Pilot Study on Mindfulness Meditation and Behavioral Flexibility Among Emerging Adults
Phase: NA
Conditions: Alcohol Abuse, Cognitive Deficit in Attention
Sponsor: University of North Carolina, Chapel Hill

 
Skills in Navigating College Life (SINC) 
 
 
NCT number NCT05560425 
Document Date 08/04/2022 
 

PROTOCOL TEMPLATE: INTERVENTIONAL STUDY 
 
Complete Title: Skills in Navigating College Life (SINC). 
Short Title: Skills in Navigating College Life (SINC). 
Drug or Device Name(s): 
FDA IND/IDE (if applicable): N/A 
Sponsor: 
Protocol Date: August 4th, 2022 (latest IRB approval) 
Amendment 1 Date: 
Amendment 2 Date:  
Amendment 3 Date: 
Amendment 4 Date:  
 
Sponsor (IND or IDE holder, if applicable) 
Sponsor Name 
Address 
City, State, Zip 
Country 
Study Principal Investigator (if multicenter study with UNC PI responsible) 
Office Address 
City, ST, ZIP 
Phone XXX-XXX-XXXX 
email: XXXXX@XXX.XXX 
 
PROTOCOL TITLE:  XXXXXX  
Short Title:  
XXXXX  
Lead Investigator: 
XXX XXXX, M.D. 
 University of North Carolina at Chapel Hill 
Protocol Version: XX.XX  
Version Date: XXX  XX, 201X 
 
I confirm that I have read this protocol and understand it.    
Principal Investigator Name:   
 
 
 
 
 
 
 
Principal Investigator Signature:  
 
 
 
 
 
 
 
Date:   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
 
ABBREVIATIONS AND DEFINITIONS OF TERMS ............................................................ 3 
PROTOCOL SYNOPSIS ................................................................................................................................... 4 
BACKGROUND AND RATIONALE .................................................................................................................. 6 
1 
STUDY OBJECTIVES ......................................................................................................................... 7 
2 
INVESTIGATIONAL PLAN ................................................................................................................. 7 
3 
STUDY PROCEDURES ...................................................................................................................... 9 
4 
STUDY EVALUATIONS AND MEASUREMENTS ............................................................................. 10 
5            STATISTICAL CONSIDERATIONS ................................................................................................. 11 
6 
STUDY INTERVENTION (DEVICE, DRUG, OR OTHER INTERVENTION) ....................................... 12 
7            STUDY INTERVENTION ADMINISTRATION (IF APPLICABLE) ..................................................... 12 
8         SAFETY MANAGEMENT ................................................................................................................. 13 
9          DATA COLLECTION AND MANAGEMENT ..................................................................................... 13 
10          RECRUITMENT STRATEGY ........................................................................................................... 13 
11          CONSENT PROCESS ..................................................................................................................... 13 
12          PLANS FOR PUBLICATION ........................................................................................................... 14 
13          REFERENCES ................................................................................................................................ 14 
APPENDIX ........................................................................................................................ 16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Abbreviations and Definitions of Terms 
 
Abbreviation 
Definition 
ABD 
Adolescent Binge Drinker 
CG 
Control group 
CRP 
C-reactive protein 
KM 
Koru Mindfulness 
MINI 
Mini-International Neuropsychiatric Interview 
NG 
Navigating College 
PHI 
Protected health information 
Co-PI 
Co-Principle Investigator 
Reward-AB 
Reward Attentional Bias 
UNC-CH 
University of North Carolina at Chapel Hill 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SYNOPSIS 
 
