Impulsive Behavior, Mental Disorders
Conditions
Keywords
impulsivity, Inhibition (Psychology), Working memory, Cognitive Remediation
Brief summary
This study is designed to test whether computer-based cognitive exercises are helpful for reducing a specific type of impulsivity. Also, the study is testing whether these are exercises are associated with specific changes in behavior and in the brain. Participants will be psychiatric patients enrolled in a partial hospitalization program. Half of these participants will receive usual treatment, and half will complete computer-based cognitive exercises in addition to usual treatment.
Detailed description
Impulsivity has different components. One personality trait related to impulsivity, known as urgency, is strongly related to many different mental health symptoms and risky behaviors. Urgency refers to impulsivity specifically in the context of strong emotions. Research shows that higher levels of urgency are related to specific deficits in cognition. Problems with response inhibition--the ability to cancel or withhold a planned action--are associated with urgency. Also, research shows that difficulties in another aspect of cognition--working memory--may moderate the relationship between inhibition deficits and urgency. One previous study found that people who practiced computerized response inhibition and working memory tasks for two weeks reported significant decreases in urgency. It is unknown if these computerized tasks would be helpful for reducing urgency in adults with psychiatric disorders. Furthermore, it is unknown if changes in urgency are related to changes in the brain mechanisms that help to support response inhibition. This study will collect data on brain activity while people are completing response inhibition tasks.
Interventions
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.
Sponsors
National Institute of Mental Health (NIMH)
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently receiving treatment at the McLean Hospital Behavioral Health Partial Hospital Program (PHP) * Report an average score of 3.0 or greater on the Negative Urgency scale, the Positive Urgency scale, or 3.0 or greater on both scales, upon admission to the PHP * Right-handed (if enrolled in EEG arm)
Exclusion criteria
* Currently undergoing electroconvulsive therapy (ECT) * Current symptoms of acute mania * Current symptoms of acute psychosis * History of traumatic brain injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Score on Negative Urgency Scale at Discharge | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge | Baseline and at study completion (discharge), an average of two weeks. Scores reported below are at discharge. | The SSRT (measured in ms) is the primary behavioral outcome measure of the Stop-Signal Response Inhibition task. It is an estimate of the average amount of time required to stop an action on this task. |
| Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population | 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. |
| Completion Rates | 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. |
| Average Perceived Helpfulness of Training | At study completion, an average of two weeks. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Treatment as Usual (TAU) Participants in the Treatment As Usual group will receive usual treatment in the partial hospitalization program. | 22 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Participant reported exclusion criterion after study enrollment. | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Total | Cognitive Training Plus Treatment as Usual | Treatment as Usual (TAU) |
|---|---|---|---|
| Age, Continuous | 31.80 years STANDARD_DEVIATION 12.71 | 33.75 years STANDARD_DEVIATION 14.53 | 29.68 years STANDARD_DEVIATION 10.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 22 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Negative Urgency Scale-Short (subscale of Short UPPS-P Scale) | 3.29 units on a scale STANDARD_DEVIATION 0.39 | 3.29 units on a scale STANDARD_DEVIATION 0.41 | 3.28 units on a scale STANDARD_DEVIATION 0.37 |
| Positive Urgency Scale-Short (subscale of Short UPPS-P Scale) | 2.36 units on a scale STANDARD_DEVIATION 0.85 | 2.26 units on a scale STANDARD_DEVIATION 0.72 | 2.47 units on a scale STANDARD_DEVIATION 0.99 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 39 Participants | 18 Participants | 21 Participants |
| Region of Enrollment United States | 46 participants | 24 participants | 22 participants |
| Sex: Female, Male Female | 25 Participants | 13 Participants | 12 Participants |
| Sex: Female, Male Male | 21 Participants | 11 Participants | 10 Participants |
| Stop-Signal Reaction Time (SSRT) | 206.27 milliseconds STANDARD_DEVIATION 82.66 | 197.22 milliseconds STANDARD_DEVIATION 99.73 | 216.22 milliseconds STANDARD_DEVIATION 59.59 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 22 |
| other Total, other adverse events | 0 / 24 | 0 / 22 |
| serious Total, serious adverse events | 0 / 24 | 0 / 22 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training Plus Treatment as Usual | Average Score on Negative Urgency Scale at Discharge | 3.17 units on a scale | Standard Deviation 0.53 |
| Treatment as Usual | Average Score on Negative Urgency Scale at Discharge | 3.19 units on a scale | Standard Deviation 0.3 |
Comparison: 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).p-value: 0.95ANOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training Plus Treatment as Usual | Average Score on the Short Positive Urgency Scale at Discharge | 2.07 units on a scale | Standard Deviation 0.77 |
| Treatment as Usual | Average Score on the Short Positive Urgency Scale at Discharge | 2.39 units on a scale | Standard Deviation 0.81 |
Comparison: 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).p-value: 0.64ANOVA
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Training Plus Treatment as Usual | Average Perceived Helpfulness of Training | PASAT Perceived Helpfulness Rating | 3.92 units on a scale | Standard Deviation 1.44 |
| Cognitive Training Plus Treatment as Usual | Average Perceived Helpfulness of Training | Go/NoGo Perceived Helpfulness Rating | 5.07 units on a scale | Standard Deviation 1.69 |
Secondary
Completion Rates
The percentage of participants enrolled in the cognitive training arm who complete the training sessions and the discharge session.
Time frame: At study completion, an average of two weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cognitive Training Plus Treatment as Usual | Completion Rates | 15 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training Plus Treatment as Usual | Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge | 224.87 milliseconds | Standard Deviation 50.61 |
| Treatment as Usual | Estimated Stop-Signal Reaction Time (SSRT) on Stop-Signal Task (ms) at Discharge | 236.69 milliseconds | Standard Deviation 62.08 |
Comparison: 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).p-value: 0.91ANOVA
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.
Time frame: Baseline and at study completion (discharge), an average of two weeks. Baseline data and discharge data are shown separately below.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cognitive Training Plus Treatment as Usual | Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population | Baseline | 7 Participants |
| Cognitive Training Plus Treatment as Usual | Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population | Discharge | 5 Participants |
| Treatment as Usual | Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population | Discharge | 2 Participants |
| Treatment as Usual | Feasibility of Assessing Change in Event-related Potentials (ERPs) During a Stop-Signal Task in a Partial Hospital Population | Baseline | 4 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training Plus Treatment as Usual | Average Score on Distress Intolerance Index (DII) Scale at Discharge | 21.77 units on a scale | Standard Deviation 10.17 |
| Treatment as Usual | Average Score on Distress Intolerance Index (DII) Scale at Discharge | 22.75 units on a scale | Standard Deviation 9.21 |
Comparison: 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).p-value: 0.24ANOVA