Mental Disorders Clinical Trial
Official title:
A Randomized Controlled Trial of Cognitive Control Training for Urgency in a Naturalistic Clinical Setting
Verified date | August 2021 |
Source | Mclean Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | McLean Hospital | Belmont | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital | National Institute of Mental Health (NIMH) |
United States,
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
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. |
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