NCT04748679Completed
Cognitive Behavioral Therapy (CBT) Study Evaluating the Updating of Persecutory Beliefs
Source: ClinicalTrials.gov · Last updated 15 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 5 Feb 2021
- Start date
- 30 Mar 2021
- Primary completion date
- 29 May 2024
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Schizophrenia
- NCT number
- NCT04748679
What you commit to
- Study type: Interventional
- Participants enrolled: 62
- From 30 Mar 2021 to the primary completion date, 29 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who are actively involved with individual cognitive therapy (Past experience with individual therapy is not an exclusion)
Other illness
- Current medical or neurological illness.
- History of severe head trauma.
- Primary diagnosis of alcohol or substance use disorder or personality disorder
- Conditions that preclude fMRI scanning (as defined in the fMRI Screening Form)
Age
- Age less than 18 or greater than 65.
Other
- Not communicative in English.
- Premorbid IQ \< 79 (WTAR)
- Unable to provide written informed consent.
- Weight \>300 lbs
Who the study is looking for
- Men and women age 18 - 65.
- Communicative in English.
- Premorbid Intelligence \>79 (WTAR)
- Provide voluntary, written informed consent.
- Physically healthy by medical history.
- Weight \<300 lbs
- Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
- 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.
- 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
- A clinically significant level of worry, as shown by a score of at least 44 on the Penn State Worry Questionnaire (PSWQ).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.