Cognitive Control Training for Urgency in a Naturalistic Clinical Setting

Mental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03527550
• Other study ID #: 2017P001550
• Secondary ID: 1F32MH115530
• Status: Terminated
• Phase: N/A
• Start date: September 11, 2018
• Est. completion date: March 11, 2020

Study information

• Verified date: August 2021
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Impulsive Behavior
• Mental Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Score on Negative Urgency Scale at 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.	Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge.
Primary	Average Score on the Short Positive Urgency Scale 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.	Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at discharge.
Secondary	Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) 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.	Baseline and at study completion (discharge), an average of two weeks. Scores reported below are at discharge.
Secondary	Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population	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.	Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below.
Secondary	Completion Rates	The percentage of participants enrolled in the cognitive training arm who complete the training sessions and the discharge session.	At study completion, an average of two weeks.
Secondary	Average Perceived Helpfulness of Training	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.	At study completion, an average of two weeks.