Study Title 
Mindfulness training effects on behavioral flexibility in emerging 
adults with a history of adolescent binge drinking. 
Funder 
UNC-CH TraCS pilot grant and Psychology & Neuroscience 
Departmental King Excellence Award 
Clinical Phase 
N/A 
Study Rationale 
Adolescent alcohol exposure is associated with heightened 
automatic responses to stimuli that impede execution of goal-
directed actions, and such behavioral inflexibility is a risk factor for 
alcohol and other substance use disorders. In this pilot study, we aim 
to determine the feasibility of delivering a 4-week online training of 
Koru mindfulness to freshman college students, in addition to a pre- 
and post-visit. Mindfulness meditation is known to reduce automatic 
responses to stimuli; however, it’s unknown whether mindfulness 
training can increase behavioral flexibility in emerging adults with 
adolescent alcohol exposure. Young college adults experience 
demanding academic and social schedules that challenge 
maintenance of healthy behaviors while learning to adapt to 
emerging adulthood. Mindfulness training is one strategy to support 
healthy outcomes that persist despite inevitable stressors. 
Study Objective(s) 
Primary  
• 
To determine the feasibility of subject recruitment, participant 
retention, visit attendance, and study design among freshman 
college students. 
Secondary 
• 
To assess participant satisfaction with study procedures. 
Test Article(s) 
(If Applicable) 
Koru Mindfulness Training 
Study Design 
 
This is a parallel assignment randomized controlled trial feasibility 
study. The two-armed study has the mindfulness meditation 
intervention and the control groups running parallel to one another. 
Participants are blinded to condition.  
Subject Population 
key criteria for Inclusion 
and Exclusion: 
Inclusion Criteria 
• 
College enrolled first-year students aged 18-19 years old 
• 
Internet access to enable online training 
• 
Fluent English speaker (< age 7) 
• 
>4 lifetime binge drinking episodes  
• 
Meditation-naïve  
Exclusion Criteria 
• 
Subjects with known neurological, psychiatric, or systemic 
disease 
• 
Subjects with any type of motor or visual disturbance that 
may interfere with performing the cognitive task 
• 
Subjects using psychoactive drugs (aside from moderate 
caffeine or alcohol) or medications 
• 
Subjects with a known history of any substance use disorder 
(not including alcohol or nicotine) or desire to seek treatment 
for excess substance use 
Number Of Subjects  
 
18  

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Study Duration 
• Each subject will undergo 4 weeks of intervention or control group 
training, a pre- and post-training visit, and a 1-month follow-up.  
• The entire study is expected to last 3 months. 
Study Phases 
Screening 
Study Treatment 
Follow-Up   
(1) Subjects screened for eligibility and obtaining consent; 
(2) Cognitive task performance, blood sample collection, surveys; 
(3) Four weeks of virtual training in Koru mindfulness or an age- and 
time-matched comparison group;  
(4) One-month follow up online surveys  
 
Efficacy Evaluations 
• Mean number of visits attended by participants and total number 
of journal entries. 
Pharmacokinetic 
Evaluations 
N/A 
Safety Evaluations 
Self-report measures of anxiety, depression, and stress will be 
evaluated at the beginning of each visit to determine any changes 
that could be in result of the intervention. 
Statistical And Analytic 
Plan 
• To assess the primary objective (feasibility) of the study, the 
primary outcome will be the count of participants in each of the 6 
visits, and the number of surveys that are completed at the 1-
month follow-up contact. 
• To assess the secondary objective (participant compliance), the 
secondary outcome will be measured by total journal entries 
submitted during the 4 weeks of intervention training.  
DATA 
AND 
SAFETY 
MONITORING PLAN 
The Co-Investigators will review participants’ experiences 
with study procedures on a weekly basis. Meditation practice may 
elicit discomfort if traumatic memories resurface or the participant is 
experiencing high stress. The Koru teacher is trained in trauma-
sensitive mindfulness and has implemented this awareness in the 
design of the visits. Nonetheless, the teacher will regularly check in 
with students to address any concerns. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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BACKGROUND AND RATIONALE  
 
