College Student Stress: Transitions Over Time
Phase: NA
Conditions: Depressive Symptoms
Sponsor: University of Michigan

College Student Stress: Transitions Over Time  
NCT06583096 
May 19, 2025 
 

 
 
College Student Stress: Transitions Over Time  
Protocol Number: 1.0 
National Clinical Trial (NCT) Identified Number:  NCT06583096 
Principal Investigator: Dr. Adam G. Horwitz 
Sponsor: University of Michigan, Michigan Medicine 
Grant Title: Low Burden Adaptive Mobile Interventions for Mood and Suicide 
Risk 
Grant Number: K23 MH131761 
Funded by: NIMH 
Version Number:  v.1.1 
1 May 2025 
 
 

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  
 

College Student Stress: Transitions Over Time 
 
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NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................................................................ 3 
1.2 
Schema ................................................................................................................................................. 3 
1.3 
Schedule of Activities .......................................................................................................................... 4 
2 
INTRODUCTION ............................................................................................................................................ 6 
2.1 
Study Rationale .................................................................................................................................... 6 
2.2 
Background........................................................................................................................................... 6 
2.3 
Risk/Benefit Assessment .................................................................................................................... 7 
2.3.1 
Known Potential Risks ..................................................................................................... 7 
2.3.2 
Known Potential Benefits ................................................................................................ 7 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 7 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 8 
4 
STUDY DESIGN ............................................................................................................................................. 9 
4.1 
Overall Design ...................................................................................................................................... 9 
4.2 
Scientific Rationale for Study Design................................................................................................ 9 
4.3 
Justification for Intervention ............................................................................................................. 11 
4.4 
End-of-Study Definition ..................................................................................................................... 11 
5 
STUDY POPULATION ................................................................................................................................ 11 
5.1 
Inclusion Criteria ................................................................................................................................ 11 
5.2 
Exclusion Criteria ............................................................................................................................... 11 
5.3 
Lifestyle Considerations .................................................................................................................... 11 
5.4 
Screen Failures .................................................................................................................................. 11 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 12 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 12 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 12 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 12 
6.1.2 
Administration and/or Dosing ....................................................................................... 14 
6.2 
Fidelity ................................................................................................................................................. 14 
6.2.1 
Interventionist Training and Tracking .......................................................................... 14 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 14 
6.4 
Study Intervention/Experimental Manipulation Adherence.......................................................... 15 
6.5 
Concomitant Therapy ........................................................................................................................ 15 
6.5.1 
Rescue Therapy ............................................................................................................. 15 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 15 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 15 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 15 
7.3 
Lost to Follow-Up ............................................................................................................................... 15 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 15 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 16 
8.2 
Safety Assessments .......................................................................................................................... 18 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 19 
8.3.1 
Definition of Adverse Events ........................................................................................ 19 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 19 

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8.3.3 
Classification of an Adverse Event .............................................................................. 19 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 20 
8.3.5 
Adverse Event Reporting .............................................................................................. 20 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 21 
8.3.7 
Reporting Events to Participants ................................................................................. 21 
8.3.8 
Events of Special Interest ............................................................................................. 21 
8.3.9 
Reporting of Pregnancy ................................................................................................ 21 
8.4 
Unanticipated Problems .................................................................................................................... 21 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 21 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 21 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 22 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 22 
9.1 
Statistical Hypotheses ....................................................................................................................... 22 
9.2 
Sample Size Determination .............................................................................................................. 22 
9.3 
Populations for Analyses .................................................................................................................. 22 
9.4 
Statistical Analyses............................................................................................................................ 22 
9.4.1 
General Approach .......................................................................................................... 22 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 23 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 23 
9.4.4 
Safety Analyses .............................................................................................................. 23 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 23 
9.4.6 
Planned Interim Analyses ............................................................................................. 23 
9.4.7 
Sub-Group Analyses ..................................................................................................... 23 
9.4.8 
Tabulation of Individual Participant Data .................................................................... 23 
9.4.9 
Exploratory Analyses ..................................................................................................... 23 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 24 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 24 
10.1.1 
Informed Consent Process ........................................................................................... 24 
10.1.2 
Study Discontinuation and Closure ............................................................................. 24 
10.1.3 
Confidentiality and Privacy ........................................................................................... 25 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 26 
10.1.5 
Key Roles and Study Governance .............................................................................. 26 
10.1.6 
Safety Oversight ............................................................................................................. 26 
10.1.7 
Clinical Monitoring .......................................................................................................... 27 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 27 
10.1.9 
Data Handling and Record Keeping ............................................................................ 27 
10.1.10 
Protocol Deviations ........................................................................................................ 28 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 28 
10.1.12 
Conflict of Interest Policy .............................................................................................. 28 
10.2 
Additional Considerations ................................................................................................................. 28 
10.3 
Abbreviations and Special Terms ................................................................................................... 29 
10.4 
Protocol Amendment History ........................................................................................................... 30 
11 
REFERENCES ............................................................................................................................................. 31 
 

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STATEMENT OF COMPLIANCE  
 
The trial will be carried out in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for 
the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects 
Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must 
be obtained before any participant is consented. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) 
will be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form. 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
 
 
Name: Adam G. Horwitz 
 
Title: 
Assistant Professor of Psychiatry, Medical School 
 
Affiliation: University of Michigan, Michigan Medicine Psychiatry Department  
Address: 4250 Plymouth Rd, Ann Arbor, MI 48109 
Telephone: 734-764-0231 
Email: ahor@med.umich.edu 
 
 
 
 
 

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1 
PROTOCOL SUMMARY. 
1.1 
SYNOPSIS  
 
Title: 
College Student Stress: Transitions Over Time 
Grant Number: 
K23 MH131761 
Study Description: 
This project will develop a mobile health personalized feedback (PF) 
intervention for college students at-risk for depressive episodes. 
Participants will complete daily and weekly assessments, be randomized 
to receive weekly PF reports regarding mood and stress and be 
randomized to receive text-messages containing tips/strategies related to 
self-care, time management, and interpersonal connection/support. We 
will utilize follow-up surveys and objective indicators of 
engagement/participation to assess feasibility and acceptability of the 
intervention. Proposed mechanisms of change (e.g., coping efficacy, 
perceived stress, readiness for help-seeking) will be assessed by 
exploring associations of intervention components (i.e., text messages, 
PF reports) with relevant outcomes. 
Objectives: 
 
Demonstrate feasibility, acceptability, and initial impact of mobile 
health PF intervention on proposed mechanisms of change via a 
feasibility micro-randomized trial (MRT).  
Endpoints: 
Participation is complete following the completion of the 6-week 
follow-up survey.  
Study Population: 
Participants will be first-year college students, ages 17 or older, 
recruited from the University of Michigan, Ann Arbor and Flint 
campuses presenting with mild-to-moderate depressive symptoms who 
are not receiving professional mental health services. 
Phase: 
Phase I-II  
Description of 
Sites/Facilities Enrolling 
Participants: 
Participants will be recruited from the University of Michigan, Ann 
Arbor and Flint campuses via email sent by the university’s Registrar.     
Description of Study 
Intervention/Experimental 
Manipulation: 
Participants will be randomized (3:1 intervention-to-control) to receive 
either 1) weekly surveys only (Assessment-only Condition), or 2) daily 
and weekly surveys, Personalized feedback reports of symptoms and 
stress (2:1 randomization to receive/not-receive PF report in a given 
week), and supportive text messages (2:1 randomization to receive/not-
receive messages in a given week; 1:1 daily-level randomization to 
receive a message during weeks in which randomized to receive 
messages).  
Study Duration: 
6 months 
Participant Duration: 
6 weeks 
 
