Reward Systems and Food Avoidance in Adolescents With Low Weight Eating Disorders
Phase: NA
Conditions: Low Weight Eating Disorders, Anorexia Nervosa
Sponsor: Icahn School of Medicine at Mount Sinai

Reward Systems and Food Avoidance in Adolescents with
Low Weight Eating Disorders
PI: Tom Hildebrandt
NCT02795455
Document Date: 4/12/2022

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
1
Revised  9/2/14
MSSM Protocol Template HRP-503a
Brief Summary of Research (250-400 words):
Anorexia nervosa (AN), a characteristically relentless pursuit of thinness with an 
intense fear of weight gain despite significantly low body weight , is a serious 
psychiatric disorder with high rates of morbidity and mortality. Low weight eating 
disorders (LW-ED), the broader category of eating pathology that includes AN 
and similar variants, are characterized by a chronic course, poor response to 
treatment, and food avoidance. Emerging neuroimaging evidence suggests that 
deficits in insula-amygdala-ventral striatum (IAVS) neurocircuitry contribute to 
individual variability in aversive and reward learning, and that these brain regions 
demonstrate abnormal responses to food/eating stimuli. Our pilot data suggest that 
patients with LW-ED experience difficulty extinguishing food-cue associations in 
a reversal learning paradigm compared to healthy controls, a difficulty that is 
related to psychophysiological measures of aversive disgust (not fear). We have 
also successfully piloted an interoceptive exposure intervention for this 
population that targets visceral sensitivity and seeks to increase ‘top-down’ 
regulation of the IAVS neurocircuit. The proposed project will (a) use novel 
fMRI-EMG to test the relationship between effective connectivity within 
amygdala-insula-ventral striatum network and its relationship to 
psychophysiological and behavioral measures of acute threat and reward learning 
in 60 adolescents with LWEDs and 30 healthy controls, (b) test the sensitivity of 
this network to an experimental interoceptive exposure paradigm relative to 
patients receiving family based therapy for weight restoration using dynamic 
causal modeling of fMRI-EMG data pre-post experimental conditions, (c) validate 
this model against objective measures of laboratory and real world eating 
behavior. The results of this study will help us better understand the core 
neurocircuitry that underlies both threat processing and reward/aversive learning 
and how this circuit relates to objective behavior. Further, we will determine the 
modifiability of this neurocircuitry via two distinct behavioral interventions 
chosen to target different aspects of affective processing and reward learning. 
These data will be used to inform future clinical interventions targeting 
aversive/reward learning within this population and dysregulation in insula-
amygdala-ventral striatum subcircuits.
1) Objectives:
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
2
Revised  9/2/14
Our primary objectives are to test our disgust-conditioning model of food avoidance 
adolescent patients with low-weight eating disorders.  We aim to do this by investigating 
the underlying neurocircuitry involved in food-cue learning and its reversal (i.e., updated 
learning through reversal of cue-absence vs. cue-target). Our aims are: 
Aim 1: Delineate neurocircuitry through which aversive-disgust responses 
to palatable food hijack the acquisition of food-cue associations in 
adolescents with LW-EDs versus health controls.
Aim 2: Characterize the impairments in neurocircuitry that underlies 
resistance to food-cue extinction in adolescents with LW-EDs versus 
controls.
Aim 3: Determine the effect of 6-sessions of interoceptive-exposure (IE) 
and family based therapy for weight regain on neurocircuitry for aversive 
food-cue acquisition and exposure in adolescents with LW-EDs.
Aim 4:  Assess the relationship between eating behavior and neurocircuitry 
for food-cue acquisition and extinction at baseline and following 
intervention.
Research Question: 
We have two primary research questions to be investigated in this proposal. First, we are 
testing for group differences in the underlying neurocircuitry of aversive learning among 
adolescents with low weight eating disorders and healthy controls and validating this 
neurocircuitry across multiple domains (psychophysiology of emotion, symptom 
expression, and objective and real world eating behavior).  Our second primary research 
question is whether interoceptive exposure can modify the connectivity within the neuro-
network that underlies food-cue learning in patients with low-weight eating disorders.  
We will validate these changes through psychophysiology measures of emotion, 
symptom change, and measures of objective and real-world eating behavior.
The proposed project will 
(a) use novel fMRI-EMG to test the relationship between effective connectivity within 
amygdala-insula-ventral striatum network and its relationship to psychophysiological and 
behavioral measures of acute threat and reward learning in 60 adolescents with LW-EDs 
and 30 healthy controls.
(b) test the sensitivity of this network to an experimental interoceptive exposure paradigm 
relative to patients receiving family based therapy for weight restoration using dynamic 
causal modeling of fMRI-EMG data pre-post experimental conditions. IE, a behavioral 
intervention hypothesized to work via altering prefrontal regulation of the insula response 
to aversive stimuli by decreasing visceral sensitivity, will be compared to a contingency 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
3
Revised  9/2/14
management driven family-based weight gain control (FB-WGC) intervention 
hypothesized to modify the striatal response to food by changing incentive value of food.
(c) validate this model against objective measures of laboratory and real world eating 
behavior.  
2) Background
Low-Weight Eating Disorders
Significance of Low Weight Eating Disorders and the IAVS Sub-Network. Anorexia 
nervosa (AN) is a serious psychiatric disorder with high rates of morbidity and 
mortality(1-6). To date, DSM-variants of AN are most commonly examined in research 
studies; however, the characteristic features of this disorder remain unchanged regardless 
of nosological system, namely a relentless pursuit of thinness with an intense fear of 
weight gain despite significantly low body weight(7). In this broader dimension of low 
weight eating disorder (LW-ED), we posit that food-cue learning relies on an 
interconnected network of the insula, anterior cingulate cortex, amygdala, and ventral 
striatum. This IAVS sub-network assigns valence and feeds forward salient sensory 
information to prefrontal regions involved in decision making and choice, and contains 
key nodes known to be dysregulated among LW-ED adolescents(8). IE, a behavioral 
intervention that theoretically targets the IAVS sub-network to extinguish learned 
associations characterized by visceral sensitivity, offers the best test of this theory. 
Studying a model of impaired food-cue (i.e., stimulus-response) learning and affective 
processing in LW-ED will help advance recent theories of impaired habit formation(7) 
and emotion regulation(9) in AN, and is a natural extension of our clinical expertise with 
LW-ED(10) and experience developing exposure therapies with this population(11).    
Reversal Learning and Low Weight Eating Disorders
