Cognitive Training for Emotion Regulation in Psychotic Disorders

NCT04414215 | Recruiting

• 1 other identifier: 00001377
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizo Affective Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cognitive training

EXPERIMENTAL

Emotional working memory training

Behavioral: Emotional working memory training

Placebo training

PLACEBO COMPARATOR

Placebo working memory training

Behavioral: Placebo working memory training

Interventions

Emotional working memory training 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

Cognitive training

Placebo working memory training BEHAVIORAL

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

Placebo training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnostic and statistical manual fifth edition diagnosis of schizophrenia or schizoaffective disorder
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Gregory P Strauss, PhD

CONTACT

706-542-0307; gstrauss@uga.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A double blind design will be used, where participants will be randomly assigned to placebo or emotional working memory training

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after study completion for 1 year
• Access Criteria: The National Institute of Mental Health Data Archive request

Locations

US (1)