Efficacy Trial of a Dissonance Based Eating Disorder Program
Phase: NA
Conditions: Eating Disorder
Sponsor: Cornell College

 
 
 
 
 
Study Title: Efficacy of a Dissonance Based Eating Disorder Program 
NCT Number: 03796091 
ID: 1516-105-GRE 
Date of IRB Approval: May 8, 2018 (revised protocol approved) 
Document Type: Study Protocol (revised protocol) 
PI: Dr. Melinda Ann Green 
Institution: Cornell College 
 
 

 
 
 
 
 
 
 
Cornell College IRB-Approved Protocol 
 
Project Number (if previously assigned): #1516-105-GRE 
Project Title: Efficacy of a Dissonance Based Eating Disorder Program 
 
Principal Investigator: Dr. Melinda Green, Department of Psychology, 106E Law Hall, 
Cornell College, 600 First Street SW, Mt. Vernon, IA 52314, mgreen@cornellcollege.edu, 
319-895-4313 
 
Research Assistants: Gabby Carlson, Kamryn Hogan, Elisabeth Sage, Yumeng Tao, John 
Bogucki, Julian Smith, Emma Hartman, Lexi Ferenzi, Undergraduate 
Research Assistants; Anne Roche, Cara Weinkes, Mallory 
Bolenbaugh, Marcie King, Graduate Research Assistants 
Medical Monitor:        Dr. Monica Meeker 
Data Safety and Monitoring Board Members: Dr. Monica Meeker, Dr. Scott Eilers, 
Yunkyong Garrison 
 
Study Protocol:   
Participants: All participants will be treated in accordance with federal guidelines 
(Title 45, Code of Regulations Part 46) for the treatment of human participants. The 
sample will include female participants ages 15-34 (postmenarcheal and 
premenopausal) who are not pregnant. Participant selection was limited to this group to 
control for the effects of estrogen on cardiac function and in accordance with meta-
analytic findings which suggest that a) dissonance-based programs are most effective 
when offered solely to females and that b) program effect sizes are greatest for females 
over the age of 15 (Stice & Shaw, 2004).  
Our preliminary data indicate age did not significantly predict program efficacy at 
postintervention or 2-month follow-up in regression models; preliminary results 
suggest the program is effective when delivered to a group of women ages 14-34. 
Results provide support for conducting the proposed full scale trial with women of this 
age group (though the lower limit of this age range was adjusted up from 14 to 15 years, 
per the recommendation offered by Stice & Shaw, 2004). Consistent with the 
methodology of the preliminary trial, participants will not be excluded from the sample 
if they are seeking other eating disorder treatment or prevention services; this will be 
treated as a covariate in a secondary analysis to control for the effect of external 
treatment or external prevention services on trial outcomes. 
Also consistent with the methodology of the preliminary trial, diagnostic level 
(clinical, subclinical) will be initially screened online via the Questionnaire for Eating 
Disorder Diagnoses (Q-EDD; Mintz, O'Halloran, Mulholland, & Schneider, 1997) with 
scoring criteria adapted for the Diagnostic and Statistical Manual of Mental Disorders 5th 

 
 
 
 
 
edition (DSM-5; American Psychiatric Association, 2013). Diagnostic status will be 
confirmed during the baseline assessment session via the Eating Disorder Examination 
Edition 16.0D (Fairburn, Cooper, O’Connor, 2008). Clinical status will be assigned for 
participants meeting DSM-5 diagnostic criteria for bulimia nervosa, anorexia nervosa, 
bulimia nervosa, binge eating disorder, or other specified feeding or eating disorder. 
Subclinical status will be assigned via recommendations offered by Mintz and colleagues 
(1997) for designating symptomatic (i.e., subclinical) eating disorder status (see Green 
et al., 2017; Green et al., in press for a description in the preliminary trial). Symptom 
status will be monitored by the Principal Investigator and the Laboratory Coordinator 
over the duration of the trial via symptoms reported on the EDE-Q at each assessment 
interval; participants with deteriorating symptoms will be given information regarding 
treatment resources. For minor participants, this information will be provided both to 
the minor participants and their parents or legal guardians.   
Participants will be recruited via letters sent to inpatient and outpatient 
behavioral and medical treatment facilities in Eastern Iowa, via letters mailed to 
sororities at nearby universities, via flyers posted at local businesses and fitness centers 
in Eastern Iowa, via an advertisement posted on the social networking sites Instagram 
and Facebook, via advertisements posted in local newspapers, via advertisements 
posted on websites for the Academy for Eating Disorders and the National Eating 
Disorders Association, via fliers posted in area high schools, colleges, and universities, 
via announcements made on a local radio station, and via advertisements on radio and 
public transit, and via the e-mail listserv of a nearby large university. Intentional efforts 
will be made to increase the representation of ethnic minority women in the sample.  
Procedure:  Postings and mailings will advertise a study examining eating 
disorder treatment and prevention practices. All participants will be screened to ensure 
they meet inclusion criteria for the trial. Participants interested in completing a 
screening will contact the Principal Investigator or Laboratory Coordinator via e-mail to 
indicate interest. The Principal Investigator or Laboratory Coordinator will e-mail 
interested participants the informed consent statements for the screening and the full-
scale trial and will provide a URL for the online screening survey (administered via 
Qualtrics). The online survey will again display the informed consent statement for the 
screening. Participants will be asked to electronically indicate their consent to 
participation before completing the screening. In the case of minors, parents will 
indicate their online consent and minors their online assent.  
Once consent is secured, participants will complete an online demographic 
questionnaire which includes an assessment of participants’ medical history, pregnancy 
status, and current medication status. Participants will also complete an online version 
of the Questionnaire for Eating Disorder Diagnoses (Q-EDD; Mintz, O'Halloran, 
Mulholland, & Schneider, 1997). This screening will take approximately 20 minutes to 
complete. At the end of the screening, an electronic debriefing will appear. Participants 
will be asked to provide their contact information so researchers can contact them if 
they meet the inclusion criteria for the full-scale trial.  Screening participants will be 

