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Clinical Trials/NCT03527550
NCT03527550
Terminated
N/A

A Randomized Controlled Trial of Cognitive Control Training for Urgency in a Naturalistic Clinical Setting

Mclean Hospital1 site in 1 country46 target enrollmentSeptember 11, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Impulsive Behavior
Sponsor
Mclean Hospital
Enrollment
46
Locations
1
Primary Endpoint
Average Score on Negative Urgency Scale at Discharge
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

This study is designed to test whether computer-based cognitive exercises are helpful for reducing a specific type of impulsivity. Also, the study is testing whether these are exercises are associated with specific changes in behavior and in the brain. Participants will be psychiatric patients enrolled in a partial hospitalization program. Half of these participants will receive usual treatment, and half will complete computer-based cognitive exercises in addition to usual treatment.

Detailed Description

Impulsivity has different components. One personality trait related to impulsivity, known as "urgency," is strongly related to many different mental health symptoms and risky behaviors. Urgency refers to impulsivity specifically in the context of strong emotions. Research shows that higher levels of urgency are related to specific deficits in cognition. Problems with response inhibition--the ability to cancel or withhold a planned action--are associated with urgency. Also, research shows that difficulties in another aspect of cognition--working memory--may moderate the relationship between inhibition deficits and urgency. One previous study found that people who practiced computerized response inhibition and working memory tasks for two weeks reported significant decreases in urgency. It is unknown if these computerized tasks would be helpful for reducing urgency in adults with psychiatric disorders. Furthermore, it is unknown if changes in urgency are related to changes in the brain mechanisms that help to support response inhibition. This study will collect data on brain activity while people are completing response inhibition tasks.

Registry
clinicaltrials.gov
Start Date
September 11, 2018
End Date
March 11, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrew D. Peckham

Research Fellow

Mclean Hospital

Eligibility Criteria

Inclusion Criteria

  • Currently receiving treatment at the McLean Hospital Behavioral Health Partial Hospital Program (PHP)
  • Report an average score of 3.0 or greater on the Negative Urgency scale, the Positive Urgency scale, or 3.0 or greater on both scales, upon admission to the PHP
  • Right-handed (if enrolled in EEG arm)

Exclusion Criteria

  • Currently undergoing electroconvulsive therapy (ECT)
  • Current symptoms of acute mania
  • Current symptoms of acute psychosis
  • History of traumatic brain injury

Outcomes

Primary Outcomes

Average Score on Negative Urgency Scale at Discharge

Time Frame: Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge.

This scale assesses tendencies towards impulsive action in response to negative emotion. The scale ranges from 1-4, with higher scores indicating more problems with this type of impulsivity.

Average Score on the Short Positive Urgency Scale at Discharge

Time Frame: Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at discharge.

This scale assesses tendencies towards impulsive action in response to positive emotion. The scale ranges from 1-4, with higher scores indicating more problems with this type of impulsivity.

Secondary Outcomes

  • Completion Rates(At study completion, an average of two weeks.)
  • Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge(Baseline and at study completion (discharge), an average of two weeks. Scores reported below are at discharge.)
  • Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population(Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below.)
  • Average Perceived Helpfulness of Training(At study completion, an average of two weeks.)

Study Sites (1)

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