tDCS for Increasing Exercise Adherence in Individuals With Elevated Depressive Symptoms
Phase: NA
Conditions: Depression, Physical Activity
Sponsor: Butler Hospital

tDCS for Increasing Exercise Adherence in Individuals with Elevated Depressive 
Symptoms 
 
NCT03178903 
 
February 21, 2018 
 
 

Background  
Depressive symptoms predict poor exercise adherence. (1, 2) (3),(4) (5-7) (8) (9) (10) (11) (12) and 
depression-specific characteristics (e.g., affect) are related to physical activity (PA) levels.  A cardinal 
symptom of depression is dysregulated affect – i.e., lower levels of positive affect and higher levels of 
negative affect (13, 14).  Positive affect has been consistently identified as a significant correlate of 
PA levels across a myriad of populations including: Parkinson’s (15), arthritis (16), ovarian cancer 
survivors (17), dementia (18), cardiovascular disease (1, 19), osteoporosis (20), knee patients (21), 
and college students (22, 23).  On the other hand, negative affect is inversely related to PA (1, 17, 21, 
22, 24).  The dysregulation in affect seen in depression is particularly concerning when it comes to PA 
level. Those with elevated depressive symptoms are placed at a disadvantage for maintaining regular 
physical activity in the long-term.   
 
Affective responses to exercise can influence exercise adherence.  While individuals almost 
universally “feel good” after engaging in PA(25), there is a fair amount of affective variability DURING 
exercise – some individuals increase in positive affect and others in negative affect (26-28).  In 
particular, increases in positive affect predict both intentions to engage in exercise(29) and actual 
exercise behavior (28, 30-33). While research on the affective experiences of exercise in those with 
depression has been limited, recent work suggests that those with a history of depression experience 
less of an increase in positive affect following PA(34).  Higher levels of depressive symptoms has also 
been associated with greater perceived physical exertion with exercise (35) and, in our own work, 
reduced PA enjoyment.  Therefore, if those with depression experience exercise as more challenging 
and less rewarding than nondepressed individuals, it can impact their likelihood of maintaining PA in 
the long-term.  
 
While physiological cues overwhelm the affective experience at higher exercise intensities, cognitive 
factors (e.g., self-regulation, attentional bias) influence affect at lower intensities (dual mode theory; 
(36)). For  example, negative mood also appears to be interfere with obese, sedentary individuals’ 
ability to self-regulate physical activity resulting in lower levels of exercise participation (37).  Further 
the inability to direct attention away from unpleasant stimuli (i.e., attentional bias; (38, 39)) is a 
hallmark of depression (40) resulting in negative affect.  Individuals with affective disturbances 
experience difficulty with attentional bias toward unpleasant emotions during exercise(41).  
Additionally, a growing body of electroencephalogram (EEG) studies support the notion that exercise 
is an emotion-eliciting event (42).  A recent review of 11 EEG studies examining the relation between 
affect and PA (43) concluded that a single session of exercise results in an asymmetric pattern of 
activity in the prefrontal cortex: greater left frontal activity before exercise is associated with greater 
positive affect during exercise, whereas, greater right frontal activity results in increases in negative 
affect during exercise.  This is particularly relevant for individuals with depression who, in both EEG 
and fMRI studies, have been found to show greater relative activity in right vs. left DLPFC (44), (45).  
Given the inherent difficulties in regulating affect experienced by depressed individuals, they may be 
“handicapped” in their ability to positively experience exercise, which may contribute toward their 
lower levels of physical activity.  Yet, regular physical activity is critical for decreasing health risks 
(e.g., obesity, diabetes, heart disease) in this population and interventions to improve the affective 
experience of PA could have a high public health impact. 
 
