Use of a Mental Health App in the Recovery of Adolescent Dancers From a Lower Extremity Injury: A Randomized Controlled Trial
Phase: NA
Conditions: Ankle Injury, Foot Injury, Lower Extremity Injury
Sponsor: University of California, San Diego

 
 
Office of IRB Administration (OIA) 
Biomedical Protocol for  
Interventional Research 
Version Date 12.08.21 
 
*= Required 
      Edited version of NIH-FDA Clinical Trial Template v1.07 
Dance – Randomized Control Trial 
Protocol Number: 812643 
Principal Investigator: Emily Cidambi, MD 
Internally Funded 
Version Number:  v.1.0 
23 June 2025 
 
Summary of Changes from Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
All 
 
 
 
 
 

 
 
  
 
ii 
Table of Contents 
1 
PROTOCOL SUMMARY ............................................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................................ 1 
1.2 
Schema ................................................................................................................................................. 2 
1.3 
Schedule of Activities (SoA) ............................................................................................................... 3 
2 
INTRODUCTION ............................................................................................................................................ 3 
2.1 
Study Rationale .................................................................................................................................... 3 
2.2 
Background........................................................................................................................................... 4 
2.3 
Risk/Benefit Assessment .................................................................................................................... 4 
2.3.1 
Known Potential Risks ..................................................................................................... 4 
2.3.2 
Known Potential Benefits ................................................................................................ 4 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 5 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 5 
4 
STUDY DESIGN ............................................................................................................................................. 5 
4.1 
Overall Design ...................................................................................................................................... 6 
4.2 
Scientific Rationale for Study Design................................................................................................ 6 
4.3 
Justification for Dose ........................................................................................................................... 6 
4.4 
End of Study Definition ....................................................................................................................... 6 
5 
STUDY POPULATION .................................................................................................................................. 7 
5.1 
Inclusion Criteria .................................................................................................................................. 7 
5.2 
Exclusion Criteria ................................................................................................................................. 7 
5.3 
Lifestyle Considerations ...................................................................................................................... 7 
5.4 
Screen Failures .................................................................................................................................... 7 
6 
STUDY INTERVENTION .............................................................................................................................. 8 
6.1 
Study Intervention(s) Administration ................................................................................................. 8 
6.1.1 
Study Intervention Description ....................................................................................... 8 
6.1.2 
Dosing and Administration .............................................................................................. 8 
6.2 
Preparation/Handling/Storage/Accountability .................................................................................. 8 
6.2.1 
Acquisition and accountability ........................................................................................ 8 
6.2.2 
Formulation, Appearance, Packaging, and Labeling .................................................. 8 
6.2.3 
Product Storage and Stability ......................................................................................... 9 
6.2.4 
Preparation ........................................................................................................................ 9 
6.3 
Measures to Minimize Bias: Randomization and Blinding ............................................................. 9 
6.4 
Study Intervention Compliance .......................................................................................................... 9 
6.5 
Concomitant Therapy .......................................................................................................................... 9 
6.5.1 
Rescue Medicine .............................................................................................................. 9 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ...................................................................................................................... 9 
7.1 
Discontinuation of Study Intervention ............................................................................................... 9 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 10 
7.3 
Lost to Follow-Up ............................................................................................................................... 10 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 11 
8.1 
Efficacy Assessments ....................................................................................................................... 11 
8.2 
Safety and Other Assessments ....................................................................................................... 12 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 12 
8.3.1 
Definition of Adverse Events (AE) ............................................................................... 12 
8.3.2 
Definition of Serious Adverse Events (SAE) .............................................................. 12 

 
 
  
 
iii 
8.3.3 
Classification of an Adverse Event .............................................................................. 12 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 13 
8.3.5 
Adverse Event Reporting .............................................................................................. 13 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 13 
8.3.7 
Reporting Events to Participants ................................................................................. 14 
8.3.8 
Events of Special Interest ............................................................................................. 14 
8.3.9 
Reporting of Pregnancy ................................................................................................ 14 
8.4 
Unanticipated Problems .................................................................................................................... 14 
8.4.1 
Definition of Unanticipated Problems (UP) ................................................................. 14 
8.4.2 
Unanticipated Problem Reporting ................................................................................ 14 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 15 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 15 
9.1 
Statistical Hypotheses ....................................................................................................................... 15 
9.2 
Sample Size Determination .............................................................................................................. 15 
9.3 
Populations for Analyses .................................................................................................................. 17 
9.4 
Statistical Analyses............................................................................................................................ 17 
9.4.1 
General Approach .......................................................................................................... 17 
9.4.2 
Analysis of the Primary Efficacy Endpoint(s) ............................................................. 17 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 17 
9.4.4 
Safety Analyses .............................................................................................................. 18 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 18 
9.4.6 
Planned Interim Analyses ............................................................................................. 18 
9.4.7 
Sub-Group Analyses ..................................................................................................... 18 
9.4.8 
Tabulation of Individual participant Data .................................................................... 18 
9.4.9 
Exploratory Analyses ..................................................................................................... 18 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 18 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 18 
10.1.1 
Study Discontinuation and Closure ............................................................................. 18 
10.1.2 
Confidentiality and Privacy ........................................................................................... 19 
10.1.3 
Future Use of Stored Specimens and Data ............................................................... 20 
10.1.4 
Key Roles and Study Governance .............................................................................. 20 
10.1.5 
Safety Oversight ............................................................................................................. 20 
10.1.6 
Clinical Monitoring .......................................................................................................... 21 
10.1.7 
Data Handling and Record Keeping ............................................................................ 21 
10.1.8 
Protocol Deviations ........................................................................................................ 22 
10.2 
Additional Considerations ................................................................................................................. 22 
10.3 
Abbreviations ...................................................................................................................................... 23 
10.4 
Protocol Amendment History ........................................................................................................... 25 
11 
REFERENCES ............................................................................................................................................. 26 
 

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1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Dance – Randomized Controlled Trial 
Study Description: 
This project aims to enhance self-compassion in adolescent dancers 
recovering from a foot and ankle injury by incorporating the use of a 
mental health intervention app using gamified design during their 
recovery.  
 