 
 
 
 
1.2 
SCHEMA  

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1.3 
SCHEDULE OF ACTIVITIES  
 

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Screening 
Baseline  Survey 
Weekly (Every 
Sunday  for 5 
weeks) 
Daily (42 days; 
Intervention-
only) 
6-week  follow-up  
(6th Sunday) 
 
Informed Consent 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Primary Randomization (Survey Only) 
 
X 
 
 
 
Secondary Randomization (MRT) 
 
X 
 
 
 
Outcome Evaluations 
 
 
 
 
 
Flourishing Scale 
X 
 
X 
* 
X 
Depression (PHQ-9) and Anxiety (GAD-7) 
X 
 
X 
 
X 
Coping Self-Efficacy 
X 
 
* 
 
X 
UCLA-Loneliness Scale 
X 
 
X 
 
X 
Mental Health Service Utilization 
X 
 
 
 
X 
Pittsburgh Sleep Quality Index-Adapted 
 
X 
* 
 
X 
Physical Activity (YRBS Adaptation) 
 
X 
* 
 
X 
Interpersonal Needs Questionnaire (INQ) 
 
X 
 
 
X 
DERS-Emotional Awareness 
 
X 
X 
* 
X 
Brief COPE 
 
X 
 
 
X 
National Comorbidity Survey (Suicidal 
Ideation and Behavior) 
 
X 
* 
 
* 
Perceived Stress Scale 
 
X 
* 
* 
X 
Life Events Checklist (LEC-5) 
 
X 
 
 
 
Readiness for Help-Seeking 
 
X 
* 
 
X 
Daily Mood 
 
 
 
* 
 
Feasibility/Acceptability Survey  
 
 
 
 
X 
Adverse Events Reporting 
 
X 
 
 
X 
Note: X = Full-scale; * = Abbreviated version 

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2 
 
INTRODUCTION 
2.1 
STUDY RATIONALE  
Depression is the #1 cause of disease-related disability worldwide and prevalence rates for depression 
and suicide have increased significantly in the United States over the past 25 years. Young adults, 
including college students, have especially high rates of depression, yet most individuals with clinically 
significant symptoms do not seek formal treatment. College students at elevated risk for suicide may 
decline formal treatment due to barriers such as lack of time, low perceived need for treatment, or 
limited access to services. Mobile health technologies offer promising new opportunities to overcome 
these barriers and improve outcomes. Further, the use of mobile technologies allows for the gathering 
of real-time subjective data, and an ability to respond to mood changes directly with an intervention at 
the time it is needed. Yet, engagement with mobile health interventions tends to wane quickly, and it is 
unclear how these interventions can best be implemented in ways that promote sustained health 
benefits. The present study seeks to develop a low-burden mobile intervention that can help first-year 
college students more readily identify negative trajectories in their mental health and take steps to 
facilitate effective coping and/or seek formal help. This two-arm pilot study, with an embedded micro-
randomized trial (MRT), will allow us to 1) evaluate the feasibility and acceptability of the study 
intervention components, 2) examine the initial impact of the study intervention components on the 
proposed mechanisms of change, and 3) through a series of micro-randomizations, inform an adaptive 
intervention design that provides personalized feedback or text messages only when it is expected to 
have a positive impact.  
2.2 
BACKGROUND  
Depression and suicidal ideation among college students have increased significantly over the past 
decade (Lipson et al., 2019). Evidence-based treatments, including psychotherapy and medication, have 
demonstrated effectiveness (Allen et al., 2007; Lee et al., 2019), yet college counseling centers have 
struggled with long waitlists and insufficient staffing, resulting in many students not receiving needed 
care (e.g., Auerbach et al., 2016; Xiao et al., 2017). In addition to access barriers, many at-risk students 
report a lack of time and a perception that their symptoms are not serious enough to require treatment 
(e.g., Epstein et al., 2010). Early intervention can mitigate the risk for future depressive episodes, yet in 
many cases, individuals are unaware or unable to name their experiences as symptoms of depression 
until symptoms are severe and causing significant impairment (e.g., Czyz et al., 2013). There is a 
significant need for effective, accessible interventions that can promote early recognition of symptoms 
and overcome common barriers to treatment for college students. 
 
With the ubiquity of smartphones in the US across socioeconomic statuses (Pew Research Center, 2021) 
and mental health patients (Campbell et al., 2015), mobile interventions offer an accessible modality to 
deliver care. Advances in mobile technologies have significant potential for reducing barriers to 
treatment for college students. To date, mobile interventions have not taken full advantage of the 
unique technological opportunities provided by smartphones to enhance engagement. Namely, mobile 
technology allows for the collection of ‘real time’ data, which can be used to provide feedback and 
confront an individual’s lack of awareness or perceived need for intervention (Lattie et al., 2019). 
Utilizing these data can dramatically transform the delivery of mobile interventions through preventive, 
adaptive approaches, whereby content is optimized and delivered in response to specific emotional or 
behavioral changes. 
 

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Given the stressors associated with beginning college (Byrd & McKinney, 2012), high prevalence and first 
onsets of depression, and multiple barriers to mental health care, first-year college students are an 
ideal, at-risk population to target with a low-burden mobile intervention optimized to prevent the 
negative progression of depressive symptoms. This study will evaluate feasibility, acceptability, and 
initial effectiveness of the intervention and explore impact on mechanisms of action. 
 
2.3 
RISK/BENEFIT ASSESSMENT  
2.3.1 KNOWN POTENTIAL RISKS  
The proposed study poses minimal risks. There is a small risk for violation of confidentiality and this risk 
exists because human participants are providing personal information. Furthermore, as a longitudinal 
study, we must maintain a link between each student’s contact information and their study IDs while 
the study is active, which is necessary for connecting data at the various follow-up timepoints and 
providing proper compensation for completed surveys. It also enables us to take appropriate action if a 
student provides information to suggest imminent risk of suicidal or other dangerous behavior. This risk 
is related to the damage that could be caused by an inadvertent release of sensitive information (e.g., 
psychiatric symptoms). Participants will be informed of these risks, the procedures taken to protect their 
confidentiality, and mandatory reporting requirements in the consent documents. The Risk 
Management Protocol will be utilized if confidentiality needs to be breached due to a safety concern. 
Participants could potentially experience emotional discomfort as a result of being asked personal 
questions about their mental and behavioral health and attitudes related to treatment-seeking. Because 
the screening portion of the study takes place via Qualtrics surveys, participants will receive crisis and 
referral information, including local and national resources (e.g., suicide hotlines, crisis text-lines, mental 
health and substance use treatment, etc.). All participants will also be notified that they are free to 
terminate the study at any time and may skip any questions that make them uncomfortable. 
2.3.2 KNOWN POTENTIAL BENEFITS  
Participation in the proposed study may benefit participants in a few ways. Participants completing the 
screen will receive a list of available resources for crisis management and mental/behavioral health and 
may choose to seek services with this information. Participants enrolled in the trial will be assessed 
weekly, and this process may provide an opportunity for reflection on their functioning. Furthermore, 
those randomized to the intervention condition may also benefit from receiving personalized feedback 
reports about their symptoms over time and receiving supportive text messages that contain helpful tips 
and strategies for managing stress. Regarding benefits to others, this research will inform the design of 
an eventual randomized control trial (RCT) for an adaptive mobile intervention seeking to prevent the 
negative progression of depressive symptoms, which, if deemed efficacious, has significant public health 
significance. In sum, the potential benefits for the research outweigh the risks for the participants. 
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
Confidentiality  
The study team has considerable experience in maintaining the confidentiality of participant data and 
has established procedures to ensure data confidentiality. Several steps will be taken to minimize the 
risk of breaches of confidentiality. Only the designated research staff will have access to research data. 
Training of staff will include information about the importance of confidentiality and techniques to 