Transcranial direct current stimulation (tDCS) as a novel approach toward regulating affective 
processes. tDCS is a form of noninvasive brain stimulation which has been investigated in a broad 
range of populations (46, 47), and has shown promise in impacting a wide variety of cognitive and 
affective processes, such as working memory (e.g., (48, 49)), motor learning (e.g. (50, 51)) and 
emotion regulation (e.g., (52-54)). tDCS uses low current electricity (typically 1-2mA) to modulate 
neuronal excitability in targeted brain areas via two electrodes placed on the head. tDCS acts via 
slight alterations to membrane potentials in areas underlying electrodes, with typical settings (e.g., two 
electrodes, 1mA current) resulting in increased likelihood of neuronal firing under the anode and 
decreased likelihood of neuronal firing under the cathode. As tDCS modulates the likelihood of 
neuronal firing, but does not directly induce an action potential (like transcranial magnetic stimulation; 
TMS), it may be particularly promising in combination with behavioral interventions to enhance activity 
in neural circuits already in use. tDCS has been used in a large number of individuals and has been 
found to be relatively safe, with the vast majority of reported side effects being mild and transient 
(e.g., headache, fatigue; (55)). Moreover, tDCS has practical benefits over other forms of 
neuromodulation (e.g., TMS, deep brain stimulation) as it is significantly less costly and more 

portable, making it more practical for widespread implementation (see Image).  
While tDCS of DLPFC has been investigated as an intervention for depression with some (though not 
universal) support for efficacy (46, 56-58), studies have suggested tDCS of DLPFC may improve 
cognitive control over emotional information (52-54, 59, 60) and corresponding reductions in the 
emotional valence of negative stimuli. Interestingly, these changes do not appear to be explained by a 
change in mood, further supporting the notion that differences observed are likely due to improved 
cognitive control over emotional material (53, 60). Consistent with these findings, in depressed 
patients reduced attentional bias to emotional stimuli has been found following anodal tDCS to 
DLPFC(54). Given the central role of the affective experience of exercise to long-term PA and given 
experimental findings relating tDCS of DLPFC to improved emotion regulation, the combination of 
tDCS (of DLPFC) with an exercise program may be a promising approach to improve exercise 
adherence.   
 
Experimental Method 
 
Brief Description of Subjects 
Eligible participants will: (a) be between 18 and 65 years of age, (b) be low active (i.e., less than 90 
min of moderate-intensity exercise/wk for the past 6 mos.), (c) have elevated levels of depressive 
symptoms (i.e., Center for Epidemiological Studies Depression Scale score ³10), (d) be interested in 
starting an exercise program in the next month, and (e) able to walk one mile on a treadmill. Exclusion 
criteria include: (a) history of mania or hypomania, (b), history of psychotic disorder, (c) current DSM-5 
diagnosis of anorexia nervosa, bulimia nervosa, or other eating disorder for which an exercise 
intervention would be contraindicated, (d) DSM-5 moderate and severe substance use disorder (e) 
current suicidality or homicidality, (f) current DSM-5 diagnosis of major depressive disorder (MDD) 
that is not currently being treated with pharmacotherapy or psychotherapy (g) physical disabilities or 
medical problems that would prevent participation in moderate intensity exercise (i.e., physician 
denied medical clearance), may be contraindicated for tDCS (e.g., seizure disorder), or other study 
procedures (e.g., contagious skin disease), (h) current pregnancy or intent to become pregnant during 
the next 8 weeks, (i) pacemaker or metal implanted in the cranial cavity, (j) psychiatric medication 
changes within 6 weeks prior to study entry. 
 
Study Design 
The goal of the proposed study is to test the preliminary efficacy of tDCS combined with an 8-week 
aerobic exercise intervention for increasing adherence to exercise in individuals with elevated 
depressive symptoms. Participants will be randomized to receive the 8-week exercise intervention 
plus anodal tDCS of DLPFC (AE+tDCS) or sham tDCS of DLPFC (AE+sham). Outcomes will be 
assessed at end-of-treatment (EOT) as well as at 3-and 6-month follow-up.  
 
