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Clinical Trial NCT04414215 for Schizophrenia, Schizo Affective Disorder is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Cognitive Training for Emotion Regulation in Psychotic Disorders 70

Recruiting
Clinical Trial NCT04414215 is an interventional study for Schizophrenia, Schizo Affective Disorder that is recruiting. It started on June 1, 2020 with plans to enroll 70 participants. Led by University of Georgia, it is expected to complete by December 31, 2029. The latest data from ClinicalTrials.gov was last updated on February 5, 2025.
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 rese...Show More
Official Title

Cognitive Training for Emotion Regulation in Psychotic Disorders

Conditions
SchizophreniaSchizo Affective Disorder
Other Study IDs
  • 00001377
NCT ID Number
NCT04414215
Start Date (Actual)
2020-06-01
Last Update Posted
2025-02-05
Completion Date (Estimated)
2029-12-31
Enrollment (Estimated)
70
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCognitive training
Emotional working memory training
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 ComparatorPlacebo training
Placebo working memory training
Placebo working memory training
Working memory training that does not involve emotional stimuli using an N-back training program
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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
University of Georgia logoUniversity of Georgia
Study Responsible Party
Gregory Paul Strauss, Principal Investigator, Associate Professor, University of Georgia
Study Central Contact
Contact: Gregory P Strauss, PhD, 706-542-0307, [email protected]
1 Study Locations in 1 Countries

Georgia

University of Georgia, Athens, Georgia, 30602, United States
Gregory P Strauss, PhD, Contact, 706-542-0307, [email protected]
Gregory P Strauss, PhD, Principal Investigator
Lawrence Sweet, PhD, Sub-Investigator
Dean Sabatinelli, PhD, Sub-Investigator
Recruiting