 
 
 
 
 
entered into a drawing to win one of two $25 gift certificates to Amazon.com. Diagnostic 
status (clinical, subclinical, asymptomatic) will be determined according to the Q-EDD 
scoring criteria outlined by Mintz and colleagues (1997) with clinical criteria adapted 
for DSM-5 (American Psychiatric Association, 2013); clinical diagnostic status will be 
conformed via the EDE 16.0D (Cooper et al., 2008) administered at baseline.   
All participants meeting the inclusion criteria for the full scale trial will be 
contacted via e-mail by the Principal Investigator or the Laboratory Coordinator. In this 
e-mail, each participant will be given an electronic version of the informed consent 
statement for the full scale study and will be asked to indicate e-mail consent. For 
minors, assent and parental consent will be required. If participants consent, the 
Principal Investigator or Laboratory Coordinator will schedule a research appointment 
and will verify the participant’s home address. A copy of the full scale study informed 
consent statement, a map to the laboratory location, and pre-appointment instructions 
will be mailed to the participant’s home approximately one week before the scheduled 
research appointment. Finally, an e-mail reminder will be sent by the Laboratory 
Coordinator one day before the scheduled research appointment.   
Participants will be randomly assigned to the expanded dissonance-based 
condition, the traditional Body Project condition, or to an educational brochure control 
condition. The experimenter will be blind to their condition. Participants in all 
conditions will complete on-line assessments of body dissatisfaction, self-esteem, self-
objectification, thin-ideal internalization, maladaptive social comparison, trait anxiety, 
and eating disorder symptoms at baseline, postintervention, and 2-month follow-up (see 
the list of specific measures below). Participants will come to the laboratory at each 
assessment period to have their height, weight, and cardiovascular function assessed.     
Participants will be instructed to avoid food, coffee, and nicotine for 3 hours prior 
to each laboratory appointment (see Low, 2003). Participants will be instructed to 
abstain from vigorous physical exercise for 24 hours prior to their appointment and will 
show no signs of acute physical illness for 48 hours prior to their appointment. If signs 
of acute physical illness develop, participants will be instructed to contact the 
Laboratory Coordinator to reschedule the appointment.  
Upon entry into the laboratory, an experimenter will greet the participants and 
will read the informed consent statement aloud. The participant will be given an 
opportunity to ask questions. If the participant provides consent, the laboratory 
protocol will begin. Minors will provide assent and parental or legal guardian consent.  
Participants will be placed in a supine posture for a 10-minute equilibration 
period; a blood pressure cuff with a heart rate monitor will be secured to the left arm. 
Blood pressure and heart rate indices will be checked at two 5-minute intervals to 
assess cardiac equilibration. Participants will be prepared for electrocardiography (ECG) 
during this equilibration period. 3 self-adhesive electrodes will be secured using a lead II 
chest configuration; ECG lead wires will be attached and a sample (~5-second) ECG 
recording will be obtained to check signal quality. Immediately after the 10-minute 
equilibration period, participants will be instructed to remain silent in a resting supine 

 
 
