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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial is studying how well a cognitive behavioral therapy (CBT)-based worry intervention works compared to an active control condition (befriending therapy) in people with persecutory delusions.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Baseline Neural Predictors of Treatment Response
Resting-State Predictors of Treatment Response

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.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,130 Total Patients Enrolled

Media Library

Worry Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04748679 — N/A
Persecutory Delusion Research Study Groups: Worry Intervention, Befriending
Persecutory Delusion Clinical Trial 2023: Worry Intervention Highlights & Side Effects. Trial Name: NCT04748679 — N/A
Worry Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04748679 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the highest participant capacity of this experiment?

"Affirmative. Clinicaltrials.gov lists this clinical trial as actively recruiting participants, with 60 people needed to be recruited from one site since its initial posting on March 30th 2021 and last update on July 18th 2022."

Answered by AI

Can individuals participate in this experiment at this time?

"Confirmed. According to records on clinicaltrials.gov, this trial was initially posted on March 30th 2021 and is currently in the process of recruiting patients. 60 participants are needed from a single site for completion of the study's objectives."

Answered by AI

What qualifications must prospective participants possess in order to be eligible for the clinical trial?

"This trial is searching for approximately 60 individuals who suffer from delusions and are aged between 18-65. To be considered, potential participants must meet these criteria."

Answered by AI

Is the elderly population included in this clinical trial's recruitment?

"The age qualifications for this trial are ages 18-65, as specified by the inclusion criteria."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cognitive Behavioral Therapy (CBT) Study Evaluating the Updating of Persecutory Beliefs
Julia Sheffield 2021. "Cognitive Behavioral Therapy (CBT) Study Evaluating the Updating of Persecutory Beliefs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04748679.
~2 spots leftby Jun 2024
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