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maintain confidentiality of all information reported by research participants. Staff will maintain human 
subjects and confidentiality certifications through the UM Program for Education and Evaluation in 
Responsible Research and Scholarship (PEERRS) system and will complete CITI Good Clinical Practice 
(GCP) Training. Consent documents will fully explain the study procedures, potential risks, and potential 
benefits. In addition, every effort will be made to ensure that study data are always confidential in terms 
of data storage, so that data cannot be linked to a particular person. Unique identification numbers will 
be assigned to all participants. Participants’ names and study IDs will be kept in a separate file from 
study data. All linking files will be maintained in a secure password-protected file on a secure server. 
Electronic data files (e.g. surveys) will be saved with passwords on a secure network and will not contain 
any identifying information. The “Subject Directory” sheets linking participant IDs to their names will be 
kept in a password-protected folder on a secure password-protected network. Prior to data entry, all 
identifying information will be removed, and only the subject IDs will be entered with the study data. 
 
Steps will also be taken to minimize breaches of confidentiality associated with the data collection tools. 
All study surveys will be developed in Qualtrics (University of Michigan Health System [UMHS]-approved 
Qualtrics version), with the initial screen/baseline link sent via e-mail and subsequent surveys delivered 
via text message. Personalized links will be developed for individual participants and processed through 
a secure study platform that complies with the Health Insurance Portability and Accountability Act 
(HIPAA) privacy regulations. Similarly, the secure study platform will also be used to deliver the text 
message intervention component; the platform will be hosted on a server whose data is always 
encrypted and which is secured in accordance with industry-standard data security practices. Moreover, 
participants will be informed of the risk that anyone who accesses their phone could see the supportive 
text messages. 
As noted below (managing safety concerns), participants’ confidentiality will be breached by the 
research study only to protect the safety and welfare of research participants and only in accordance 
with state and federal law. These confidentiality exceptions will be explained in detail as part of the 
study consent process.  
Managing Distress and Safety Concerns  
Our team has extensive experience conducting longitudinal research studies with individuals at risk for 
depression and suicide. Dr. Horwitz will closely supervise research staff to ensure potential safety issues 
are appropriately addressed in accordance with the protocol. All participants are free to terminate the 
study at any time or refuse to respond to any questionnaire item. Any suicidal ideation endorsement on 
the baseline, weekly, or follow-up survey will result in an automated notification informing participants 
about crisis resources (phone numbers and text line) and recommending use of these resources if they 
feel unable to resist acting on their suicidal thoughts. Participants will be informed that their survey 
responses are not monitored by research staff.  
Finally, in the event that a participant sends a text message to the phone number used to send daily 
surveys or supportive text messages, the participants will receive an automated response with 
information that the phone number does not receive text messages or phone calls and with information 
about how to contact the study with questions during business hours as well as information for 
accessing emergency services/immediate support (e.g., crisis line, local emergency department).  
 
3 
OBJECTIVES AND ENDPOINTS  
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
Primary 
 
 
 
Feasibility and acceptability 
of mobile health PF 
intervention 
 
Completion of the 
6-week follow-up 
survey  
This assessment will take 
place at the completion of the 
texting program and allow for 
immediate feedback about 
their experiences.    
N/A 
Secondary 
 
 
 
Initial impact of mobile 
health PF intervention on 
proposed mechanisms of 
change 
 
Completion of the 
6-week follow-up 
survey 
We will assess whether 
individuals receiving text-
messages or PF reports in a 
given week demonstrated 
greater improvements in 
depressive and anxiety 
symptoms, perceived stress, 
flourishing, coping self-
efficacy, and readiness to 
seek help relative to weeks in 
which they did not receive 
these interventions.  
N/A 
 
4 
STUDY DESIGN 
4.1 
OVERALL DESIGN 
This project is a two-armed randomized control trial (RCT) with an embedded MRT aimed to help 
develop a mobile health intervention for college students at-risk for depressive episodes. Participants 
will complete daily and weekly assessments, be randomized to receive weekly PF reports regarding 
mood and stress and be randomized to receive text-messages containing tips/strategies related to self-
care, time management, and interpersonal connection/support. We will utilize follow-up surveys and 
objective indicators of engagement/participation to assess feasibility and acceptability of the 
intervention. Proposed mechanisms of change (e.g., coping efficacy, perceived stress, readiness for help-
seeking) will be assessed by exploring associations of intervention components (i.e., text messages, PF 
reports) with relevant outcomes. This study has the following aims: 1) demonstrate feasibility and 
acceptability in intervention components, and 2) examine the initial impact of the mobile health  
intervention on proposed mechanisms of change. The total time for study completion for an individual 
participant is 6 weeks, with completion marked as completing the 6-week follow-up survey. The entirety 
of the study will run for 6 months.  
 
We will send out a brief mental health screening survey to 2,500 first-year college students, and 
anticipate that 425 will consent to participate and complete the screen, and 142 will meet study 
inclusion criteria for mild-to-moderate depressive symptoms and no current mental health treatment. 
From this group, we anticipate 120 will provide their cellphone number, complete the baseline survey 
(~15 additional minutes to 8-minute screening survey), and be randomized into the six-week 
intervention trial (90 into the ‘Pilot MRT’ intervention condition, and 30 into the ‘Assessment Only’ 

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condition). Participants in the Pilot MRT will complete daily 1-minute (5-item) assessments of their 
mood, social relationships, emotional awareness, interest in activities, and efficacy to cope with stress. 
All participants will receive a brief, weekly 10-minute ‘Sunday survey’ assessing various aspects of their 
health and well-being. Pilot MRT participants will be randomized each week at a 2:1 ratio to receive (or 
not receive) a Monday personalized feedback report that provides a graphical depiction summary of 
their scores up until that point in time on depression, anxiety, perceived stress, and flourishing scales, 
with a written description of the corresponding severity levels and links to available mental health 
resources. Pilot MRT participants will also be randomized each week, at a 2:1 ratio, to receive or not 
receive supportive text messages offering strategies and tips for health promotion and stress 
management during the week, which includes a daily-level 50:50 randomization (during weeks when 
randomized to receive texts). At the end of six weeks, all participants will complete a 25-minute follow-
up assessment, with additional items for those in the Pilot MRT condition assessing 
feasibility/acceptability of the PF reports and text-message intervention components. 
 
With respect to randomization procedures, we will pre-randomize specific ID numbers and assign 
numbers sequentially based on completion of the baseline survey, blocking every 20 participants (15 
Pilot MRT, 5 Assessment Only) to ensure balance. Those in the Pilot MRT condition will have further 
randomizations at the weekly level for six weeks, with each week randomized 2:1 to receive a Monday 
PF report, and each week randomized 2:1 to receive supportive text messages. As an MRT, we will not 
block for number of weeks receiving each intervention component, and participants may receive 
different ‘doses’ of the intervention components over the course of six weeks. Those randomized to 
receive supportive messages in a given week, as part of the Pilot MRT condition, will have a daily-level 
50:50 randomization to receive or not receive a message. If randomized to receive a message on a given 
day, the message will be randomly pulled from a pool of 25 messages, with each message assigned a 
numerical value, and this message will be removed from the available pool once it has been received by 
a given participant. Participants will receive an average of 14 messages over the course of 6 weeks (i.e., 
~4 weeks with messages x ~3.5 messages per week). This randomization will allow for the examination 
of within-person differences for weeks in which a participant is receiving PF reports versus not receiving 
PF reports, weeks receiving supportive messages versus not receiving supportive messages, between-
person differences for volume of messages received at the weekly level, between-person differences for 
volume of messages or PF reports over the course of six weeks, and short-term (i.e., next-day) within-
person changes associated with messages versus not receiving messages.  
 
