Clinical trial NCT04414215: Cognitive Training for Emotion Regulation in Psychotic Disorders
Official title: Cognitive Training for Emotion Regulation in Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double blind design will be used, where participants will be randomly assigned to placebo or emotional working memory training
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Prefrontal blood oxygen level dependent activation in the prefrontal cortex
timeFrame: Change from baseline to 15 days or 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
References: