Cognitive Training for Emotion Regulation in Psychotic Disorders

Schizophrenia Clinical Trial

Official title:

Cognitive Training for Emotion Regulation in Psychotic Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04414215
• Other study ID #: 00001377
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: University of Georgia
• Contact: Gregory P Strauss, PhD
• Phone: 706-542-0307
• Email: gstrauss[@]uga.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

Intervention

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
• Placebo working memory training
Working memory training that does not involve emotional stimuli using an N-back training program

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prefrontal blood oxygen level dependent activation in the prefrontal cortex	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	Change from baseline to 15 days or 30 days