Specific Procedures or Treatments 
Initial Screening and Medical Clearance Procedures. Interested individuals will contact our research 
staff and we will conduct a screening of participants’ current level of physical activity and depressive 
symptoms. Participants appearing to meet study criteria will be scheduled for a more comprehensive 
baseline assessment. Research staff will obtain informed consent and then participants will be 
evaluated using the diagnostic and screening measures detailed below to confirm eligibility. 
Participants will also complete a brief computer task at the initial appointment and at the end of the 
12-week program that is designed to test working memory. The task involves matching letters to those 
on screen and lasts approximately 10 minutes.  At this interview, we will obtain a release of 
information to contact their primary care physician (PCP) to request medical clearance for engaging in 
moderate-intensity exercise AND for engaging in tDCS.  In addition to the PCP’s own clinical 
judgment, the PCP will be provided with a list of medical issues that would exclude the participant 
from exercise and/tDCS. We have successfully used this approach in previous exercise intervention 
studies. Upon receiving medical clearance, participants will undergo a standardized 1-mile Rockport 
treadmill walk test, administered by an exercise physiologist, in order to obtain a baseline measure of 
cardiorespiratory fitness.  
 
Study Assessments. All participants will complete a baseline assessment, as described above, as well 
as follow-up interviews at EOT and 3- and 6-months after baseline. Assessments will include 

evaluator-administered interviews and self-report questionnaires, as well as measures of physical 
health and activity level (e.g., body composition, blood pressure, accelerometry). Additionally, the 
SAFTEE-SI will be administered weekly to assess for side effects of the intervention (see Human 
Subjects section for additional detail). Specific assessments to be used and the timepoints at which 
they will be administered are presented in Table 1 (below). Participants will be completing 
questionnaires on a laptop computer or tablet device, using REDCap (see Data Analysis Overview), 
for ease of data collection. From our prior experience conducting exercise interventions in psychiatric 
populations, we expect to be able to contact 80-90% of participants at follow-ups.  
 
Randomization and Intervention Conditions. After the medical clearance, participants will be 
randomized to AE+tDCS or AE+sham. These conditions will differ only in whether active or sham 
tDCS is being delivered. Participants, evaluators, and those delivering the tDCS will all be blinded to 
condition. Each intervention session will begin with 20 minutes of either active or sham tDCS, followed 
by supervised aerobic exercise.  
 
tDCS. tDCS is a form of noninvasive brain stimulation which uses low amplitude current (typically 1-2 
mA) to modulate excitability of underlying cortex (61). The stimulation is delivered via two electrodes 
placed on the scalp.  Current passes between them resulting in altered cortical excitability. If tDCS is 
delivered for a sufficient duration (e.g., >10 min,) these excitability changes have been found to 
persist for up to 1 hour (62, 63). The device is battery-powered and is adjustable in intensity and 
duration of stimulation delivered. A review of clinical research with tDCS noted that “tDCS has been 
tested in thousands of subjects worldwide with no evidence of toxic effects to date” (46). The most 
common side effects include mild local sensations at the electrode sites, including tingling or itching, 
(55, 64) moderate fatigue, and headache (64).  
 
In the present study, each participant will undergo a 20-minute session of either active or sham tDCS 
of DLPFC during each intervention session in a between-subjects design. Each session of tDCS will 
be immediately followed by the supervised AE (see “Aerobic Exercise Component” section below). 
Active tDCS intensity will be 1 mA. The anode and cathode are each contained in a 5x5cm 
rectangular sponge (25 cm2). The anode will be placed over left DLPFC (F3 on the EEG 10-20 
system) and the cathode over the contralateral supraorbital region (just above the right eyebrow). 
Stimulation will be delivered via two saline-soaked surface sponge electrodes and a battery-driven, 
constant current stimulator (NeuroConn DC Stimulator Plus). This device includes a study mode, in 
which subject-specific codes are entered to deliver active or sham stimulation, keeping the 
administrator blinded.  Sham stimulation will use a “ramp up/ramp down” method in which stimulation 
will be ramped up and back down over a 30-second period. This approach has been found to be an 
effective sham condition in previous studies using tDCS at 1-2mA (49, 56, 65). Immediately following 
the 20-minute tDCS period participants will engage in a supervised moderate-intensity aerobic 
exercise session.  These procedures will occur 3x/week for 8 weeks. 
 
