Cognitive Control Training for Urgency in a Naturalistic Clinical Setting

NCT ID: NCT03527550

Last Updated: 2021-08-20

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2020-03-11

Brief Summary

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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

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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.

Conditions

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Impulsive Behavior Mental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cognitive Training plus Treatment as Usual

Participants in this arm will receive daily computerized cognitive training sessions during partial hospitalization, in addition to treatment as usual. Cognitive training sessions will alternate between response inhibition training and working memory training.

Group Type EXPERIMENTAL

Cognitive Control Training

Intervention Type OTHER

Cognitive Control Training involves daily practice with one of two computerized interventions. The first intervention is an adaptive Go/No-Go task to provide practice in the domain of response inhibition. Participants press a key as fast as possible in response to stimuli (letters of the alphabet), but must inhibit responses to a specific letter. The second intervention is an adaptive Paced Auditory Serial Addition Task (PASAT), designed to practice working memory. Participants are presented with single numbers presented aurally, and must add each number they hear to the previous number and click the correct sum on the screen.

Treatment as Usual (TAU)

Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Control Training

Cognitive Control Training involves daily practice with one of two computerized interventions. The first intervention is an adaptive Go/No-Go task to provide practice in the domain of response inhibition. Participants press a key as fast as possible in response to stimuli (letters of the alphabet), but must inhibit responses to a specific letter. The second intervention is an adaptive Paced Auditory Serial Addition Task (PASAT), designed to practice working memory. Participants are presented with single numbers presented aurally, and must add each number they hear to the previous number and click the correct sum on the screen.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Andrew D. Peckham

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

References

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Peckham AD, Johnson SL. Cognitive control training for emotion-related impulsivity. Behav Res Ther. 2018 Jun;105:17-26. doi: 10.1016/j.brat.2018.03.009. Epub 2018 Mar 27.

Reference Type BACKGROUND
PMID: 29609103 (View on PubMed)

Peckham AD, Sandler JP, Dattolico D, McHugh RK, Johnson DS, Bjorgvinsson T, Pizzagalli DA, Beard C. Cognitive control training for urgency: A pilot randomized controlled trial in an acute clinical sample. Behav Res Ther. 2021 Nov;146:103968. doi: 10.1016/j.brat.2021.103968. Epub 2021 Sep 14.

Reference Type DERIVED
PMID: 34562728 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1F32MH115530

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017P001550

Identifier Type: -

Identifier Source: org_study_id

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