Clinical trial NCT04748679: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia; Psychosis
Persecutory Delusion
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Computational Parameters of Belief Updating as Measured During a Probabilistic Reversal Learning Task
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks
measure: Change in Delusion Severity Utilizing the Change in Psychotic Symptoms Rating Scale (PSYRATS)
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks
measure: Change in Neural Correlates of Belief Updating Parameters
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Baseline Neural Predictors of Treatment Response
timeFrame: Baseline
measure: Resting-State Predictors of Treatment Response
timeFrame: Baseline
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: