Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 2:46 PM
Study NCT ID:
NCT03527550
Status:
TERMINATED
Last Update Posted:
2021-08-20
First Post:
2018-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cognitive Control Training for Urgency in a Naturalistic Clinical Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007266', 'term': 'Inhibition, Psychological'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adpeckham@mclean.harvard.edu', 'phone': '617-855-2946', 'title': 'Dr. Andrew Peckham', 'organization': 'McLean Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': "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).", 'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Training Plus Treatment as Usual', 'description': '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.\n\nCognitive 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.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment as Usual', 'description': 'Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Score on Negative Urgency Scale at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training Plus Treatment as Usual', 'description': '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.\n\nCognitive 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.'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.17', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '3.19', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in negative urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in negative urgency as a function of condition (interaction of condition X time; reported below).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).'}], 'paramType': 'MEAN', 'timeFrame': 'Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of 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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Average Score on the Short Positive Urgency Scale at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training Plus Treatment as Usual', 'description': '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.\n\nCognitive 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.'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.07', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in positive urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in positive urgency as a function of condition (interaction of condition X time; reported below).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).'}], 'paramType': 'MEAN', 'timeFrame': 'Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are 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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training Plus Treatment as Usual', 'description': '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.\n\nCognitive 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.'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.'}], 'classes': [{'categories': [{'measurements': [{'value': '224.87', 'spread': '50.61', 'groupId': 'OG000'}, {'value': '236.69', 'spread': '62.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).', 'groupDescription': 'A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in stop-signal reaction time at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in stop-signal reaction time as a function of condition (interaction of condition X time; reported below).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at study completion (discharge), an average of two weeks. Scores reported below are 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.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training Plus Treatment as Usual', 'description': '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.\n\nCognitive 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.'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Discharge', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below.', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Completion Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training Plus Treatment as Usual', 'description': '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.\n\nCognitive 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At study completion, an average of two weeks.', 'description': 'The percentage of participants enrolled in the cognitive training arm who complete the training sessions and the discharge session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Perceived Helpfulness of Training', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training Plus Treatment as Usual', 'description': '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.\n\nCognitive 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.'}], 'classes': [{'title': 'PASAT Perceived Helpfulness Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.92', 'spread': '1.44', 'groupId': 'OG000'}]}]}, {'title': 'Go/NoGo Perceived Helpfulness Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.07', 'spread': '1.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At study completion, an average of two weeks.', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'POST_HOC', 'title': 'Average Score on Distress Intolerance Index (DII) Scale at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training Plus Treatment as Usual', '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.\n\nCognitive 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.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.77', 'spread': '10.17', 'groupId': 'OG000'}, {'value': '22.75', 'spread': '9.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.24', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in distress intolerance at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in distress intolerance as a function of condition (interaction of condition X time; reported below).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).'}], 'paramType': 'MEAN', 'timeFrame': 'Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of discharge.', 'description': 'This scale assesses self-reported difficulties tolerating distress. Total scores range from 0 to 40, with higher scores indicating greater difficulties tolerating distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Training Plus Treatment as Usual', 'description': '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.\n\nCognitive 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.'}, {'id': 'FG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant reported exclusion criterion after study enrollment.