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Cognitive Control Training for Urgency in a Naturalistic Clinical Setting

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ClinicalTrials.gov Identifier: NCT03527550
Recruitment Status : Terminated (Data collection ended due to COVID-19 (study site closed to in-person visits))
First Posted : May 17, 2018
Results First Posted : March 25, 2021
Last Update Posted : August 20, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Andrew D. Peckham, Mclean Hospital

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.

Condition or disease Intervention/treatment Phase
Impulsive Behavior Mental Disorders Other: Cognitive Control Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized Controlled Trial of Cognitive Control Training for Urgency in a Naturalistic Clinical Setting
Actual Study Start Date : September 11, 2018
Actual Primary Completion Date : March 11, 2020
Actual Study Completion Date : March 11, 2020

Arm Intervention/treatment
Experimental: 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.
Other: 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.

No Intervention: Treatment as Usual (TAU)
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.



Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge [ Time Frame: Baseline and at study completion (discharge), an average of two weeks. Scores reported below are at discharge. ]
    The SSRT (measured in ms) is the primary behavioral outcome measure of the Stop-Signal Response Inhibition task. It is an estimate of the average amount of time required to stop an action on this task.

  2. Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population [ Time Frame: Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below. ]
    We evaluated the feasibility of using EEG to assess event-related potentials during the Stop-Signal task, in an acute partial hospital setting. This involves testing the percentage of participants who are able to complete and provide ERP data for the stop-signal task.

  3. Completion Rates [ Time Frame: At study completion, an average of two weeks. ]
    The percentage of participants enrolled in the cognitive training arm who complete the training sessions and the discharge session.

  4. Average Perceived Helpfulness of Training [ Time Frame: At study completion, an average of two weeks. ]
    This is a study-specific measure developed by the investigators to capture self-reported perceived helpfulness of the intervention. It consists of two separate questions that assess "how helpful" the Go/NoGo task and PASAT tasks were perceived to be. Each question is rated on a 1 ("completely disagree") to 7 ("completely agree") scale, with higher scores indicating better outcomes (i.e., greater perceived helpfulness of the task). Scores shown below are averages for each of these two items.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527550


Locations
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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
National Institute of Mental Health (NIMH)
  Study Documents (Full-Text)

Documents provided by Andrew D. Peckham, Mclean Hospital:
Study Protocol  [PDF] December 14, 2020
Statistical Analysis Plan  [PDF] February 19, 2021

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrew D. Peckham, Research Fellow, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03527550    
Other Study ID Numbers: 2017P001550
1F32MH115530 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2018    Key Record Dates
Results First Posted: March 25, 2021
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon completion of data analysis, de-identified data from this study will be made available to the National Database for Clinical Trials Related to Mental Illness (NDCT).
Supporting Materials: Study Protocol
Time Frame: Data will be made available when primary data analysis is complete.
Access Criteria:

Data will be made available to users of the NDCT website:

https://data-archive.nimh.nih.gov/

URL: https://data-archive.nimh.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew D. Peckham, Mclean Hospital:
impulsivity
Inhibition (Psychology)
Working memory
Cognitive Remediation
Additional relevant MeSH terms:
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Mental Disorders
Impulsive Behavior