Trial Outcomes & Findings for Cognitive Control Training for Urgency in a Naturalistic Clinical Setting (NCT NCT03527550)
NCT ID: NCT03527550
Last Updated: 2021-08-20
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge.
Results posted on
2021-08-20
Participant Flow
Participant milestones
| Measure |
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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Treatment as Usual (TAU)
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
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|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
|
Overall Study
COMPLETED
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
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.
|
Treatment as Usual (TAU)
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
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|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Participant reported exclusion criterion after study enrollment.
|
1
|
0
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Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Cognitive Training Plus Treatment as Usual
n=24 Participants
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.
|
Treatment as Usual (TAU)
n=22 Participants
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
|
Total
n=46 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
33.75 years
STANDARD_DEVIATION 14.53 • n=24 Participants
|
29.68 years
STANDARD_DEVIATION 10.28 • n=22 Participants
|
31.80 years
STANDARD_DEVIATION 12.71 • n=46 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=24 Participants
|
12 Participants
n=22 Participants
|
25 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=24 Participants
|
10 Participants
n=22 Participants
|
21 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=24 Participants
|
2 Participants
n=22 Participants
|
4 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=24 Participants
|
20 Participants
n=22 Participants
|
42 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=46 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=24 Participants
|
21 Participants
n=22 Participants
|
39 Participants
n=46 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=24 Participants
|
1 Participants
n=22 Participants
|
2 Participants
n=46 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
22 participants
n=22 Participants
|
46 participants
n=46 Participants
|
|
Negative Urgency Scale-Short (subscale of Short UPPS-P Scale)
|
3.29 units on a scale
STANDARD_DEVIATION 0.41 • n=24 Participants
|
3.28 units on a scale
STANDARD_DEVIATION 0.37 • n=22 Participants
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3.29 units on a scale
STANDARD_DEVIATION 0.39 • n=46 Participants
|
|
Positive Urgency Scale-Short (subscale of Short UPPS-P Scale)
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2.26 units on a scale
STANDARD_DEVIATION 0.72 • n=24 Participants
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2.47 units on a scale
STANDARD_DEVIATION 0.99 • n=22 Participants
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2.36 units on a scale
STANDARD_DEVIATION 0.85 • n=46 Participants
|
|
Stop-Signal Reaction Time (SSRT)
|
197.22 milliseconds
STANDARD_DEVIATION 99.73 • n=22 Participants • 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.
|
216.22 milliseconds
STANDARD_DEVIATION 59.59 • n=20 Participants • 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.
|
206.27 milliseconds
STANDARD_DEVIATION 82.66 • n=42 Participants • 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.
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PRIMARY outcome
Timeframe: Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge.Population: 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.
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.
Outcome measures
| Measure |
Cognitive Training Plus Treatment as Usual
n=15 Participants
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.
|
Treatment as Usual
n=17 Participants
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
|
|---|---|---|
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Average Score on Negative Urgency Scale at Discharge
|
3.17 units on a scale
Standard Deviation 0.53
|
3.19 units on a scale
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at discharge.Population: 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.
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.
Outcome measures
| Measure |
Cognitive Training Plus Treatment as Usual
n=15 Participants
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.
|
Treatment as Usual
n=18 Participants
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
|
|---|---|---|
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Average Score on the Short Positive Urgency Scale at Discharge
|
2.07 units on a scale
Standard Deviation 0.77
|
2.39 units on a scale
Standard Deviation 0.81
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SECONDARY outcome
Timeframe: Baseline and at study completion (discharge), an average of two weeks. Scores reported below are at discharge.Population: 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.
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.
Outcome measures
| Measure |
Cognitive Training Plus Treatment as Usual
n=11 Participants
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.
|
Treatment as Usual
n=19 Participants
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
|
|---|---|---|
|
Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge
|
224.87 milliseconds
Standard Deviation 50.61
|
236.69 milliseconds
Standard Deviation 62.08
|
SECONDARY outcome
Timeframe: Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below.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.
Outcome measures
| Measure |
Cognitive Training Plus Treatment as Usual
n=24 Participants
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.
|
Treatment as Usual
n=22 Participants
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
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|---|---|---|
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Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population
Baseline
|
7 Participants
|
4 Participants
|
|
Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population
Discharge
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At study completion, an average of two weeks.The percentage of participants enrolled in the cognitive training arm who complete the training sessions and the discharge session.
Outcome measures
| Measure |
Cognitive Training Plus Treatment as Usual
n=24 Participants
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.
|
Treatment as Usual
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
|
|---|---|---|
|
Completion Rates
|
15 Participants
|
—
|
SECONDARY outcome
Timeframe: At study completion, an average of two weeks.Population: 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.
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.
Outcome measures
| Measure |
Cognitive Training Plus Treatment as Usual
n=14 Participants
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.
|
Treatment as Usual
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
|
|---|---|---|
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Average Perceived Helpfulness of Training
PASAT Perceived Helpfulness Rating
|
3.92 units on a scale
Standard Deviation 1.44
|
—
|
|
Average Perceived Helpfulness of Training
Go/NoGo Perceived Helpfulness Rating
|
5.07 units on a scale
Standard Deviation 1.69
|
—
|
POST_HOC outcome
Timeframe: Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge.Population: 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.
This scale assesses self-reported difficulties tolerating distress. Total scores range from 0 to 40, with higher scores indicating greater difficulties tolerating distress.
Outcome measures
| Measure |
Cognitive Training Plus Treatment as Usual
n=13 Participants
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.
|
Treatment as Usual
n=16 Participants
Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.
|
|---|---|---|
|
Average Score on Distress Intolerance Index (DII) Scale at Discharge
|
21.77 units on a scale
Standard Deviation 10.17
|
22.75 units on a scale
Standard Deviation 9.21
|
Adverse Events
Cognitive Training Plus Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place