 
1.1 Introduction 
 
Lifetime risk for developing an alcohol use disorder increases with earlier onset of alcohol consumption [1-3]. 
This risk may reflect a tendency for escalated alcohol intake among youth due to immature executive control, 
leading to more frequent binge drinking, which is associated with more alcohol-related problems [4, 5]. Binge 
drinking is associated with deficits in behavioral flexibility [6, 7], which may suggest impaired control networks 
that contribute to automatic behavior [8]. Individuals with an alcohol or substance use disorder (A/SUD) exhibit 
attentional bias toward drug- or alcohol-related stimuli that have attained salience through consistent use [9-13]. 
Reward history increases attention towards non-drug stimuli, even among individuals with no lifetime A/SUD [14, 
15]. Our preliminary data, from a nationally representative US adult sample using data collected via Prolific, 
found that a questionnaire measure of mindfulness moderates the relationship between alcohol misuse and 
attention to reward. Given evidence that heavy alcohol drinking impairs behavioral flexibility [6, 16], which in turn 
promotes escalating intake [17], insight into the relationship between mindfulness and behavioral flexibility could 
inspire new strategies to prevent alcohol and substance use disorders in people at elevated risk. 
 
1.2 Name and Description of Investigational Product or Intervention  
 
Koru Mindfulness (KM) Intervention Training 
The Koru Basic curriculum [18] will consist of four weekly interactive 75-minute classes delivered online through 
Zoom. Each class will consist of an overview of 2-3 skills, group practice of the skills, and group reflection. Class 
size will be limited to 9 participants. Participants will have their video off and will have their own unique identifier 
(instead of identification by name). Participants will be instructed to practice a skill for 10 minutes/day and log 
their reflection on that practice using the Koru phone application.  
 
Navigating College (NC) Control Group Training 
The control group will consist of four weekly 75-minute classes delivered online through Zoom. Each class will 
consist of lecture and group discussions on topics related to navigating college [19]. Participants will be instructed 
to journal about learned information and skills for 10 minutes/day. 
 
1.3 Non-Clinical and Clinical Study Findings 
 
Potential benefits of this study include learning skills that may help the participant navigate their college 
experience with more ease. Additionally, participants in the KM intervention may experience decreased stress, 
anxiety, and sleep problems [18].  
 
Answering the surveys may make the subjects uncomfortable and could cause emotional distress or 
embarrassment. Completing questionnaires and participating in computerized tasks may make subjects anxious 
or uncomfortable. Participants will be asked questions regarding use of illegal alcohol consumption (< age 21), 
use of illegal substances, and involvement in activities such as driving while under the influence of drugs and/or 
alcohol. To minimize this risk, participants may choose not to answer any question and they may terminate 
participation at any time during all tasks. Participant's data will only be identified using an ID assigned to them 
at the beginning of the study. Any paperwork that includes participants’ names or other personal information will 
be kept separate from study documents with their ID number and will be stored in a locked file cabinet in the 
locked lab. All data will be archived without personal identifiers, using only ID numbers. 
 
In 10 years of testing participants at UNC, including a study that recruited alcoholics (unlike this study), we have 
experienced a single instance of an acutely intoxicated participant arriving for a study, and no instances of 
participants in acute withdrawal. Therefore this scenario is highly unlikely. However, in the event that a participant 
arrives for a session intoxicated, we will help them arrange a ride home. If intoxication of withdrawal symptoms 
are severe, study personnel will escort participants to the UNC emergency room. 

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There are no risks for injury expected to occur with virtual discussion and training of mindfulness, meditation or 
college skills. Potential risks include boredom, fatigue, or discomfort with spending additional time on the 
computer, aside from schoolwork. Additional discomfort may arise during mindfulness practice for subjects who 
have previously experienced trauma or are currently experiencing high stress. Participants will be observed for 
any obvious discomfort and followed up with by the mindfulness teacher with trauma resources if necessary. 
Rare: A participant's personal information could be linked with their study data. To minimize this risk, no one 
outside of the research team will have access to participants’ data. Participants’ data will only be identified in all 
computer analyses with their ID numbers. Any paperwork that includes participants’ names or other personal 
information will be stored in a locked file cabinet in the locked lab. All data will be archived without personal 
identifiers, using only ID numbers. 
 
Potential minor risks and discomforts are associated with cognitive testing. Although it is hoped that subjects will 
complete the study, subjects may stop participation at any time during the cognitive testing.  
 
