Feasibility and Acceptability of an App-Based Mindfulness Training for Individuals With Anorexia Nervosa and Bulimia Nervosa
Phase: NA
Conditions: Anorexia Nervosa, Bulimia Nervosa, Anorexia Nervosa, Atypical, Bulimia; Atypical
Sponsor: Yeshiva University

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PROTOCOL SUMMARY 
 
i. 
COVER SHEET 
Study title: Feasibility and Acceptability of an App-Based Mindfulness Training for Individuals 
with Eating Disorders 
Investigators:  
Margaret Sala, Yeshiva University 
Corey Roos, Yale University 
Hedy Kober, Yale University 
Cheri Levinson, University of Louisville 
 
ii. 
PURPOSE OF THE STUDY AND BACKGROUND 
BACKGROUND 
Eating disorders (EDs) include anorexia nervosa (AN) and bulimia nervosa (BN) are serious 
psychiatric disorders with high comorbidity and one of the highest mortality rates of any 
psychiatric disorder.1,2 EDs chronic and disabling; with most individuals never achieving full 
remission, even after intensive treatment. Relapse after acute treatment for EDs remain common, 
with more than half of individuals who present to acute care relapsing within one year after 
admission.3 Furthermore, readmission to acute care is expensive, costing an average of $20,817 
per person at discharge.4 Novel and efficacious relapse prevention interventions for EDs, 
especially those targeting core mechanisms that maintain EDs, are urgently needed.  
A large and diverse body of research5–7 suggests that emotion dysregulation (deficits in the 
ability to recognize and accept emotions, modulate emotions, and engage in goal-directed 
behavior while experiencing negative emotions) is a core mechanism in the development and 
maintenance of EDs. Importantly, emotion dysregulation does not improve with weight 
restoration,8 and emotion dysregulation predicts an increase in eating disorder psychopathology 
after intensive treatment.9 Furthermore, processes related to emotion dysregulation (e.g., 
comorbidity) are related to relapse in EDs.10 
A particularly effective approach for targeting emotion dysregulation is mindfulness 
treatment.11,12 Mindfulness treatment involves meditation training to foster awareness- and 
acceptance-based skills for recognizing, tolerating, and responding to negative emotions in 
adaptive ways. Mindfulness treatment is efficacious across many psychiatric illnesses.13 
Importantly, mindfulness treatment appears particularly efficacious in preventing relapse (e.g., 
for depression and substance use disorder 14 15) and alters neural systems associated with emotion 
regulation.12 Initial findings from our pilot data, and those of colleagues,16 suggest that 

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mindfulness treatment for EDs may be promising. Digital treatments (e.g., computerized, web-
delivered, app-based) are valuable as they are highly scalable, and address the shortage of 
specialists providing ED treatment. Importantly, digital mindfulness treatments are feasible and 
efficacious in other clinical populations.  
PURPOSE OF THE STUDY 
The objectives of this study are to provide pilot data to inform the development of an app-based 
mindfulness treatment for EDs, called Mindful Courage. We will recruit 50 individuals with 
EDs. Additionally, participants will receive eight weeks of Mindful Courage content, consisting 
of: (1) six 50-minute long multimedia web module with videos, audio-guided mindfulness 
practices, and interactive questions, as well as briefer modules with guided meditations; (2) 
weekly brief phone coaching calls by members of the research team to provide accountability as 
well as motivational and technical support; (3) 3-4 text reminders per week to engage in the app, 
(4) additional phone and text contact as needed for participants not engaging in the app, and (5) 
additional technical support as needed by phone or text. 
In this study, we will develop eight weeks of Mindful Courage content and assess its 
acceptability (usability, understandability, and helpfulness) and feasibility (completion of 
modules).  
HYPOTHESES TO BE TESTED 
I. 
At least 50% of participants will complete the web module and at least 50% of the 
mini modules  
II. 
Acceptability outcomes (usability, understandability, and helpfulness) for the 
modules will be rated each > 3 on 5-point Likert Scale.  
 
