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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2024-05-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Schizophrenia; Psychosis Persecutory Delusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Worry Intervention

Intervention Type BEHAVIORAL

The worry intervention is weekly individual therapy with a trained therapist

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.

Group Type ACTIVE_COMPARATOR

Befriending

Intervention Type BEHAVIORAL

The worry intervention is weekly individual therapy with a trained therapist

Interventions

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Worry Intervention

The worry intervention is weekly individual therapy with a trained therapist

Intervention Type BEHAVIORAL

Befriending

The worry intervention is weekly individual therapy with a trained therapist

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No