An interventional study of Worry Intervention and Befriending in Schizophrenia; Psychosis and Persecutory Delusion, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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 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
The worry intervention is weekly individual therapy with a trained therapist
The worry intervention is weekly individual therapy with a trained therapist
Computational Parameters of Belief Updating as Measured During a Probabilistic Reversal Learning Task
change in computational parameters after intervention
Time frame: 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.
Time frame: 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
Time frame: Baseline, 8 weeks
Baseline Neural Predictors of Treatment Response
BOLD signal during belief updating task at baseline predicting treatment response
Time frame: Baseline
Resting-State Predictors of Treatment Response
resting-state connectivity of functional networks predicting treatment response
Time frame: Baseline
Plan to share: No
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Vanderbilt University Medical Center