A.1.1 Reversal Learning 
and Food Avoidance. 
Figure 1 highlights the 
basic conditioning 
processes we theorize 
cause persistent food 
avoidance among patients 
with LW-ED.  Aversive 
conditioning and extinction 
models are broadly 
implicated in mental 
illness(12) and have a well-
defined neurocircuitry 
translated from pre-clinical 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
4
Revised  9/2/14
to human studies(13-15). Our theory builds on seminal work by Co-I Shiller(16), which 
extends classic conditioning models to reversal learning. The latter offers a measure of 
the ability to extinguish learned associations in the context where the original threat 
remains present in the environment, despite the extinction of the conditioned stimulus 
(CS)+UCS association. Consequently, reversal learning may better generalize to human 
experience where the predictability of threat changes, but the threat remains(17). Among 
patients with LW-EDs, impaired reversal of food associations could be why dieting (i.e., 
associations of calorie dense food with an aversive threat state) becomes a chronic, 
pathological pattern of food avoidance. In our model (see Figure 1), stimuli that signal 
information about food (e.g., eating environments) and eating itself become associated 
with an aversive state (i.e., feeling fat, gross, etc.) and other stimuli (e.g., dieting tips, 
exercise cues, etc.) are paired with ‘safety’ or the absence of this aversive state (e.g., 
empty stomach). These relationships form in the context of a typical diet and motivate 
food avoidance, resulting in weight loss. However, when weight loss becomes unhealthy, 
it should be possible to reverse these associations to promote consumption of higher 
density food and avoid the reversed cue associated with the threat of malnutrition. 
Individuals with LW-ED fail to reverse these associations, which contributes to food 
avoidance.  
Development of Interoceptive Exposure for Food Avoidance and Visceral Sensitivity
Our interoceptive exposure (IE) was developed to reduce visceral sensitivity by 
altering interoceptive conditioning similar to interventions for irritable bowl 
syndrome(18-22), consequently increasing tolerance for insula-driven interoception. IE 
specifically reduces the threshold for visceral sensitivity in anxiety(22, 23) and somatic 
disorders(24). IE mediates psychotherapy outcomes via specific reductions in visceral 
sensitivity(25-27) indicating that IE works by changing the influence of interoceptive 
information on affect and associated behavior (e.g., avoidance). We have developed and 
pilot tested a 6-Session IE module for LW-ED(11, 28). Details regarding the IE 
intervention are provided in multiple other sections of the application. Visceral sensitivity 
plays a primary role in food choice and consumption, and increased tolerance of these 
sensations should reduce the use of food avoidance. As the insula is integral to almost all 
salient aspects of food/eating, including somatic symptoms (e.g., stomach distention in 
the absence of food(29)), we theorize IE targets the effective role of the insula in 
processing food-cue associations characterized by visceral sensitivity (e.g., bloating, 
etc.).  
Eating and AN 
Although some research has attempted to measure the pathology of eating behavior, 
most of the measures are subjective and rely heavily on patient report.   Currently, there 
is a limited amount of studies that have objectively examined the food intake of patients 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
5
Revised  9/2/14
with low weight eating disorders. An examination of the eating behavior among adult 
women with anorexia nervosa in an inpatient setting showed that despite improvements 
in psychological symptoms, eating disturbances persisted after patients achieved weight 
restoration(30).  The level of anxiety is modifiable via traditional exposure therapy(31, 
32), however, these changes have almost no measurable impact on eating behavior.  
Consequently, adaptations to interventions that may improve eating behavior have 
significant value in developing treatments for this population.
3) Setting of the Human Research
Research will take place at the Mount Sinai Eating and Weight Disorders Program 
(EWDP) (for consenting, intakes, and behavioral/psychological assessment) and 
Translational and Molecular Imaging Institute (TMII) at the Icahn School of 
Medicine at Mount Sinai to conduct fMRI tasks and EMG readings. 
Potential subjects will be identified through our clinic, and through other referrals 
from their treatment providers, as well as through flyers distributed throughout 
Mount Sinai and the surrounding areas. As per Mount Sinai Resource, we will be 
also recruiting via MSSM Update Weekly Newsletter, MSSM psychiatry list-serv 
and MSSM post-doc list-serv. 
4) Resources Available to Conduct the Human Research
The Mount Sinai EDWP sees a high volume of clients, many of whom fall within 
the age and eligibility guidelines for this study.  Therefore, we expect no 
difficulty recruiting all participants within the planned time schedule.
Prior to commencing this study, all persons assisting with this research will be 
trained on the protocol instructions detailing their trial-related duties and 
functions will be provided in a clear and concise manner.  In addition, all persons 
assisting with this research will have completed the IRB education requirements 
for Human Subjects research prior to their involvement in the study.
Principal Investigator:
The PI will be responsible for monitoring and directing the overall progress of all aspects 
of the study proposed in this application. Specifically, the PI will screen potential 
research participants, oversee training of the research assistants, supervise database 
creation and entry, and serve as the secondary statistician on data analyses (ensuring data 
quality, management, and interpretation of statistical models). He will also lead weekly 
staff meetings and be responsible for submitting grant related materials (IRB, Progress 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
6
Revised  9/2/14
Report, etc.) and lead efforts in manuscript preparation and publication from the study. 
Further, the PI will be one of the providers of the experimental 6-week behavioral 
challenge. 
Co-Investigators:
Co-Investigators will be responsible for reviewing data collected during the single and 
multi-item test meals (e.g., amount and types of food consumed) and will assure the 
quality of the laboratory meal assessments. They will work closely to offer expertise 
related to the measurement of eating behavior and assist with the interpretation of data, 
the presentation of results, and preparation of study reports. The Co-Investigators will 
examine scans to check for medical abnormalities, aid in the interpretation of 
neurobiological data and results overall, and review labs for medical clearance to 
participate in the study. Additionally, Co-I’s will  aid in the collection and analysis of 
EMG data, oversee the data processing and the statistical analysis of imaging data. They 
will also be responsible for ensuring the integrity of the scans and behavioral data 
collected from the reversal learning task.
Co-I’s will also contribute to data analysis by co-registering the facial EMG findings with 
the neuroimaging data and using dynamic causal modeling to examine connectivity 
within the regions of interest.
 