1.4 Relevant Literature and Data 
 
Our preliminary data, from a nationally representative US adult sample, found that a questionnaire measure of 
mindfulness moderates the relationship between alcohol misuse and self-report attention to reward (Figure 2). It 
is unknown whether increasing mindfulness will show similar effects using a task measure of attentional bias.  
 
The Reward-Attentional Bias (Reward-AB) task will be used to measure attentional bias pre- and post-
intervention. The task includes a training and testing portion, each of which are adapted from tasks described 
elsewhere that measure the influence of reward on visual attention [15, 20, 21].  
 
Although not a primary objective, trait mindfulness will be measured using the Five Facet Mindfulness 
Questionnaire (FFMQ) and Mindful Attention Awareness Scale (MAAS). The FFMQ contains 5 subscales, with 
Cronbach αs for the subscales range from 0.73 to 0.91 [22]. This measure has also been shown to reliably 
compare mindfulness pre- and post-training. The MAAS has been shown to have good 4-week test-retest 
reliability [23] and this measure correlates with other common measures of mindfulness, such as the Freiburg 
Mindfulness Inventory [24].    
 
STUDY OBJECTIVES 
 
The purpose of this pilot study is to explore the feasibility of the study design and compliance of freshman college 
students with task procedures.  
 
2.1 Primary Objective 
 
The primary objective will be to assess the feasibility of the study design and determine factors crucial to the 
success of a larger scale study, including those that influence recruitment and retention, consistency of practicing 
skills learned during training, and adherence to all study procedures.  
 
2.2 Secondary Objective 
 
Secondary objectives include participant satisfaction with study procedures, the expectancy of learning skills in 
their assigned training group, and satisfaction with skills learned during training. 
 
INVESTIGATIONAL PLAN  
 
3.1 Study Design 
 

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This proposed study is a parallel assignment randomized controlled trail. Interested individuals will be initially 
screened for psychiatric and neurological health, medications, use of psychoactive substances, the presence of 
study specific contra-indications, and prior experience with meditation. Participants who meet inclusion criteria 
according to the initial phone-based screening will then be invited to the lab for further screening and possible 
participation. Upon arrival and consent, subjects will be given a urine test to screen for psychoactive drugs and 
a breathalyzer test to detect alcohol currently in system. Positive results will exclude participants from further 
participation.   
 
Interested participants are instructed to first complete an online screening survey (through REDCap). Potential 
participants are then contacted for a more in-depth phone screen. When the participant comes in for the first 
visit, they will be screened for any current alcohol intoxication or recent substance use, followed by a mental 
health assessment with the Mini-International Neuropsychiatric Interview (MINI) [25]. The participant will then 
have blood collected by finger prick, complete the Reward-AB task, and fill out some paper surveys. During visits 
2 through 5, participants will complete virtual training on either mindfulness and meditation skills, or navigating 
college skills. Each visit will last approximately 90 minutes, starting with the completion of a few online surveys. 
Visit 6 is similar to visit 1, without the health interview. Participants will be contacted one month following the 
date of the 6th study visit to complete online surveys.  
 
3.2 Allocation to Treatment Groups and Blinding (if applicable) 
 
At the end of visit 1, participants will be randomly assigned to either the training group where they will learn 
mindfulness and meditation skills, or the control group to learn skills in navigating college. An online random 
number generator will be used to determine which subject IDs will be allocated to each training group (18 people 
total, 9 in each group).   
 
3.3 Study Duration, Enrollment and Number of Subjects 
 
The entire duration of the study is expected to take no more than 3 months. About 5-6 weeks will elapse from 
the first visit to the 6th visit, and the inclusion of a one-month follow-up survey adds another 4 weeks, totaling a 
little over 2 months. Eighteen subjects are expected to be enrolled in the study, with 9 participants randomized 
to each of two training groups (Koru Mindfulness as the intervention training, Navigating College serving as the 
age- and time-matched comparison group).  
 
3.4 Study Population 
 
Inclusion Criteria 
• 
High school educated; college enrolled first-year student 
• 
Medically healthy 
• 
Ages 18-19 
• 
Native-English speaker (or fluent < 7 years old)  
• 
Self-report of >4 lifetime binge drinking episodes (>4 drinks/2hours for females, >5 drinks/2 hours for 
males). 
 
