A Randomized Controlled Trial of Cognitive Control Training for Urgency in a Naturalistic Clinical Setting
Phase: NA
Conditions: Impulsive Behavior, Mental Disorders
Sponsor: Mclean Hospital

 
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Study Protocol 
 
Study Title: 
A Randomized Controlled Trial of Cognitive Control 
Training for Urgency in a Naturalistic Clinical Setting 
 
Date: 12/14/2020 
NCT#: NCT03527550 
 
 

 
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Title of Research Project: A Randomized Controlled Trial of Cognitive Control Training for 
Urgency in a Naturalistic Clinical Setting   
 
Overall Protocol Summary:  
 
BACKGROUND AND SIGNIFICANCE 
 
What do depression, binge eating, self-injury, addiction, anxiety, and aggressive behavior 
all have in common? These phenotypically diverse diagnoses and behaviors have each been 
associated with elevated impulsivity. More specifically, they are all linked with one particular 
type of impulsivity—urgency, which describes reflexive behavioral responses in response to 
either negative or positive emotions (12, 27). Cross-sectional studies have provided consistent 
support for the idea that urgency is a transdiagnostic construct (28), with a large meta-analysis 
showing robust correlations between urgency and symptoms of depression, anxiety, eating 
disorders, substance use, aggression, and borderline personality disorder (13). 
Urgency is associated with destructive, maladaptive behaviors that are common across 
types of mental illness. For example, urgency is robustly correlated with measures of aggression 
(13, 29, 30). Urgency is also strongly correlated with non-suicidal self-injury (NSSI) and with 
suicide attempts (13, 31), and there is evidence that NSSI mediates the relationship between 
urgency and attempting suicide (32). Many studies have found strong relationships between 
urgency and alcohol and cigarette use (33, 34) and drug use (35, 36). Beyond these cross-
sectional findings, urgency prospectively predicts maladaptive behaviors and symptoms over 
time, suggesting that this form of impulsivity is not merely an artifact of other symptoms. 
Urgency predicts the first occurrence of NSSI (16), as well as increased urges to self-injure in the 
context of sad mood (37). Urgency also prospectively predicts increases in drug and alcohol use, 
as well as problems related to using alcohol (14, 35, 38). Other prospective studies find that 
urgency is predictive of a range of destructive behaviors, such as problem gambling (15), risky 
sexual behavior (38), and binge eating (15). Given its role in a wide range of maladaptive 
behaviors, urgency is an important transdiagnostic treatment target, yet few studies have 
evaluated whether this aspect of impulsivity is responsive to existing treatments. In one recent 
study, urgency at baseline was associated with worse treatment outcome for people with binge 
eating disorder (39). To assess how urgency responds to treatment of acute symptoms of 
psychopathology, the PI conducted a Preliminary Study (A) analyzing change in urgency in 348 
patients seeking treatment in a partial hospitalization program. Results of this study showed that 
although urgency decreased following treatment, negative urgency levels on discharge day from 
the program correlated with depression (partial r = .37, p< .001) and modestly correlated with 
NSSI urges (partial r = .17, p < .01) and urges to use substances (partial r= .18, p < .01). 
Together, these findings suggest that individuals with higher levels of urgency may not respond 
to existing treatments, and individuals for whom existing treatment does not adequately improve 
urgency continue to struggle with associated clinical symptoms. 
In contrast to the paucity of treatment studies, many studies have evaluated the putative 
underlying mechanisms of urgency. These studies are largely based on the hypothesis that 
deficits in top-down cognitive control play a role in the expression of urgency (40). Although a 
number of candidate cognitive mechanisms have been tested, the most consistent evidence shows 
that deficits in prepotent response inhibition—the ability to override or cancel a dominant 
response—are most robustly correlated with urgency (1, 17). In a metaanalysis co-authored by 
this PI, findings showed that correlations between inhibition deficits and urgency were 
strongest in clinical samples (1). In addition to inhibition deficits, two-mode models of 
impulsivity and addiction emphasize the potential moderating role of working memory deficits, 

 
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which are hypothesized to exacerbate weaknesses in bottom-up reactivity to emotion (41). There 
is evidence that this theory applies to urgency as well, with one study finding that working 
memory deficits moderate the effect of inhibition deficits on negative urgency (18). In sum, both 
response inhibition and working memory may be crucial mechanisms underlying the expression 
of urgency. 
 