Aerobic Exercise Component. After having received either tDCS or sham, participants will engage in 
an AE session at Butler Hospital’s Fitness Facility. Exercise sessions will be 20-30 minutes of 
moderate-intensity aerobic exercise on a treadmill.  These sessions will be supervised by an exercise 
physiologist who will monitor their heart rate and blood pressure to ensure safety and that activity is 
occurring at a moderate-intensity (i.e., 64-76% of age predicted maximal heart rate).  Participants will 
be asked to rate their affect and RPE (see C.9.b) during exercise sessions.  Sessions will include a 5-
min warm-up and a 5-min cool-down to ensure safe exercise procedures. Participants will be asked to 
answer questions about affect before, during, and after exercise. An additional working memory task 
that involves remembering numbers will be completed three times during the AE intervention (detailed 
above). In the later weeks of the study, participants will be instructed to gradually increase physical 
activity outside these supervised sessions toward a goal of 150 minutes of moderate-intensity aerobic 
exercise per week.  Participants will be provided with resources for increasing their physical activity at 
home.   
 
Fitbit Alta activity tracker. Participants will be asked to wear the Fitbit Alta activity tracker daily. A g-
mail account will be created for each participant in order to register the trackers on Fitbit.com.  In 
doing so, the investigators will have access to the participant’s activity data throughout the course of 
the study. No identifying information will be entered into this account.  The participant will not be given 

access to this account, in order to allow tracking of activity while reducing effect of the Fitbit on 
behavior. Participants will be able to see the display on the Fitbit Alta tracker, which provides data for 
the day it is being worn. We will sync the participant’s Fitbit at each session using a study computer. 
 
Data Analysis  
Sample Size Considerations. We aim to have a total of 60 participants complete the study 
(approximately 30 per group). Based on our previous work, we expect approximately 10-20% attrition. 
Therefore, we will aim to enroll a total of 72 participants to obtain our desired sample size of 60. 
Primary Hypotheses: We will first examine patterns of missing data to determine possible 
mechanisms of missingness and will explore different techniques to impute missing data values145,146. 
To test our first primary hypothesis, we plan to use a mixed modeling approach to test for differences 
in MVPA between conditions across time-points (EOT, 3- and 6-month follow-up). To test our second 
aim 1 hypothesis, we will conduct a between-groups t-test to examine whether session attendance 
differs between groups during the 8-week intervention. 
 
 
 
 
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blind sham-controlled clinical studies in brain stimulation. Clinical neurophysiology : official journal of 
the International Federation of Clinical Neurophysiology. 2006;117(4):845-50. 
 
 
 

CONSENT FOR PARTICIPATION IN A RESEARCH PROJECT – BUTLER HOSPITAL 
 
 tDCS for Increasing Exercise Adherence in Individuals with Elevated Depressive Symptoms 
 
Sponsorship 
This study is being paid for by a grant from the National Cancer Institute. 
 
 
Research Project Summary 
You are invited to participate in a research study designed to test the effects of transcranial 
direct current stimulation or tDCS – a type of noninvasive brain stimulation – on people’s 
exercise habits. You have been invited to participate because you have said you are interested in 
starting an exercise program and are experiencing some depressive symptoms. Your 
participation in the study will last for approximately six months, including initial assessments, an 
eight week exercise program, and three follow-up assessments.  The eight-week exercise 
program will require three visits to our research lab each week over the eight weeks. 
Assessments will last about two hours each. You will complete two days of assessments before 
starting the exercise program, and three separate assessments after completing the exercise 
program - one at the end of the program, as well as three and six months after your baseline 
assessment.  
 