 
Objectives: 
Primary Objective: To assess rates of return to dance without limitations 
after start of non-operative treatment in dancers recovering from foot and 
ankle injuries 
Secondary Objectives: 1) To assess self-compassion in the recovering 
dancer during and after the nonoperative treatment of their foot and 
ankle injury 2) To assess musculoskeletal function during and after the 
recovery process 
Endpoints: 
Primary Endpoint: Return to dance after treatment of injury 
Secondary Endpoints: 1) Self Compassion (SCS) scores collected at 3, 6, 12, 
18, and 24 months 2) Foot and Ankle Ability Measure (FAAM) and Patient-
Reported Outcome Measurement Information System (PROMIS) 
Study Population: 
13-18 year old dancers  
Phase: 
Not applicable – not a drug trial 
Description of 
Sites/Facilities Enrolling 
Participants: 
  
 
Rady Children’s Hospital, San Diego  
Description of Study 
Intervention: 
Qualifying participants will all be placed in a physical therapy recovery 
program for their injury and randomized into treatment or control group 
for implementation of the gamification mental health app to use during 
their recovery path.  Outcomes scores for pain, physical function and 
emotional distress will be collected at the time of enrollment, 3 months, 6 
months, 12 months, 18 months and 24 months after the start of 
treatment. 
Study Duration:  
4 years 
Participant Duration: 
2 years 
 
 

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1.2 
SCHEMA 
 
 
 
 

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1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
 
Procedures 
E
n
r
o
8 
w
e
3 
m
o
6 
m
o
1 
y
e
1
8 
m
2 
y
e
a
Informed 
consent 
X 
 
 
 
 
 
 
Demographic
s 
X 
 
 
 
 
 
 
Medical 
History 
X 
 
 
 
 
 
 
Randomizati
on 
X 
 
 
 
 
 
 
Physical 
Exam  
X 
X 
X 
X 
X 
X 
X 
Outcomes 
Scores 
X 
 
X 
X 
X 
X 
X 
Standard PT 
activities 
X 
X 
X* 
 
 
 
 
App 
intervention 
(treatment 
group only) 
X 
X 
X 
 
 
 
 
*= Additional PT up to 12 weeks/3months may or may not be ordered by the treating physician for both the 
treatment group and observation group depending on the recovery of the subject’s foot and/or ankle injury 
 
2 
 
INTRODUCTION 
 
 
2.1 
STUDY RATIONALE  
A dance injury can create psychological distress (11). We aim to explore the effect on return to dance, 
recurrence of injury and mental health during and after treatment of dance injury via the use of a 
mental health intervention. Low self-compassion specifically has been linked to psychological distress in 
athletes which can impair the recovery process during injury (21). This is an unexplored area in the 
dance population, which we aim to examine through this study. The gamified mental health app 
SuperBetter has been shown to have a positive and comparable effect on anxiety and depression scores 
when compared with group Cognitive Behavioral Therapy (CBT) interventions (5). We do not currently 
have the resources to administer group CBT interventions and therefore are using the gamified app as a 
proxy. It has also been shown to be an effective intervention with improved outcomes in treatment of 
adolescent concussion patients (1). Its use has not been explored in adolescent athletes. Thus, this 
project aims to enhance self-compassion in adolescent dancers recovering from a non-operative foot 

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and ankle injury by using a gamification mental health app to augment the physical therapy and home 
exercise program during the recovery course. 
 
 
2.2 
BACKGROUND  
 
There is a noticeable disparity in the amount of research focusing on mental health and injury 
prevention in athletics versus dance, particularly when it comes to available interventions for use during 
the recovery process. In athletics, numerous studies examine mental health issues like depression and 
anxiety, with well-developed injury prevention strategies. These studies often feature well-designed, 
prospective research. In contrast, dance-related studies on mental health are fewer, with a lack of 
applied interventions, and a predominant focus on young adult dancers. Injury prevention in dance is 
less explored, with some studies highlighting risk factors but calling for more research on mental and 
preventive strategies. Overall, athletics outside of dance has a more extensive body of research, while 
dance still needs more comprehensive studies, particularly in the application of mental health 
interventions. The SuperBetter app was created by Jane McGonigal to address psychological symptoms 
that affected her during recovery from a serious concussion (23). A study in 2021 looked at the efficacy 
of app usage for mental health and demonstrated efficacy in improving anxiety and depression for the 
SuperBetter app (22). We plan to use it as a proxy to traditional CBT and explore the association 
between direct mental health intervention and the indirect effect on self-compassion during injury 
recovery in this study.  
 
2.3 
RISK/BENEFIT ASSESSMENT   
2.3.1 KNOWN POTENTIAL RISKS  
 
Use of the gamification app requires use of an electronic device which could increase screen time use in 
developing adolescents.  The use of the app would be limited to no more than 15 minutes daily and 
would be discussed with guardians prior to implementation.  Patients who do not have access to a smart 
phone or tablet may not be able to participate in the study. Patients may experience boredom or fatigue 
with the app and/or study questionnaires. Though unlikely, subjects may experience emotional 
discomfort or distress from the content of the app and/or study questionnaires. While the 
questionnaires do not ask about specific, potentially traumatic experiences, broadly being asked about 
feelings such as depression and compassion for oneself may feel uncomfortable for some. To avoid this 
risk, we will verbalize during enrollment that subjects may skip any questions they wish should any make 
them feel uncomfortable. The only additional risk to participants involved in the trial is potential loss of 
confidentiality. All measures to ensure patient confidentiality will be employed, including password 
protection of research files and devices, locked access to the research cabinet, coding of data with 
separate storage of the key and coded data, and restricted access limited to those who have a need to 
know for performance of their responsibilities.   
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
Use of the SuperBetter app offers mental health benefits using a gamification design which has been 
shown to be an effective mental health intervention and also allows asynchronous intervention, 
preventing missed school and extra medical visits that would be required for virtual or in-person mental 

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health interventions (5). As such, use of the app may serve as a tool within the ongoing shortage of 
mental health resources. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
 
Many older children/adolescents are using technology (computers, smart phones, tablets) for school 
and personal reasons, therefore the investigators do not feel use of this app would add significantly to 
the overall screen time for each individual patient, therefore the theoretical risks to the patient are low 
and the potential benefit high. 
 
