Cognitive Training for Emotion Regulation in Psychotic Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Emotional working memory training, Placebo working memory training.
- Who it may be relevant to
- Registry conditions: Schizophrenia, Schizo Affective Disorder. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Psychotic disorders are serious and debilitating mental illnesses that incur substantial suffering for patients and present major challenges to our health care system. Difficulties with emotion regulation (i.e., the ability to control the emotion response using strategies) significantly predict the development and maintenance of psychotic symptoms and poor community-based functional outcomes. Recent neuroimaging research indicates that hypofrontality may underlie these deficits. Unfortunately, there is no accepted technique for remediating these emotion regulation abnormalities in psychotic disorders. Recent advances from the field of cognitive neuroscience provide hope for a resolution to this critical unmet need in psychotic disorder therapeutics, demonstrating that brief computerized cognitive training interventions are capable of improving emotion regulation ability by targeting neural activation in the prefrontal cortex. The goal of the proposed project is to determine whether an emotional working memory cognitive training program is effective for remediating emotion regulation abnormalities and associated clinical outcomes in people with psychotic disorders. Outpatients with psychotic disorders will be randomly assigned to either an emotional working memory training (n = 35) or placebo (P: n = 35) cognitive training control intervention delivered via an app on a smart phone for 30 days. The primary aim is to determine whether the emotional working memory intervention successfully engages the target mechanism and enhances prefrontal activation on a non-trained emotion regulation transfer task beyond a pre-specified effect size criterion. Results will also be used to determine the treatment duration (15 vs. 30 days) that most effectively and efficiently improves the target.
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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Georgia — Athens
Identifiers
NCT: NCT04414215 · 00001377