iii. 
CRITERIA FOR SUBJECT SELECTION 
TARGET POPULATION AND RECRUITMENT METHODS 
The target population will include adults ages 18 years and older who meet diagnostic DSM 5 
diagnostic criteria for an eating disorder (AN, BN). Participants will be recruited from the 
national community (online, through eating disorder treatment centers, flyers).  
N= 50 
Age: 18+ years 
Gender: male or female or non-binary gender identity 
Racial and Ethnic Origin: There are no enrollment restrictions based on race or ethnic origin.  
Attrition: We expect approximately 20% attrition.  
STUDY INCLUSION AND EXCLUSION METHODS 
 

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Inclusion: 
CRITERION  
METHOD OF ASCERTAINMENT 
(1) Age 18+ years inclusive 
Online pre-screening questionnaire/video-
based screening interview 
(2) Meet diagnostic DSM 5 diagnostic criteria 
for an ED (AN, BN) 
Online pre-screening questionnaire/video-
based screening interview 
(3) Can read and write in English 
Online pre-screening questionnaire/video-
based screening interview 
(4) Owns a smartphone 
Online pre-screening questionnaire/video-
based screening interview 
(5) Ability to do video-based Zoom calls 
Online pre-screening questionnaire/video-
based screening interview  
(6) Willing and able to participate in a six-
week long research study 
Online pre-screening questionnaire/video-
based screening interview 
(7) Have a private quiet space at home or 
headphones to complete modules 
Online pre-screening questionnaire/video-
based screening interview 
 
Exclusion: 
CRITERION  
METHOD OF ASCERTAINMENT 
(1) Recent alcohol or drug dependence  
Online pre-screening questionnaire/video-
based screening interview 
(2) Recent untreated psychotic or bipolar 
disorder 
Online pre-screening questionnaire/video-
based screening interview 
(3) Current suicidal intent 
Video-based screening interview only 
(4) Significant cognitive impairment that 
would impair the ability to use Mindful 
Courage effectively 
 
Online pre-screening questionnaire/video-
based screening interview 
(5) BMI <15 or medically unstable 
Online pre-screening questionnaire/video-
based screening interview 
 
iv. 
METHODS AND PROCEDURES 
STUDY PROCEDURES  
Screening Procedures:  
Online Pre-Screening Questionnaire  
All potential participants will be recruited via advertisement via clinician/treatment center 
referrals, clinical announcements, email (e.g., alumni network email, current email), social media 
(e.g., Pwitter, Facebook, Reddit, Google, Instagram), and the research sites lab website. 

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Participants who are interested will be directed to a website on Qualtrics to determine 
preliminary eligibility. Electronic informed consent for screening will be obtained at the 
beginning of the eligibility screen.  
The brief survey will include a brief overview of the project and survey questions including 
name (first name only) and contact information (phone and email), demographics (age, gender, 
race/ethnicity, height, weight), ED diagnosis (measured via the Eating Disorder Diagnostic 
Scale, or EDDS), other psychiatric disorders (measured via DSM-5 Self-Rated Level 1 Cross-
Cutting Symptom Measure), medical problems, access to devices with Internet connection, and 
access to a private, quiet space at home to complete the video-based study assessments and web 
modules. If participants are deemed ineligible based on the pre-screening questionnaire, their 
name and contact information will be deleted immediately.  
Zoom-Based Screening Interview: 
 