Numerous studies have investigated mental health in athletics, yet mental health in dancers is 
understudied. We believe through utilizing minimal-risk questionnaires about mental health and 
physical function, as well as implementing this mental health intervention, may help shed light on an 
important knowledge gap for this population and their recovery from injuries, including return to dance.  
 
3 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
To assess rates of return to 
dance without limitations after 
start of non-operative treatment 
in dancers recovering from foot 
and ankle injuries 
Return to dance after 
treatment of injury 
Investigators want to 
see the immediate 
effect of the mental 
health app on short-
term recovery and 
return to dance, but 
also the longer lasting 
effects (if present) after 
injury recovery. 
Secondary 
 
 
To assess self-compassion in the 
recovering dancer during and 
after the nonoperative 
treatment of their foot and 
ankle injury 
To assess musculoskeletal 
function during and after the 
recovery process 
 
FAAM, PROMIS, and Self 
Compassion scores collected at 
3, 6, 12, 18, and 24 months 
Investigators want to 
see the immediate 
effect of the mental 
health app on short-
term recovery and 
return to dance, but 
also the longer lasting 
effects (if present) after 
injury recovery. 
Tertiary/Exploratory  
 
 
None 
 
 
 
 
4 
STUDY DESIGN  

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4.1 
OVERALL DESIGN 
 
Null hypothesis (H0): There will be no difference in self compassion scores to return to unrestricted 
dance at 3 months between the mental health app group and control group.  
 
Alternative hypothesis (H1): Self compassion and return to unrestricted dance is expected to be 
improved in the mental health app treatment group compared to control group. 
 
Patient Enrollment and Randomization: Patients who meet inclusion criteria at this single site will be 
offered enrollment in this RCT. Enrolled patients will be randomized into one of 2 groups. It will be true 
randomization without patient preference but will not be blinded. There are no sub-studies or 
stratifications to be performed within this group.  
 
Trial Interventions: Following randomization, the control group will undergo physical therapy treatment 
only while the experimental group will also participate in mental health exercises through the app, 
SuperBetter, for approximately 10 minutes 5 days per week for 12 weeks. All participants will have a 
minimum order of 8 weeks of physical therapy. At 8 weeks, depending on the individual patient and 
injury, the doctor may order an additional 4 weeks of PT, for a total of 12. This will be according to the 
physician’s standard of care for their practice and clinical expertise. The number of PT visits ultimately 
attended by each subject will be recorded. If those in the treatment arm are not prescribed 4 additional 
weeks of PT at the 8-week time period, they will still use the app for 4 additional weeks for a total of 12 
weeks of app usage.  
 
Data collection: All patients in both groups will return to clinic at 3 months, 6 months, 12 months, 18 
months, and 24 months. The 24-month visit represents completion of participation in the study. 
Throughout the trial, patients will be monitored for safe usage and engagement with the mobile app, to 
determine if they need to stop or limit the intervention.  
 
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
The current study utilizes 2 groups, where one is treated with the intervention of the mental health app 
in addition to PT, and the other group only participates in SOC PT alone, as we are trying to see whether 
adding the mental health app component plays a role in improving rates of return to dance and 
recovery.  
 
4.3 
JUSTIFICATION FOR DOSE 
 
Dosage of the SuperBetter mental health app will be 10 minutes, 5 days per week, for 12 weeks. The 10 
minute length of the exercise is predetermined by the app. 5 days per week is the recommended 
frequency of app usage, which came from a 2021 study which showed 10 minutes per day, 5 days per 
week was effective to offer support to individuals with mild-to-moderate depression and anxiety 
symptoms, and be a possible, alternative solution for those who cannot attend in-person therapeutic 
sessions (22).  
 
4.4 
END OF STUDY DEFINITION 

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A participant is considered to have completed the study if he or she has completed all phases of the 
study including the last visit or the last scheduled procedure shown in the Schedule of Activities (SoA), 
Section 1.3. 
 
The end of the study is defined as completion of the last visit or procedure shown in the SoA in the trial 
globally. 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Provision of informed consent (adult participant), or consent of parent/legal guardian in 
conjunction with adolescent assent (minor participant) 
2. 13 to 18 years of age 
3. Endorses dance as their primary sport, or participates 3 days per week or greater in dance prior 
to injury  
4. Stated willingness to comply with all study procedures including the intervention regimen and 
availability for the duration of the study  
5. Access to a device with which the SuperBetter app can be downloaded and used  
 
5.2 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Dance is not a primary sport or less than 3 days per week spent dancing prior to injury (skater, 
gymnast, other sport) 
2. Requiring surgery or prior surgery for the injury being treated  
3. Injury outside of the leg below the knee  
4. Known eating disorder or bone density issue (documented abnormal Z score and/or eating 
disorder diagnosis upon review of the medical chart) 
5. Verbalized plans to not return to dance after recovery from the injury  
 
 
5.3 
LIFESTYLE CONSIDERATIONS 
 
Not applicable.  
 
5.4 
SCREEN FAILURES 
 
Potential subjects will not be consented for this study unless they meet all of the inclusion criteria. 
Subjects that are enrolled in the study but are later determined to meet exclusion criteria will be 
considered screen failures and will be removed from the study and the reason for their removal will be 
documented.   
 
 

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6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION DESCRIPTION 
 
The study intervention will be mental health exercises via the SuperBetter app for dancers participating 
in PT rehab for foot or ankle injuries. The control will be PT rehab only, without implementation of the 
SuperBetter app.  
 
Subjects who enroll and are randomized into the treatment arm will be assisted in clinic to log into the 
app SuperBetter. They will be added to the group run by the “host”/study staff. The SuperBetter app 
offers a daily exercise on a schedule that will be managed by the “host” or study staff. Subject will 
complete 1 full activity per day. This activity will not exceed 15 minutes in total including app boot-up, 
but the full activity itself will not exceed 10. These activities ask participants to practice different 
exercises that might be found in Cognitive Behavioral Therapy, such as mindfulness. They are framed 
like a game for engagement, where the subject can “get a power up” when they take 30 seconds to 
breathe deeply and think of 3 loved ones, as an example. 1 full daily activity is constituted by 4 to 6 very 
brief activities similar to the previously described. 
 