 
 
 
posture while a 5-minute and 30-second ECG recording is conducted. Next participants’ 
height and weight will be assessed in the laboratory. At the conclusion of each 
assessment session, participants will be compensated via a $40 online Amazon gift card 
in exchange for their participation. They will be debriefed after the final assessment 
session and will receive an assessment report containing the assessment data from each 
of their 3 assessment sessions. 
After the baseline session, participants in the expanded dissonance-based 
condition will complete an altered version of the Body Project, adapted for the present 
trial to address maladaptive social comparison and objectification. Participants in the 
traditional Body Project condition will complete the standard program as specified by 
Stice and colleagues (2001).  Participants in the enhanced and traditional conditions will 
meet in four 60-minute group sessions, once per week, for one month. Homework will 
be assigned between group sessions and during the 2-month follow-up assessment 
period. Group sessions will be facilitated by the Principal Investigator, the Laboratory 
Coordinator, or one advanced graduate student in a Clinical Psychology program at a 
large Midwestern university and a Cornell College undergraduate student.   
Session content in the expanded condition will be identical to the traditional Body 
Project prevention program with the following exceptions: 1) the concept, origins, and 
consequences of cultural objectification will be introduced and discussed alongside the 
thin-ideal during the first session; 2) a thought record exercise designed to monitor and 
reframe appearance-based maladaptive upward social comparison will be added to 
session one homework; 3) behavioral exercises designed to decrease the frequency of 
trait self-objectification and maladaptive social comparison will be added to session 
three; 4) a behavioral exercise designed to increase understanding of the consequences 
of the cultural objectification of women and trait self-objectification will be added to 
session four; and 5) homework designed to decrease the frequency of maladaptive social 
comparison will be added to the final homework exercise.  Across both dissonance 
conditions, participants will be compensated $40 in Amazon gift cards for each program 
session, $10 in Amazon gift cards for each set of homework activities between sessions, 
and $40 for the final homework conducted over the 2-month follow-up period. 
Participants in the educational brochure control condition will receive a 2-page 
handout from the National Eating Disorder Association which describes negative and 
positive body image, delineates the relationship between negative body image and 
disordered eating, and offers strategies for improving body image. This educational 
brochure control condition was used by Stice and colleagues (2014) in the evaluation of 
the efficacy of a dissonance-based prevention program.  
Measures: 
Questionnaire for Eating Disorder Diagnoses (Q-EDD). The Questionnaire for 
Eating Disorder Diagnoses (Q-EDD: Mintz et al., 1997) was used to determine diagnostic 
status. The Q-EDD is a self-report questionnaire used to assess level of eating disorder 
symptomatology.  The Q-EDD operationalizes diagnostic criteria for eating disorder 
diagnoses according to the Diagnostic and Statistical Manual of Mental Disorders, 4th 

 
 
 
 
 
edition, Text Revision (DSM-IV-TR; American Psychiatric Association, 2000). Q-EDD 
scoring criteria will be adapted in the proposed trial to fit criteria specified by the 
Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5; American 
Psychiatric Association, 2013). The Q-EDD has good convergent validity when compared 
to the Revised Bulimia Test (BULIT-R; Thelen, Farmer, Wonderlich, & Smith, 1991) and 
the Eating Attitudes Test (EAT; Garner & Garfinkel, 1979) in undergraduate and 
community samples.   
Rosenberg Self-Esteem Scale (RSE). The Rosenberg Self-Esteem Scale (RSE: 
Rosenberg, 1965) is a widely used measure designed to assess global feelings of self-
worth and self-esteem. Originally designed as a Guttman scale, the RSE is now 
conceptualized and scored as a Likert scale. The RSE includes 10 items (e.g. “I feel that 
I’m a person of worth) rated on a four-point scale (1 = strongly disagree, 4 = strongly 
agree). Higher scores indicate higher levels of self-esteem. The RSE has high test-retest 
reliability, typically ranging from .82 to .88 depending upon the sample (Blascovich & 
Tomaka, 1993). Coefficient alphas range from .73 to .85 (Corning, Krumm & Smitham, 
2006; Hawkins, Richards, Granley & Stein, 2004).  
Eating Disorder Examination (EDE-Q 16.0D) & Eating Disorder Examination 
Questionnaire (EDE-Q). The Eating Disorder Examination-Questionnaire 16.0D is the 
gold standard semi-structured diagnostic interview for evaluating eating disorder 
symptoms, adapted from the original Eating Disorder Examination (EDE: Cooper, 
Cooper, & Fairburn, 1989). The EDE will be used to confirm diagnostic level for 
participants with clinical symptoms.  The EDE-Q shows high convergent validity with 
EDE subscales (Mond, Hay, Rogers, Owen, & Beumont, 2004); it will be used to evaluate 
level of eating disorder symptoms at each assessment.    
Body Shape Questionnaire (BSQ). The Body Shape Questionnaire (BSQ: Cooper, 
Taylor, Cooper, & Fairburn, 1986) is a 34-item measure designed to assess body 
dissatisfaction. Items are measured on a 6-point Likert scale designed to measure the 
frequency of negative body-related thoughts (1= never, 6 = always). Higher scores 
indicate higher frequency of negative body-related thoughts and higher levels of body 
dissatisfaction. The BSQ shows strong test-retest reliability and good convergent validity 
when compared with other measures of body dissatisfaction in clinical and nonclinical 
college and community samples (Rosen, Jones, Ramirez, & Waxman, 1996).  
Social Comparison Rating Scale (SCRS). The Social Comparison Rating Scale (SCRS: 
Allan & Gilbert, 1995) is an 11-item scale designed to assess perception of social rank.  
The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by 
the numbers 1 through 10. For each adjective pair, participants are asked to rank 
themselves in comparison to others. A score around 60 indicates a person, on average, 
sees themselves approximately equal to others. Higher scores indicate higher levels of 
favorable social comparison and higher perceived social rank. Test-retest reliability of 
the 11-item scale is high (Cronbach’s α = .88).  
Self-Objectification Questionnaire (SOQ). The Self-Objectification Questionnaire 
(SOQ: Fredrickson et al., 1998) was used to assess trait self-objectification. The SOQ is a 

