Clinical trial NCT03527550: Cognitive Control Training for Urgency in a Naturalistic Clinical Setting
Official title: A Randomized Controlled Trial of Cognitive Control Training for Urgency in a Naturalistic Clinical Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Impulsive Behavior
Mental Disorders
Keywords: impulsivity
Inhibition (Psychology)
Working memory
Cognitive Remediation
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-05-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Average Score on Negative Urgency Scale at Discharge
timeFrame: Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge.
measure: Average Score on the Short Positive Urgency Scale at Discharge
timeFrame: Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at discharge.
Secondary outcomes:
measure: Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge
timeFrame: Baseline and at study completion (discharge), an average of two weeks. Scores reported below are at discharge.
measure: Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population
timeFrame: Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below.
measure: Completion Rates
timeFrame: At study completion, an average of two weeks.
measure: Average Perceived Helpfulness of Training
timeFrame: At study completion, an average of two weeks.
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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.