Since this is a pilot study, our primary goals are to determine the feasibility and acceptability of the 
intervention components. We will utilize formal measures of feasibility and acceptability of the 
intervention components, including degree of agreement with specific statements regarding 
intervention features (e.g., frequency and timing of assessments, PF reports, and supportive messages; 
perceptions of confidentiality, helpfulness, usability, etc.), as well as objective data gathered from rates 
of attrition and adherence to study procedures (e.g., responding to surveys, clicking links to PF reports). 
While we are not designed to detect an intervention effect, we will explore whether patterns of change 
are in the desired directions for intervention components at the weekly level, and for overall between 
group differences in the Pilot MRT and Assessment only conditions. We will also utilize advanced 
statistical methods outlined in the training plan to identify predictors of change over the course of the 
study period, which will be used to inform the design of an adaptive version of this mobile intervention 
that will only send PF reports or messages under specific conditions.   
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 

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An MRT allows individuals to serve as their own control and examine within-subject differences with 
respect to weeks receiving an intervention versus weeks not receiving an intervention. For this pilot 
study, we also opted to include a small assessment-only group as a control to examine trends in overall 
impact of having received the MRT intervention compared to not receiving any of the intervention 
components.  
 
4.3 
JUSTIFICATION FOR INTERVENTION 
With rising rates of depression among college students, and college entailing numerous life stressors, 
our intervention offers an opportunity for students to have greater awareness of changes in their levels 
of distress and access coping skills during this transitional period. As a pilot trial, we will be seeking 
feedback about how to best optimize the length of the study and the volume of text messages and PF 
reports, as well as their content, to balance intervention and habituation. The text-messaging program 
has the potential to help remind patients to seek out support and engage in coping strategies when 
experiencing distress and PF reports will raise awareness to students’ well-being and present functioning 
and serve as a possible motivator for formal help-seeking. 
 
4.4 
END-OF-STUDY DEFINITION 
A participant is considered to have completed the study when they have completed the 6-week follow-
up survey.  
 
5 
STUDY POPULATION 
5.1 
INCLUSION CRITERIA 
First-year college students (ages of 17 or above) who are full-time or part-time students enrolled at the 
University of Michigan, Ann Arbor or Flint campuses with mild-to-moderate depressive symptoms, and 
who are not receiving professional mental health services will be eligible to participate. Students who 
may be eligible will first be identified through the university’s administrative database. Depressive 
symptoms and current treatment-seeking status will be verified via email administered questionnaires, 
after obtaining informed consent from interested students.  
5.2 
EXCLUSION CRITERIA 
Exclusion criteria will include: (1) being under the age of 17, (2) currently be receiving mental health 
therapy/counseling from a healthcare professional, (3) experiencing minimal depressive symptoms 
(PHQ-9 < 5), (4) experiencing moderately severe to severe depressive symptoms (PHQ-9 >14). 
5.3 
LIFESTYLE CONSIDERATIONS 
N/A 
5.4 
SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Individuals who do not meet 
the criteria for participation in this trial (screen failure) because of meeting one or more exclusion 

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criteria will not be re-screened, as the initial screening period for this intervention will occur over the 
course of only two weeks. 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
We will send out an e-mail to a randomized batch of approximately 2,500 students (2,000 UM-Ann 
Arbor, 500 UM-Flint), provided by the respective student registries, inviting them to complete an initial 
8-minute survey. We anticipate approximately 425 (17%) will consent to participate and complete the 
screening survey, and that 142 (33%) will screen as eligible (mild-to-moderate depression symptoms as 
defined by PHQ-9 score of 5-14; no current MH treatment) for the intervention portion of the study. The 
screening survey will be administered to all invited participants and takes approximately 8-10 minutes to 
complete. After initially sending out the screening survey, we will also send two follow-up reminders via 
email a couple days apart to remind potential participants of the opportunity to participate in the study. 
Our full sample will be recruited in this ~10-day period. 
We anticipate 120 students (85%) will continue to this next phase of the study, provide a cell-phone 
number, and complete the baseline survey (all within this same Qualtrics flow as the screening survey). 
Once the baseline survey has been completed, participants will be randomized 3:1 to a “Assessment 
Only” (n = 30) or “Intervention” (n=90) condition. Based on student enrollment and screening rates from 
a prior study, we anticipate our sample to be 67% female, 63% White, 20% Asian, 9% Black, 8% Multi-
racial, and 12% Hispanic. 
Our research group has developed several successful strategies to improve participant retention. For 
completion of the baseline survey, daily and weekly assessment surveys, and final follow-up survey we 
will provide participants with financial compensation in the form of a re-loadable digital Visa card. For 
the initial completion of the screening survey, participants will be entered into a drawing for one of ten 
$50 digital Visa cards.  For completion of the baseline survey, participants will receive $20. For daily 
surveys, participants will receive $1 for each completed survey. For weekly assessments, participants 
will receive $10 for each completed survey. Finally, participants will receive $25 for completing the final, 
6-week follow-up survey. Participants will have payments issued each week based on the number of 
completed surveys.  
 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
Participants in both the assessment-only and pilot MRT conditions will complete a baseline survey, a 
weekly Sunday survey, and a 6-week follow-up survey. The following components will be administered 
only to the Pilot MRT condition: 
Daily Surveys 

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Some research has indicated that completing daily mood reports on their own can serve as an 
intervention, so brief 5-item/1-minute daily surveys will be completed by the intervention group. 
Personalized Feedback (PF) Reports 
For individuals who are randomized to receive a Personalized Feedback Report, we will send them a text 
on a Monday with the feedback from their prior survey (Baseline survey in the first week, weekly survey 
in the next five weeks). There will be graphs for depression, anxiety, stress, and flourishing. The four 
scales have the following ranges and categories: 
Depressive Symptoms (PHQ-9: 0-27): Minimal depressive symptoms (0-4), mild depressive symptoms (5-
9), moderate depressive symptoms (10-14), moderately-severe depressive symptoms (15-19), and 
severe depressive symptoms (20-27). 
Anxiety Symptoms (GAD-7: 0-21): Minimal anxiety symptoms (0-4), mild anxiety symptoms (5-9), 
moderate anxiety symptoms (10-14), severe anxiety symptoms (15-21). 
Stress (Perceived Stress Scale-4: 0-16): Low stress (0-5), moderate stress (6-10), high stress (11-16). 
Flourishing (Flourishing Scale: 8-56; higher scores are better): Struggling (8-40), Managing (41-47), 
Thriving (48-56)  
 
 
At the bottom of the page, there will be a summary statement: “In your last survey, you indicated 
[Minimal/Mild/Etc.] depressive symptoms, [Minimal/Mild/Etc.] anxiety symptoms, 
[Low/Moderate/High] stress levels, and results on the Flourishing scale indicated you were 
[Thriving/Managing/Struggling]. If you feel you might benefit from some support, there are a range of 
resources available to assist you. Please see {Link: tailored to UM-AA/UM-Flint} for more information. 
The graph will highlight where a person is on the week of the PF report and include a trend line for 
responses leading up to the current week to show changes over time.  

