therapy with a trained therapist

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Neural Correlates of Belief Updating Parameters	Change in blood oxygen dependent level (BOLD) signal after intervention	Baseline, 8 weeks
Secondary	Baseline Neural Predictors of Treatment Response	BOLD signal during belief updating task at baseline predicting treatment response	Baseline
Secondary	Resting-State Predictors of Treatment Response	resting-state connectivity of functional networks predicting treatment response	Baseline