Cognitive Training for Emotion Regulation in Psychotic Disorders

NCT ID: NCT04414215

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2029-12-31

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.

Conditions

Schizophrenia; Schizo Affective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive training

Emotional working memory training

Group Type: EXPERIMENTAL

Emotional working memory training

Intervention Type: BEHAVIORAL

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 training

Placebo working memory training

Group Type: PLACEBO_COMPARATOR

Placebo working memory training

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Placebo working memory training

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Georgia

OTHER

Sponsor Role: lead

Responsible Party

Gregory Paul Strauss

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Georgia

Athens, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gregory P Strauss, PhD

Role: CONTACT

gstrauss@uga.edu

706-542-0307

Facility Contacts

Gregory P Strauss, PhD

Role: primary

gstrauss@uga.edu

706-542-0307

Other Identifiers

00001377

Identifier Type: -

Identifier Source: org_study_id