 
 
 
 
 
10-item self-report inventory designed to assess the relative importance of body 
competence versus body appearance in physical self-concept (Fredrickson et al., 1998). 
Participants are asked to rank 5 appearance-based attributes (e.g., physical 
attractiveness) and 5 competence-based attributes (e.g., physical coordination) in order 
of their impact on physical self-concept.  Attributes are ranked from 0 to 9 with higher 
scores representing higher importance. An overall trait self-objectification score is 
computed by summing competence and appearance ratings and subtracting the sum of 
competence ratings from the sum of appearance ratings. Resulting scores range from -
25 to 25. Higher scores denote higher levels of trait self-objectification.  According to 
Noll & Fredrickson (1998), the Self-Objectification Questionnaire displays acceptable 
convergent validity when compared to the Body Image Assessment (Williamson, Davis, 
Bennett, Goreczny, & Gleaves, 1985) and the Appearance Anxiety Questionnaire (Dion, 
Dion, & Keelan, 1990) in a college student sample. The measure also demonstrates 
acceptable internal consistency (α = .80) in a college student sample (Hebl, King, & Lin, 
2004).   
Ideal Body Stereotype Scale – Revised. The Ideal Body Stereotype Scale - Revised 
(IBSS-R: Stice, 2001) was used to assess the extent to which participants internalized the 
cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks 
participants to report their level of agreement with 6 statements which indicate what 
attractive women look like on a 5-point scale ranging from strongly disagree (1) to 
strongly agree (5). Responses are averaged to compute a total score. Higher scores 
indicate higher levels of thin-ideal internalization. The scale demonstrates acceptable 
internal consistency (α = .83-.89) and discriminant, convergent, and predictive validity 
in college student samples (see Stice, 2001).   
State Trait Anxiety Inventory – Form Y. The State Trait Anxiety Inventory- Form Y 
(STAI: Spielberger, Gorsuch, & Lushene, 1970) is a 20-item self-report measure designed 
to assess level of trait anxiety. Each item consists of a statement which assesses feelings 
of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). 
Scores range from 20 to 80. Higher scores indicate higher levels of anxiety. The STAI 
demonstrates high internal consistency in college student samples, as well as strong 
reliability and validity indices (see Spielberger, 1983).   
Body Mass Index: Body mass index (BMI) will be calculated based on height and 
weight data [weight (kg)/height (m2)] (see Garrow & Webster, 1985).   
Cardiac Indices: The ECG signal will be acquired via PowerLab 16/35 
psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware 
setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV 
data and ECG data will be analyzed via PowerLab LabChart 8 software.   
 