Another Co-I role will be analyzing data obtained from the FaceReader emotional 
detection software. FaceReader output is of a high density, with 20 recordings made 
every second. Furthermore, many of the recordings will be obtained while the participant 
is eating, adding to the amount of noise present in the data (i.e., the act of chewing can be 
mistaken for emotional reactions). The Co-I will oversee the data processing and analysis 
of these data after data has been collected, fitting the best models while removing as 
many of the extraneous recordings as possible. They will work closely to estimate and 
calibrate DCMs and advise on issues related to data interpretation. 
Non-Key Personnel:
Clinical Psychologist
The Clinical Psychologist will be primarily responsible for diagnostic interviewing and 
for providing the behavioral challenge. They will oversee coordination between the post-
doctoral fellow and research assistant to generate integrity ratings for interviews and will 
have immediate oversight of the clinical status of participants with low weight eating 
disorders.
Nutritionist
            
The nutritionist will aid the Co-I in the preparation and coding of the test-meal 
replacement shake and standardized multi-item meal. Specifically, the nutritionist will 
assist with the execution and analysis of laboratory test meals (e.g., measuring food 
residue), and will help with the interpretation of eating behavior data.
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
7
Revised  9/2/14
Post-Doctoral Fellow
   
               
The post-doctoral fellow will be responsible for diagnostic interviewing and for 
providing the behavioral challenge. The post-doctoral fellow will also coordinate with the 
research assistant to generate integrity ratings for interviews and will have immediate 
oversight of the study’s process. 
Clinic Research Coordinators
Our coordinators will work closely with the PI, and will attend to the administrative 
components of the project. These responsibilities include, but are not limited to, 
recruitment of subjects; coordinating and scheduling clinical assessments; ensuring that 
all rating scales and clinical reports are completed in a timely fashion; ensuring that 
checks are generated to reimburse subjects for their participation in the protocol as well 
as other fiscal aspects of the study (e.g., purchasing supplies).  In addition, this person 
will be responsible for preparing all IRB documentation and will make sure that all 
consenting of subjects is appropriately completed.
Volunteers
Our volunteer interns will work closely with the PI and the Clinical Research 
Coordinators on this project. Responsibilities include, but are not limited to, recruitment 
of subjects, escorting participants to other areas at Mount Sinai and inputting data.
5) Study Design
a) Recruitment Methods
Adolescent female participants with AN and healthy comparison controls will be 
recruited for this study. Participants will be recruited via phone calls to the Project 
Coordinator at the Mount Sinai Eating and Weight Disorders Program, and through 
advertisements and emails to listservs of school counseling centers, and hospitals. In 
addition, the study will be publicized on the Mount Sinai Clinical Trials and Eating 
and Weight Disorders Program websites, as well as in the local media via IRB-
approved flyers. Staff will recruit healthy comparison controls predominantly through 
posting flyers at local schools and community centers. All potential advertising tools 
will be submitted to the IRB for approval prior to their use. Participants will be 
instructed to contact the Project Coordinator at 212-659-8724 and will be invited for a 
consultation in which the study will be thoroughly explained to them in verbal and 
written form by the principal investigator or by another member of the research team 
(i.e. project coordinator, research assistant, or extern therapists). Individuals that call 
the Mount Sinai Eating and Weight Disorder Program looking for treatment will be 
informed of the study. Interested participants and/or parent(s) will be informed that at 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
8
Revised  9/2/14
least one parent or legal guardian will be expected to attend the initial in-person 
screening visit with the adolescent participants and provide informed consent at that 
time. 
b) Inclusion and Exclusion Criteria
Low Weight ED Patients
Inclusion criteria:

Females,

Adolescents ages 12-18, 

Speak English,

Seeking treatment

Refusal to maintain greater than minimally low body weight based on BMI for 
age percentiles and growth trajectories,

Clinically significant restriction of food intake on the dietary restraint subscale 
of the EDE or evidence of persistent food avoidance as reported by patient or 
guardians.

Given medical clearance from pediatrician or equivalent.
Exclusion criteria:

Current psychotropic medication that would have an effect on performance on 
behavioral tasks (i.e., anti-anxiety medication), 

Comorbid psychotic or bipolar disorder,

Active suicidal ideation, 

Major medical illness known to influence eating or weight,

Current substance dependence,

Previous exposure therapy for LW-ED.

Physical limitation that would prevent participation (e.g., allergic to 
chocolate),

For patients with current or a history of sexual or physical abuse by parents, 
siblings, or guardians, perpetrators of the abuse will be excluded from 
treatment; if physical or sexual abuse by a family member occurs during the 
course of treatment, perpetrators will be excluded from ongoing treatment
Healthy Comparison Adolescents
Inclusion criteria:

Females,

Adolescents ages 12-18,

Speak English. 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
9
Revised  9/2/14
Exclusion criteria:

Current psychotropic medication that would have an effect on performance on 
behavioral tasks (i.e., stimulant medication), 

Current or lifetime history of any psychiatric disorder, including eating 
disorders by K-SADS,

Current or lifetime history of learning disorder or developmental disability 

Active suicidal ideation, 

Major medical illness,

Other physical limitation that would prevent participation (e.g., allergic to 
chocolate).
c) Number of Subjects
A total of 118 female adolescents will be recruited to obtain complete assessments on 
60 female adolescents with a low weight ED and 30 healthy comparison adolescents 
between the ages of 12-18.
d) Study Timelines
Participants’ participation will include 10 visits over approximately 8-week 
period for AN participants and 4 visits for healthy comparison controls. 
During the 6 weeks separating the testing, adolescents with low weight EDs 
will receive an intervention (please see below), whereas healthy comparison 
adolescents will not have additional contact with study staff during this time.
Visit 1 will consist of screening procedures to determine eligibility, 
completion of self-report questionnaires, and a laboratory based eating 
measure.
In Visit 2, all participants will complete a reversal learning computerized task 
while undergoing an fMRI scan with EMG, computerized task also using 
EMG, and lastly the completion of a multi-item meal task in which we will 
analyze eating behavior via video recording and facial recognition software. 
The next 6 visits will only apply for LW-ED participants and not healthy 
controls and will consist of the exposure-based intervention, across a span of 
6 weeks. Participants will be randomized into one of two intervention groups, 
a weight gain control group and an interoceptive exposure group. 
In Visit 9, all participants will complete self-report measures, single item meal 
task, and height and weight.  
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
10
Revised  9/2/14
In Visit 10, all participants will complete the same self-report questionnaires, 
concurrent fMRI--EMG, and computerized learning task,  and the multi-item 
meal task. 
After the 10 visits, LW-ED participants are offered 20 sessions of free open-
label family-based treatment.
The duration anticipated to enroll all study subjects is 42 months [~1.5 LW-
ED patients per month with 60 enrolled by ~month 40 (2 months start-up)], 
leaving 6 months to analyze the data.
The anticipated duration of the study is 4 years.
 