In order to decide whether or not you wish to be a part of this research study, you should know 
enough about its risks and benefits to make an informed judgment.  This consent form gives you 
detailed information about the research study which a member of the research team will discuss 
with you.  This discussion should go over all aspects of this research:  its purpose, the procedures 
that will be performed, risks associated with the procedures, possible benefits of participation 
and possible alternatives.  Once you understand the study, you will be asked if you wish to 
participate; if so, you will be asked to sign this form. 
 
Description of Procedures 
If you decide to participate, you will be asked to come in for several assessments, as well as 
complete an eight-week program combining exercise and tDCS. 
 
Baseline Assessment and Medical Clearance. If you decide to participate, you will first 
complete an interview with one of our research staff members to confirm that you are eligible for 
the study. Our study staff will ask you questions to learn about you and your exercise habits, and 
determine if this study is a good fit for you. You will be interviewed by research staff and will 
also complete some forms and questionnaires on a computer. These will include questions about 
your exercise habits, eating, physical health, and psychiatric symptoms.  You will also be asked to 
complete a brief computer task at the initial appointment and at the end of the 8-week program that is 
designed to test working memory. The task involves matching letters to those on screen and lasts 
approximately 10 minutes. You will be asked to wear an accelerometer (e.g., small device that 
counts your movements so that we know how active you are) for a week before each assessment 
time point including baseline. This, and other study assessments, will be audiorecorded. 
 
Before becoming a participant in this study, we will need to receive medical clearance from your 
primary care physician (PCP). We will ask you to give us your signed permission to be in contact 
with your PCP.  Your PCP will be receiving a letter that explains what is involved in this study. 
Your PCP will then indicate whether or not the study is safe for you. However, it is your 

responsibility to inform study staff of current medical conditions and of changes in your health 
that take place over the course of the study to ensure your continued safety in the exercise 
program.  
 
After receiving medical clearance, we will determine your current level of fitness by having you 
participate in a treadmill exercise test. An exercise physiologist on our study team will do the 
test with you and all procedures will be discussed with you prior to the test. During the exercise 
test, you will be walking on a treadmill at a speed that you can comfortably maintain for one mile 
(i.e. you choose the speed). During testing, your heart rate and blood pressure will be monitored. 
If you feel dizzy, weak, or very short of breath, or if you have chest pains or any other adverse 
signs and symptoms, the test will be stopped. During this exercise testing session, we will also 
measure your weight, height, and percent body fat.  
 
It is possible that, based on the interview, medical screen, and/or exercise test, you will not be 
found eligible to participate in this study. In addition, if you are unable to walk one-mile on the 
treadmill, you will not be eligible to participate in this study. 
 
Exercise Program with tDCS. After the baseline assessment, you will complete an eight week 
exercise program which will combine tDCS and exercise. This program will require you to attend 
program sessions three times each week for the eight weeks. Each session will last about an 
hour. As part of this program you will have either active tDCS or simulated tDCS - which one you 
get will be assigned randomly, like the flip of a coin, and neither you nor the study staff you meet 
with will know which one you are getting. You will have either the active 
or simulated (sham) tDCS for approximately 20 minutes at the beginning 
of each exercise program visit. In order to provide the active or sham 
stimulation, two wet sponges containing electrodes will be placed on your 
head. These sponges will be held in place by large rubber bands. During 
the stimulation period, these sponges and rubber bands will remain on 
your head (see image).  
 
All study participants will participate in a moderate-intensity aerobic exercise program, 
regardless of the type of tDCS they get. During each visit, participants will complete 30 minutes 
of exercise in our study gym at Butler Hospital, using exercise equipment at this facility (e.g., 
treadmills, stationary bikes, elliptical machines). Each workout session will also include a 5-10-
minute warm up and 5-10 minute cool down.  Throughout the 8 week program, you will be asked 
to keep a log of any type of exercise you do each day. You may also be asked to answer questions 
about how you feel before, during, and after exercise, and complete a brief working memory 
number task. 
 