Data and Human Protections:  
Human Participant Training:  All members of the research team will review the 
Cornell College IRB handbook available at 
https://www.cornellcollege.edu/irb/files/Handbook%202018.pdf.  Please note the NIH 

 
 
 
 
 
human subjects training was no longer available as of September 26th, 2018 but all 
members of the current team completed this training prior to its removal.   All members 
of the team signed Cornell College confidentiality assurance forms available at 
https://www.cornellcollege.edu/irb/files/WebConfAssur2018.pdf. 
All records will be kept confidential and participants’ records will not be made 
publicly available. Participants in all conditions will be assigned an experimental 
number which will appear on all study materials.  There will be a separate master file 
which links experimental numbers to participant names.  Only research team members 
will have access to this data file.  All data will be kept in a locked laboratory location. On-
line data will be downloaded to a password-protected electronic file. Data from the 
present study will be analyzed by the research team. The resulting dataset will be 
analyzed and summarized in a publication intended to appear in a scientific journal. This 
dataset will be archived in a password protected file for future analysis and publications 
by the Principal Investigator.  The dataset without participants’ names or identifiers will 
be available on ClinicalTrials.gov and will be submitted to journals alongside published 
articles for interested readers to access on journal websites.  It may also be requested 
for re-analysis by interested persons reading the relevant research articles.  Again, the 
data will contain no identifying information.   
Protection of sensitive data collected online.  An online data acquisition platform 
(Qualtrics) will be used for the collection of all screening and assessment data.  Qualtrics 
uses TLS encryption for all transmitted data and participants will be sent password 
protected survey links (a function available in Qualtrics).  The Qualtrics security 
statement is available at  https://www.qualtrics.com/security-statement/. Only 
laboratory members have access to the Qualtrics login information for the laboratory. 
Qualtrics data is downloaded to the Cornell College server to a password 
protected shared drive that only laboratory members have access to.  The Cornell 
College also has a high-end firewall systems and the IT staff regularly assesses and 
ameliorates vulnerabilities to the secure server.  Cornell College retains a certified 
secure 3rd party storage and disaster recovery site roughly 25 miles from our campus, 
to store our retained data and nightly/weekly backups. All student data and financial 
records/data are encrypted and transferred through secure, encrypted connections. All 
administrative system user and administrator logins and passwords are stored in a 
centralized, encrypted password vault.  
At the start of a relationship with the College and annually thereafter, every 
College employee, student, and contracted worker is required to read a statement of 
responsibility for the security and confidentiality of data and data networks and agree to 
the following conditions: Keep personal passwords private. Assume responsibility and 
be held accountable for all data modifications made using his/her ID and password.  Not 
allow unauthorized use of any information in files or databases.  Not provide or permit 
access to College data infrastructure or networks by any unauthorized individuals.  Not 
seek personal benefit or permit others to benefit personally through the use of any 
confidential information which has come to him/her through his/her work assignment.  

 
 
 
 
 
Not exhibit or divulge the contents of any record or report to any person except in the 
conduct of his/her regular work assignment.  Not aid, abet, or act in conspiracy with any 
person to violate any part of the statement of responsibility.    
Assessment of Medical Risks and Appropriateness for Outpatient Treatment: 
Medical risk will be assessed at baseline, post, and follow-up. The medical monitor will 
be responsible for monitoring eating disorder risk status, cardiac risk, and BMI at each 
assessment session and will work with the Laboratory Coordinator and the PI to 
communicate this information to participants who have indicators of medical risk or 
worsening symptoms. In the case of minor participants, this information will also be 
communicated to parents directly. This will be done both via a written letter and a 
phone call from the study staff.   
All ECG strips which deviate from typical human physiological function be 
reviewed by the medical monitor and the medical monitor will sign off on any referral 
letters. Participants with atypical ECG findings will receive a copy of their ECG strip and 
will be referred to their primary care physician to determine if additional testing or 
intervention is needed.  
Participants in the high medical risk category will also be given a list of local 
mental health providers specializing in eating disorder treatment and will be referred to 
a mental health care specialist for additional eating disorder assessment and treatment 
planning.  If the trial does not interfere with other treatment services recommended by 
the primary care physician and mental health care specialist, then the participant will 
remain eligible for the trial. 
Assessment of Medical Risks at Baseline: With regard to the assessment of medical 
risk at baseline, research indicates eating disorder patients with body mass indices 
(BMI) < 18 are at a significantly greater risk for negative physical outcomes, most 
notably disorder-related cardiac risks (see Fairburn, 2008; Swenne & Larsson, 1999).  
Patients with low BMIs (regardless of electrolyte status) are significantly more likely to 
show QTc interval prolongation and dispersion, indicators of increased risk for sudden 
cardiac arrhythmia and death (Swenne & Larsson, 1999).  Participants meeting this low 
weight criterion (BMI < 18) or with QTc interval duration of >500msec (Swenne & 
Larsson, 1999) will be considered to have an initial high risk symptom presentation and 
will be referred to their primary care physician for a medical assessment prior to 
beginning the trial.   
According to American Psychiatric Association level of care guidelines for 
patients with eating disorders (Yager et al., 2006), patients are considered at to be at a 
medically high risk (and in potential need of inpatient care) if they demonstrate a HR < 
40 bpm or BP < 90/60.  Participants meeting one or both of these criteria will be 
similarly referred to a primary care physician for a medical assessment prior to 
beginning the trial.   
According to American Psychiatric Association guidelines (Yager et al., 2006), 
patients are also at high medical risk (and in potential need of inpatient care) if they are 
unable to control multiple daily episodes of purging that are severe, persistent, and 