Although most studies of mechanisms related to urgency have relied upon performance 
on behavioral tasks, studies have increasingly sought to understand links between cognitive 
control and urgency at the neural level. However, findings from these studies have not been 
consistent. Supporting the hypothesis that urgency is driven by weaknesses in top-down 
cognitive control mechanisms, some evidence shows that in the context of viewing emotionally 
stimulating pictures, negative urgency is related to lower activation in areas including the 
orbitofrontal cortex (OFC) and anterior cingulate cortex (ACC) (42). Other studies using 
functional connectivity analysis identify that higher levels of positive urgency are related to 
reduced connectivity between the ACC and areas of the parietal cortex (20, 30). In contrast, 
several studies suggest that during response inhibition tasks with negatively valenced images, 
urgency is related to increased activity in brain regions associated with cognitive control, 
including ventrolateral prefrontal cortex (vlPFC) and OFC (21, 43). Thus, it is 
not clear whether urgency is sustained by a deficit in the ability to recruit cognitive control 
regions or whether it is related to a maladaptive overuse of cognitive control to regulate behavior 
when experiencing negative affect, as has been suggested by Chester and colleagues (21). From 
either perspective, enhancing inhibitory control may help reduce urgency either by potentiating 
greater use of cognitive control or by providing training in the 
flexible application of control when necessary. 
Existing research on the neural basis of urgency has yielded mixed results and has 
primarily used fMRI methodology. Surprisingly, very few studies have taken advantage of event-
related potential ERP methods to examine neural correlates of urgency. ERP methodology is 
very well-suited to testing hypotheses about cognitive control, given its high temporal precision 
and the strong evidence for specific event-related potentials that relate to activation in brain 
regions implicated in cognitive control (e.g., [22, 23]). Only one study to date has used ERP 
paradigms in relation to urgency. In that study, urgency was unrelated to ERN amplitude unless 
individuals also reported low levels of conscientiousness; these individuals showed enhanced 
ERN amplitude in responses to errors (25). To our knowledge, there have been no investigations 
of the relationship between urgency and cognitive control using EEG methodology in a clinical 
sample. 
Although the neural basis of urgency is not well understood, response inhibition and 
working memory are each well-characterized at the biological level of analysis. Evidence from 
lesion studies, fMRI, and EEG all suggest that inhibition is primarily based on activation of the 
right vlPFC, driven by activation in the right inferior frontal cortex (44, 45). In many common 
response inhibition paradigms, this activation is preceded by activation of the ACC, which is 
thought to detect conflict and potentiate the activation of inhibitory mechanisms (22). The neural 
basis of working memory is similarly well-understood, with strong evidence showing a central 
role for activation in the dorsolateral prefrontal cortex (dlPFC; 46). Beyond understanding the 
neural basis of these cognitive capabilities, research has increasingly shown the potential for 
cognitive training to induce improved performance on working memory and response inhibition 
tasks, as well as changes in the underlying biology supporting both of these cognitive functions. 
Several studies have shown training-based behavioral enhancements in inhibitory control, nearly 
all of which using either the Go/NoGo or Stop Signal paradigms (47). Multiple studies have now 
shown changes in brain activity associated with inhibitory control following use of these training 
paradigms (47). Many of these studies find evidence for reduced activation in regions of the 

 
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brain implicated in inhibitory control after training (47, 48), including reductions in the N2 
event-related potential (ERP) thought to indicate preparation for inhibition (26). One 
interpretation of these findings, proposed by Spierer and others (47), is that training inhibition 
improves efficiency. Similarly, training using working memory paradigms has shown to be 
effective in increasing performance on working memory tasks, although these 
paradigms have been associated with increased activation of the dlPFC (49). In sum, these 
studies support the malleability of cognitive control at both the behavioral and neural level. 
 