The study is estimated to be completed 4 years from the date of initial IRB 
approval.
e) Study Endpoints
The study is estimated to be completed 4 years from the date of initial IRB approval 
including months 43-48 for data analysis.
f) Procedures Involved in the Human Research
All tests and procedures being performed are completely research-related and are not 
part of clinical care. LW-ED participants will complete Visits 1-10 while healthy 
comparison adolescents will only complete the Baseline Assessments (Visits 1 and 2) 
and the final two visits (Visit 9, and 10). The total timeline for participation is 
approximately 9 weeks. 
The study will be described to interested participants (or parents) and the first of two 
baseline assessment sessions will be scheduled. Participants with low weight EDs 
will not be enrolled into the study until clearance to receive outpatient therapy 
has been received from her pediatrician. We will provide a medical clearance 
form with guidelines for the necessary tests to determine if participants can be 
seen on an outpatient basis. If necessary, participants may be further medically 
evaluated by a psychiatrist on staff.  The psychiatrist will provide feedback and 
facilitate the coordination of care if medical evaluation reveals abnormalities. 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
11
Revised  9/2/14
The Baseline Assessment includes Visits 1-2:
Visit 1 (2 hours total)
This is an in-person screening visit to determine eligibility. 
Table 1:  Summary of Visits and Measures Associated with Each Measure
Baseline
Session 1 
of IE or 
FBT
Session 2  
of IE or 
FBT
Session 3  
of IE or 
FBT
Session 
4  of IE 
or FBT
Session 5  
of IE or 
FBT
Session 
6  of IE 
or FBT
Post-Treatment 
Visit 1
(Day 0)
Visit 2
(Day 1-7)
Visit 3
(Day 14)
Visit 4
(Day 21)
Visit 5
(Day 28)
Visit 6
(Day 35)
Visit 7
(Day 42)
Visit 8
(Day 49)
Visit 9
(Day 50-57)
Visit 10
(Day 57-
80)
2 hours
1 hour
1 hour
1 hour
1 hour
1 hour
Eligibility
1) Consent/
Assent
2) K-SADS 
3) EDA-5 
4) C-SSRS 
fMRI-
EMG 1) 
reversal
food-cue 
learning 
2)disgust 
conditioni
ng task
Video 
Coding 
Video 
Coding
Video 
Coding
Video 
Coding
Video 
Coding
Video 
Coding
fMRI-EMG 
1) reversal
food-cue 
learning 
2)disgust 
conditionin
g task
Self-Report 
Measures (6): 
1) CIA
2) DSR
3) ASI-III
4) BAQ
5)CES-DC
6) YEDE-Q
EMG-
behavior 
reversal 
$$-cue 
learning
Self-Report 
Measures 
(6): 
1) CIA
2) DSR
3) ASI-III
4) BAQ
5)CES-DC
6) YEDE-Q
EMG-
behavior 
reversal 
$$-cue 
learning
Lab eating 
paradigm 
(meal 
replacement 
shake)
Lab 
eating 
paradigm 
(multi-
item 
meal)
Lab eating 
paradigm 
(meal 
replacement 
shake)
Lab 
eating 
paradigm 
(multi-item 
meal)
Height/
Weight
Height/
Weight
Real 
World 
Eating
Food 
records 
collected
Real 
World 
Eating
Food 
records 
collected
**Healthy controls will complete only Visits 1,2, 9,10.
**Timeline is approximate; however, intervention sessions would occur 7 days apart. 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
12
Revised  9/2/14
Consent/Assent Process: 
Conducted with a trained member of the research team (project coordinator 
or study therapist). In order for the adolescent to participate in the study, at 
least one parent or guardian must participate in intervention sessions. Any 
parent(s) who will be involved in the intervention will sign an informed 
consent document and written assent will be obtained from all adolescents.
Assessments:
EDA-5 for eating disorder diagnoses and psychopathology.
Relevant sections of the K-SADS (mania, psychosis, alcohol and substance 
abuse) to determine any lifetime psychiatric disorder to determine eligibility.
Columbia-Suicide Severity Rating Scale (C-SSRS) to assess for suicidal 
ideation. 
Self-Report
Clinical Impairment  Assessment (CIA)
Disgust Scale-Revised (DSR)
Anxiety Sensitivity Index-III (ASI-III)
Body Awareness Questionnaire (BAQ)
Center for Epidemiological Studies Depression Scale for Children (CES-
DC)Youth Eating Disorder Examination-Questionnaire (YEDE-Q)
We will have a trained study coordinator review medical clearance from the 
participant’s physician, consistent with our clinic’s procedures for outpatient 
care.
If found eligible after these assessments, the participant will complete 
the single-item meal and will be scheduled for Visit 2. 
Single-Item Meal:  A standardized laboratory test meal will be used as an objective 
assessment of food avoidance in adolescents with LW-EDs. The meal consists of a 
strawberry yogurt shake used previously in a study of AN by Dr. Sysko (Co-I)(30). 
Limited intake observed in this test meal before and after intensive inpatient 
treatment and subjective reports of anxiety by patients suggest the utility of this 
paradigm for LW-EDs. Procedures are based on those described by Sysko et al.(30, 
31), and will be identical for experimental IE sessions. Participants will be presented 
with an 55 fluid ounce (1626.50-mL) covered opaque container containing 
approximately 1475 grams (1 kcal per gram, or 1475 kcal) of strawberry yogurt 
shake. Patients will be informed that the meal consists of a strawberry yogurt shake, 
but will not be told the amount provided in the container. The instructions will direct 
participants to consume as much of the shake as they would like and that the meal 
will serve as their lunch (or dinner) for the day and to avoid touching or 
manipulating the container in any way. The meal will be placed on a modified 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
13
Revised  9/2/14
version of an eating monitor, which measures intake (in g) every 5 s. During the 
meal, participants will also be observed through a closed-circuit video monitor to 
ensure that they are following instructions and to monitor behavior. Ratings will be 
made before and after the test meal of hunger, fullness, sickness, loss of control, 
urge to eat, preoccupation with thoughts of food, disgust, and fear of fatness on a 15-
cm visual analog scales (VAS). Consumption of the shake in Kcal will be the 
primary outcome, with secondary outcomes of rate of eating in Kcal/min during the 
30 min meal. 
Visit 2 (3 hours total)
After Visit 1, all participants will complete fMRI and lab procedures, then patients 
with LW-EDs will be randomized to an intervention.
(1) fMRI-EMG reversal food-cue learning task and disgust conditioning task 
(Total completion Time: 2hrs) Both tasks will take place within the scanner. 
Participants will first be given instructions for the two tasks and will do a short 
practice version in the mock scanner with the study coordinator to ensure they are 
comfortable. Participants will be in the fMRI scanner for a total of 1 hour. 
a. Reversal food-cue learning task: During phase one of the Reversal Food 
Validation fMRI task, (i.e., Acquisition) participants will be presented with visual 
food or neutral stimuli on a computer screen. Some stimuli, conditioned stimuli, 
will sometimes be followed by a food or a no outcome (e.g., loss or gain of a food 
item, M&Ms or Hershey’s kisses). Other stimuli will never be followed by an 
outcome and will be used for comparison. Phase two of the task, Reversal, is 
similar to Acquisition only the reinforcement contingencies will be reversed. That 
is, some of the previously non-paired stimuli will be now paired with the outcome 
while the previously paired stimuli will be now unpaired. A response pad will be 
placed around the participant’s right arm and the participant will be instructed to 
make ratings. Participants will also have MRI safe EMG electrodes from BioPac 
systems attached in order to provide a physiological measure of learned 
contingencies. For this task, participants are instructed that afterwards they will be 
given the equivalent number of M&Ms (240) or Hershey’s kisses (48) that they are 
presented in the task, regardless of their responses. 
 