 
 
 
 
 
disabling. In line with these recommendations, patients demonstrating multiple daily 
episodes of self-induced vomiting, daily laxative abuse, daily diuretic, or > 3 episodes of 
24-hour fasts per week in the past 28 days as assessed by the Q-EDD (Mintz et al., 1997) 
will be considered to be at medically high risk and will be referred to their primary care 
physician for a medical assessment prior to beginning the trial.    
Assessment of Medical Risks Throughout the Trial: Eating disorder symptom 
severity, BMI, and cardiac risk indices will be assessed at baseline, postintervention (4-6 
weeks after the baseline assessment), and 2-month follow-up.  Tracking eating disorder 
symptom status, BMI, and cardiac function at the 3 assessment periods will allow for the 
careful monitoring of symptom deterioration over the duration of the trial.   
Eating disorder symptom severity will be assessed by the global scale of the Eating 
Disorder Examination – Questionnaire (Fairburn et al., 2014) and via the Questionnaire 
for Eating Disorder Diagnoses (Mintz et al., 1997), both reliable and valid indicators of 
eating disorder pathology.  The same medical risk criteria outlined in the “Assessment of 
Medical Risks at Baseline” section above will be applied throughout the trial.  Increased 
frequency of binge and purge behaviors as indicated on the Q-EDD (Mintz et al., 1997) and 
the EDE-Q (Fairburn et al., 2014) will be evaluated in conjunction with BMI and cardiac 
risk indices (QTc interval length > 500 msec, mean R wave amplitude < .5 mV) by the 
medical monitor to determine medical risk and need for referral. Participants 
demonstrating deterioration on these indices across assessment periods will be referred 
by the medical monitor to their primary care physicians for medical assessment and to 
local mental health providers specializing in eating disorder treatment.  
Group Intervention: Confidentiality Risks.  Participants will be notified in the 
informed consent document that the trial incorporates a group intervention, that there 
is a chance they may know others enrolled in the group, and that group interventions 
pose inherent risks for confidentiality since others in the group will know their 
identities.  Participants will be asked to check a series of boxes on the informed consent 
documents which indicate they acknowledge these unique risks.  In an attempt to reduce 
the risk that confidential information discussed during the group intervention will be 
shared outside of the group, each participant will be asked to sign a confidentiality 
agreement in which they promise to keep the identity of other groups members private 
and not to discuss group content outside of the group context.  We believe this approach 
will inform participants of the unique confidentiality concerns associated with group 
interventions and will discourage sharing of confidential group data outside of the group 
context.   
 
Qualifications and Supervision of Group Facilitators: Graduate facilitators will be second 
to fourth year doctoral students from nearby PhD programs in Clinical and Counseling 
Psychology who have previous practicum experience with the administration of group 
interventions and preferably experience with the administration of eating disorder 
interventions.  Graduate facilitators will have taken at least one course in counseling 
theories and techniques and had at least 1 practicum experience in an applied mental 

 
 
 
 
 
health setting.  Undergraduate facilitators will be required to have completed one 
counseling and psychotherapy course and to be an ongoing member of the student-
faculty research team with previous team-based training in dissonance-based eating 
disorder interventions.   
All facilitators will undergo facilitator training during which they learn to 
administer the intervention programs.  During the training, facilitators will practice all 
components of the intervention protocol and will review safety guidelines and 
procedures for adverse group events (including if a participant experiences an adverse 
health event during a group intervention session or if a group member expresses ideas 
of self-harm during a group intervention session).   
During group intervention sessions, the Laboratory Coordinator will be present 
in the building and the Principal Investigator will be on call.  If a group member 
expresses ideas of self-harm, facilitators will inform the participant they would like to 
explore the issue more fully following the conclusion of the group session.  The 
facilitators will notify the Laboratory Coordinator who will promptly call the PI.  The PI 
and Laboratory Coordinator will then meet with the participant immediately after the 
group session to conduct a thorough suicide assessment and to determine the 
appropriate level of care.  The PI will then facilitate needed referrals.  If it is clear the 
participant is at imminent risk for self-harm, the PI will offer to transport the participant 
voluntarily to the emergency department of a local hospital for a psychiatric assessment.  
If the participant is at imminent risk for self-harm but refuses voluntary transport, 
campus safety and local law enforcement will be contacted and the imminent risk for 
self-harm explained.  If the PI is unable to be on-call for a given session, the PI will 
recruit another licensed psychologist who is familiar with the intervention paradigms to 
be on-call in her absence.   
All intervention sessions will be rated for fidelity and compliance in order to 
provide supervision on the protocol.  Formal rating forms will be completed by trained 
raters in order to provide feedback on the fidelity and compliance.    
 