Many types of emotion regulation are supported by the same prefrontal cortical circuitry 
that subserves inhibitory control and working memory, including vlPFC and dlPFC (44, 50). 
Building on this shared basis, studies have found that training on cognitive control tasks leads to 
improvements in aspects of emotion regulation. For example, several studies using an adaptive 
auditory working memory task found reductions in rumination on negative affect following 
training (51, 52). Another recent study reported that inhibition training transferred to improved 
emotion regulation at the neural level on a reappraisal task after training (53). Thus, there is 
encouraging evidence that training on “cold” cognitive tasks (those that train basic cognitive 
abilities) may strengthen underlying neural circuitry important for regulation of “hot” cognition 
(regulation of affect). Based on the hypothesis of combined deficits in response inhibition and 
working memory influencing urgency, on evidence suggesting the malleability of inhibition and 
working memory, and on the potential for cognitive training to influence affective outcome, the 
PI of this proposal conducted a Preliminary Study (B) that tested a combined cognitive training 
intervention for urgency. In this study, individuals with high levels of urgency completed a six-
session cognitive training intervention with a response inhibition task (adaptive Go/NoGo) and a 
working memory task (adaptive Paced Auditory Serial Addition Task [PASAT]). Three primary 
findings emerged, all of which directly inform the present study: (1) performance on response 
inhibition and working memory tasks improved from pre to post-training; (2) urgency showed a 
significant decrease from preto post-training (Cohen’s d= 0.66), with no significant change 
during a waitlist control period, and (3) participants reported improvements on two measures of 
emotion regulation, including increased use of reappraisal (d = 0.52) and decreased rumination 
(d = 0.49). Despite these highly encouraging findings, this was a pilot study with several 
limitations, including lack of measurement of neural correlates of cognitive control, which 
prevents a clear conclusion about effects of the training on underlying cognitive control 
capabilities. Additionally, this study was conducted in a non-clinical sample of students and 
community members. Given that the relationship between inhibition deficits and urgency is 
strongest in clinical samples (1), it is unknown whether the intervention tested in this study might 
yield similar effects in a clinical sample. 
 
SPECIFIC AIMS 
1. The first aim of this study is to confirm target engagement of cognitive control training at 
both the behavioral and neural levels of analysis in a clinical sample of patients reporting 
high levels of urgency. We predict that compared to the control group, patients 
completing cognitive training will show lower interference (improved behavioral 
performance) and decreased ERN and N2 amplitudes on a Stop-Signal response 
inhibition task. 
2. The second aim is to examine clinical outcomes of cognitive control training. Based on 
Preliminary Study A, we predict that all patients receiving treatment at the BHP will 
report lower urgency scores at discharge; however, we predict that this decrease will be 
significantly greater in those receiving cognitive training. In addition, we predict that 

 
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participation in the training will be associated with greater reductions in depression 
symptoms, urges to engage in NSSI, and craving related to substance use. 
3. The third aim is to assess this training’s feasibility and acceptability to patients in a real-
world clinical setting. We predict that at least 75% of enrolled patients will complete all 
training sessions. 
 
 
SUBJECT SELECTION 
This is a sub-study under the existing protocol entitled “Establishing the Effectiveness of 
Cognitive-Behavioral Partial Hospitalization for Anxiety, Depression, and Overall Functioning” 
(# 2010-P-001047/6). We will recruit 110 participants from the patient population at the McLean 
Hospital Behavioral Health Partial Hospital Program (BHP). Inclusion criteria include: (a) BHP 
patient, (b) score above a 3 on either the UPPS Negative Urgency Scale or the UPPS Positive 
Urgency Scale at admission, (c) able to complete a computer task for 15 minutes, and (d) consent 
to main BHP study protocol (# 2010-P-001047). Participants will be excluded from participation 
if they are experiencing acute symptoms of mania or psychosis; if they are currently undergoing 
ECT; or if they have a history of a traumatic brain injury. Participants who are left-handed will 
be excluded from the EEG portion of the study but will be allowed to complete all other portions 
of the study. 
 
Additional inclusion criteria for the research study will be consistent with admission criteria for 
the BHP program. Specifically, patients who are acutely psychotic and are deemed unfit for 
admission at the BHP will not be invited to participate in this study.  
 
SUBJECT ENROLLMENT 
 
Procedures under existing BHP protocol: Upon arrival to the Behavioral Health Partial Program, 
all patients will be oriented by the Community Residence Counselors and/or Nurse Practitioner 
(all CITI certified staff members) to the program, building and set-up of the treatment.  Once 
oriented, patients will also be informed that as part of their treatment at the BHP they will be 
completing extensive self-report measures and a diagnostic interview. The research coordinator 
will explain to patients about our current research study examining the efficacy of CBT in 
naturalistic settings and asked whether or not they would like to consent to having their 
assessments be de-identified and included in our research database.  It will also be explicitly 
instructed to patients, that if they were to refuse consent/participation, their treatment at the BHP 
will not be affected in any way.  Patients will have the option to rescind their 
consent/participation at any point, and subsequently the Research Coordinator will take the 
appropriate measures to accommodate this decision.   
Procedures under proposed protocol: The research coordinator or another member of the study 
staff will approach eligible patients (scoring above a 3 on either the Negative or Positive 
Urgency scale of the UPPS-P and consented to main BHP study) on their second or third day in 
the program and inform them about the study. Interested patients will then receive a detailed 
description of the study procedures, risk, and benefits and will sign an informed consent form. 
 