Exclusion Criteria 
• 
Psychiatric disease (such as depression or psychosis) using the MINI [25] 
• 
Systemic disease such as cancer, cardiovascular or inflammatory disease which could influence 
cognitive functioning 
• 
Motor or visual disturbance (e.g., colorblind)  

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• 
Current use of psychoactive drugs (aside from moderate caffeine or alcohol), including prescription 
medications, or individuals with a known history of any substance use disorders (not including alcohol; 
including nicotine) or desire to seek treatment for excess substance (not including alcohol) use.  
 
STUDY PROCEDURES  
4.1 Screening/Baseline Visit procedures 
 
Individuals who show initial interest in the study are contacted via phone or e-mail with a questionnaire containing 
items related to psychiatric and neurological health, medications, use of psychoactive substances, the presence 
of study-specific contra-indications, and prior experience with meditation. Evidence of neurological or psychiatric 
disorders, current use of psychoactive medications or other drugs (excluding alcohol or moderate caffeine), or 
prior experience with meditation will result in non-inclusion in the study. For the purpose of this study, meditation 
includes loving kindness, guided imagery or visualization, qi gong, and yoga. Those participants who meet 
inclusion criteria according to initial phone screening will be invited to the lab for further screening and possible 
participation. Upon arrival to the initial visit, after reading and signing the informed consent form, subjects are 
given a urine test to screen for psychoactive drugs (amphetamine/methamphetamine/MDMA (“ecstasy”), 
cocaine, opiates, THC, and PCP) and a breathalyzer test to detect alcohol currently in system (approx. 5 
minutes). Results of these screening tests are not written down, but positive results will exclude participants from 
further participation. 
 
4.2 Intervention procedures (by visits) 
 
See Figure 1 for overview of study visits. 
 
Visit 1 
• 
Written consent, MINI interview [25], urine drug screen and breathalyzer alcohol test, C-reactive protein 
(CRP) assay, Reward-AB task 
Visits 2-5 
• 
Randomization to either the Koru Mindfulness (KM) intervention or the Navigating College (NC) control 
group. 
• 
Each training visit will consist of the following:  
o Surveys completed online through REDCap. 
o 75 minutes of instructor-led discussion  
o Breakout sessions for participants to share their thoughts and experiences in response to 
instructor’s prompt. 
 
Navigating College (NC) Control Group Training 
Topics discussed during each training visit include: habits, roommate issues, homesickness, the internet (week 
1); strategies when sinking, study skills, getting involved, habit formation (week 2); HALT, gateway habit (week 
3); and academic success tips, taking notes, and procrastination (week 4). 
 
Koru Mindfulness (KM) Intervention Training 
Topics discussed during each training visit include: belly breathing, dynamic breathing, body scan (week 1); 
walking meditation, gatha (week 2); guided imagery, labeling thoughts (week 3); eating meditation, and labeling 
feelings (week 4).  
 
Daily Logging of Skills 
Participants in the CG intervention will be asked to journal by hand or via Qualtrics every day for >10 minutes, 
on anything related to the topics learned during that week’s training visit. Participants in the KM intervention will 

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be asked to practice every day for >10 minutes any mindfulness or meditation skill previously learned during 
training visits, in addition to logging their practice and reflection using the Koru application.  
 
Visit 6  
• 
Similar to visit 1, without repeating the MINI interview. 
 
4.3 Follow- up procedures (by visits) 
One month after the conclusion of visit 6, participants will be recontacted via email with a link to REDCap to 
complete several surveys. 
 
4.4 Subject Completion/ Withdrawal procedures 
 
Participants will be screened for drug and alcohol use upon arrival to visits 1 and 6. If the test results from a urine 
sample and breathalyzer are positive, subjects will be withdrawn from the study. If participants in the KM group 
are experiencing extreme discomfort during weeks when visits 2-6 take place, due to resurfacing of traumatic 
experiences, subjects will be withdrawn from the study and given resources (see attachments) to alleviate 
distress. Investigators may also terminate an individual's participation if the subject is uncooperative or otherwise 
behaves in a way that makes study personnel feel uncomfortable or unsafe. 
 