Data Safety and Monitoring: Despite overall low risk to participants in the trial, we will 
be instituting a fully independent DSMB to maximally ensure patient safety. The DSMB 
will operate in compliance with NIH Policy for Data and Safety Monitoring (1998) as 
specified at https://grants.nih.gov/grants/guide/notice-files/not98-084.html. We will 
be recruiting DSMB members who meet the NIH guidelines, and will include least one 
eating disorders expert and one biostatistician. One DSMB member will be a physician 
who will also serve as the study’s medical monitor (see “Assessment of Medical Risks” 
section below for additional details about this role).  
 
Serious Adverse Events (SAE) will be identified, monitored, and reported throughout the 
study in accordance with the NIH Reportable Events Policy (April 16, 2015) as specified 
at https://www.nimh.nih.gov/funding/clinical-research/nimh-reportable-events-
policy.shtml.    

 
 
 
 
 
 
Active or Passive Deception: This protocol involves no active or passive deception. 
 
Inherent Risks: The foreseeable risks inherent in this study slightly exceed those encountered 
in everyday life. Examining weight-related thoughts, emotions, and behaviors may cause 
discomfort and may precipitate a negative psychological reaction in some individuals. Should 
a participant experience a negative psychological reaction to the study, they will be asked to 
contact the Principal Investigator for further direction on services available to them in the 
area. Participants will also be given contact information for the IRB Chair.  If a participant 
experiences an unexpected negative psychological reaction to the study that does not remit, a 
list of mental health service agencies in the area are listed out in the Informed Consent 
document. If atypical results appear in a participants’ ECG results, the Primary Investigator 
(Dr. Melinda Green) will send the relevant data to the medical monitor who will then make a 
recommendation on whether or not participants should receive an atypical results letter and 
phone call.  
 
Benefits and Compensation: The present study may be a direct therapeutic benefit to the 
participant if they are in the traditional or the expanded Body Project intervention conditions. 
Previous findings indicate participants in a similar intervention programs experienced lower 
symptoms of disordered eating and associated risk factors.  However, there may be variability 
with regard to outcomes and all participants may not experience this reduction. Data from this 
trial will help to increase scientific knowledge regarding the effectiveness of eating disorder 
treatment and prevention programs.  
As compensation for the participants’ time and transportation expenses participants 
will receive Amazon gift cards. Each participant will receive $120 in exchange for their 
participation in the 3 evaluation sessions (3 sessions x $40 per session = $120).  If the 
participant is assigned to either the traditional Body Project or the expanded Body Project 
interventions, they will receive an extra $40 for each intervention attended (4 sessions x $40 = 
$160). Participants in these conditions will also receive an extra $30 ($10 each sessions) for 
completing homework for sessions 2-4) and and $40 for the final homework assigned over the 
2-month follow-up period ($350 total for participants in the traditional and expanded Body 
Project intervention conditions: $120 assessments, $160 intervention program, $70 
homework).  Participants in the educational brochure condition will not receive compensation 
for reading the educational brochure but will receive $120 in compensation for attending the 3 
assessment sessions. 
 
Inclusion of Special Populations: Adolescent women between the ages of 15 and 17 will 
be admitted into the study since eating disorders commonly onset during the adolescent 
period. Based on our recruitment strategy (a portion of which occurs in area high 
schools and clinics which serve adolescents), and statistics from our previous samples 
which used the same recruitment strategy, we anticipate approximately 10-20% of our 
sample will be comprised of women in the 15-17 age range.  We chose to include women 
in this age range based on the fact that eating disorder symptoms commonly onset 

 
 
