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
|Condition or disease||Intervention/treatment||Phase|
|Impulsive Behavior Mental Disorders||Other: Cognitive Control Training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|