Both groups will undergo physical exams at their normally scheduled orthopedic appointments at 
baseline, 8 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months where presence/absence 
of reinjury, return to dance, adherence to PT and/or the SuperBetter app, type(s) of dance, and hours of 
dance per week will be assessed. Both groups will be asked to complete the PROMIS, SCS, and FAAM at 
baseline, 3-, 6-, 12-, 18-, and 24 months.  
6.1.2 DOSING AND ADMINISTRATION 
 
All subjects will receive an initial PT order for 8 weeks. The treating physician may order an additional 4 
weeks of PT depending on the individual patient and injury. Total number of attended PT appointments 
for each patient will be recorded. Subjects randomized into the treatment group will undergo mental 
health exercises 5 days per week, approximately 10 minutes per day, for 12 weeks alongside their 8 or 
12 weeks of normally scheduled PT appointments. They will practice these exercises on a mobile device 
via the SuperBetter app. Those randomized into the control group will also participate in a physical 
therapy treatment program for 8 weeks or 12 weeks with no utilization of the SuperBetter app.  
 
6.2 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
Leave blank. Text should be included under the relevant subheadings below. 
 
6.2.1 ACQUISITION AND ACCOUNTABILITY 
 
Not applicable, as our project utilizes a mobile app rather than a physical product or device.  It will be 
readily accessible by downloading from the app store.  
 
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
 

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Not applicable.  
 
6.2.3 PRODUCT STORAGE AND STABILITY 
 
Not applicable.  
 
6.2.4 PREPARATION 
 
Study staff will assist in downloading and accessing the SuperBetter app for those patients in the 
treatment arm. The application goes through an introductory training with the participant prior to 
completing their first exercise.  This introductory training will consist of instructions for using the app 
and will be done at the participant’s home.  
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
Patients who meet inclusion criteria at this single site will be offered enrollment in this RCT. Enrolled 
patients will be randomized into one of 2 groups. It will be true randomization without patient 
preference but will not be blinded. There are no sub-studies or stratifications to be performed within 
this group. 
 
6.4 
STUDY INTERVENTION COMPLIANCE 
 
Email reminders will be sent through the app by the study team to remind the subject to complete their 
exercise(s). Subjects in the study group will be asked if they have been participating in the app usage 
and/or PT exercises prescribed at their clinic visits. The study staff will serve as a “host,” and new 
treatment arm participants will be added to a group that is managed by the “host”/study staff. The host 
account has the capability to see whether a participant has completed daily exercise(s) or not. 
Noncompliance will be determined as a subject not registering in the app, or not using the app at all. If a 
subject is using the app less than prescribed, they will still be included but we will make note of their 
number of activities completed and will verbally inquire about their app usage at their following clinic 
visit.    
 
6.5 
CONCOMITANT THERAPY 
 
Not applicable.  
 
6.5.1 RESCUE MEDICINE 
 
Not applicable.  
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
 

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Discontinuation from the SuperBetter exercises does not mean discontinuation from the study, and 
remaining study procedures should be completed as indicated by the study protocol.  If a clinically 
significant finding is identified (including, but not limited to changes from baseline) after enrollment, the 
investigator or qualified designee will determine if any change in participant management is needed. 
Any new clinically relevant finding will be reported as an adverse event (AE). 
 
The data to be collected at the time of study intervention discontinuation will include the following: 
• 
Clinical exam 
• 
Outcomes (FAAM, PROMIS, SCS)  
• 
Type of dance 
• 
Hours of dance per week 
• 
Number of PT sessions completed  
• 
Duration of time in PT from start to finish  
• 
Type of injury 
• 
Amount of PT done prior to enrollment 
• 
Repeat and new injuries  
• 
Full return to dance (only if discontinuing past 12 weeks) 
• 
Persistent pain with dance (only if discontinuing past 12 weeks) 
• 
Additional treatment 
 
 
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a participant from the study for the following reasons: 
 
• 
Failure to follow up 
• 
Change of mind regarding randomization 
• 
Significant study intervention non-compliance, defined as not registering in or using the app 
once 
• 
If any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
participant 
• 
Disease progression which requires discontinuation of the study intervention 
• 
If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
The reason for participant discontinuation or withdrawal from the study will be recorded on the 
enrollment log. Research participants who sign the informed consent form and are randomized or are 
not randomized will be replaced.  
 
7.3 
LOST TO FOLLOW-UP 
 

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A participant will be considered lost to follow-up if he or she fails to return for the 24 month visit and is 
unable to be contacted by the study site staff.  
 
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 
• 
The site will attempt to contact the participant and reschedule the missed visit within 10 days 
and counsel the participant on the importance of maintaining the assigned visit schedule and 
ascertain if the participant wishes to and/or should continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address or local equivalent methods). 
These contact attempts should be documented in the participant’s medical record or study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
EFFICACY ASSESSMENTS  
 
• 
Physical examination (all visits) 
o Presence/absence of reinjury 
o Return to Dance status   
o Adherence to PT and/or SuperBetter app exercises  
o Type of dance  
o Hours of dance per week  
• 
Administration of questionnaires (all visits) 
o PROMIS + PROMIS mental health  
o SCS 
o FAAM  
 
The Self Compassion Scale (SCS) is a validated measure of self-compassion in individuals, which is a 
concept or trait associated with psychological wellbeing including, potentially, lower depression and 
anxiety (7). It asks patients questions about their self-kindness or, conversely, self-judgment during 
everyday times of difficulty. We will be using the short form version which has been shown to be an 
economical alternative to the long Self Compassion Scale, saving time for subjects by reducing the 
length of the questionnaire by half, while still being reliable (16). This survey will take approximately 5 
minutes to complete.  
 
The Foot and Ankle Ability Measure (FAAM) is a validated measure of physical function for a broad 
range of musculoskeletal conditions of the lower leg, foot, and ankle (17). It asks patients questions 
about their current level of difficulty performing different everyday tasks, activities, and sports motions. 
This survey will take no more than 10 minutes to complete.  
 
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an effective measure 
seen to be useful in evaluating pain interference in diverse settings, and mental health among 
musculoskeletal patients (19,20). It asks questions regarding patients’ pain interference with activity and 
daily living, mobility, and current depression and anxiety symptoms. This survey will take no more than 
10 minutes to complete.  