b. Disgust choice conditioning task: The conditioning procedure will test the 
ability to learn and extinguish disgust associations.  The task includes distinct 
acquisition and extinction phases. In the acquisition phase, the conditioned stimuli 
(CS), consisting of blue and green squares, will be presented individually at 
fixation, followed 4 s later by the co-presentation of the unconditioned stimuli 
(UCS) to the left and right of the CS. The UCS will consist of two sets of pictures 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
14
Revised  9/2/14
depicting either intact fresh food or rotted versions of the same food items.  
Subjects will be instructed to attend to possible associations between the CS and 
UCS and to rate the “disgust” versus “desire” associated with the UCS on a Likert 
scale presented during the inter-trial interval using a 5-button fiber optic system on 
the right hand.  In the extinction phase, the CS will be displayed again individually 
at fixation, but the UCS will not be presented alongside the CS and the ITI will not 
include the Likert scale. Subject awareness of the response contingencies will be 
assessed with a post-scan interview.
(2) Reversal $$-cue learning (completion time, 25 min):  This paradigm mirrors 
that of the fMRI-EMG except that it is completed outside the scanner with stimuli 
delivered via laptop and keypad used for item response.  The stimuli will be a small 
monetary rewards that correspond to 15 cent reinforcements as cued by pictures of  
either 15 pennies or 3 nickels. Participants are instructed that afterwards they will be 
given the equivalent amount of money that they are presented in the task, either 240 
pennies or 48 nickels equating to $2.40, regardless of their responses. 
The stimuli for the food-cue learning task and the $$-cue task are paired and 
counter-balanced for the pre- and post-scans. The 2 stimuli groups include 
M&Ms/pennies and Hershey’s kisses/ nickels. Participants randomized to 
M&Ms/pennies in the pre-scan will receive Hershey’s kisses/nickels in the 
post-scan, and vice versa. 
(3) Lab eating paradigm (Multi-Item Meal)
Along with the fMRI scan, participants will also participate in an eating behavior 
task as a part of the study. Prior to beginning the study, participants will be 
instructed to eat all daily meals as usual, with no meal occurring within 4 hours prior 
to the eating behavior task. Participants will be given scripted instructions by a study 
coordinator and will be asked to “eat as much or as little as you’d like.” They will be 
presented with a multi-item meal that will consist of a variety of foods (e.g., bread, 
chicken, apples, oranges, oreos, potato chips, etc.). 
As part of the task, participants will also be asked to make ratings before and after 
the test meal using the VAS. .   Participants will be instructed to ring a bell to 
indicate the end of the meal, and will be asked to complete questionnaires. Test 
meals will be observed via closed-circuit television by a member of the staff. 
Outcome measures will include amount consumed, macronutrient distribution, and 
duration of eating.  
Since it is possible participants will be distressed following the multi-item meal, 
study coordinators will conduct a short debriefing interview with them after 
completion.
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
15
Revised  9/2/14
Treatment (Visits 3-8)
After the baseline assessment (Visits 1-2), patients with LW-EDs will be 
randomized to 6 weekly sessions of FBT-WG or IE. Randomization will occur 
after we have processed the baseline fMRI scans.  If the study coordinators 
have determined the participant’s scan is free of interference from motion in 
the scanner, the participant will be randomized within this group. If the study 
coordinators determine a participant’s scan is unusable, the participant will be 
excluded from the study. 
In both FBT-WG and IE, the first session lasts two hours and the remaining 5 
sessions last one hour.
FBT-Weight Gain Control (FBT-WG):  Participants and families randomized to 
FBT-WG will receive 6-weeks of FBT treatment for AN111. Sessions occur weekly, 
with the first session lasting two hours and the remaining 5 sessions one hour. FBT is 
atheoretical in terms of the etiology, but uses parent-enforced contingencies to 
increase value of eating and decrease the value of food avoidance. The six sessions of 
FBT focus primarily on disordered eating, using a functional analysis to facilitate 
parental use of positive/negative contingencies to motivate eating behavior. In session 
2, a family meal provides the therapist with an opportunity for direct observation of 
the familial interaction patterns around eating. The therapist makes careful and 
persistent requests for united parental action toward re-feeding and/or regulating 
eating habits, the primary concern at this point of the treatment, and the therapist tries 
to create and reinforce a strong parental alliance around efforts at feeding the child, 
and align the patient with the sibling sub-system. Parents are taught to reinforce even 
minimal efforts at eating and creating clear consequences for food avoidance and 
successful eating. Weekly sessions offer an opportunity for therapist to 
reinforce/update the contingency plan and reinforce the parents for remaining 
consistent and persistent in their re-feeding of the adolescent.  
IE-Paradigm: Participants randomized to this intervention are provided with 
a meal replacement shake of ‘unknown’ Kcal or macronutrient content and are 
asked to mindfully observe the sensations (aversive taste, texture, bloating, 
icky feeling, etc.) and associated emotional states (i.e., disgust) with the 
empathetic support of parents/therapist in session, without expectation of 
habituation. The IE 6-session paradigm builds on our proposed model of food 
avoidance in AN(10), which posits that a conditioned aversive response to 
food coupled with a pleasurable response to the absence of food accounts for 
maladaptive food avoidance. Sessions occur on a weekly basis with session 
one lasting 2 hrs. During the 1st hour, the therapist explains an aversive 
conditioning model of LW-ED, sensory components of eating, and the 
concept of IE. The therapist explains the goal of IE is to help patients learn to 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
16
Revised  9/2/14
tolerate their interoceptive experience (e.g., disgust), so that eating can 
become more flexible. At the end of the first session, the therapist and 
parent(s) review a manual, which provides clear instructions for structuring 
the re-feeding process (e.g., sitting with child during all mealtimes; guidelines 
for IE homework; planning meals). In the 2nd hour, participants are given a 
meal replacement shake and instructed to focus on internal bodily sensations 
and to continue eating while experiencing and labeling these sensations. This 
practice is then assigned for homework, charging parents with orchestrating 
IE in similar pattern using a visceral sensitivity hierarchy established in the 
first session and is continued through the end of the module. The therapist 
uses an empathetic active stance to encourage IE that will subsequently serve 
as an example for parents in IE homework assignments. Participants rate their 
level of distress 4 times in the session and physiological response is recorded 
using EMG and facial recognition software. The remaining 5 sessions last one 
hour, and participants eat a meal replacement shake over 30-minutes, identical 
to the first session. All sessions include debriefing and development of IE 
homework that includes daily practice of IE.
Visit 9 and 10: These visits will follow the same procedures as Visits 1 and 2 
respectively. 
The eating sessions in visits 1 and 2 and visits 3 and 4 (9 and 10 for adolescents with a 
low weight eating disorder) and the treatment sessions (visits 3-8) will be video recorded 
to be decoded via software to analyze participants' emotional responses to 
eating. Treatment integrity will also be evaluated from the recording of the intervention 
sessions.  The video recordings will be stored securely for the duration of the study in a 
password protected file that only the study staff can access.
g) Specimen Banking
Not applicable. 
h) Data Management and Confidentiality
DATA SHARING PLAN
We will share the primary outcome data from this project with the National Data 
Archive managed by the National Institutes of Mental Health.  The data archive contains 
anonymized raw data from NIH sponsored programs and research for use in testing 
reliability of findings from these studies and allowing for future discovery from these 
data by other investigators or in combination with data collected from other investigators.  
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
17
Revised  9/2/14
Our plan will be to upload our primary outcomes which include neuroimaging data 