 
If potential participants appear eligible based on their responses to the online pre-screening 
questionnaire, they will be contacted by phone by a research coordinator to arrange an 
appointment for the Zoom-based screening interview, which will last approximately 15 minutes. 
At the beginning of the Zoom-based screening interview, the research coordinator will obtain 
electronic informed consent. The Zoom-based screening interview will involve interview 
questions on current BMI, current enrollment in ED treatment, medical problems, alcohol or 
drug dependence, current bipolar or psychiatric disorder, suicidal ideation/intent/plan, and recent 
ED diagnosis (measured via the SCID interview ED module). Of note, if a participant endorses 
ideation, suicidal intent or plan, a risk protocol will be in place such that the research assistant 
will contact Drs. Roos (Licensed Clinical Psychologist) or Sala (Licensed Clinical Psychologist), 
who will assess the level of immediate risk and possibility of hospitalization. 
If potential participants are eligible for the study based on the screening interview, they will be 
invited to enroll in the study, and will be invited to proceed to attend the Zoom-based baseline 
study assessment.  
Study Procedures After Enrollment: 
Zoom-Based Baseline Study Assessment 
The baseline assessments will include trait-level questionnaires, and will last approximately 20 
minutes. Trait-level questionnaires will include the Cognitive and Affective Mindfulness Scale-
Revised (CAMS-R) to measure trait mindfulness, the Difficulties in Emotion Regulation (DERS) 
to measure emotion regulation, the positive and negative affect schedule (PANAS) to measure 
positive and negative affect, the Eating Disorder Examination-Questionnaire (EDE-Q) to 
measure eating disorder symptoms, and Body Shape Questionnaire (BSQ) to measure body 
satisfaction, the Savoring Beliefs Inventory (SBI), the General Anxiety Disorder (GAD-7) scale 
to measure anxiety, the Patient Health Questionnaire (PHQ-9) to measure depression, and the 

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Clinical Impairment Assessment Questionnaire (CIA) to measure eating disorder impairment.  
(see Table 1) 
Daily EMA Questionnaires: Participants will complete 4 brief assessments per day with 4 
surveys randomly administered in four evenly spaced out 90-minute timeblocks occurring 
between 8am – 8:30pm a week before beginning the app, and a week after the last study visit. 
EMA will be conducted to assess acceptability and feasibility of EMA with this population, and 
to understand momentary processes and behaviors.  
Zoom-Based Treatment Initiation Visit  
Participants will complete another visit where they meet with a research assistant and start using 
the app. During the visit, they will complete the initial 40-minute digital module with videos, 
audio-guided mindfulness practices, and interactive questions. Specifically, the module will 
include a two minutes introduction video, a 4-5 minute audio-guided mindfulness practice, 
psychoeducation on mindfulness and how it relates to anorexia nervosa recovery, 
psychoeducation on the a Breathe, Observe, Accept, Take a Moment (BOAT) practice, an 8 
minute guided BOAT mindfulness practice, and reflection questions. While participants 
complete the module, the research coordinator will be available over Zoom to answer any 
questions. After completing the first module participants will engage in a one-on-one user testing 
interview session and will complete self-report measures too (see Table 2). The one-on-one user 
testing interview session will be audio-recorded (with the consent of participants). 
Ongoing engagement in the app: After completing the treatment initiation visit, participants will 
be asked to complete 31 additional digital modules (ranging from 10 to 30 min each) over an 8-
week period. They will receive 3-4 weekly text reminders encouraging them to engage in the 
app. Text reminders will include general reminders and encouraging statements to promote 
engagement in the app, as well as praise for continued engagement in the app. They will also 
complete weekly brief phone-coaching calls for motivational and technical support by graduate 
students from the MEAL lab at Yeshiva University, supervised by Drs. Sala and Roos. The 
phone check-ins will occur to provide supportive accountability 17 and will involve a 
safety/clinical check-in (i.e., brief validated suicidality measure), outpatient treatment 
engagement/enrollment, and a weight check-in. 
End of Study Visit: Upon completion of the eight weeks, participants will also complete an 
acceptability and feasibility questionnaire related to the entire program. Participants will 
complete follow-up questionnaires and user-testing (see Table 2). 
2-month follow-up: At two month follow-up, participants will complete the same baseline 
assessments that they completed at baseline (see Table 2). 

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Criteria for study withdrawal: Patients will be withdrawn prematurely from the study for safety 
reasons if they evidence any urgent medical or mental health issues (e.g., suicidal intent, need for 
hospitalization, need for more intensive care), as determined by the study investigators.  
Table 1. Schedule of Assessments 
 
Table 2. User Testing Measures. 
Construct 
Measurement Instrument 
Baseline 
Visit 
 
8-week 
user 
testing 
period 
End of 
Study 
 
Interview-Based Measures 
 
Interview-
Based 
Overall, what are your thoughts/impressions after 
completing the session? 
x  
 
 
 
X 
Pre-
screen 
Baseline 
Visit 
End of 
Study 
2-
month 
Follow-
Up 
Informed Consent 
X 
 
 
 