 
 
 
during this age and earlier treatment and prevention interventions are critical to 
positive outcomes.  By excluding this population, we would be limiting prevention and 
treatment research essential for this group.   
That said, we are very mindful that the inclusion of adolescents in this research 
requires extra protections for this population.  As delineated in our human participants 
section, minor assent and parental/legal guardian consent is required for inclusion in 
this trial.  In addition, any assessments outcomes which indicate symptom deterioration 
or atypical results in ECG findings will be communicated to both minor participants and 
parents/legal guardians.  Any necessary treatment referrals will also be communicated 
to both parties by the PI or the Laboratory Coordinator.  In addition, any adverse 
reactions to the trial (assessed at all assessment intervals) reported by an adolescent in 
the study will result in the PI or the Laboratory Coordinating contacting both the minor 
participant and the parents/legal guardian to discuss the adverse reaction and to 
provide appropriate treatment referrals and follow-up resources.   
In recognition of the important of protecting children in research, our IRB follows 
the relevant federal guidelines (see below). With regard to the proposed trial, written 
parental consent is required for all participants under age 18 and written assent is 
required by the child. The IRB has determined that parents are to be made aware that 
they have the right to have complete access to their child’s assessment results if they are 
requested. The minor child is made aware of this parental right as well as part of the 
informed consent statement.  
§46.408 Requirements for permission by parents or guardians and for assent by 
children.  
(a) In addition to the determinations required under other applicable sections of this 
subpart, the IRB shall determine that adequate provisions are made for soliciting 
the assent of the children, when in the judgment of the IRB the children are 
capable of providing assent. In determining whether children are capable of 
assenting, the IRB shall take into account the ages, maturity, and psychological 
state of the children involved. This judgment may be made for all children to be 
involved in research under a particular protocol, or for each child, as the IRB 
deems appropriate. If the IRB determines that the capability of some or all of the 
children is so limited that they cannot reasonably be consulted or that the 
intervention or procedure involved in the research holds out a prospect of direct 
benefit that is important to the health or well-being of the children and is 
available only in the context of the research, the assent of the children is not a 
necessary condition for proceeding with the research. Even where the IRB 
determines that the subjects are capable of assenting, the IRB may still waive the 
assent requirement under circumstances in which consent may be waived in 
accord with §46.116 of Subpart A.  
(b) In addition to the determinations required under other applicable sections of this 
subpart, the IRB shall determine, in accordance with and to the extent that consent is 
required by §46.116 of Subpart A, that adequate provisions are made for soliciting the 

 
 
 
 
 
permission of each child's parents or guardian. Where parental permission is to be 
obtained, the IRB may find that the permission of one parent is sufficient for research to 
be conducted under §46.404 or §46.405. Where research is covered by §§46.406 and 
46.407 and permission is to be obtained from parents, both parents must give their 
permission unless one parent is deceased, unknown, incompetent, or not reasonably 
available, or when only one parent has legal responsibility for the care and custody of 
the child.  
(c) In addition to the provisions for waiver contained in §46.116 of subpart A, if the 
IRB determines that a research protocol is designed for conditions or for a subject 
population for which parental or guardian permission is not a reasonable requirement 
to protect the subjects (for example, neglected or abused children), it may waive the 
consent requirements in Subpart A of this part and paragraph (b) of this section, 
provided an appropriate mechanism for protecting the children who will participate as 
subjects in the research is substituted, and provided further that the waiver is not 
inconsistent with federal, state, or local law. The choice of an appropriate mechanism 
would depend upon the nature and purpose of the activities described in the protocol, 
the risk and anticipated benefit to the research subjects, and their age, maturity, status, 
and condition. 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
INSTITUTIONAL REVIEW BOARD APPROVAL LETTER  
 
May 8, 2018 
 
IRB—Determination for Proposal # 1516-105-GRE 
 
Dear Prof. Green, this letter is in response to your request for changes to the IRB 
approved project (#1516-105-GRE) Efficacy Trial of a Dissonance Based Eating Disorder 
Program at Cornell College.  The IRB has reviewed the modifications to your previously 
approved study and approved the renewal with the stated modifications.  You may begin 
your data collection using the methods approved in this proposal for one year from this 
date (May 8, 2018).  In addition, please have any students working on the project fill out 
the Confidentiality Assurance before they begin collecting data and send an electronic 
version to the IRB chair for his file on the project. 
 
If you wish to collect additional data after this date, and there is no change to the project 
as described in the original proposal you may receive expedited review.  If there are 
changes please, consult with the chair of the IRB before submitting a new proposal for 
an initial determination of the review category that is most appropriate.  If the change is 
deemed substantial, a separate proposal must be submitted for review. 
 
Please remember that you are obligated to promptly report any unanticipated problems 
or adverse effects of the research to the Institutional Review Board. The IRB must be 
notified if adverse events occur and what actions the investigator has taken to respond.  
 
Changes in the procedures of collecting data from human subjects must be re-reviewed 
and approved by the IRB.  
 
The IRB requires you to keep all documentation, particularly Informed Consent Forms, 
for three years following the termination of the project. 
 
Please contact wdragon@cornellcollege.edu if you have questions.