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| ID | Type | Description | Link |
|---|---|---|---|
| 1F32MH115530 | U.S. NIH Grant/Contract | View source |
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Data collection ended due to COVID-19 (study site closed to in-person visits)
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Treatment as Usual (TAU) | No Intervention | Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Control Training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29609103 | Background | 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. | |
| 34562728 | Derived | 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. |
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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).
Data will be made available when primary data analysis is complete.
Data will be made available to users of the NDCT website:
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Training Plus Treatment as Usual | Participants in this arm received daily computerized cognitive training sessions during partial hospitalization, in addition to treatment as usual. Cognitive training sessions alternated between response inhibition training and working memory training. 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. |
| FG001 | Treatment as Usual (TAU) | Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Training Plus Treatment as Usual | Participants in this arm received daily computerized cognitive training sessions during partial hospitalization, in addition to treatment as usual. Cognitive training sessions alternated between response inhibition training and working memory training. 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Note: two participants in the Treatment as Usual condition did not answer all questions for the Negative Urgency scale at discharge, so an average score was not computed, resulting in 17 participants with complete data. | Posted | Mean | Standard Deviation | units on a scale | Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge. |
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Adverse event data were collected during the duration of a participant's study participation (approximately two weeks, corresponding to the overall length of partial hospitalization).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Training Plus Treatment as Usual | Participants in this arm received daily computerized cognitive training sessions during partial hospitalization, in addition to treatment as usual. Cognitive training sessions alternated between response inhibition training and working memory training. 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. |
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Recruitment for this trial was terminated early, prior to reaching the target sample size, due to the recruitment site shutting down during the COVID-19 pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Peckham | McLean Hospital | 617-855-2946 | adpeckham@mclean.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2020 | Feb 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 19, 2021 | Feb 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007175 | Impulsive Behavior |
| D001523 | Mental Disorders |
| D007266 | Inhibition, Psychological |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 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. |
| 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. |
| 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. |
| Participant reported exclusion criterion after study enrollment. |
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| BG001 | Treatment as Usual (TAU) | Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Negative Urgency Scale-Short (subscale of Short UPPS-P Scale) | UPPS-P: Short Version of Urgency, (lack of) Premeditation, (lack of) Perseverance, Sensation Seeking, Positive Urgency scale. Negative Urgency Scale-Short: The range for this scale is 1-4, scored here such that higher scores reflect worse outcomes (higher levels of this type of impulsivity). | Mean | Standard Deviation | units on a scale |
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| Positive Urgency Scale-Short (subscale of Short UPPS-P Scale) | UPPS-P: Short Version of Urgency, (lack of) Premeditation, (lack of) Perseverance, Sensation Seeking, Positive Urgency scale Positive Urgency Scale-Short: The range for this scale is 1-4, scored here such that higher scores reflect worse outcomes (higher levels of this type of impulsivity). | Mean | Standard Deviation | units on a scale |
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| Stop-Signal Reaction Time (SSRT) | Two participants in each arm did not complete the stop-signal task. In the cognitive training arm, 1 participant reported an exclusion criterion and discountined participation prior to completion of this task. 1 additional participant did not attend their session in which this task was to be completed. In the TAU arm, 1 participant dropped out of the study prior to completion of this measure, and 1 additional participant was not able to complete the task because of time constraints. | Mean | Standard Deviation | milliseconds |
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| OG001 | Treatment as Usual | Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program. |
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| 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. | Note: one participant in the Treatment as Usual condition did not answer all questions for the Positive Urgency scale at discharge, so an average score was not computed, resulting in 18 participants with complete data. | Posted | Mean | Standard Deviation | units on a scale | Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at discharge. |
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| 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. | 4 participants in the Cognitive Training plus Treatment as Usual group did not complete the Stop Signal task at discharge, for various reasons including: no-show to data collection session (1), equipment problem (1), clinical issues interfering with data collection (1), and time constraints (1); this resulted in a total of 11 participants with data for this task in this arm. | Posted | Mean | Standard Deviation | milliseconds | Baseline and at study completion (discharge), an average of two weeks. Scores reported below are at discharge. |
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| 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. | Posted | Count of Participants | Participants | Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below. |
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| Secondary | Completion Rates | The percentage of participants enrolled in the cognitive training arm who complete the training sessions and the discharge session. | Posted | Count of Participants | Participants | At study completion, an average of two weeks. |
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| 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. | One participant did not fill out this measure due to clinical issues interfering with data collection, resulting in 14 participants with available data. One additional participant filled out the measure but declined to fill out the item assessing perceived helpfulness of the PASAT, resulting in 13 participants available for anaylsis for this specific item. | Posted | Mean | Standard Deviation | units on a scale | At study completion, an average of two weeks. |
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| Post-Hoc | Average Score on Distress Intolerance Index (DII) Scale at Discharge | This scale assesses self-reported difficulties tolerating distress. Total scores range from 0 to 40, with higher scores indicating greater difficulties tolerating distress. | Note: two participants in the Cognitive Training plus Treatment as Usual arm, and 3 participants in the Treatment as Usual arm, did not answer all questions for the Distress Intolerance Index at discharge, so an average score was not computed, resulting in smaller sample sizes for these analyses. | Posted | Mean | Standard Deviation | units on a scale | Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge. |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Treatment as Usual | Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program. | 0 | 22 | 0 | 22 | 0 | 22 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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