Demographics and Baseline Questionnaire 
X 
 
 
 
DSM-5 Self-Rated Level 1 Cross-Cutting 
Measure 
X 
 
 
 
Eating Disorder Diagnostic Scale (EDDS) 
X 
 
 
 
SCID Telephone Interview for AN 
X 
 
 
 
 
 
 
 
 
Trait-Level Questionnaires 
 
 
 
 
Cognitive and Affective Mindfulness Scale-
Revised (CAMS-R) 
 
X 
X 
X 
Difficulties in Emotion Regulation Short Form 
(DERS-SF) 
 
X 
X 
X 
Positive and Negative Affect Schedule 
(PANAS) 
 
X 
X 
X 
Eating Disorder Examination Questionnaire 
(EDE-Q)  
 
X 
X 
X 
Body Shape Questionnaire (BSQ) 
 
X 
X 
X 
 Savoring Beliefs Inventory 
 
X 
X 
X 
General Anxiety Disorder (GAD-7) 
 
X 
X 
X 
Patient Health Questionnaire (PHQ-9) 
 
X 
X 
X 
Clinical Impairment Assessment Questionnaire 
(CIA) 
 
X 
X 
X 
Acceptability Questionnaire  
 
X 
X 
X 

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Qualitative 
Feedback 
After First 
Module at 
Baseline Visit 
What did you learn? 
What parts of the session were most helpful? Least 
helpful? 
Did you find the session engaging? 
Was there anything about the program that felt like a 
“barrier” or “turn-off” that would make you hesitant 
about using the app? 
If you had a magic wand, what would you change 
about the app? 
Do you have any concerns about using this app? 
Interview-
Based 
Qualitative 
Feedback at 
Post-Testing 
Visit 
In the past two months… 
What have  been the most important things you 
learned from the app? 
What aspects of the app have been the most helpful? 
What aspects of the app have been the least helpful? 
What is your experience like as you use the app over 
an extended period of time? Does the program feel 
too fast or too slow? Is it too repetitive? Is there 
enough variety in the things you are learning? 
What would you have liked added to this app? 
Was there anything about the app that has felt like a 
“barrier” or “turn-off? 
Have you found the app engaging? Why or why not? 
What would have helped you to engage in the app 
more? 
If you had a magic wand, what would you change 
about the app? 
Do you have any concerns about using this app? 
 
 
 
x 
 
Self-Report Measures 
 
Construct 
Measurement Instrument 
Baseline 
Visit 
 
8-week 
user 
testing 
period 
End of 
Study 
Acceptability  
Treatment acceptability items based on the 
theoretical framework of acceptability (TFA) and the 
System Usability Scale (SUS)  
x  
 
x 
Willingness to 
engage in 
program 
I am willing to try out a smartphone app that teaches 
mindfulness skills for improving one’s recovery 
 
x 
 
 
 
Usability  
System Usability Scale (SUS)  
 
x 
 
 
X 
Understandabi
lity  
The material covered in the session I just completed 
was clear and understandable (after each module) 
Overall, the material covered in the program was 
clear and understandable (at post-program visit) 
x 
 
x 
 
X 

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Engage-
ability 
The session I just completed did a good job at 
keeping me engaged as I was going through it (after 
each module) 
Overall, the program did a good job at keeping me 
engaged as I was going through it (at post-program 
visit) 
x 
 
x 
 
X 
Appeal of 
visual content 
For the session I just completed, I thought the visual 
content of the program was appealing and high 
quality (after module 1) 
Overall, I thought the visual content of the program 
was appealing and high quality (at post-program 
visit) 
x 
 
 
X 
Helpfulness 
I found the material covered in the session to be 
helpful for me and my recovery (after each module) 
Overall, I found the program helpful for me and my 
recovery (at post-program visit) 
x 
 
x 
 
X 
Acquisition of 
skills 
I learned valuable skills after completing this session 
(after each module) 
Overall, I learned valuable skills after participating 
in the program 
(at post-program visit) 
x 
 
x 
 
X 
Confidence 
implementing 
skills 
I am confident in my ability to apply these skills in my 
daily life 
x 
 
x 
 
X 
Written 
Qualitative 
Feedback 
Overall, what are your thoughts/impressions after 
completing the session? 
What did you learn? 
What parts of the session were most helpful? Least 
helpful? 
 