In order to track your physical activity, you will be asked to wear a Fitbit device each day during 
the course of the 8-week program. We will set-up a Fitbit account for your tracker on Fitbit.com, 
which you will not have access to. However, you will be able to see your daily activity data on the 
tracker’s display. At your first exercise session, we will provide you with instructions on how to 
wear and use the Fitbit. At the beginning of each exercise session thereafter, we will sync the 
Fitbit data using a study computer. After you have completed the study, the Fitbit is yours to 
keep and you can choose to create an account on Fitbit.com if you’d like. 
 
Follow-up Assessments. At the end of the eight-week program, you will come in for another 
assessment, similar to the baseline assessment. Again, you will be interviewed by our study staff 

and will be asked to complete some forms and questionnaires on a computer. As in the baseline 
assessment, we will have you walk on the treadmill and we will gather information on your 
physical health. You will also be asked to wear an accelerometer (e.g., small device that counts 
your movements so that we know how active you are) for a week before each assessment. You 
will come back and complete similar assessments three months and six months after completing 
your baseline assessment.  
 
Risks and Inconveniences   
There are minimal risks associated with participating in a submaximal exercise test (used to 
predict maximum aerobic ability) and a regular exercise program such as the one we offer in this 
study. You may experience general fatigue (tiredness) during your participation in these 
activities. You may also experience sprains, muscle pulls, shin splints, or bone 
injuries.  Precautions should be taken to prevent such injuries, such as careful adherence to your 
exercise prescription. In addition, during exercise, your heart rate and blood pressure will 
increase, and under extreme conditions, this can lead to a serious cardiac event (such as heart 
attack). The possibility of experiencing a serious cardiac event has been estimated to be less than 
2 per 20,000 in exercising adults.  
 
You may experience mild and temporary stress associated with completing the self-report 
measures. You can choose to not answer any given question or discontinue the study at any time. 
You may also find the computerized working memory task to be tedious and/or boring. You may 
choose to discontinue the task at any point. 
 
You may also experience worsening depressive symptoms.  As part of the study, we will closely 
monitor your depressive symptoms with questionnaires and brief interviews.  This may also 
include receiving a phone call from study staff when you miss a session.  If your depressive 
symptoms were to significantly worsen, we may want to contact your mental health treatment 
provider.   
 
There is some risk with tDCS. There is a risk of skin irritation and temporary redness on your 
scalp where the stimulation occurs. Local skin burns are also possible; however, these would be 
considered extremely rare given the type of tDCS used in this study. Hypomania, (feelings of 
elevated mood or too much energy), has also been reported in a small percent of people who 
received daily tDCS for depression. In one study where daily tDCS was used for depression with 
or without antidepressant medication, as many as 5-6% of people developed hypomania. In most 
cases, the hypomania went away after stopping tDCS or by making adjustments to medications. 
However, the overall risk of hypomania occurring with tDCS is still unclear. Thus, this may be a 
risk. Other side effects such as temporary headache, nausea, and fatigue are sometimes reported 
with tDCS, as well. It is possible that tDCS may have other unforeseen side effects. We will 
monitor you closely for skin burns and discomfort. However, if you experience discomfort, please 
tell us immediately. A physician will be on-call during all tDCS procedures. We will also check in 
with you regularly during your weekly visits about any side effects you may be experiencing.   
We will make all efforts to protect your confidential information. However, in any study there is 
always a risk that your confidential information could be disclosed, despite our best efforts to 
protect your information. In order to keep the audio recordings of assessments confidential and 
private, research staff will transfer the digital audio file to a secure drive after the assessment or 
treatment session and delete it from the audio recorder. These files will not be labeled or stored 
with your name or any other identifying information and will be deleted at the end of the study. 
 

Women Please Note: The effects of tDCS as used in this study during pregnancy are unknown. 
Therefore, if you are a woman able to bear children who is pregnant, who may be pregnant, who 
is planning to become pregnant, or who is currently breastfeeding, we cannot include you in this 
study at this time. For women of child-bearing age, we will do a pregnancy test at the beginning 
of the study to make sure you are not pregnant. We will specifically ask you to let us know if you 
change your mind and decide to become pregnant during the study. 
 