(structural scan, BOLD sequence, and task behavioral data) as well as participant weight, 
eating, and self-report questionnaire data.  No identifying information will be shared 
(e.g., video data, names, address, date of birth).  All data will be stored via a unique ID, 
generated by the data archive that is independent of the unique ID by which data at 
Mount Sinai is stored.  These two IDs will only be stored by the Mount Sinai 
investigators.  
a) Data Management and Confidentiality
All data stored in the computer database will be anonymized when entered 
into the database. Data will be stripped of all personal identifiers and each 
subject will be referred to by a unique research code. The file that contains 
the link between identifying information and the research code will be 
kept in a locked file cabinet in the Mount Sinai EWDP in a different 
location from where the data stored with the research code is maintained. 
Only authorized members of the research staff will have access to this 
link.
National Database for Autism Research (NDAR) Data-Sharing –With 
parental consent, this study will collect and provide research data and 
related findings to the National Database Archive (NDA). NDA is a 
biomedical informatics system and data repository created by the National 
Institutes of Health – part of the U.S. Department of Health and Human 
Services (DHHS), an agency of the U.S. Government – to assist 
biomedical researchers working to develop a better understanding of 
mental health and/or to develop more effective methods to diagnosis, treat 
and prevent mental health conditions. Data entered into NDA will be kept 
confidential, with NDA being designed for access by researchers only. 
Data provided to NDA as part of participation in this research study can 
not be linked to your identifying information. Once data are uploaded, 
they will not have a direct link back to identifying information held at 
Mount Sinai. If parents consent to sharing data with NDA, they mat at any 
time request that their data or their child’s data be removed from NDAR, 
but they must do so in writing to the Principal Investigator at the address 
on the first page. If they do not want to consent to sharing their data, they 
will still be eligible for participation in this study.
b)
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
18
Revised  9/2/14
Raw data will be stored in locked filing cabinets in the project coordinators’ office in 
the EWDP at The Mount Sinai Medical Center.  The data to be stored will include de-
identified information pertaining to consented participants will receive individualized 
identifier codes that will be generated in advance of any data acquisition.  These 
codes will be used on all future documents instead of names. An Excel file of the key 
to the codes (that links names of participants to assigned codes) will be password 
protected on an encrypted personal network drive that only Mount Sinai EDWP staff 
can access. Additionally, only designated study staff will have access to the locked 
password key containing the password to this file. The de-identified data to be stored 
will include information pertaining to demographic and psychiatric status obtained 
from the questionnaires and clinical interview. Data will be stored for a minimum of 
7 years, with the exception of the video recordings that will only be stored for the 
duration of the study. All questionnaire and interview data and video recordings will 
use study identification numbers and electronically stored data will be coded and 
password protected in a secure database (with a password protected back-up device in 
a locked office).. Contact information for participants’ parents will also be stored on a 
password protected file and will only be used for scheduling purposes. Only the 
coordinator and the Principal Investigator will have direct access to this information. 
The Primary Investigator, Dr. Thomas Hildebrandt, will provide intermittent review 
of procedures employed to ensure proper data management that protects participant 
confidentiality. The research data file will be kept on an encrypted personal network 
drive on the Academic Computing file server located in the medical center's secure 
data center. 
c) Provisions to Monitor the Data to Ensure the Safety of subjects
Only the primary investigator and the research assistants within his laboratory have 
access to file cabinet keys and computer passwords.
MSSM Principal Monitor: Indicate whether this person is the PI, a Team Member, 
or is Independent:
PI: 
Last Name: Hildebrandt
First Name: Thomas
Academic Title: Senior Faculty Member
Department: Psychiatry
Mailing Address: One Gustave L. Levy Place, Box #1230
Phone: 212-659-8673
Fax: 212- 849-2561
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
19
Revised  9/2/14
E-mail: tom.hildebrandt@mssm.edu
The research team will have methods in place for dealing with any adverse events that 
may arise during study procedures. The PI will ensure that any adverse events that 
occur are recorded and reported within 24 hours of discovery to the ISMMS IRB; this 
includes both expected and unexpected adverse events.  
All prospective participants will also be screened for psychotic symptoms using the 
KSADs. Any endorsement of psychotic symptoms will exclude the participant from 
the study; however, referrals will be made for the treatment of these symptoms. 
In the case of active suicidal or homicidal plans or intent revealed during the course 
of evaluation, a licensed psychologist/psychiatrist will evaluate the patient. If 
necessary, the participant will be taken to the emergency room or admitted to the 
inpatient facility. In the discovery of a previously unknown psychiatric disorder 
during evaluation, if safety is compromised or could potentially be compromised, the 
procedure above will be followed. If not (e.g., the discovery of a Major Depressive 
Disorder with no psychotic features and no suicidality), the participant will be 
notified and encouraged to seek help in a sequenced fashion following treatment. The 
patient’s primary clinician will also be notified assuming a written release is signed 
by the participant.
In the event of a medical emergency during study procedures, emergency services 
will be notified to take the patient to the hospital. 
In the case of clinically significant worsening of eating disordered symptoms 
identified during study participation, a clinician will determine whether the patient 
needs to be referred to a higher level of care based on the clinical standards for 
adolescents utilized within the Eating and Weight Disorders Program. The clinician 
and PI will subsequently determine whether the patient needs to be withdrawn from 
the study (e.g., in the case of a referral for psychiatric medication), or if continued 
participation is possible (e.g., brief medical hospitalization with a new medical 
clearance to receive outpatient treatment from the treatment team). We will not 
interfere with any recommendations about the decision to receive or discontinue 
outpatient treatment made by the providers providing additional care to study 
participnts.
d) Withdrawal of Subjects
Patients are free to end their participation in the study at any point. In addition, 
patients may be discharged involuntarily if they meet any exclusion criteria during the 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
20
Revised  9/2/14
course of their participation (i.e. if a patient becomes pregnant).  If a patient is 
withdrawn from the study, the research team will explain the reasons for the 
withdrawal. Withdrawal from this study will not affect a patient’s clinical care or 
access to any care or other opportunities to which they are otherwise entitled. 
Subjects may also withdraw permission for the use and disclosure of any protected 
information for research, but must do so in writing to the Principal Investigator at the 
address listed in the consent document.
Participants with low weight EDs will be informed that not participating in the study 
will not change or restrict their eligibility for treatment in the Eating and Weight 
Disorders Program and will not jeopardize their relationship with their pediatric 
subspecialist, if they were referred from Pediatric Associates or the Adolescent 
Health Center.
6) Risks to Subjects
Risks to patients in the study would be no more than those that exist as a result of the 
illness and no more than are usual in clinical practice and management.
From a psychological standpoint, there is the potential for participants to become 
upset or anxious during the tests or interviews.  Participants may also experience 
fatigue when completing the tasks in the assessments. All evaluations will be 
conducted by trained clinicians and the fMRI scans will be conducted by trained 
imaging staff. If a participant becomes upset or anxious, a member of the study team 
will ask the patient if she wishes to continue their participation. The protocol will be 