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Text messages 
Text messages will be sent Mondays-Sunday if someone is randomized to receive them in a given week, 
with a daily 50:50 send/no-send randomization. A bank of 25 text messages will be used for the study, 
providing tips/strategies across a range of topics, including managing time and academic stressors, 
recommendations for self-care and mood management, and messages geared towards fostering social 
connections and support. Participants will be asked to provide a rating for each message they receive to 
evaluate message helpfulness. Some messages will contain links to videos, websites, or articles for more 
information on a topic. Please see below for five sample messages: 
1. We often default to 'fine' or 'ok' when asked how we're doing. What happens when you open up 
a bit more next time? 
2. Not getting enough sleep? Consider steps you can take to improve your 'sleep hygiene' (link 
sleep hygiene to: 
https://sdlab.fas.harvard.edu/files/sdlab/files/sleephygienecheckliststriveweekly.pdf) 
3. When we're our own worst critic, apply the 'reverse' golden rule-- treat yourself how you'd treat 
your friends. 
4. We're not designed to work for hours on end. Consider the Pomodoro method to break things 
down. (link Pomodoro method to: https://www.youtube.com/watch?v=mNBmG24djoY) 
5. Being resourceful is a sign of intelligence--asking for help from others when you're struggling is a 
strength. 
6.1.2 ADMINISTRATION AND/OR DOSING 
 
Each participant ID will be pre-randomized to a specific sequence PF reports and text messaging, using a 
2:1 ratio for weekly assignment to a PF report, and a 2:1 ratio for receiving text messages during a given 
week (with daily 50:50 randomization to message/no-message). Participants will, on average, receive 4 
personalized feedback reports over the course of six weeks and will receive an average of 14 messages 
(average of 4 weeks receiving messages and 3.5 messages per week). As an MRT, there will be variation 
in dosage (e.g., some participants may receive 5 or 6 PF reports and some may receive 2 or 3) for the 
intervention components. This variability, whereby some weeks will include no texts/PF, PF and no texts, 
texts and no PF, or both PF and texts, will allow for comparisons that inform an eventual adaptive 
design.   
6.2 
FIDELITY 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
The mobile health PF intervention and assessments will be self-guided. Text-messaging, survey 
assessments, and PF report processes are automated and will not require formal human fidelity training. 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
Participants will be assigned sequentially to Study ID numbers that have been pre-randomized with 
respect to study arm (3:1 ratio, blocking every 20 participants at 15:5). Each study ID will also have a 
randomized sequence for receiving or not receiving PF reports and/or text messages for weeks 1-6 of 
the study. Specific text messages will also be randomly pulled from a pool of messages, with previously 

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used message from a specific participant being pulled for subsequent randomizations (to not send the 
same message twice to same participant). Assessments are administered electronically and are all self-
report. Thus, no blinding procedures are necessary.  
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
As a pilot study, we will monitor number of and reasons for withdrawals, and percentage of participants 
who remain active (i.e. do not request to stop messages), as well as adherence to surveys as indicators of 
adherence.  
6.5 
CONCOMITANT THERAPY 
N/A 
6.5.1 RESCUE THERAPY 
N/A 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
Participants have the option to withdraw from study participation at any time. Those in the intervention 
conditions will also have the option to withdraw from receiving texts or feedback reports while continuing 
participation in surveys and follow-up assessments.  
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants have the option to withdraw from study participation at any time.  
An investigator may discontinue a participant from the study for the following reasons: 
• 
Any event or medical condition or situation occurs such that continued collection of follow-up  
study data would not be in the best interest of the participant. 
• 
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 for 
acceptability/feasibility tracking purposes.  
7.3 
LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if they do not complete the six-week follow-up 
assessment.  
Before a participant is deemed lost to follow-up, study staff will make up to two telephone contacts and 
up to two e-mail contacts following the initial survey invitation. 
8 
STUDY ASSESSMENTS AND PROCEDURES 

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8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
To recruit participants, we will 
obtain e-mail addresses of 2,500 
first-year undergraduate students 
from the registrar (2,000 randomly 
selected from UM-Ann Arbor, and 
500 from UM-Flint, which reflects 
the full annual enrollment of first-
year undergraduate students at the 
UM-Flint campus) and invite them 
to participate in an 8-minute survey 
screen of their mental health, with 
an online consent form. We 
anticipate approximately 425 
students will consent to participate 
and complete the screening survey, 
and that 142 students will meet 
criteria for a positive screen of 
mild-moderate depressive 
symptoms (PHQ-9 score of 5-14) 
and no current psychotherapy for 
the intervention portion of the 
study. We anticipate that 85% of 
the 142 participants who screened 
eligible for the study will continue 
to this next phase of the study, 
provide a cell-phone numbers, and 
complete the baseline survey (all within the same Qualtrics flow of the screening survey). The screening 
survey will be administered to all invited participants who consent to participate and takes 
approximately 8 minutes to complete. It will be sent out on a Tuesday, with reminders on Friday, and 
following Monday. Participants are deemed eligible if they score 5-14 on the PHQ-9, denoting mild-to-
moderate depressive symptoms and report they are not currently enrolled in a form of mental health 
care (e.g., therapy). The baseline survey will be administered to participants screening positive on the 
screen, when they provide their cell phone number, and takes 10-15 additional minutes to complete. 
Randomization (3:1 to intervention versus assessment-only) occurs after baseline survey has been 
completed. Daily surveys will be administered to participants in the intervention group only, and take 
approximately 1 minute to complete, with links to the survey texted at 8pm each day. Weekly surveys 
are administered to all participants on Sunday evenings and take approximately ten minutes to 
complete. The final follow-up survey takes approximately 25 minutes to complete and will be 
administered to all randomized participants (n=120) on their sixth Sunday of the project. Administration 
of all surveys will be conducted via an online, automated system (Qualtrics). 
Primary Outcomes: The primary outcomes include feasibility and acceptability measured by: (1) 
percentage of eligible participants who agree to participate, (2) percentage of completed follow-ups, (3) 
number of and reasons for withdrawals, (4) of those randomized to text-messages, percentage of 
participants who remain active (i.e. do not request to stop messages), (5) visits/clicks for an individual’s 