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8.2 
SAFETY AND OTHER ASSESSMENTS 
 
 
Subjects will be assigned exercises within the app by the “host,” which will be managed by the study 
staff. One activity will be released per day. They will only be sent 5 per week. To mitigate any potential 
fatigue, discomfort, or distress from the app usage, or questionnaires, we will inform participants that 
they may leave any survey question blank that they do not wish to answer, and to communicate with us 
should they feel they need to stop using the app at any time.    
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
 
 The FDA definition of an Adverse event is any untoward medical occurrence associated with the use of 
an intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)).  
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
 
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital 
anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the participant and may require medical or surgical intervention to prevent one of 
the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do 
not result in inpatient hospitalization, or the development of drug dependency or drug abuse. 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
 
8.3.3.1 SEVERITY OF EVENT 
 
The following guidelines will be used to describe severity of AEs: 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”.] 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
 
• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 

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intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 
8.3.3.3 EXPECTEDNESS  
 
There are no expected adverse events.  
 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant presenting for medical care, or 
upon review by a study monitor. 
 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate case report form (CRF). Information to be collected includes event description, time of 
onset, clinician’s assessment of severity, relationship to study product (assessed only by those with the 
training and authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs 
occurring while on study must be documented appropriately regardless of relationship. All AEs will be 
followed to adequate resolution. 
 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any 
time during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
The Principal Investigator will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation. Events will be followed for outcome information until resolution or stabilization. 
 
8.3.5 ADVERSE EVENT REPORTING  
 
Since this study is applying mental health exercises, there are not potential adverse events as there may 
be in an experimental drug study. Any complications that arise, such as emotional distress from the app 
or questionnaires, will be documented in the study database and in the subject’s medical record and will 
be treated according to standard of care. There may be a remote possibility that an unforeseen adverse 
event could occur which would be reported to the IRB.  
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
 

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As this is a minimal-risk study in healthy children, and there is no study drug or device, SAEs are not 
expected. However, should an SAE occur, it would be followed until satisfactory resolution or until the 
site investigator deems the event to be chronic or the participant is stable. It will be reported to the IRB 
as soon as possible, but in no event later than 10 working days after the investigator first learns of the 
effect. 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
Families will be notified of any SAEs, including, but not limited to, emotional distress or discomfort as a 
result of the questionnaires and/or app and that if that occurs they should reach out to their clinical care 
team.  
 
8.3.8 EVENTS OF SPECIAL INTEREST  
 
Not applicable 
 
8.3.9 REPORTING OF PREGNANCY  
 
Not applicable 
 
 
8.4 
UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
participants or others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
8.4.2  UNANTICIPATED PROBLEM REPORTING  
 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the Data Coordinating Center (DCC)/lead principal investigator (PI). The UP report will 
include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• 
A detailed description of the event, incident, experience, or outcome;  

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• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP;  
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB within 48 hours of the 
investigator becoming aware of the event.  
• 
Any other UP will be reported to the IRB within 10 days of the investigator becoming aware of 
the problem.  
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and the Office for 
Human Research Protections (OHRP) within 10 days of the IRB’s receipt of the report of the 
problem from the investigator. 
 
 
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
Participants in this study will be informed of UPs by one of the physicians working on the study. 
9 
STATISTICAL CONSIDERATIONS  
 
9.1 
STATISTICAL HYPOTHESES 
 
• 
Primary Efficacy Endpoint(s):  
o Null Hypothesis (H₀): There will be no difference in self compassion scores to return to 
unrestricted dance at 3 months between the mental health app group and control 
group. 
o Alternative Hypothesis (H₁): Self compassion and return to unrestricted dance is 
expected to be improved in the mental health app treatment group compared to 
control group. 
o Type of Comparison: Superiority 
o Time Point: 12 months 
o Analysis Method: Logistic regression or Fisher’s exact test depending on data 
distribution. 
• 
Secondary Efficacy Endpoint(s): 
o Change in Self-Compassion Scale scores over time (repeated measures ANOVA or 
nonparametric equivalent) in experimental group compared to control group 
o Association of self-compassion with FAAM and PROMIS scores (correlation/regression) 
o Time to initial return to dance (Kaplan-Meier with log-rank test or Cox regression) 
o Reinjury incidence (descriptive comparison by self-compassion group) 
 
9.2 
SAMPLE SIZE DETERMINATION 
 

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Planned Sample Size and Feasibility  
The total number of participants planned for enrollment is 50, which includes a buffer to account for 
expected attrition.  
 
Outcome Measure Used for Sample Size Calculations  
Return to unrestricted dance participation at 12 months, a binary (yes/no) outcome. 
 
Test Statistic 
A Fisher’s exact test will be used to compare the proportion of participants who return to unrestricted 
dance between experimental and control groups (dichotomized by a median split or similar method). 
 
Statistical Hypotheses 
Null Hypothesis (H₀): There will be no difference in self compassion scores to return to unrestricted 
dance at 3 months between the mental health app group and control group. 
Alternative Hypothesis (H₁): Self compassion and return to unrestricted dance is expected to be 
improved in the mental health app treatment group compared to control group. 
 
Assumptions for Sample Size Calculation 
• 
Alpha (Type I error rate): 0.05 (two-tailed) 
• 
Power (1 - Beta): 0.80 (80%) 
• 
Effect Size: Odds Ratio (OR) = 5.0 
• 
Expected Proportions: 
 
Control group: 60% expected to return to dance 
 
Experimental: 95% expected to return to dance 
• 
These assumptions are informed by preliminary data and theoretical rationale suggesting that 
higher self-compassion is strongly associated with better emotional regulation, adherence to 
rehabilitation, and psychological resilience—all of which plausibly contribute to better recovery 
outcomes in dancers (Zarzycki et al., Gennarelli et al., Christino et al).  
 