Once enrolled, participants will be randomly assigned by a random number generator to one of 
two arms: treatment as usual + Cognitive Control Training (TAU+CCT), or treatment as usual 
(TAU). The PI or post-doctoral fellow will be responsible for randomization, and will notify the 

 
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Research Coordinator of each participant’s assignment. Up to 20 participants will be assigned to 
the non-randomized pilot phase that will only include TAU+CCT, with no EEG session. 
 
 
STUDY PROCEDURES 
 
Design overview. We will conduct a randomized controlled trial of computerized cognitive 
control training among patients admitted to the BHP who report elevated scores on the urgency 
scales. Prior to beginning the randomized phase, we will enroll up to 20 participants into a pilot 
phase that will include the training program and all measure described below, with the exception 
of the EEG task. Next, Up to 90 patients will be randomized, with the goal of at least 68 patients 
completing baseline and discharge measures of impulsivity, symptoms, and craving for 
substances; half of these participants will be randomized to active training while half will 
undergo treatment as usual in the BHP. Participants randomized to the active training condition 
will be asked to complete eight to ten sessions of computerized cognitive training that combines 
working memory training and response inhibition training. This is a sub-study under the existing 
protocol entitled “Establishing the Effectiveness of Cognitive-Behavioral Partial Hospitalization 
for Anxiety, Depression, and Overall Functioning” (# 2010-P-001047/6). Data obtained under 
the existing BHP protocol will be shared with Investigators from this study. 
 
Procedures under existing BHP protocol: This research will be conducted with each patient who 
enters our program (up to 900 adult patients each year).  As the Behavioral Health Partial 
Program is an adult CBT-based program, all patients are at least 18 years of age and up.  Upon 
registration in our program, patients will receive the Mini-International Neuropsychiatric 
Interview (M.I.N.I.), a 20-45 minute non-invasive, structured diagnostic psychiatric interview to 
assess for psychiatric diagnostic criteria. Patients will also be asked to complete a self-report 
questionnaire assessing for demographic variables, symptom severity, functional impairment, 
and CBT skill acquisition upon registration, upon discharge, and four and eight weeks following 
discharge from our program. Information will be stored on-site, in a locked drawer, in a secure 
office. Patients’ original questionnaires will be maintained for no longer than five years.  Only 
the Principal Investigator, Research Coordinator, Post-Doctoral Fellow, Nurse Director (Lynn 
Kopeski), and Program Director (Throstur Bjorgvinsson) will have access to PHI.  However, the 
majority of PHI will be stored electronically.  The proposed research will be using RedCap 
Database, an encrypted, electronic database that is both HIPPA compliant (Health Insurance 
Portability and Accountability Act) and approved by Partners IRB for the administration and 
storage of human subject information (for addition information on the RedCap Database feature 
see http://rc.partners.org).  To minimize inconvenience and provide maximum benefit to patients, 
data collection will be streamlined as a part of standard clinical care. Clinically salient 
information, including diagnostic output and patient's self report scores, will be highlighted and 
presented to clinical team managers and others involved in patient services. Non-BHPP patients 
will not be able to participate in this research. Procedures for Proposed Protocol: Participants’ 
data collected as part of protocol (# 2010-P-001047/6) will be used to characterize the 
demographic and clinical characteristics of the sample and as outcome assessments. Thus, only 
participants who consent to the main BHP study protocol will be eligible for the current study. 
 
Baseline and Post-Training Research Assessment. All participants will complete a baseline 
assessment of symptoms, craving for substances, and cognitive control. Participants deemed 
eligible for the EEG portion of the study will complete one additional session on the day of the 
baseline assessment and one additional session on the day of the post-training assessment, which 

 
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will include high-density ERP data during completion of one of these cognitive tasks. Baseline 
assessments will take place on the day following admission or on the following day (3rd day). 
The tasks at baseline and post-training will include: 
 