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personalized feedback report page, and (6) participant self-reported satisfaction with the intervention 
components. Participants’ feedback will be obtained with Likert scale items and open-ended questions, 
including overall perspective on personalized feedback reports, and receiving text messages, experience 
(e.g., ease of accessing intervention components, acceptability of intervention timing, frequency, and 
duration), and recommended changes. 
Additional measures 
Daily Survey: The daily survey contains five items that assess: 1) mood (On a scale from 1 (lowest/worst) 
to 10 (highest/best), how was your mood today? ____), 2) connectedness (My social relationships were 
supportive and rewarding today (Likert Strongly Disagree (1) to Strongly Agree (7))), 3) coping efficacy (I 
feel confident that I can cope with the demands and/or stressors in my life (Likert Strongly Disagree (1) 
to Strongly Agree (7))), 4) Emotional awareness (I was aware of my emotional state and feelings today 
(Likert Strongly Disagree (1) to Strongly Agree (7))), 5) Interest/energy (I was engaged and interested in 
my activities today (Likert Strongly Disagree (1) to Strongly Agree (7))). 
Screen/Baseline/Weekly/Follow-up Measures 
Flourishing (Screen/Weekly/Follow-up). The Flourishing Scale (Diener et al., 2010) is a brief 8-item 
summary measure of the respondent’s self-perceived success in important areas such as relationships, 
self-esteem, purpose, and optimism. The scale provides a single psychological well-being score (range: 8-
56). 
Depression (Screen/Weekly/Follow-up). The PHQ-9 (Kroenke et al., 2002) is a 9-item standardized self-
report scale for the assessment of depressive symptoms, with a scale range of 0-27.  
Anxiety (Screen/Weekly/Follow-up). The GAD-7 (Spitzer et al., 2006) is a 7-item validated self-report 
scale for the assessment of symptoms consistent with generalized anxiety disorder, with a scale range of 
0-21.  
Coping self-efficacy (Screen/Weekly-abbv./Follow-up). We use a thirteen-item coping self-efficacy scale 
(Chesney et al., 2006) to assess confidence in engaging in specific coping strategies when under stress at 
baseline and follow-up. During weekly assessments, an item from each of the scale's three factors 
(problem solving, seeking support, stopping unpleasant thoughts/emotions) will be administered. 
Loneliness (Screen/Weekly/Follow-up). The UCLA Loneliness scale (Russel et al., 1978) is a self-report 
measure assessing quality of interpersonal connections and relationships-- we will utilize the 3-item 
short form for baseline, weekly, and follow-up assessments, which has a scale range of 0-6. 
Perceived Stress (Screen/Weekly-abbv./Follow-up). We use the 10-item Perceived Stress Scale (Cohen et 
al., 1983) at baseline and follow-up assessment; the 4-item PSS short form is used at weekly 
assessments.  
Mental health service utilization (Screen/Follow-up). At baseline, participants will be assessed for 
lifetime and current use of therapy/counseling from a professional health provider (those currently 
receiving services are excluded from the trial). At follow-up, participants are asked about any (and 
number of sessions) counseling or therapy sessions for emotional/mental health in the past six weeks. 

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Trauma history (Baseline). The Life Event Checklist (LEC-5; Weathers et al., 2013) will ask participants to 
indicate whether they have every experienced one of twelve types of Criterion A traumatic events, and 
if so, whether or not these had been experienced in the past 12 months. 
Sleep (Baseline/Weekly-abbv./Follow-up). We will use a 9-item adapted version of the Pittsburgh Sleep 
Quality Index (Buysse et al., 1989) to capture self-report of sleep duration, quality, and sleeping 
difficulties at baseline and follow-up. Two items focused on sleep duration and quality will be utilized at 
weekly assessments. 
Physical activity (Baseline/Weekly/Follow-up). We use three derived from the Youth Behavior Risk 
Survey (Grunbaum et al., 2002) to assess frequency and duration of moderate and vigorous exercise at 
baseline, weekly, and follow-up assessments. 
Interpersonal functioning (Baseline/Follow-up). We use 15 items from the Interpersonal Needs 
Questionnaire (Van Orden et al., 2012), a self-report measure of perceived burdensomeness and 
thwarted belongingness-- two interpersonal constructs believed to contribute to suicidal desire. 
Emotional Awareness (Baseline/Weekly/Follow-up). We use the 6-item subscale ‘Emotional Awareness’ 
from the Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004) at baseline, weekly, and 
follow-up assessments. 
Coping Behaviors (Baseline/Follow-up). We use the 28-item Brief Cope (Carver, 1997) to assess 
frequency of using 14 specific coping behaviors that encompass various forms of problem-focused 
coping, emotion-focused coping, and avoidant coping strategies. 
Suicidal thoughts and behaviors (Baseline/Weekly—abbv./Follow-up—abbv.). 4 items adapted from the 
National comorbidity survey will assess history of suicidal thoughts and behaviors at baseline, and two 
items will assess past-week suicidal thoughts at weekly and follow-up assessments. 
Readiness for help-seeking (Baseline/Weekly-abbv./Follow-up). We use four items on a 10-point 
readiness scale (King et al., 2022) for seeking help from different sources (e.g., family/friends, online 
resources, professional services, support group) for mental health at baseline and follow-up. Weekly 
assessments will include two items: readiness for online resources and professional services. 
Intervention Acceptability (Follow-up). We use a modified version of the 4-item Acceptability of 
Intervention Measure (Weiner et al., 2017) to obtain self-report subjective ratings of intervention 
acceptability and participants will indicate acceptability of numerous intervention features (e.g., 
frequency/timing of surveys, personalized feedback; confidentiality; satisfaction; helpfulness) using a 7-
point agreement scale (strongly disagree to strongly agree). 
8.2 
SAFETY ASSESSMENTS 
There will be no direct contact between participants and study staff, as consent and assessment 
procedures are completed digitally. Individuals who are deemed ineligible due to elevated depressive 
symptoms are presented with mental health resources and crisis contacts when exiting the survey 
platform. Likewise, individuals indicating recent thoughts of suicide are presented with resources and 
crisis contact information and are informed that study staff do not review their responses. 

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8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
An adverse event is any experience or abnormal finding that has taken place during a research project and 
was harmful to the subject participating in the research, or increased the risks of harm in the research, or 
had an unfavorable impact on the risk/benefit ratio. 
 
For this study, expected AE include worsening depressive symptoms and onset of suicidal ideation. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
Serious adverse event (SAE) is an adverse event that: results in death; is life-threatening (places the 
participant at immediate risk of death from the event as it occurred); results in inpatient hospitalization 
or prolongation of existing hospitalization; results in a persistent or significant disability/incapacity; 
results in a congenital anomaly/birth defect; or based upon appropriate medical judgment, may 
jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the 
other outcomes listed in this definition.  
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines will 
be used to describe severity.  
 
• 
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/EXPERIMENTAL MANIPULATION 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by an appropriately trained clinician based on temporal relationship and his/her clinical 
judgment. Dr. Horwitz will be responsible for reporting adverse events and serious adverse events. The 
degree of certainty about causality will be graded using the categories below.  
 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to study procedures administration and cannot be 
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study procedures should be clinically plausible. The event must be pharmacologically or 
phenomenologically definitive. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a 

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reasonable time after administration of the study procedures, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal.  
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study procedures administration makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study 
procedures) and in which other drugs or chemicals or underlying disease provides plausible 
explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study procedures administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician.] 
8.3.3.3 EXPECTEDNESS  
Dr. Horwitz will be responsible for determining whether an adverse event is expected or unexpected. An 
AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent with 
the risk information previously described for the study procedures. 
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 review of assessments of a study participant or if a participant makes direct 
contact with study staff through the project e-mail address. All AEs, not otherwise precluded per the 
protocol, will be captured on the appropriate case report form (CRF). Information to be collected includes 
event description, time of onset, assessment of severity, relationship to study procedures, and time of 
resolution/stabilization of the event. All AEs occurring while on study will be documented appropriately 
regardless of relationship. Within 48 business hours of learning of these events, the coordinator will then 
bring all possible AEs to the attention of the PI for evaluation and appropriate reporting. AE’s will be 
assessed by the PI for expectedness (expected, unexpected) and relatedness (definitely related, probably 
related possibly related, unlikely related, not related). A log of all AE’s will be maintained by the study 
coordinator, and the log will be additionally reviewed for completeness at weekly intervals during the 
active recruitment period. 
8.3.5 ADVERSE EVENT REPORTING  
In accordance with U-M IRBMED reporting guidelines, moderate and mild AEs that are expected will not 
be reported to the IRB. Moderate/mild AEs that are unexpected and definitely or possibly related will be 
reported to the IRB at the time of scheduled continuing review. Moderate AEs that are unexpected and 
definitely not related will not be reported to the IRB. A summary of AEs will be reported each year to the 
IRBMED at continuing review. In addition, we will also follow the NIMH Reportable Events Policy and 
timeline to promptly report these events to the NIMH as required. Safety events requiring expedited 
reporting will be sent to the) Chair (and forwarded if necessary to the full board) and program office 