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Training Plus Treatment as Usual', 'description': '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.\n\nCognitive 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.'}, {'id': 'BG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.75', 'spread': '14.53', 'groupId': 'BG000'}, {'value': '29.68', 'spread': '10.28', 'groupId': 'BG001'}, {'value': '31.80', 'spread': '12.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Negative Urgency Scale-Short (subscale of Short UPPS-P Scale)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.29', 'spread': '0.41', 'groupId': 'BG000'}, {'value': '3.28', 'spread': '0.37', 'groupId': 'BG001'}, {'value': '3.29', 'spread': '0.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'UPPS-P: Short Version of Urgency, (lack of) Premeditation, (lack of) Perseverance, Sensation Seeking, Positive Urgency scale.\n\nNegative 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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Positive Urgency Scale-Short (subscale of Short UPPS-P Scale)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.26', 'spread': '0.72', 'groupId': 'BG000'}, {'value': '2.47', 'spread': '0.99', 'groupId': 'BG001'}, {'value': '2.36', 'spread': '0.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'UPPS-P: Short Version of Urgency, (lack of) Premeditation, (lack of) Perseverance, Sensation Seeking, Positive Urgency scale\n\nPositive 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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stop-Signal Reaction Time (SSRT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '197.22', 'spread': '99.73', 'groupId': 'BG000'}, {'value': '216.22', 'spread': '59.59', 'groupId': 'BG001'}, {'value': '206.27', 'spread': '82.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '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.\n\nIn 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.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-14', 'size': 376270, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-22T11:31', 'hasProtocol': True}, {'date': '2021-02-19', 'size': 61459, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-22T11:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'whyStopped': 'Data collection ended due to COVID-19 (study site closed to in-person visits)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2018-04-19', 'resultsFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2018-05-04', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-22', 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Score on Negative Urgency Scale at Discharge', 'timeFrame': 'Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are at day of 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.'}, {'measure': 'Average Score on the Short Positive Urgency Scale at Discharge', 'timeFrame': 'Admission and at study completion (day of discharge), an average of two weeks. Scores reported below are 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.'}], 'secondaryOutcomes': [{'measure': 'Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge', 'timeFrame': 'Baseline and at study completion (discharge), an average of two weeks. Scores reported below are 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.'}, {'measure': 'Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population', 'timeFrame': 'Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below.', '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.'}, {'measure': 'Completion Rates', 'timeFrame': 'At study completion, an average of two weeks.', 'description': 'The percentage of participants enrolled in the cognitive training arm who complete the training sessions and the discharge session.'}, {'measure': 'Average Perceived Helpfulness of Training', 'timeFrame': 'At study completion, an average of two weeks.', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['impulsivity', 'Inhibition (Psychology)', 'Working memory', 'Cognitive Remediation'], 'conditions': ['Impulsive Behavior', 'Mental Disorders']}, 'referencesModule': {'references': [{'pmid': '29609103', 'type': 'BACKGROUND', '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.'}, {'pmid': '34562728', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nResearch 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.\n\nIt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently receiving treatment at the McLean Hospital Behavioral Health Partial Hospital Program (PHP)\n* 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\n* Right-handed (if enrolled in EEG arm)\n\nExclusion Criteria:\n\n* Currently undergoing electroconvulsive therapy (ECT)\n* Current symptoms of acute mania\n* Current symptoms of acute psychosis\n* History of traumatic brain injury'}, 'identificationModule': {'nctId': 'NCT03527550', 'briefTitle': 'Cognitive Control Training for Urgency in a Naturalistic Clinical Setting', 'organization': {'class': 'OTHER', 'fullName': 'Mclean Hospital'}, 'officialTitle': 'A Randomized Controlled Trial of Cognitive Control Training for Urgency in a Naturalistic Clinical Setting', 'orgStudyIdInfo': {'id': '2017P001550'}, 'secondaryIdInfos': [{'id': '1F32MH115530', 'link': 'https://reporter.nih.gov/quickSearch/1F32MH115530', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Training plus Treatment as Usual', '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.', 'interventionNames': ['Other: Cognitive Control Training']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual (TAU)', 'description': 'Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program.'}], 'interventions': [{'name': 'Cognitive Control Training', 'type': 'OTHER', '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.', 'armGroupLabels': ['Cognitive Training plus Treatment as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02478', 'city': 'Belmont', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'McLean Hospital', 'geoPoint': {'lat': 42.39593, 'lon': -71.17867}}]}, 'ipdSharingStatementModule': {'url': 'https://data-archive.nimh.nih.gov/', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be made available when primary data analysis is complete.', 'ipdSharing': 'YES', '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).', 'accessCriteria': 'Data will be made available to users of the NDCT website:\n\nhttps://data-archive.nimh.nih.gov/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mclean Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Andrew D. Peckham', 'investigatorAffiliation': 'Mclean Hospital'}}}}