Self-Report and Interview Measures 
a. Negative and Positive Urgency Scales are subscales of the UPPS-P, a multidimensional 
impulsivity self- report measure (56, 27). These scales reflect impulsive response to negative and 
positive emotions, respectively. The Negative and Positive Urgency scales are often highly 
correlated, and factor analysis has found that these dimensions share a common underlying 
construct of emotion-related impulsivity (57). 
b. Alexian Brothers Urge to Self-Injure Scale (ABUSI; 60) is a brief self-report measure that 
assesses frequency and intensity of urges to engage in NSSI. 
c. Craving Scale (based on [61]) is a 3-item scale predictive of future substance use for 
substances such as alcohol, opioids, and cocaine (61-63). Patients will rate their craving for their 
primary substance of choice. 
d. Positive and Negative Affect Scale-10 item (PANAS-10; 69), a ten-item questionnaire 
assessing current positive and negative emotions. This scale will also be administered at the 
beginning of each of the training sessions. 
e. Distress Intolerance Index (DII; 70), a ten-item self-report measure assessing perceived ability 
to tolerate distressing physical and emotional states. 
f. Ruminative Responses Scale (RRS; 71), a self-report measure of thinking styles in response to 
negative mood. 
g. Attentional Control Scale (ACS, 72); a brief self-report measure of cognitive control. 
h. Edinburgh Handedness Inventory-Short Form (74). At the baseline session only, participants 
will complete a 4-item measure to determine handedness. 
i. Debriefing. At the post-training session only, participants will complete a debriefing 
questionnaire to assess their perceptions of the study. 
 
Participants will also complete two measures that are already administered as part of standard 
clinical care at the BHP:  
The Mini International Neuropsychiatric Interview (MINI; 58) is a structured interview that 
assesses the presence of DSM-5 disorders. The BHP has well-established training and reliability 
procedures, including review of randomly-selected recorded MINI interviews to verify inter-rater 
reliability across the team. The MINI will be administered by doctoral practicum students and 
interns in clinical psychology who will receive weekly supervision by the post-doctoral fellow. 
The Patient Health Questionnaire-9 Depression Scale (PHQ-9, 59) is a brief self-report measure 
of current depression symptoms. 
 
Cognitive Control Tasks 
a. Stop Signal Task (64) (with concurrent EEG/ERP for those completing the EEG session). 
Improvement in response inhibition will be assessed using a visual Stop Signal task, a 
well-established behavioral task that assesses ability to withhold a predominant 
behavioral response (65). Participants are presented with a series of stimuli on a computer 
(such as shapes) and are asked to respond as quickly as possible to the shape by pressing 
a corresponding button. On a minority of trials, a shape is followed by a “stop signal” 
cue, which signals participants to inhibit their response. The primary behavioral outcome 
is the Stop-Signal Reaction Time, calculated by subtracting the median interval between 
go and stop signals on stop trials from the median response time to the “go” trials (69). 
The Stop Signal Task will be used to evaluate transfer of response inhibition gains based 

 
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on the cognitive training intervention.  
 
During completion of the Stop Signal task, EEG-eligible participants will undergo ERP 
recording using high-density, 96-channel electroencephalography (EEG, Brain Products GmbH).   
EEG recording will take place in specialized sound- and acoustically shielded testing room at the 
Center for Depression, Anxiety, and Stress Research (Director: Diego A. Pizzagalli, Ph.D.), 
located directly next to the BHP (approximately a 3-minute walk from door to door). EEG 
recording during the Stop-Signal task will be conducted to specifically identify two ERP 
components relevant to inhibition: the error-related negativity (ERN) and the N2. ERP data will 
be analyzed using BrainVision Analyzer software. ERN will be identified by a negative 
deflection of the ERP occurring within 100ms of errors committed on the Stop Signal Task (e.g., 
pressing the “go” button after a stop signal has been presented or incorrect responses). The N2 
will be identified as the largest peak of a negative-going deflection occurring between 200 and 
400 ms after stimulus onset on each trial, reflecting preparation for inhibition. 
b. Dual N-Back Working Memory Task (67). To assess change in working memory, participants 
will complete a dual N-back working memory task. This task evaluates participants’ ability to 
simultaneously remember both visual and auditory cues at varying time intervals. The Dual N-
back task will be used to evaluate transfer of working memory gains based on the cognitive 
training intervention. 
c. Trails Task (73). To assess baseline performance and change in processing speed and 
switching, participants will complete a brief computerized Trails Task. The Trails task will be 
used to evaluate how baseline speed and switching ability predicts response to training, and to 
evaluate potential transfer effects. This task is administered via TestMyBrain, which is a not-for-
profit website dedicated to internet-based experiments. TestMyBrain uses SSL (secure sockets 
layer) encryption to protect any information that is being transferred between a browser and 
server. Data is backed up automatically on a nightly basis and only authorized users have access 
to the database. TestMyBrain does not collect any identifying information about the participant. 
All participant test data are transmitted directly from the TestMyBrain.org database to the 
Researcher using either secure http file transfer or secure SQL connection protocol. 
 
