Impulsive BehaviorNCT03527550
Cognitive Control Training for Urgency in a Naturalistic Clinical Setting
A study of Impulsive Behavior and Mental Disorders, run by Mclean Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impulsive Behavior, Mental Disorders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2018to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Currently undergoing electroconvulsive therapy (ECT)
- Current symptoms of acute mania
- Current symptoms of acute psychosis
- History of traumatic brain injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Cognitive Control Training for Urgency in a Naturalistic Clinical Setting
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.
Read the 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.
- Conditions
- Impulsive Behavior, Mental Disorders
- Being tested
- Cognitive Control Training
- Keywords
- impulsivity, Inhibition (Psychology), Working memory, Cognitive Remediation
- Medical subject headings
- Impulsive Behavior, Mental Disorders, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Control TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training plus Treatment as Usual | Experimental | 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. Receives: Other: Cognitive Control Training |
| Treatment as Usual (TAU) | No intervention | Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge.
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.
Measured: Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at discharge.
Secondary outcomes (4)
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.
Measured: Baseline and at study completion (discharge), an average of two weeks. Scores reported below are at discharge.
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.
Measured: Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below.
Completion Rates
The percentage of participants enrolled in the cognitive training arm who complete the training sessions and the discharge session.
Measured: At study completion, an average of two weeks.
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.
Measured: At study completion, an average of two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start11 Sep 2018
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Why it stopped: Data collection ended due to COVID-19 (study site closed to in-person visits)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Impulsive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Andrew D. Peckham, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527550
- Sponsor's protocol ID
- 2017P001550
- Other IDs
- 1F32MH115530
- Status last verified
- Aug 2021
- First submitted
- 19 Apr 2018
- Last updated
- 20 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 29609103Peckham 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.
PubMed 34562728
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Cognitive Control Training for Urgency in a Naturalistic Clinical Setting
- ClinicalTrials.gov ID
- NCT03527550
- Acronym / sponsor ID
- 2017P001550
- Conditions
- Impulsive Behavior, Mental Disorders
- Keywords
- impulsivity, Inhibition (Psychology), Working memory, Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data collection ended due to COVID-19 (study site closed to in-person visits)
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Posted 25 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training plus Treatment as Usual | Experimental | Other: Cognitive Control TrainingParticipants 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. |
| Treatment as Usual (TAU) | No intervention | –Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- Currently undergoing electroconvulsive therapy (ECT)
- Current symptoms of acute mania
- Current symptoms of acute psychosis
- History of traumatic brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Control TrainingCognitive 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. | Other | Cognitive Training plus Treatment as Usual |
Primary outcome
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.
4 secondary outcomes
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.
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.
Completion Rates
Time frame: At study completion, an average of two weeks.
Average Perceived Helpfulness of Training
Time frame: At study completion, an average of two weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29609103Peckham 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.
- Derived from this study: PubMed 34562728Peckham 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Impulsive Behavior and Mental Disorders, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527550, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.