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within 48 hours of notification of the event. A formal report will be submitted to the IRB and NIH within 
7 days. 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
In accordance with U-M IRBMED reporting guidelines, study-related, life threatening serious adverse 
event (SAE) reports will be submitted to IRBMED no later than 7 calendar days after learning of the event. 
If the SAE is expected, it will be reported within 14 days. For SAEs that are not related to the study, 
reporting will occur at the time of scheduled continuation, or not at all if determined to be expected, per 
standard reporting timetable of the U-M IRBMED. 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
N/A 
8.3.8 EVENTS OF SPECIAL INTEREST  
N/A 
8.3.9 REPORTING OF PREGNANCY  
N/A 
8.4 
UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all 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 PROBLEMS REPORTING  
Dr. Horwitz will report unanticipated problems (UPs) to the reviewing Institutional Review Board (IRB). 
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  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 

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• 
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 in accordance with description in 
section 7.6.4.  
• 
Any other UP will be reported to the IRBMED within 14 business 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 7 days of the IRB’s receipt of the report of the 
problem from the investigator. 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
If there is a UP that directly impacts a participant, they will be informed within 7 days. 
9 
STATISTICAL CONSIDERATIONS  
9.1 
STATISTICAL HYPOTHESES 
As a pilot study, our primary goal is to examine feasibility and acceptability with descriptive data, and we 
therefore do not have formal hypotheses. 
9.2 
SAMPLE SIZE DETERMINATION 
We will be enrolling 120 participants in the study, including 90 for the pilot feasibility micro-randomized trial. 
The proposed sample size is not based on detecting an intervention effect but on the goals to determine 
the acceptability of the intervention components, perceived helpfulness of intervention components (e.g., 
personalized feedback reports, supportive text messages), and feasibility metrics such as rates of attrition 
and adherence to study procedures. This number of participants will be sufficient to examine feasibility and 
acceptability and to explore the range and distribution of outcomes.  
9.3 
POPULATIONS FOR ANALYSES 
Analyses will be conducted using an intent-to-treat approach. 
9.4 
STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
 
For descriptive statistics, categorical and continuous data will be presented via percentages, with ranges, 
means, and standard deviations when applicable. In keeping with an experimental therapeutics model, 
we will conduct exploratory analyses comparing the intervention and assessment-only group on the 
proposed mechanisms (e.g., coping self-efficacy, emotional awareness, readiness to seek-help). We will 
also be able to utilize multi-level models accounting for repeated assessments to examine associations of 
intervention components with mechanisms of interest at daily and weekly levels. With 50:50 

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randomizations for supportive text messages during ~4 week of the 6 weeks, there will be approximately 
14 messages (3.5 per week x 4 weeks) for 90 participants, yielding approximately 1,260 next-day outcome 
datapoints. The six assessment points (five weekly assessments and final follow-up) will also allow for up 
to 540 outcomes (90 participants x 6 assessments) to compare associations of those randomized to 
receive PF reports and those who did not receive PF reports on a given week (360 with PF reports vs. 180 
without PF). Model diagnostics will be utilized to determine whether corrections for autocorrelation or 
other model violations are necessary. We will utilize multiple imputation strategies to provide estimates 
and account for missing data, which is expected in the context of studies with daily assessments. Because 
pilot studies are not specifically powered for efficacy, we will examine if the pattern of change associated 
with receiving PF reports and/or supportive text messages are in the desired direction.  
 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
The primary outcomes include feasibility and acceptability measured by: (1) percentage of eligible 
participants who agree to participate, (2) percentage of completed follow-ups, (3) number of and reasons 
for withdrawals, (4) of those randomized to text-messages, percentage of participants who remain active 
(i.e. do not request to stop messages), (5) visits/clicks for an individual’s personalized feedback report 
page, and (6) participant self-reported satisfaction with the intervention components. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
N/A 
9.4.4 SAFETY ANALYSES 
N/A 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
Baseline descriptive statistics will be used to verify randomization procedures, including sex, campus, 
race/ethnicity, and suicide attempt history. 
 
9.4.6 PLANNED INTERIM ANALYSES  
N/A 
9.4.7 SUB-GROUP ANALYSES 
As part of the evaluation of feasibility/acceptability, we will examine whether features of the intervention 
were moderated by group-level factors such as age, sex, race/ethnicity, or history of formal mental health 
care.  
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
N/A 
9.4.9 EXPLORATORY ANALYSES 
All planned exploratory analyses should be specified in the protocol. 
 
Because pilot studies are not specifically powered for efficacy, we will examine if the pattern of change 
associated with receiving PF reports and/or supportive text messages are in the desired direction. We will 
also examine whether dose of an intervention (e.g., numbers of texts, number of weeks with texts, 

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number of personalized feedback reports) had a directional influence on mechanisms of interest. We will 
also explore whether randomization to the intervention group had an impact on mechanisms of interest 
relative to those in the assessment-only condition. 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
Consent forms describing in detail the study intervention, study procedures, and risks will be given to 
the participant and participants will confirm their review of the document and consent to participate 
prior to initiating the survey. The study consent form and the e-mail invitation documents are provided 
as supplements to this protocol.  
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Participants will be invited via e-mail to participate in the study and be provided with an electronic 
consent form that can be viewed and downloaded. Participants will be informed of the general nature of 
the study, expectations for their participation, the voluntary nature of their participation, the 
risk/benefits, limitations to confidentiality, and that they may withdraw from the study at any time. As a 
digital study, formal written consent will be waived and participants will be required to attest that they 
have reviewed the consent form and wish to participate prior to proceeding to the screening survey. A 
waiver for parental consent will be obtained so that 17-year-old first-year college students may 
participate in the study. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly 
inform study participants, the Institutional Review Board (IRB), and sponsor/funding agency 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 of study staff to the protocol   (i.e., significant protocol violations) 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 

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The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, IRB, Food and Drug Administration (FDA), or other relevant 
regulatory or oversight bodies (OHRP, DSMB).] 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
The study team has considerable experience in maintaining the confidentiality of participant data and 
has established procedures to ensure data confidentiality. Several steps will be taken to minimize the 
risk of breaches of confidentiality. Only the designated research staff will have access to research data. 
Training of staff will include information about the importance of confidentiality and techniques to 
maintain confidentiality of all information reported by research participants. Staff will maintain human 
subjects and confidentiality certifications through the UM Program for Education and Evaluation in 
Responsible Research and Scholarship (PEERRS) system and will complete CITI Good Clinical Practice 
(GCP) Training. Consent documents will fully explain the study procedures, potential risks, and potential 
benefits. In addition, every effort will be made to ensure that study data are always confidential in terms 
of data storage, so that data cannot be linked to a particular person. Unique identification numbers will 
be assigned to all participants. Participants’ names and study IDs will be kept in a separate file from 
study data. All linking files will be maintained in a secure password-protected file on a secure server. All 
data and assessments will be coded with this ID rather than with a name. Electronic data files (e.g. 
surveys) will be saved with passwords on a secure network and will not contain any identifying 
information. The “Subject Directory” sheets linking participant IDs to their names will be kept in a 
password-protected folder on a secure password-protected network. Prior to data entry, all identifying 
information will be removed, and only the subject IDs will be entered with the study data. 
 