Cognitive Control Training.  
Participants randomized to complete the cognitive control training exercises will complete 8 to 
10 sessions of the exercises described below, lasting about 15 minutes each time. Prior to each 
training session, participants will view a brief powerpoint slide reminding them how the task 
pertains to impulsivity. Participants will be asked to complete ten sessions; however, participants 
may complete as few as five sessions if there are problems finding time to schedule all ten 
sessions (e.g., computer availability, participant availability during lunchtime or before or after 
program hours, etc.). The two training tasks will alternate on each day of training: each day of 
training, participants will complete either the Go/NoGo task or the PASAT task described below; 
participants will be randomly assigned to begin with either the Go/NoGo task or the PASAT 
task. 
 
a. Adaptive Go/NoGo is a response inhibition training paradigm previously used by this PI to 
train inhibition (19) based on similar Go/NoGo training paradigms used in previous training 
studies (i.e., 48, 68). Participants are instructed to press a button as fast as possible (“go”) 
whenever they see a stimulus (a single letter) presented onscreen; however, on each new block 
they must withhold their response when a target letter is presented (“no-go”), with the target 
letter switching in each new block. The training includes three 5-minute blocks per session. 
Similar to other inhibition training paradigms (46), the difficulty level is adapted to performance 

 
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based on participants’ reaction time to “go” trials; as participants correctly respond to “go” trials, 
the amount of time in which they have to respond to these trials is reduced. The nonadaptive 
version of this task will be used to assess baseline and post-training task performance. 
b. Adaptive Paced Auditory Serial Addition Task (PASAT, [51]) In this task, participants listen 
to a series of aurally-presented numbers and are instructed to add each number to the last number 
presented and enter the sum onscreen. The performance-adaptive version of the task decreases 
the inter-stimulus interval as performance improves (making the task more challenging by 
reducing the amount of time per trial, or decreasing difficulty by increasing time). The training 
includes three 5-minute blocks per session. The nonadaptive version of this task will be used to 
assess baseline and post-training task performance. 
 
Sessions will be completed during the lunch hour, in between groups, or at the end of the day. 
Sessions will begin on the second or third day and continue until discharge. The average length 
of stay in the BHPP is 8.5 days. Sessions will be completed in the BHP computer lab, where 
patients complete daily progress monitoring as part of their standard clinical care, or a private 
room when available. A member of the study staff, typically the research coordinator, will set up 
the computer task and be available for any questions or problems. 
 
BIOSTATISTICAL ANALYSIS: ERP data will be pre-processed to remove artifacts (e.g., by 
using independent component analyses) and identify ERPs using BrainVision Analyzer. 
Hypothesis 1 will be tested using a 2 (condition: TAU+training, TAU) x 2 (time: baseline, 
discharge) mixed-model analysis of variance (ANOVA) with Stop-Signal Reaction Time as the 
dependent variable; two separate ANOVAs with the same predictors will also test dependent 
variables of ERN and N2 amplitudes. Hypothesis 2-3 will be similarly tested via mixed-model 
ANOVA with the same predictors; one model will test the DV of Negative Urgency; one will 
test the model of Positive Urgency; and three models will test change in craving, depression, and 
self-harm urges. Hypothesis 4 will be tested via descriptive statistics assessing the percentage of 
enrolled participants who complete the training intervention and their mean level of satisfaction 
at discharge. Analyses will consider the impact of several a priori potential confounds on effects 
of the intervention, using Pearson correlations to test if performance on cognitive tasks are 
related to age, medication, primary diagnosis, or percentage of completed training sessions. If 
significant correlations are identified, these variables will be included in the above analyses as 
covariates. 
 
Power analysis: A priori power analysis conducted in G*Power indicated that a sample size of 68 
individuals is necessary to achieve adequate power (1- β= 0.9) to detect small to medium effects 
(Cohen’s f = 0.2) in repeated-measures ANOVA. To ensure adequate power, we will recruit up 
to 90 patients to begin the study, based on predicted attrition rates (see “Potential Problems and 
Alternate Strategies”). To complete recruitment within two years, we will enroll 3.75 patients per 
month, or roughly one per week. In previous cognitive training studies conducted by Dr. Beard 
in the BHP, she has successfully enrolled patients at a rate of one per week, indicating that the 
target in the present study is highly feasible. 
 
