NCT04414215 · University of Georgia
Cognitive Training for Emotion Regulation in Psychotic Disorders
What this study is about
The current study examines the effectiveness of a cognitive training intervention for improving emotion regulation in psychotic disorders. it is hypothesized that the cognitive training program will enhance prefrontal activation, leading to enhanced emotion regulation.
View original scientific description
The current study examines the efficacy of a cognitive training intervention for improving emotion regulation in psychotic disorders. it is hypothesized that the cognitive training program will enhance prefrontal activation, leading to enhanced emotion regulation.
Interventions
BEHAVIORAL
Emotional working memory training
Participants will complete an emotional working memory n-back training program that progressively increases difficulty and has been shown to enhance prefrontal activity in a non-psychiatric sample
BEHAVIORAL
Placebo working memory training
Working memory training that does not involve emotional stimuli using an N-back training program
Primary outcome measures
Prefrontal blood oxygen level dependent activation in the prefrontal cortex
Time frame: Change from baseline to 15 days or 30 days
blood oxygen level dependent change in the prefrontal cortex as measured using functional magnetic resonance imaging. This will be calculated as a change from baseline to follow-up on the contrast score (unpleasant passive viewing condition - reappraisal) on the emotion regulation reappraisal task
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- diagnostic and statistical manual fifth edition diagnosis of schizophrenia or schizoaffective disorder
- 18-60 years old
- speaks English
- premorbid intelligence quotient \> 70
- clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months.
Exclusion criteria
- history of intellectual disability or neurological disorder
- history of traumatic brain injury with loss of consciousness \> 10 minutes or behavioral sequelae
- substance use disorder within the last 6 months (other than nicotine)
- 4\) endorsement of MRI exclusion factors
Where
- Athens, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2025 · Source of record for eligibility and locations