 
x 
 
 
 
Sample Size Justification:  
Given the proof-of-concept and pilot nature of this study, we are limiting the sample size to 40 
enrolled individuals. 
OUTCOME MEASURES/INSTRUMENTS 
• DSM-5 Self-Rated Level 1 Cross-Cutting Symptoms Measure – A 23-item self-report 
questionnaires used to screen for psychiatric disorders. It will be administered at the online 
pre- screening assessment. 
• Eating Disorder Diagnostic Scale (EDDS) 18 – A 22-item self-report questionnaire used to 
identify eating disorders according to the DSM-5. In the current study, we will only include 
the items to identify AN. It will be administered at the online pre- screening assessment. 

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• Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) 19 A 12-item self-report 
questionnaire measuring trait mindfulness. It will be administered at the baseline, at the end 
of study, and at the two-month follow-up. 
• Difficulties in Emotion Regulation Short Form (DERS-SF) 20– A 16-item self-report 
questionnaire measuring emotion regulation difficulties. It will be administered at the 
baseline, at the end of study, and at the two-month follow-up. 
• Positive and Negative Affect Schedule (PANAS) 21. A 20-item self-report questionnaire 
measuring trait positive and negative affect. It will be administered at the baseline, at the end 
of study, and at the two-month follow-up. 
• Eating Disorder Examination Questionnaire (EDE-Q) 22 – A 28-item self-report 
questionnaire which is the self-report version of the Eating Disorder Examination 
Questionnaire, and measures core features of eating disorders. It will be administered at the 
baseline, at the end of study, and at the two-month follow-up. 
• Body Shape Questionnaire (BSQ) 23– A 34-item questionnaire that measures concerns about 
body shape. It will be administered at the baseline, at the end of study, and at the two-month 
follow-up.  
• Acceptability Questionnaire – Participants will be asked 13 Likert-scale questions and 11 
open-ended questions to measure perceived usability, understandability, and helpfulness. It 
will be administered at the baseline, at the end of study, and at the two-month follow-up. 
• Feasibility – Engagement with web modules will be tracked by the app program where the 
modules will be hosted 
• User-Testing – Participants will complete several user-testing measures at baseline, during 
weekly online assessments throughout the eight-weeks, and at the end of study visit. See 
Table 2 above.  
• General Anxiety Disorder-7 (GAD-7) - A 7-item brief screening measure that tests the 
severity of one’s anxiety symptoms. It will be administered at the baseline, at the end of 
study, and at the two-month follow-up.  
• Patient Health Questionairre-9 (PHQ-9) - A 9-item brief screening measure that tests the 
severity of one’s depressive symptoms. It will be administered at the baseline, at the end of 
study, and at the two-month follow-up. 
• Clinical Impairment Assessment Questionnaire (CIA)- A 16-item self-report measure that 
tests the severity of psychosocial impairment due to eating disorder features. It will be 
administered at the baseline, at the end of study, and at the two-month follow-up. 
 
 
DATA ANALYSIS and DATA MONITORING 
 
Descriptive statistics will be used to examine acceptability and feasibility. Open-ended 
acceptability questions will be analyzed via thematic content analysis, which focuses on 
grouping together similar patterns within the text and is often used to analyze open-ended survey 
questions 29.  

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For exploratory analyses, paired samples t-tests will be conducted to evaluate: changes use of 
mindfulness skills, positive affect, negative affect, emotion regulation, eating disorder 
symptoms, body satisfaction, anxiety, depression, and clinical impairment. 
 