Steps will also be taken to minimize breaches of confidentiality associated with the data collection tools. 
Baseline and follow-up surveys will be developed in Qualtrics (University of Michigan Health System 
[UMHS]-approved Qualtrics version). No identifying information will be collected via Qualtrics. Daily 
messages sent to participants will be sent via text messages to participants' phones using a secure study 
platform; the platform complies with the Health Insurance Portability and Accountability Act (HIPAA) 
privacy regulations. The platform will be hosted on a server whose data is encrypted at all times and 
which is secured in accordance with industry-standard data security practices. Moreover, participants 
will be informed of the risk that anyone who accesses their phone could see the supportive text 
messages. Participants will be encouraged that they can further protect their privacy by password-
protecting their phone/device. 
Participants’ confidentiality will be breached by the research study only to protect the safety and 
welfare of research participants and only in accordance with state and federal law. Although study 
assessments will not ask about child abuse, in the unlikely event that a participant self-discloses the 
abuse of a child, staff will be trained to report this information to local child protective services/family 
independence agencies. These confidentiality exceptions will be explained in detail to participants as 
part of the study consent process.  
 
It is NIH policy that the results and accomplishments of the activities that it funds should be made 
available to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms 
used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, 
and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not 

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be traceable to a specific study participant). Plans for archiving and long-term preservation of the data 
will be implemented, as appropriate.  
 
Certificate of Confidentiality: To further protect the privacy of study participants, the Secretary, Health 
and Human Services (HHS), has issued a Certificate of Confidentiality (CoC) to all researchers engaged in 
biomedical, behavioral, clinical or other human subjects research funded wholly or in part by the federal 
government.  Recipients of NIH funding for human subjects research are required to protect identifiable 
research information from forced disclosure per the terms of the NIH Policy (see 
https://humansubjects.nih.gov/coc/index). As set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 
8.3, recipients conducting NIH-supported research covered by this Policy are required to establish and 
maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance 
that the award is managed in compliance with Federal statutes, regulations, and the terms and 
conditions of award. It is the NIH policy that investigators and others who have access to research 
records will not disclose identifying information except when the participant consents or in certain 
instances when federal, state, or local law or regulation requires disclosure. NIH expects investigators to 
inform research participants of the protections and the limits to protections provided by a Certificate 
issued by this Policy. 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
Data collected for this study will be analyzed and stored at the University of Michigan for a minimum of 
three years after the conclusion of the award or public release, whichever comes later.  After the study is 
completed, the de-identified, archived data will be transmitted to a public repository and stored for use 
by other researchers, including those outside of the study. Permission to transmit data will be included in 
the informed consent. 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Adam Horwitz, PhD, Assistant Professor 
University of Michigan Medical School  
4250 Plymouth Rd., Ann Arbor, MI, 48109 
734-764-0231 
ahor@umich.edu 
10.1.6 SAFETY OVERSIGHT 
While we are specifically targeting students with mild-to-moderate symptoms of depression, there may 
be students whose symptoms worsen over the course of the study (as we would expect among first-year 
college students, regardless of study participation). Participants reporting suicidal thoughts in Qualtrics 
surveys will receive an immediate response including crisis hotline telephone numbers and the local 
Psychiatric Emergency Department.  

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As the PI, Dr. Horwitz will ensure that all relevant University of Michigan IRBMED policies, procedures, 
and stipulations are being followed. He will be responsible for ensuring that research staff adhere to the 
IRBMED policies, including: 1) all participants will understand and agree to an electronic consent form 
before participating; 2) all participants will be provided with a copy of the informed consent; 3) strict 
adherence to participant’s right to withdraw or refuse to answer any questions will be maintained; 4) the 
assessments will be completely confidential and no names will be associated with the assessment data; 
5) identifying information will be kept separate from the actual participant data; 6) all identifying 
information will be locked/saved with passwords on secure servers; 7) participants will be informed in 
writing in the consent form how to contact the PI and IRB office with any questions or concerns. 
10.1.7 CLINICAL MONITORING 
Study monitoring will be conducted to ensure that the rights and well-being of participants are protected, 
that the reported data are accurate, complete, and verifiable, and that the conduct of the study is in 
compliance with the protocol and with applicable regulatory requirements. Dr. Horwitz will be responsible 
for monitoring the data safety and quality. All research projects involving human participants require 
approvals from the University of Michigan Medical School’s Institutional Review Board (IRBMED). Annual 
reviews will be conducted by IRBMED, including the number of subjects screened, enrolled, and 
withdrawn. The IRB will also review protocol deviations, adverse events, and complaints that arise in 
connection with the study. As the PI, Dr. Horwitz will ensure that all relevant IRBMED policies, procedures, 
and stipulations are being followed.  
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
An emphasis will be placed on maintaining strict patient confidentiality. No participant names will be 
associated with the data. Forms containing identifying information will be kept separate from 
participant study data and electronic files will be password protected on secured servers. The study 
platform is HIPAA compliant and will use a secure SMS service (Twilio) to deliver text messages to 
participants. When data from Qualtrics is downloaded by investigators, the aggregated dataset will 
contain no PII. Quality control and reliability of assessments will be monitored by the PI, Dr. Horwitz. He 
will meet weekly with research assistants on the project to monitor the quality of the data files and 
identify any inconsistencies that may require adjustment to the programming of the Qualtrics survey or 
study platform.  
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection will be the responsibility of the research staff under the supervision of the PI. The PI will 
be responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data. Data will 
be collected only with informed consent. The primary sources of data will be gathered via 
questionnaires collected at: (1) screening/baseline survey, which will be collected through an e-mailed 
Qualtrics survey link; (2) weekly (six time-points) follow-up assessments, which will be collected through 
a texted Qualtrics survey link; and (3) daily surveys (intervention-only group), which will be collected 
through a texted Qualtrics survey link. Assessment instruments have been used widely and evaluated for 
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concerning acceptability of intervention components as well as input on barriers and facilitators to 
participation to inform future implementation. 
 
10.1.9.2 STUDY RECORDS RETENTION  
Study documents will be retained for a minimum of 3 years. 
10.1.10 
PROTOCOL DEVIATIONS   
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council 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 will be developed by the site and implemented 
promptly. Because study participation is voluntary, participants not completing aspects of the study are 
not considered protocol violations. Protocol deviations will be sent to the reviewing Institutional Review 
Board (IRB), NIMH, and DSMB per their reporting requirements. 
10.1.11 
PUBLICATION AND DATA SHARING POLICY  
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals.  Data from this study may be requested from other researchers by contacting the PI.  
Considerations for ensuring confidentiality of these shared data are described in Section 10.1.3. 
 
10.1.12 
CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence is critical. Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest 
will be required to have such conflicts managed in a way that is appropriate to their participation in the 
design and conduct of this trial. The study leadership in conjunction with the NIH has established policies 
and procedures for all study group members to disclose all conflicts of interest and will establish a 
mechanism for the management of all reported dualities of interest. 
10.2 ADDITIONAL CONSIDERATIONS 
N/A 

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10.3 ABBREVIATIONS AND SPECIAL TERMS 
 
Abbv. 
Abbreviated 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
EMA 
Ecological Momentary Assessment 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Council on Harmonisation  
IRB 
Institutional Review Board 
IRBMED 
Institutional Review Board Medicine  
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
MOP 
Manual of Procedures 
MRT 
Micro-randomized Trial 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PF 
Personalized Feedback 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
RCT 
Randomized Control Trial 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
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 
v.1.0 
07/08/2024 
Not applicable; this is the first 
version of the protocol 
Not applicable; this is the first 
version of the protocol 
v.1.1 
5.1.2025 
Updated enrollment to reflect 120 
recruited 
IRB amendment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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