Benefits 
You may have health benefits from starting a new exercise program as part of this study. 
However, we cannot guarantee that you will benefit. The main benefits of this study are to help 
researchers and clinicians develop future interventions to help people start and continue to 
exercise.  
 
Economic Considerations   
You will receive up to $200 for completing all study visits/procedures. You will receive $50 for 
completing the baseline assessment, $50 for completing the assessment at the end of the exercise 
program, and $50 for each of the 3- and 6-month follow-up assessments. These amounts will be 
distributed by a check from Butler Hospital or gift cards to a local store, whichever you choose.  
 
Depending on the amount of payment you might receive for your participation in this study, you 
might have to provide your name, address, and taxpayer ID or Social Security number to the 
Butler/CNE Research Accounting Department. In order to receive $300 or more for participation 
in research, you will have to complete and sign a W-9 form.  If you are paid $600 or more in any 
calendar year for research participation, the IRS will be notified of the total amount you were 
paid, in accordance with federal regulations. You should ask the researcher for more information 
if you have questions about this process. 
 
In Case of Injury   
We will offer you the care needed to treat any injury that results directly from taking part in this 
research study.  We reserve the right to bill your insurance company or other third parties, if 
appropriate, for the care you get for the injury.  We will try to have these costs paid for, but you 
may be responsible for some of them.  For example, if the care is billed to your insurer, you will 
be responsible for payment of any deductibles and co-payments required by your insurer.   
 
Injuries sometimes happen in research even when no one is at fault.  There are no plans to pay 
you or give you other compensation for any injury, should one occur.  However, you are not 
giving up any of your legal rights by signing this form.   
 
If you think you have been injured or have experienced a medical problem as a result of taking 
part in this research study, tell the person in charge of this study as soon as possible.  The 
researcher’s name and phone number are listed on the last page of this consent form.    
 
Alternative Treatments/Alternative to Participation  
No treatments are being offered as part of this study for any physical or mental health problem. 
As an alternative to participating in this study, you may also seek to begin an exercise program 
on your own, with your physician’s advice to do so, and utilize community resources such as 
gyms, bike paths, etc. 
 
Financial Disclosure   

Not applicable.  
 
Voluntary Participation 
You are free to decide whether or not to participate in this study, and you are free to withdraw 
from the study at any time by informing the researchers verbally or in writing.  If you decide you 
do not wish to provide additional protected health information to the researchers, you may 
withdraw from the study. Research information collected up to the time that you decide to 
withdraw will remain as part of the study data. A decision not to participate or to withdraw from 
the study will not adversely affect future interactions with Butler Hospital or Brown University. 
Your participation in the study may be terminated by the researchers without regard to your 
consent; in that case, you are entitled to an explanation of the circumstances leading to that 
decision. 
 
Confidentiality and Protection of Your Health Information  
You will not be personally identified in any reports or publications that may result from this 
study.  The confidentiality of the information you provide to us will be maintained in accordance 
with state and federal laws. To keep your information safe, we will store all information in locked 
file cabinets and on password protected secure computer servers. To the extent possible, we 
store identifying information (such as your name or address) separately from study data (such 
as questionnaires that you complete). In addition to keeping research data, we will place a note 
with a brief description of study involvement and procedures (including tDCS procedures) in a 
Butler Hospital medical record. All identifying information except what is part of your medical 
record at Butler will be destroyed 6 years after the completion of the study.  
 
If you tell us something that makes us believe that you or others have been or may be physically 
harmed, we will report that information to the appropriate agencies if required by law. In Rhode 
Island, we are required to report child abuse and neglect and elder abuse to state authorities. 
 
General information about this study has been or will be submitted to the federal clinical trial 
registry databank, which can be accessed on the Internet at www.ClinicalTrials.gov. 
 