discontinued if a participant experiences a level of emotional discomfort such that she 
wishes to end her participation in the protocol. She may end her participation in this 
study at any time, with no consequence to her ability to access services at Mount 
Sinai in the future. If the participant experiences emotional discomfort as a result of 
her participation in the study, the research team member administering the protocol 
will attempt to provide comfort to the participant, will contact the Principle 
Investigator, and will discuss with the participant the need for a referral for further 
mental health services. To minimize fatigue, if the participant states feeling tired 
during testing or if the examiner notices this, the participant will be encouraged to 
take a break. 
In the case of active suicidal or homicidal plans or intent revealed during the course 
of evaluation, a licensed psychologist or psychiatrist will evaluate the patient. If 
necessary, the participant will be taken to the emergency room or admitted to the 
inpatient facility. If safety is compromised or could potentially be compromised by 
the discovery of a previously unknown psychiatric disorder during evaluation, the 
procedure above will be followed. If not (e.g., the discovery of a Major Depressive 
Disorder with no psychotic features and no suicidality), the participant will be 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
21
Revised  9/2/14
notified and encouraged to seek help in a sequenced fashion following treatment. The 
patient’s primary pediatrician clinician will also be notified assuming a written 
release is signed by the participant.
Psychophysiology: There is limited risk to the electrophysiological recording 
procedures. There is potential for slight irritation at the site of electrode application. 
There is no discomfort or physical risk associated with the recording of skin 
conductance and facial EMG.
Lastly, there are no known risks of the fMRI procedure. Some people may find it 
difficult to lie perfectly still in the scanner for one hour. The scanning is also noisy, 
and some might find that noise and confinement uncomfortable. The technician will 
remain with participants until they are comfortable inside the scanner. If the 
participant feels uncomfortable inside the scanner at any time, the test will be stopped 
immediately and the participant will have the option to withdraw from the study. 
Rarely, people react strongly to being enclosed in a small space and may become 
extremely anxious.  Every precaution will be implemented to ensure such instances 
do not occur.
In this study, patients may overeat or binge eat.  There are minimal physical risks 
associated with this behavior among patients with a LW-ED who regularly engage in this 
behavior and who show no physical deterioration as a result.  We are not asking patients 
to do anything differently from what happens in the course of their illness.   
Psychologically, participants may be upset after overeating and feel depressed or guilty 
afterward.  A member of the staff is present during both meal sessions, and will be 
available to speak with the participant if he or she becomes upset.  With asking more than 
100 patients to eat in the laboratory in a series of similar studies, we have not 
encountered any significant adverse physical or psychological events.
7) Provisions for Research Related Injury
We do not expect any research related harm or injury to occur to participants during 
their participation in this study.  However, if a patient is harmed during the course of 
their participation in the study, the research team will respond to any immediate 
emergencies, and then make referrals for follow-up care, as appropriate.
8) Potential Benefits to Subjects
Potential benefits to the patients in this proposed study include the possibility of a 
reduction of symptoms associated with low weight eating disorders. Healthy 
comparison adolescents are not expected to derive benefits from participation. 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
22
Revised  9/2/14
Indirect benefits:  Benefits to future patients, researchers, clinicians, and health care 
planners could include valuable information about ways to improve treatment for low 
weight eating disorders and a greater understanding of the neurocircuitry that 
underlies different types of learning.
9) Provisions to Protect the Privacy Interests of Subjects
During the consent process, the member of the research team will thoroughly 
explain the provisions made to ensure data confidentiality. As part of this 
process, the acting member of the research team will explain that these 
provisions are in place to ensure that information deemed sensitive or private 
is protected. If, during the clinical interview, the administering clinician 
senses that a participant is uncomfortable with the nature of the interview, the 
clinician will stop the interview and review the guidelines in place for the 
protection of participant privacy. If the participant continues to exhibit distress 
or states that he/she is uncomfortable with the information being asked, the 
clinician will cease that line of inquiry.
10)
Economic Impact on Subjects
Patients will not incur any costs associated with the study evaluations or 
interventions. Any potential costs of EWDP treatment not included in the protocol (or 
at external treatment centers or with non-EWDP treatment providers) will be the 
patients’ responsibility, as this is not part of the study protocol. Any eating-disorder 
related care outside of the EWDP but intersecting with its standard approach (e.g., 
DXA, physician costs to obtain medical clearance or ongoing medial management; 
management of psychotropic medication by an outside psychiatrist) will also be the 
responsibility of the patient. 
11)
Payment to Subjects
All participants will be paid $275 for the pre and post-intervention assessments. 
Specifically, participants will be paid $50 for visit 1, $65 for visit 2, $70 for visit 
3 (visit 9 for adolescents with eating disorders), and $90 for visit 4 (visit 10 for 
adolescents with eating disorders).
Follow-up Treatment: LW-ED participants will also be offered 20 free sessions of 
open label psychotherapy for their eating low weight eating disorderover a maximum 
of six months in the EWDP as compensation for participation. If participants wish to 
attend these sessions, the first session will continue approximately one week after 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
23
Revised  9/2/14
Visit 10 and all 20 sessions would be completed within 6-months following Visit 10. 
When deciding to participate in this study, all participants will be made aware of the 
full range of treatment option offered by the EWDP, including that our program 
routinely offers free treatment for eating disorders through our student extern 
therapists. Therefore, participants should feel no obligation to participate in this study 
only to receive free treatment for their eating disorder.
12)
Consent Process
Voluntary written informed assent/consent will be obtained from all participants and 
parents prior to study entry in accordance with the Institutional Review Board of 
Mount Sinai.  Assent/consent will be obtained at the Icahn School of Medicine at 
Mount Sinai in a closed office with only members of the research group present. The 
initial assent/consent forms describe the nature of the procedures and time 
requirements, potential risks, the confidentiality of information, and the rights of 
research subjects. This will include an explanation of the protocol, of its risks and 
benefits, and of alternatives to participation. Participants will be made aware that if 
they choose to participate, they must give consent to be video recorded as needed in 
the protocol. 
Consent forms of parents of adolescents with low weight EDs will indicate 
procedures that parents need to complete as part of the intervention to which they are 
randomized. Participants with low weight EDs will be informed that not participating 
in the study will not change or restrict their eligibility for treatment in the Eating and 
Weight Disorders Program and will not jeopardize their relationship with their 
pediatric subspecialist, if they were referred from Pediatric Associates or the 
Adolescent Health Center. Participants’ understanding of the protocol will be 
examined by direct questioning prior to their signing the assent/consent forms.  
A standard, formal assent procedure (as mandated by the Icahn School of Medicine 
Institutional Review Board) will be conducted for all children. This will include 
explanation of the protocol in a developmentally appropriate way, discussing 
alternatives to participation in the project with the individual, providing the 
opportunity to ask questions, and certification of assent of a minor that will be 
witnessed by a nurse or a clinician that is not related to the child and is not a part of 
the research team. 
      