Statistical Method and Software 
• 
Sample size was calculated using: 
 
Validated using G*Power 3.1 (Faul et al. 2007) 
• 
Using these assumptions, the required sample size is: 
 
38 participants total (19 per group) to detect an OR of 5.0 with 80% power at α = 0.05. 
• 
Missing data on the primary endpoint (i.e., return to dance status at 12 months) will be 
minimized through close follow-up and contact strategies. If missing data occur, analyses will 
proceed using available-case analysis and sensitivity analyses will be conducted as described in 
Sections 9.4.2 and 9.4.3. 
• 
Interim Analyses 
 
No formal interim analyses are planned due to the small sample size and short duration 
of primary outcome measurement. Therefore, no statistical correction (e.g., O’Brien-
Fleming or Pocock boundaries) is required. 
• 
Sensitivity and Robustness Checks 
 
Given the small sample size and reliance on a relatively large assumed effect size (OR = 
5.0), the robustness of the sample size was tested under varying assumptions: 
Control Group Return 
Rate (p₁) 
Experimental Group Return 
Rate (p₂) 
Effect Size 
(OR) 
Required n per 
group 
Total 
Sample Size 

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60% 
95% 
12.7 
19 
38 
60% 
90% 
6.0 
26 
52 
60% 
85% 
4.25 
33 
66 
 
• 
This supports the feasibility of the current design to detect large effects, while highlighting that 
smaller effects will not be statistically detectable in this study. 
• 
 
 
9.3 
POPULATIONS FOR ANALYSES 
 
• 
Intent-to-Treat (ITT): All participants who initiate treatment 
• 
Per-Protocol (PP): Participants with full follow-up data and ≥80% adherence to recovery protocol 
• 
Safety Population: All participants (reporting adverse events and reinjury) 
• 
Exploratory Subgroups: Participants may be stratified into tertiles or above/below median self-
compassion for exploratory comparisons 
 
9.4 
STATISTICAL ANALYSES 
 
 
9.4.1 GENERAL APPROACH 
 
• 
Descriptive statistics will be presented. Continuous data will be evaluated with the Shapiro-Wilk 
test of normality, data that is considered normal with that test will be evaluated with Levene’s 
test of homogeneity of variances. Data that are found to be parameteric with both tests, will be 
treated as normally distributed and evaluated with analysis of variance (ANOVA). Continuous 
data that fails either test of normality listed above will be evaluated with the Mann-Whitney U. 
Continuous data will be presented as means ± standard deviation, with the range. Non-
parameteric continuous data will include the median as well.  
• 
Categorical data will be evaluated with Pearson’s Chi-square, or Fisher’s exact test. Odds ratios 
will be calculated for categorical data that is found to be significantly different among the two 
groups.  
• 
Statistical significance will be defined as p<0.05. 
 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
 
• 
The primary outcome of interest is return to dance (binary). 
• 
The proportion of subjects in each group that returned to dance will be evaluated with 
Pearsons’s chi-square or Fisher’s exact test depending on the distribution of outcomes. If there 
is fewer than 10 subjects in any group (control that returned to dance, control that did not 
return to dance, experimental group that returned to dance, experimental group that did not 
return to dance), Fisher’s exact test will be used.  
• 
Odds ratios will be calculated and presented for significant findings.  
• 
Subjects will be excluded if they are missing data related to our primary outcome of interest.   
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 

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• 
Our secondary outcomes of interest are self-compassion scale (continuous), FAAM (continuous), 
PROMIS (continuous). 
• 
Normally distributed data will be evaluated with ANOVA. Nonparametric data will be evaluated 
with the Mann-Whitney U.  
• 
Subjects will be excluded from analysis if they are missing secondary outcomes of interest.  
 
9.4.4 SAFETY ANALYSES 
 
This is not applicable to this study.  
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
• 
Demographic descriptive statistics will include age at enrollment, hours of dance per week, 
number of physical therapy (PT) visits total, and amount of PT prior to enrollment. These 
continuous variables will be compared among the two groups using ANOVA or the Mann-
Whitney U as described above.  
• 
Additional demographic data that will be presented is sex, type of dance, prior treatment, 
whether or not the current injury is a new injury, or a repeat injury. This data will be presented 
as a percentage, but will not be analyzed.  
 
9.4.6 PLANNED INTERIM ANALYSES  
Not applicable.  
 
9.4.7 SUB-GROUP ANALYSES 
 
We are basing our sample size on our primary outcome of interest, and we do not anticipate having a 
large enough ample to evaluate subgroups.  
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
Individual participant data will not be listed by measure and time point.  
 
9.4.9 EXPLORATORY ANALYSES 
 
There are no planned exploratory analyses for the study.  
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
 
10.1.1 STUDY DISCONTINUATION AND CLOSURE 
 

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This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to study participants, investigator, funding agency, and 
regulatory authorities.  If the study is prematurely terminated or suspended, the Principal Investigator 
(PI) will promptly inform study participants, the Institutional Review Board (IRB) and will provide the 
reason(s) for the termination or suspension.  Study participants will be contacted, as applicable, and be 
informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the IRB and/or Food and Drug Administration (FDA). 
 
10.1.2 CONFIDENTIALITY AND PRIVACY  
Enrollment will occur in the clinic. The clinic schedule will be screened for eligible participants by age 
and presence of non-operative foot or ankle injury. The record of those candidates will be reviewed for 
presence/absence of abnormal Z score and/or prior or current diagnosis of an eating disorder, presence 
of either would be exclusionary. For those eligible candidates, the treating physician will confirm during 
appointment primary sport, which is standard of care for orthopedic injury appointments. Those 
otherwise eligible candidates who endorse dance as primary sport will then be considered fully eligible. 
During these eligible subjects’ routine clinic visit, the treating physician will briefly discuss the study to 
gauge interest in participating. If the family expresses interest, a member of the study team will enter 
the exam room and directly explain the study in depth and obtain written consent and HIPAA 
authorization from the subject prior to data collection.  
 