RISKS AND DISCOMFORTS 
 
Potential Risks 
i. Privacy and Confidentiality of Data: As with all research, there is a risk of loss of 
confidentiality and/or breach of data security. Given the substantial measures put in place to 
protect privacy and confidentiality within the BHP’s clinical research program (described 

 
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above), there is a low likelihood of this risk. 
ii. Frustration: The behavioral tasks that are administered at the baseline, training sessions, and 
discharge session require sustained concentration and focus. These tasks are relatively 
demanding by design, and thus some participants may feel moderately frustrated by the 
challenging nature of the tasks. However, in order to appropriately engage the putative 
underlying mechanisms of response inhibition and working memory capacity, it is necessary to 
include tasks that assess participants’ ability to effectively recruit these domains under somewhat 
challenging conditions. Thus, there is a moderate possibility of frustration after completion of 
these tasks for some individuals. 
iii. Fatigue: Participants may become tired following completion of relatively demanding 
cognitive tasks that require sustained concentration and focus. This may be particularly true for 
participants randomized to the TAU+training condition, as this condition involves up to 10 
sessions of 15-minute cognitive exercises. It is likely that some participants may feel mentally 
fatigued after completion of such training sessions. 
iv. Emotional Discomfort: Participants may find it upsetting to answer questions on self-report 
measures about their level of depression symptoms, urges to engage in self-injury, and/or craving 
for substances of abuse. However, these questions do not greatly differ from questions that are 
asked as part of routine clinical care in the BHP, and thus the risk of increased discomfort is 
relatively low. 
v. Worsening of Clinical Symptoms: Given the acute symptom presentation of this proposed 
study sample, it is possible that some participants may report new or worsening clinical 
symptoms during the course of the study, such as suicidal ideation or increased depression. As 
this study is conducted in a naturalistic setting, participants recruited for this study are expected 
to vary substantially in their clinical presentation and course of treatment, and thus there is a 
moderate risk of worsening clinical symptoms. 
vi. Discomfort with electrodes during EEG recording: Application of the net of EEG sensors to 
the scalp may feel mildly uncomfortable. We foresee only minimal risks from the EEG 
recording, a commonly and widespread procedure used to non-invasively measure electrical 
brain activity. The EEG will be recorded with actiCAP active electrodes (Brain Products 
GmbH), which requires no scalp abrasion. On rare occasions, individuals with very sensitive skin 
may experience a slight irritation at the site of sensor application due to the use of electrolyte gel. 
The Brain Products actiCHamp/actiCAP EEG system has been certified as safe under the safety 
and effectiveness standards of medical electrical equipment published by the International 
Electrotechnical Commission (IEC 60601-1:2005, 3rd edition). 
 
b. Protections Against Risk 
i. Privacy and Confidentiality: To protect participants’ privacy and confidentiality, multiple 
protective measures will be implemented. Identifying data (participants’ names) will be stored 
separately from all other study documents. A key database linking participants’ study ID 
numbers and their names will be stored on a secure, protected server that is separate from all 
other study documents. Participants’ original informed consent documents are stored in a locked 
file cabinet in a locked office accessible only by senior members of study staff. All study data 
will be stored electronically in protected databases, stored on a McLean Hospital research server 
accessible only to members of study staff. We plan to make de-identified data from this study 
available via the NIMH Data Archive (NDA) in accordance with NIMH policy, to be stored in 
the National Database of Clinical Trials. Apart from the self-report and interview measures that 
are also used in clinical care, all other study measures and tasks will be completed in private 
clinic rooms to maintain confidentiality within the program. 
ii. Frustration and Fatigue: Participants will be fully informed that some of the cognitive tasks 

