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Cognitive Control Training for Urgency in a Naturalistic Clinical Setting

Primary Purpose

Impulsive Behavior, Mental Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Control Training
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Impulsive Behavior focused on measuring impulsivity, Inhibition (Psychology), Working memory, Cognitive Remediation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Training plus Treatment as Usual

Treatment as Usual (TAU)

Arm Description

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.

Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Completion Rates
The percentage of participants enrolled in the cognitive training arm who complete the training sessions and the discharge session.
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.

Full Information

First Posted
April 19, 2018
Last Updated
August 18, 2021
Sponsor
Mclean Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03527550
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Data collection ended due to COVID-19 (study site closed to in-person visits)
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
March 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsive Behavior, Mental Disorders
Keywords
impulsivity, Inhibition (Psychology), Working memory, Cognitive Remediation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Training plus Treatment as Usual
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
Intervention Type
Other
Intervention Name(s)
Cognitive Control Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Score on Negative Urgency Scale at Discharge
Description
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.
Time Frame
Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge.
Title
Average Score on the Short Positive Urgency Scale at Discharge
Description
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.
Time Frame
Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at discharge.
Secondary Outcome Measure Information:
Title
Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge
Description
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.
Time Frame
Baseline and at study completion (discharge), an average of two weeks. Scores reported below are at discharge.
Title
Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population
Description
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.
Time Frame
Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below.
Title
Completion Rates
Description
The percentage of participants enrolled in the cognitive training arm who complete the training sessions and the discharge session.
Time Frame
At study completion, an average of two weeks.
Title
Average Perceived Helpfulness of Training
Description
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.
Time Frame
At study completion, an average of two weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).
IPD Sharing Time Frame
Data will be made available when primary data analysis is complete.
IPD Sharing Access Criteria
Data will be made available to users of the NDCT website: https://data-archive.nimh.nih.gov/
IPD Sharing URL
https://data-archive.nimh.nih.gov/
Citations:
PubMed Identifier
29609103
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.
Results Reference
background
PubMed Identifier
34562728
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.
Results Reference
derived

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Cognitive Control Training for Urgency in a Naturalistic Clinical Setting

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