If you sign this document, you give permission to Drs. Abrantes and Garnaat (study directors) 
and their research staff at Butler Hospital to use and share your health information that 
identifies you, for the purpose of conducting the research study described above.  
 
Your health information related to this study may also be shared with and used by individuals 
outside of Butler Hospital, including:  
 
• Your primary care provider. We will ask you to sign a release of information for that 
provider.  Your primary care provider will let us know if it is safe for you to begin an 
exercise program.  We may also contact him/her during the study to discuss any changes 
in your health status that may impact your ability to engage in exercise. 
• Specialty mental health care providers for whom you provide a release of information.  If 
there is a change to your mental health status (e.g., you become more depressed or 
experience new symptoms and may need more treatment), we will communicate with 
your mental health provider about this. 
• Other healthcare and public safety professionals, if we are concerned that you are at risk 
of hurting yourself or others.  
 

The health information that we may use or share with others for research purposes includes any 
information that you give us as part of your study participation, and results of any assessments 
that we do as part of the study.  
 
Your health information may also be shared with a public health authority that is authorized by 
law to collect or receive such information for the purpose of preventing or controlling disease, 
injury, or disability, and conducting public health surveillance, investigations, or interventions.  
 
Butler Hospital is required by law to protect your health information. Individuals outside of 
Butler that receive your health information may not be required by Federal privacy laws (such as 
the HIPAA Privacy Rule) to protect it, so we can not guarantee that they will not share it without 
your permission. 
 
Please note that:  
• You do not have to sign this consent form, but if you do not, you may not participate in or 
receive research-related treatment in this study.   
• Butler Hospital may not withhold treatment or refuse to treat you, based on whether you 
sign this consent form.  
• You may change your mind and revoke (take back) this consent and authorization at any 
time. If you no longer want to give us permission to use your health information for this 
research study, you must contact one of the Principal Investigators, Ana Abrantes or 
Sarah Garnaat and you will be instructed to provide a written statement.  
• Even if you revoke (take back) this consent and authorization, Butler researchers may still 
use or share health information about you that they already have obtained, when doing so 
is necessary to maintain the integrity or reliability of the current research.  
• You generally will not have access to your personal health information related to this 
research until the study is completed. At the conclusion of the research and at your 
request, you will have access to your health information that Butler Hospital maintains in 
a designated record set, according to the Notice of Privacy Practices provided to you by 
Butler Hospital. The designated record set includes medical information or billing records 
used by doctors or other health care providers at Butler Hospital to make decisions about 
individuals.  
• Your health information will be provided to you or to your physician if it is necessary for 
your care.  
 
This Authorization will expire when all the activities associated with this research study have 
concluded. 
 
Questions   
In preparation of this consent form, it was necessary to use several technical words.  Please ask 
for an explanation of any that you do not understand. 

Authorization:  I have read this form and decided that   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
(name of subject) 
will participate in the project described above.  Its general purposes, the nature of my 
involvement, and possible hazards and inconveniences have been explained to my satisfaction.  
My signature also indicates that I have received a copy of this consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Relationship (self, parent, guardian) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Principal Investigator  
 
 
    
 
 
 
 
 
Telephone 
 
 
 
 
or 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Obtaining Consent 
 
 
     
    
 
 
 
 
Telephone 
 
If you have further questions about this project or about research-related injuries, please contact 
Ana Abrantes, Ph.D. at 401-455-6440 or Sarah Garnaat, Ph.D. at 401-455-6659.  If you have 
questions about your rights as a research subject, please contact Linda L. Carpenter, M.D., Chair, 
Butler Hospital Institutional Review Board, at 401-455-6349. 
THIS FORM IS NOT VALID UNLESS THE FOLLOWING 
BOX HAS BEEN COMPLETED BY THE IRB OFFICE 
 

 
THIS FORM IS VALID UNTIL 
 
 
    DATE:  
 
 
    IRBNET ID#  
    BUTLER IRB REFERENCE# 
 
 
    BY (ADMINISTRATOR):