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

Not Applicable

Completed

• Conditions: Schizophrenia; Psychosis; Persecutory Delusion
• Interventions: Behavioral: Befriending; Behavioral: Worry Intervention

• Registration Number: NCT04748679
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Study Start: 2021-03-30
• Primary Completion: 2024-05-29
• Study Completion: 2024-05-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Befriending	Befriending	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.
Worry Intervention	Worry Intervention	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.

Primary Outcome Measures

Name	Time	Method
Computational Parameters of Belief Updating as Measured During a Probabilistic Reversal Learning Task	Baseline, 4 weeks, 8 weeks, 24 weeks	change in computational parameters after intervention
Change in Neural Correlates of Belief Updating Parameters	Baseline, 8 weeks	Change in blood oxygen dependent level (BOLD) signal after intervention
Change in Delusion Severity Utilizing the Change in Psychotic Symptoms Rating Scale (PSYRATS)	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.

Secondary Outcome Measures

Name	Time	Method
Baseline Neural Predictors of Treatment Response	Baseline	BOLD signal during belief updating task at baseline predicting treatment response
Resting-State Predictors of Treatment Response	Baseline	resting-state connectivity of functional networks predicting treatment response

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States