What is the mechanism of action of this treatment?

Cognitive-behavioral therapy (CBT) is a common treatment for persecutory delusions, focusing on cognitive restructuring to reduce worry and delusional conviction. The mechanism of action involves identifying and challenging irrational beliefs, teaching patients to observe their thoughts and generate alternative, more realistic perspectives. This process helps reduce the intensity and frequency of delusional thoughts by addressing the underlying cognitive distortions. For persecutory delusion patients, this is crucial as it directly targets the maladaptive thought patterns that fuel their delusions, thereby improving their overall mental health and quality of life.

What side effects are associated with this type of intervention?

Cognitive-behavioral therapy (CBT) for persecutory delusions, including interventions aimed at reducing worry and delusional conviction, is generally well-tolerated with minimal side effects. Common side effects may include temporary increases in anxiety or distress as patients confront their fears and beliefs during therapy sessions. Some individuals may experience emotional discomfort or fatigue due to the intensive nature of the therapy. However, these side effects are typically mild and transient, and the overall risk profile of CBT is considered low compared to pharmacological treatments.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of psychotic disorders, which can include persecutory delusions. These medications include atypical antipsychotics such as risperidone, olanzapine, and aripiprazole. Cognitive Behavioral Therapy (CBT), particularly interventions focused on cognitive restructuring to reduce worry and delusional conviction, is a widely recognized non-pharmacological treatment, although it is not specifically FDA-approved as it is a therapeutic approach rather than a drug. The combination of antipsychotic medications and CBT is often used to manage symptoms effectively.

What other types of research exist?

Promising novel alternatives to CBT-based worry intervention for persecutory delusion patients include: 1) Befriending therapy, which serves as an active control condition and focuses on social support, 2) Neuromodulation procedures such as subcallosal cingulate deep brain stimulation and bilateral anterior capsulotomy, which have shown clinical improvements in treatment-resistant cases, and 3) Pharmacological augmentation strategies, such as the use of antipsychotic medications or adjunctive therapies like acetylcholinesterase inhibitors to enhance cognitive function.

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Cognitive Behavioral Therapy for Persecutory Delusions

N/A

Waitlist Available

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women age 18 - 65

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

Must not have

Current medical or neurological illness

Weight >300 lbs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial examines how therapy changes patients' beliefs about being persecuted. It focuses on people with severe worries and false beliefs about harm. The therapy aims to help them understand and manage these worries better.

Who is the study for?

This trial is for adults aged 18-65 with a non-affective psychotic disorder, such as schizophrenia, who have stable medication use and a specific type of delusion (persecutory). They must be English speakers, in good physical health without severe neurological issues or substance abuse disorders. Participants need to have had their delusions for at least two weeks and experience significant worry.

What is being tested?

The study tests if Cognitive Behavioral Therapy (CBT) focused on worry can change how strongly people with persecutory delusions believe in them compared to befriending therapy. It also looks at brain activity related to these beliefs using fMRI scans before and after treatment to see if it predicts how well patients will respond.

What are the potential side effects?

Since the interventions are psychological therapies rather than medications, typical side effects associated with drugs may not apply. However, participants might experience discomfort discussing personal thoughts or feelings during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have strong, lasting beliefs of being harmed that aren't due to substance use.

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I have been diagnosed with a type of non-affective psychotic disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a current medical or neurological condition.

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I weigh more than 300 lbs.

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I am either younger than 18 or older than 65.

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I cannot communicate in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Delusion Severity Utilizing the Change in Psychotic Symptoms Rating Scale (PSYRATS)

Change in Neural Correlates of Belief Updating Parameters

Computational Parameters of Belief Updating as Measured During a Probabilistic Reversal Learning Task

Secondary study objectives

Baseline Neural Predictors of Treatment Response

Resting-State Predictors of Treatment Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Worry InterventionExperimental Treatment1 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 II: BefriendingActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Worry Intervention

2021

N/A

~70

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive-behavioral therapy (CBT) is a common treatment for persecutory delusions, focusing on cognitive restructuring to reduce worry and delusional conviction. The mechanism of action involves identifying and challenging irrational beliefs, teaching patients to observe their thoughts and generate alternative, more realistic perspectives. This process helps reduce the intensity and frequency of delusional thoughts by addressing the underlying cognitive distortions. For persecutory delusion patients, this is crucial as it directly targets the maladaptive thought patterns that fuel their delusions, thereby improving their overall mental health and quality of life.