 
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may induce frustration and/or fatigue. To mitigate these risks, participants will be encouraged to 
frequently take breaks during completion of the training tasks. The cognitive training sessions 
also have built-in task-adaptive programming that automatically adjusts task difficulty based on 
participants’ online performance. This means that for participants whose score begins to decline 
due to either frustration or fatigue, the task will automatically slow down in order to become 
moderately easier to complete. In addition, a member of study staff will be physically present 
during completion of all cognitive tasks and will be trained to monitor participants for signs of 
increased fatigue or frustration. These members of study staff will encourage participants to take 
breaks between blocks of the task. 
iii. Emotional Discomfort: Participants will be reminded that they may discontinue a 
questionnaire or interview at any time if they feel uncomfortable or upset answering questions. 
Participants will also be encouraged to share any emotional distress with a member of study 
staff, so that study staff can appropriately refer that participant to speak with a professional 
clinical member of their treatment team (e.g., case manager, psychiatrist, or therapist). In 
addition, the study sponsor (Dr. Courtney Beard) and the BHP Director (Dr. Throstur 
Bjorgvinsson) are licensed clinical psychologists who are available during program hours to 
provide clinical assessment of study participants, if necessary. 
iv. Worsening Clinical Symptoms: Members of study staff will be trained to monitor and 
recognize signs of increased distress among study participants. As part of routine clinical care in 
the BHP, certain self-report measures that are part of the main study protocol (# 2010-P-
001047/6) are reviewed on the day they are completed; if answers to self-report questions 
indicate a heightened level of risk for self-injury or suicidality (e.g., increased suicidal ideation 
or urges to self-harm) a staff member will contact a member of the patients’ clinical team. 
Similarly, clinicians who administer the interview-based measure of symptoms and diagnoses 
will assess for suicidal ideation and report any significant findings to other clinical team 
members. 
v. EEG session: Collecting EEG data is a common and widespread procedure used measure to 
assess electrical brain activity on the surface of the head.  The only known risk is that on rare 
occasions, individuals with very sensitive skin may experience a slight irritation at the site of 
sensor application due to the pressure from the blunted end of the needle that is used to ensure a 
good connection between the scalp and the electrode. The EEG cap may become uncomfortable 
after a long exam, but we will do our best to adjust it so this will not happen. Study staff will 
undergo extensive training and practice with EEG procedures prior to collecting EEG data with 
human subjects, and study staff will be trained to routinely check in with participants to make 
sure they are still comfortable with EEG procedures.  
 
 
POTENTIAL BENEFITS

 
12 
All participants who enroll in the study receive additional interactions with members of 
study staff, which may benefit participants by providing them with enhanced symptom 
monitoring while attending the partial hospital program. If participants show evidence of 
worsening symptoms, members of study staff are trained to immediately refer that person to their 
clinical team, which may enhance their existing clinical care. Finally, participants who are 
enrolled in the TAU+training condition receive access to an experimental cognitive training 
program that might help to reduce impulsivity. 
Although this study also involves the risk of fatigue, frustration, and possible emotional 
distress while filling out questionnaires, these risk factors are common in studies of cognitive 
training in clinical samples. Previous studies using similar designs have yielded important 
conclusions about the utility of cognitive training paradigms among people with mental illness, 
while also carrying similar risks. We believe that the potential benefit of testing cognitive 
training in this setting outweighs the slight to moderate risks associated with this type of study 
design. Similarly, although the risk of breach of confidentiality is a significant concern for all 
research, we believe that the protections described above are adequate and that the benefit of 
novel treatment development is an important goal that partially offsets these risks. The proposed 
research also has broader potential benefits outside of the immediate study participants. The 
results of this study may well provide important conclusions about the extent to which cognitive 
training paradigms for impulsivity can be integrated into the partial hospital context, which may 
benefit future generations of partial hospital patients who struggle with similar forms of 
impulsivity. 
 
MONITORING AND QUALITY ASSURANCE 
 
The proposed research plan will strictly adhere to the data and safety monitoring 
guidelines set forth by McLean Hospital and Partners Healthcare. As the proposed study is a 
relatively small clinical trial that does not meet the definition of an NIH-defined Phase III 
clinical trial, and given the relatively low risk to study participants, we have not proposed a full 
Data Safety and Monitoring Board for the present study. However, we will implement a series of 
data and safety monitoring procedures to ensure optimal safety for all participants. The Principal 
Investigator (Andrew Peckham) and the study sponsor (Courtney Beard) will hold responsibility 
for monitoring the safety of study participants and the security of data collected in this study. 
Safety monitoring will be conducted on an ongoing basis via several procedures. First, 
participants’ self-report measures include data that indexes patient safety (i.e., suicidal ideation, 
self-harm urges), and these measures will be reviewed daily by a member of study staff. If 
participants report an increase in risk based on these measures, the study staff member will 
immediately contact the PI. Also, members of study staff will inform the PI of any participants 
who verbally report any new safety concerns (either during the clinical interview or during 
routine study procedures). Any adverse events or serious adverse events will be reported to the 
Partners Healthcare Institutional Review Board (IRB). In accordance with Partners Healthcare 
policy, any unanticipated problems or adverse events will be reported within 5 working days or 7 
calendar days from the date the problem is discovered. Serious adverse events would be reported 
within 24 hours of discovery.  
In addition to these ongoing safety procedures, the PI will conduct a review of specific 
data points relevant to patient safety every twelve months. This review will encompass a 
statistical test of changes in symptoms on self-report measures from baseline to discharge in both 

 
13 
the TAU and the TAU+training groups. This will allow for evaluation of any potential negative 
effects arising from participation in the training program. 
 
 
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