Clinical trial for Schizophrenia Disorder
Official title A Virtual Reality Mindfulness Application for Aggression in Schizophrenia
ClinicalTrials.gov ID: NCT07434479
What this study is testing
- What it's testing
- The study wants to find out whether mindfulness delivered through VR can lower impulsive aggression and change brain activity in a region that controls emotions.
- Who it's for
- Adults who have schizophrenia or schizoaffective disorder and experience aggressive or impulsive behavior.
- What's involved
- Participants will be randomly assigned to receive different amounts of VR mindfulness sessions or distraction tasks. They will also have brain scans (fMRI) while doing an emotion‑regulation task and complete clinical questionnaires about aggression.
- Time commitment
- The study involves several VR sessions over a period of weeks, plus a few fMRI scans and clinical visits.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Is willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements...
- Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
- Be on optimized and stable atypical antipsychotic treatment as indicated by no antipsychotic changes in 2 weeks prior to enrollment.
- Demonstrate documented evidence of good medication adherence for the 2 weeks prior to enrollment, as determined by electronic medication records...
- Have a history of impulsive aggression as assessed by a score of ≥ 4 on any item on Impulsive Aggression Factor (IA) on the Impulsive- Premeditated...
You likely can't join if
- Have past head trauma
- Diagnosed with a neurological disorder
- Are pregnant or breastfeeding women as evidenced by the participant's medical record.
- Have unstable medical illness that compromises the safety of the patient
- Have significant suicidal ideation at screening (as assessed by the Columbia - Suicide Severity Rating Scale (C-SSRS
- Are on Electroconvulsive therapy (ECT) within 6 months of the study, participants with metal in their bodies or who have claustrophobia or who do not...
See the full eligibility criteria
- Is willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
- Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
- Be on optimized and stable atypical antipsychotic treatment as indicated by no antipsychotic changes in 2 weeks prior to enrollment.
- Demonstrate documented evidence of good medication adherence for the 2 weeks prior to enrollment, as determined by electronic medication records review and prescriber reported adherence to prescribed schedule as...
- Have a history of impulsive aggression as assessed by a score of ≥ 4 on any item on Impulsive Aggression Factor (IA) on the Impulsive- Premeditated Aggression Scale (IPAS; Stanford et al., 2003).
- Have adequate visual and auditory abilities to complete assessments, see and hear stimuli in the VR
- Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia or schizoaffective disorder, as defined in the SCID-5-RV at the Screening Visit.
- Adult or late adolescent, between 18 and 64 years of age at the time of informed consent.
- Have past head trauma
- Diagnosed with a neurological disorder
- Are pregnant or breastfeeding women as evidenced by the participant's medical record.
- Have unstable medical illness that compromises the safety of the patient
- Have significant suicidal ideation at screening (as assessed by the Columbia - Suicide Severity Rating Scale (C-SSRS
- Are on Electroconvulsive therapy (ECT) within 6 months of the study, participants with metal in their bodies or who have claustrophobia or who do not pass the criteria in NKI's Magnetic Resonance Safety Questionnaire...
- Score \< 4 on all items on Impulsive Aggression Factor (IA) on the IPAS (Stanford et al., 2003)
- Have a violent episode requiring seclusion, restraints, or a prn within the week before screening
- Evidence of suboptimal medication adherence in the 2 weeks prior to enrollment, as determined by electronic medication records review, and demonstrated by prescriber reported non- adherence to prescribed schedule.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
- White Plains, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States; White Plains, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.