If a participant is under the age of 18 and completes the assent procedure at the 
beginning of her participation then turns 18 during the course of her participation, she 
will be required to complete formal adult consent procedures in order to continue her 
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
24
Revised  9/2/14
participation. Children will be reconsented when they turn 18 years old to have their 
data stored in the National Data Archive. If a child is lost to follow up when they turn 
18, their data will be removed from the archive and destroyed.
Consistent with Federal and State guidelines, all participants will be informed that if 
an unreported case of child abuse is discovered during the course of the study it will 
be reported. The assent/consent forms will specifically read: “An exception to 
confidentiality is a previously unreported incident of child abuse and neglect that is 
obtained during research. The investigator will report this information to the 
appropriate local (e.g., Administration for Children’s Services) or state agency in 
accordance with New York State law.” A copy of the assent/consent form is provided 
to all participants. If the individual decides not to participate in this study, a project 
staff member provides reasonable and timely assistance in obtaining an alternative 
referral, if applicable and so desired. The decision not to participate does not affect 
eligibility to participate in future studies, to receive treatment at the participating 
institution, or to receive treatment on a private basis from a referring clinician.
13)
Process to Document Consent in Writing
The standard PPHS consent template will be used.
14)
Vulnerable Populations
Children: 1. Mount Sinai Medical Center Certification of Assent procedure will be 
used. The investigator will explain the protocol to the child in a developmentally 
appropriate manner.  If the child agrees to participate she will be asked about the 
protocol by an independent clinician, who is not related to the child and is not 
involved in the study (e.g., non-study personnel). This clinician will need to certify in 
writing that the child indeed understands the protocol and is assenting to it. If assent 
is not obtained, evaluation will not commence even if the parent consents.  
2.  The clinicians involved in this study will be trained in the management and 
interviewing of children. 
Financially disadvantaged persons: The study population is expected to include 
participants from all financial and social strata. We will not exclude a participant 
based on financial parameters nor will we ask for a payment for the evaluation. The 
reimbursement of free treatment for patients with low weight EDs is not coercive, in 
that it does not constitute an unreasonably high incentive for participation even for 
financially disadvantaged persons. The opportunity to receive free treatment allows 
for persons in this situation to receive at least the equivalent of standard care provided 
by specialists in ED treatment.
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
25
Revised  9/2/14
15)
Multi-Site Human Research (Coordinating Center)
Not applicable.
16)
Community-Based Participatory Research
Not applicable.
17)
Sharing of Results with Subjects
Not applicable.
18)
External IRB Review History
Not applicable.
19)
Control of Drugs, Biologics, or Devices
Note: The IDS has its own forms that must be completed and a review process 
that must be followed before the IDS representative will sign off on Appendix B 
for submission to the PPHS.
Not applicable.
Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
26
Revised  9/2/14
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Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
27
Revised  9/2/14
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Effective Date: 4/12/2022
End Date:4/11/2023

Protocol Title:
Reward Systems and Food Avoidance in Adolescents with 
Low Weight Eating Disorders
Principal Investigator
Name/Contact Info: 
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Primary Contact 
Name/Contact Info
Tom Hildebrandt, Psy.D.
212-659-8673; tom.hildebrandt@mssm.edu
Date Revised:
Study Number:
GCO#15-0939  IF# 2446156   HS# 16-00570
28
Revised  9/2/14
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20570701; PMCID: PMC2939314.
Effective Date: 4/12/2022
End Date:4/11/2023