An application for a partial HIPAA waiver is being requested to identify potential study participants. 
Identification of subjects satisfies the four criteria for granting a waiver of consent:  
 
a) The research activity of identifying subjects is minimal risk 
a. No data will be collected on subjects that do not meet the inclusion criteria of the study. 
Only the name of the subject and appointment time will be collected for subjects that 
do meet the inclusion criteria and those subjects will be asked to provide written 
consent to participate in the study. The date of birth, date of appointment, and 
appointment time will be discarded for subjects that do not provide written consent to 
participate in the study. The name and medical record number of subjects that do not 
wish to participate in the study will be kept with the consent log with a note indicating 
that the subject has been approached and does not wish to participate. This is necessary 
to ensure that subjects that do not wish to participate are not approached more than 
once. The name and medical record number of subjects that do not wish to participate 
in the study will be discarded once enrollment for this study is complete.  
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a. The waiver is being requested for identification purposes only and will in no way affect 
the rights and welfare of the subjects. All appropriate methods to ensure continued 
confidentiality of patients will be employed, thus we do not feel this waiver increases 
risk to patient rights/welfare. 
c) The research activity of identifying subjects to be consented for enrollment in the study could 
not practicably be carried out without the waiver. 
a. We intend to collect written consent on all subjects included in this study. We would not 
be able to identify subjects without a waiver allowing us to identify them.  
d) Whenever appropriate, the subjects will be provided with additional pertinent information after 
participation. 
a. We do not anticipate that additional pertinent information about individual subjects will 
arise as a result of participation in this study.The following PHI will be collected for 
recruitment purposes under the waiver: Name, medical record number, date of birth, 
date of appointment, and time of appointment. This information is necessary both to 
access the patient’s medical chart and to determine age at the time of enrollment. We 
must know the date and time of appointment in order to have research staff present 
and available for candidates who are potentially eligible for enrollment in the study. 
Access to the medical record using the name and MRN will allow us to view their record 
for history of documented abnormal Z score or eating disorder diagnosis, which is an 
exclusion criterion.  
 
All measures to ensure patient confidentiality will be employed. Each site will enter coded data into a 
password-protected database on a secure server. Only the investigators and research teams at each site 
will have access to their own data.   
 
10.1.3 FUTURE USE OF STORED SPECIMENS AND DATA  
 
There are no biological specimens related to this study. While we have no current plans to share patient 
data, we have included in the informed consent that de-identified data may be shared for future uses in 
the event that this becomes desirable at a later time.  
  
10.1.4 KEY ROLES AND STUDY GOVERNANCE 
Principal Investigator 
Emily Cidambi, MD 
Rady Children’s Hospital 
3030 Children’s Way, San Diego 
CA 92123 
858-576-1700 
Ecidambi@rchsd.org 
 
10.1.5 SAFETY OVERSIGHT 
 
Parents may supervise children’s use of the app to ensure use within appropriate limits. Subjects’ use of 
the app is also limited by the length of the single activity which takes approximately ten minutes only to 
complete. These activities will only be released once daily, 5 days per week. They will be released on a 
schedule set by the “host” which is the study team through the app, and will not exceed 5 days per 
week, for 12 weeks.  

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In order to join the SuperBetter app, patients will be added to a group in the app run by the “host” 
(study team). Name and date of birth of new participants added to the group will be coded for patient 
anonymity. Parent email, or patient if over the age of 18, will be required and the app may send periodic 
updates regarding changes to the app or collecting feedback. Some information will be automatically 
collected by the app including device information, approximated geolocation information, and app 
activity log data. App users traditionally have the option to log in using social media credentials, such as 
Facebook or Apple, in which case additional information may be collected. However, we will standardize 
to request families only log in with parent, or adult participant, email addresses to minimize additional 
data collected(18).  
 
SuperBetter does not sell personal information to third parties and does not generate revenue by selling 
in-app advertising(18).  
o 
 
 
10.1.6 CLINICAL MONITORING 
 
Patients enrolled in this study are participating in a physical therapy program which is monitored for 
patient safety according to standard of care clinical treatment by the treating physician and athletic 
trainer(s) on site.  
 
10.1.7 DATA HANDLING AND RECORD KEEPING  
 
10.1.7.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant enrolled in the study.  Data recorded in the electronic case report 
form (eCRF) derived from source documents should be consistent with the data recorded on the source 
documents.  
 
Clinical data (including adverse events (AEs), concomitant medications, and expected adverse reactions 
data) and clinical laboratory data will be entered into the appropriate 21 CFR Part 11-compliant data 
capture system provided by the Data Coordinating Center. The data system includes password 
protection and internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source 
documents. 
 
10.1.7.2 STUDY RECORDS RETENTION  
 

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Study documents should be retained for a minimum of 3 years after termination of the study for 
departmental recordkeeping and the University of California San Diego IRB recommendations.  
10.1.8 PROTOCOL DEVIATIONS  
 
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on 
Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
It is the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 10 working days of identification of the protocol deviation, or within 10 working days 
of the scheduled protocol-required activity.  All deviations must be addressed in study source 
documents and reported to the Data Coordinating Center. Protocol deviations must be sent to the 
reviewing Institutional Review Board (IRB) per their policies. The site investigator is responsible for 
knowing and adhering to the reviewing IRB requirements.  
 
10.2 ADDITIONAL CONSIDERATIONS 
 
None 
 
 

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10.3 ABBREVIATIONS 
 
AE 
Adverse Event 
ANOVA 
Analysis of Variance  
CFR 
Code of Federal Regulations 
CMP 
Clinical Monitoring Plan 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
eCRF 
Electronic Case Report Forms 
FAAM 
Foot and Ankle Ability Measure  
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ITT 
Intention-To-Treat 
MOP 
Manual of Procedures 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
PROMIS 
Patient Reported Outcomes Measurement Information 
System 
PT 
Physical Therapy  
RCT 
Randomized Control Trial  
RTC 
Return to Clinic 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SCS 
Self Compassion Scale  
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 

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SOC 
Standard of Care  
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version 
Date 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11 REFERENCES  
 
