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NCT Number: NCT04414215

Cognitive Training for Emotion Regulation in Psychotic Disorders

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Georgia

Athens, Georgia, 30602, United States

Location status: Recruiting

Location contact

Dean Sabatinelli, PhD

SUB_INVESTIGATOR

Gregory P Strauss, PhD

CONTACT

[email protected]

706-542-0307

Gregory P Strauss, PhD

PRINCIPAL_INVESTIGATOR

Lawrence Sweet, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo working memory training

Behavioral

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

Primary outcomes

  1. Prefrontal blood oxygen level dependent activation in the prefrontal cortex

    Time frame: Change from baseline to 15 days or 30 days

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory P Strauss, PhD

CONTACT

[email protected]

706-542-0307

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Registry information

Important dates

Study start
2020
Primary completion
2029
Study completion
2029
First posted
Jun 4, 2020
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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