DATA STORAGE and CONFIDENTIALITY 
• Most of the data entry is computerized (including telephone screening interview data); 
questionnaires will be administered via Qualtrics survey software  
• The app will be hosted on Qualtrics.  
• Audio-recordings will contain no identifiable information. 
CONFIDENTIALITY 
Participant information will be anonymized and stored on a secure, password-protected 
computer. Only members of the research team will have access to the anonymized database in 
the future, unless required by law or by an audit of the research ethics board / quality assurance. 
Only members of the research team will have access to hard copies of data collection forms or 
information regarding the identity of the participants. 
All data collected will be kept confidential and used for professional purposes only. Publications 
using this data will be conducted in a manner that fully protects participants’ anonymity.   
v. 
RISK/BENEFIT ASSESSMENT 
RISK CATEGORY 
Minimal risk: the probability and magnitude of harm or discomfort anticipated in the research are 
not greater than those ordinarily encountered in daily life or during the performance of routine 
physical or psychological examinations or tests. 
ANTICIPATED RISKS and PROTECTION AGAINST RISKS 
Participants will be asked to describe psychiatric symptoms, which may cause unpleasant 
feelings (similar to what might be expected from a doctor’s visit).  
Participants will receive app-based mindfulness training. However, mindfulness meditation is 
well-established, and is well-tolerated and has minimal risk. Furthermore, at the end of the 
completion of the web module at the baseline assessment, participants will be invited to share 
any negative reactions to the program. In addition, participants will be notified on the app at both 
login and logoff that any feelings or thoughts that concern them should be discussed immediately 
with their clinician, the research coordinator, Dr. Sala, and/or other co-investigators. 
Furthermore, the weekly calls will serve as an opportunity to monitor the participant’s clinical 
status, and ensure identification and withdrawal from the study of participants who show 

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significant psychological or symptomatic deterioration (and thus may require a higher level of 
care). 
The screening of patients using the inclusion and exclusion criteria will minimize the risk of 
enrolling participants inappropriate for the study. 
Participants will be withdrawn from the study if they show severe psychological or symptomatic 
deterioration, unacceptable levels of adverse events as determined by the PI or if clinically 
necessary for ethical or safety purposes. Participants dropped from the study for these reasons or 
because they wish to withdraw from the study will be referred to a higher level of care, such as 
an intensive outpatient or inpatient facility, when appropriate. There will be no penalty for 
withdrawing. For all participants, if an emergent medical or psychiatric issue emerges from any 
treatment or test given as part of the proposed study, these will be assessed by the investigators 
and appropriate referral or treatment will be delivered.  
 
POTENTIAL BENEFITS 
There are no known specific benefits for participants upon completion of study measures, other 
than finding the questions potentially interesting.  
vi. 
SUBJECT IDENTIFICATION, RECRUITMENT, and CONSENT/ASSSENT 
PARTICIPANT RECRUITMENT 
• Interested participants will complete a brief online pre-screening questionnaire  
• If potential participants are eligible based on their responses to the online pre-screening 
questionnaire, they will be contacted by the research coordinator to arrange an 
appointment for a Zoom-based screening interview.  
• If potential participants are eligible for the study based on the screening interview, they 
will be invited to enroll in the study and will be invited to proceed to attend the Zoom-
based baseline study assessment. 
• To ensure voluntariness of participation; compensation will be appropriate to the time 
required of participants and will not be so high as to be coercive; participants will be 
informed in writing and verbally during the informed consent process that they can end 
their participation at any time without penalty; and participants will be assured that 
services will not be affected by their decision to participate in the study. 
• To ensure participants’ privacy, telephone screening interviews will be held in a private 
location; participants will be assigned a numerical code and all identifying information 
will be stored in a database separate from the participant data (data will be linked to 
participants only via the numerical code); and all participant data will be stored on 
secure, password protected computers accessible only by members of the research team. 

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INFORMED CONSENT PROCESS and FORMS 
• See attached informed consent form. 
• Informed consent will be obtained by trained research assistants at the beginning of the 
Zoom-based screening interview.  
SUBJECT COMPREHENSION 
Participants will be provided with a written information sheet and will be given an opportunity to 
ask questions to the researcher. 
COMPENSATION 
Participants will be paid $10 for baseline visit, up to $38 for baseline EMA ($1 for each of 28 
survey, $10 for completing 75% or more of the phone surveys), $20 for treatment initiation visit, 
$20 for completing all 32 sessions, $30 for post-intervention visit, up to $38 for follow-up EMA 
($1 for each of 28 survey, $10 for completing 75% or more of the phone surveys), and $40 for 
follow-up visit 
 
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