 
1) Worthen-Chaudhari, L., McGonigal, J., Logan, K., Bockbrader, M. A., Yeates, K. O., & Mysiw, W. J. 
(2017). Reducing concussion symptoms among teenage youth: Evaluation of a mobile health 
app. Brain injury, 31(10), 1279-1286. 
2) Neff, K. D., Tóth-Király, I., Yarnell, L., Arimitsu, K., Castilho, P., Ghorbani, N.,… Mantios, M. 
(2019). Examining the Factor Structure of the Self-Compassion Scale using exploratory SEM 
bifactor analysis in 20 diverse samples: Support for use of a total score and six subscale scores. 
Psychological Assessment, 31 (1), 27-45. 
3) Walter HJ, Bukstein OG, Abright AR, Keable H, Ramtekkar U, Ripperger-Suhler J, Rockhill C. 
Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents With 
Anxiety Disorders. J Am Acad Child Adolesc Psychiatry. 2020 Oct;59(10):1107-1124. doi: 
10.1016/j.jaac.2020.05.005. Epub 2020 May 18. PMID: 32439401. 
4) Psihogios AM, Stiles-Shields C, Neary M. The Needle in the Haystack: Identifying Credible Mobile 
Health Apps for Pediatric Populations during a Pandemic and beyond. J Pediatr Psychol. 2020 
Nov 1;45(10):1106-1113. doi: 10.1093/jpepsy/jsaa094. PMID: 33068424; PMCID: PMC7588098. 
5) Bantjes, J., Hunt, X., Cuijpers, P., Kazdin, A. E., Kennedy, C. J., Luedtke, A., Malenica, I., 
Petukhova, M., Sampson, N., Zainal, N. H., Davids, C., Dunn-Coetzee, M., Gerber, R., Stein, D. J., 
& Kessler, R. C. (2024). Comparative effectiveness of remote digital gamified and group CBT 
skills training interventions for anxiety and depression among college students: Results of a 
three-arm randomised controlled trial. Behaviour Research and Therapy, 178, 104554. 
https://doi.org/10.1016/j.brat.2024.104554 
6) Neff, K. D., Bluth, K., Tóth-Király, I., Davidson, O., Knox, M. C., Williamson, Z., & Costigan, A. 
(2021). Development and validation of the Self-Compassion Scale for Youth. Journal of 
personality assessment, 103(1), 92-105. 
7) Neff, K. D. (2003). Development and validation of a scale to measure self-compassion. Self and 
Identity, 2, 223-250. 
8) Semenchuk BN, Strachan SM, Fortier M. Self-Compassion and the Self-Regulation of Exercise: 
Reactions to Recalled Exercise Setbacks. J Sport Exerc Psychol. 2018 Feb 1;40(1):31-39. doi: 
10.1123/jsep.2017-0242. Epub 2018 Mar 26. PMID: 29580155. 
9) Noh, Y. E., Morris, T., & Andersen, M. B. (2007). Psychological intervention programs for 
reduction of injury in ballet dancers. Research in sports medicine, 15(1), 13-32. 
10) van Winden, D., van Rijn, R. M., Savelsbergh, G. J., Oudejans, R. R., & Stubbe, J. H. (2021). The 
association between stress and injury: a prospective cohort study among 186 first-year 
contemporary dance students. Frontiers in psychology, 12, 770494. 
11) Rowan, M. R., & Wilson, K. L. (2017). Psychological issues facing the injured adolescent 
dancer. Prevention of Injuries in the Young Dancer, 203-213. 
12) Mainwaring, L. M., & Finney, C. (2017). Psychological risk factors and outcomes of dance injury: 
a systematic review. Journal of Dance Medicine & Science, 21(3), 87-96. 
13) Zarzycki R, Failla M, Arundale AJH, Capin JJ, Snyder-Mackler L. Athletes with a Positive 
Psychological Response to Return to Sport Training Have Better Outcomes One and Two Years 
after ACL Reconstruction. Orthop J Sports Med. 2017;5(7 suppl6):2325967117S00324. Published 
2017 Jul 31. doi:10.1177/2325967117S00324 

Dance - RCT 
Version 1.0 
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29 April 2025 
Biomedical Protocol – Interventional Research 
 
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14) Gennarelli SM, Brown SM, Mulcahey MK. Psychosocial interventions help facilitate recovery 
following musculoskeletal sports injuries: a systematic review. Phys Sportsmed. 2020 
Nov;48(4):370-377. doi: 10.1080/00913847.2020.1744486. Epub 2020 Mar 25. PMID: 32186423. 
15) Christino MA, Fantry AJ, Vopat BG. Psychological Aspects of Recovery Following Anterior 
Cruciate Ligament Reconstruction. J Am Acad Orthop Surg. 2015 Aug;23(8):501-9. doi: 
10.5435/JAAOS-D-14-00173. PMID: 26209145. 
16) Raes, F., Pommier, E., Neff, K.D. and Van Gucht, D. (2011), Construction and factorial validation 
of a short form of the Self-Compassion Scale. Clin. Psychol. Psychother., 18: 250-255. 
https://doi.org/10/1002/cpp.702  
17) Martin RL, Irrgang JJ, Burdett RG, Conti SF, Swearingen JMV. Evidence of Validity for the Foot 
and Ankle Ability Measure (FAAM). Foot & Ankle International. 2005;26(11):968-983. 
doi:10.1177/107110070502601113 
18) SuperBetter, Privacy Policy, 2023 https://superbetter.com/privacy-policy/ 
19) Askew, Robert L. et al. Evidence from diverse clinical populations supported clinical validity of 
PROMIS pain interference and pain behavior Askew, Robert L. et al.Journal of Clinical 
Epidemiology, Volume 73, 103 - 111 
20) Wei Zhang, Som P Singh, Amdiel Clement, Ryan P Calfee, Janine D Bijsterbosch, Abby L Cheng 
Relationships between improvement in physical function, pain interference, and mental health 
in musculoskeletal patients medRxiv 2023.02.12.23285824; doi: 
https://doi.org/10.1101/2023.02.12.23285824 
21) Mosewich, AD., Kowalski, KC., Sabiston, CM., Sedgwick, WA., & Tracy, JL. (2011). Self-compassion: 
a potential resource for young women athletes. Journal of Sport & Exercise Psychology, 33(1), 103-
123. https://doi.org/10.1123/jsep.33.1.103 
22) Marshall, JM., Dunstan, DA., Bartik, W. (2021). Smartphone psychological therapy during COVID-
19: a study on the effectiveness of five popular mental health apps for anxiety and depression. 
Frontiers in Psychology, 12, https://doi.org/10.3389/fpsyg.2021.775775 
23) SuperBetter, Our Story, 2025 https://superbetter.com/our-story/  
 
 
 
 
 
 
 
 
 
 
Commented [DM1]: make proper references