4.5 Screen failure procedures 
 
All study personnel will review study materials required for screening and will be trained in phone screening, 
including conducting interviews with the MINI. Personnel will also be trained in blood collection by finger prick so 
that any safety concerns can be addressed. Voicemails and emails left by interested participants will be checked 
daily.   
 
STUDY EVALUATIONS AND MEASUREMENTS   
Surveys, a CRP assay, and the Reward-AB task will be administered pre- and post-training of skills learned in 
the intervention or control group. Surveys will be administered at the beginning of each training visit.   
 
5.1 Surveys 
To identify factors that may contribute to individual or group differences, participants will complete several 
questionnaires via REDCap [26] or in person. These include the Credibility/Expectancy Questionnaire (CEQ; 
[27]) to measure expectancy/credibility of the intervention and control groups, self-report measures of substance 
use and consequences: the Alcohol Use Disorder Identification Test (AUDIT; [28]), an Alcohol-Related Blackouts 
Questionnaire (ARBQ; see appendix); the Carolina Alcohol Use Patterns Questionnaire  [CAUPQ], which is a 
modified version of the Alcohol Use Questionnaire [29], the Daily Drinking Questionnaire (DDQ; [30]), the 
Rutgers Alcohol Problem Index (RAPI; [31]), the Brief Young Adult Alcohol Consequences Questionnaire (B-
YAACQ; [32]), and the Drinking Motives Questionnaire-Revised (DMQ-R; [33]); measures of familial alcohol 
misuse [34], adult resilience (ARM-R; [35]), depression, anxiety and stress (DASS-21; [36]); and personality 
measures with the Barratt Impulsiveness Scale (BIS-11; [37]). We will also collect two questionnaire measures 
of behavioral flexibility: Value-Driven Attention Questionnaire (VDAQ; [38]) and the Creature of Habit Scale 
(COHS; [39]). Finally, we will administer two indices of mindfulness: the Five Facet Mindfulness Questionnaire 
([FFMQ; [22]) and the Mindful Attention Awareness Scale (MAAS; [23]). 
 
5.2 C-Reactive Protein (CRP) Assay  
Using aseptic technique, we will use a contact-activated lancet to collect a small blood sample from the finger to 
generate a dried blood spot (Approximately 1 cm diameter on Cytiva Watman 903 cards) for use in CRP 
quantification assays. Blood will be collected on the indicated cards designed for this purpose, marked with the 
participant’s ID code which will then be airdried, sealed in a freezer bag with silica gel packs, and placed in a 
designated area within a freezer. Commercially available Simple Plex microfluidic cartridge immunoassays (Bio-

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Techne, https://www.proteinsimple.com/ella.html) will be used. In all cases, every sample is run in triplicate, and 
the cartridge will include positive and negative controls.   
 
5.3 Reward-Driven Attention Bias (Reward-AB) Task 
The Reward-AB task is a modified version of tasks measuring the influence of reward on visual attention [15, 20, 
21]. Participants will complete the reward-conditioning phase (training) followed by the testing phase of the task. 
In brief, participants are instructed to indicate the orientation (vertical/horizontal) of a line inside a target circle 
(blue/yellow) among an array of circles. One color is associated with probabilistic (80%) monetary reward for 
correct responses; the other target color does not yield a monetary reward for a correct response. The training 
phase consists of two 60 trial runs. The testing phase of the Reward-AB task measures attentional control in the 
presence of a reward-conditioned distractor [21]. In this component, two colored circles appear on either side of 
a fixation cross. Inside each circle is a letter, either a target letter (‘S’ or ‘P’), or a neutral letter (‘E’ or ‘H’). 
Participants are instructed to pick the target letter, with correct answers not associated with any monetary reward. 
There are 3 runs of the testing phase, with each run consisting of 120 trials. The total duration of the task is ~30 
minutes.   
 
5.4 Safety Evaluations 
The DASS-21 will be used to measure depression, anxiety and stress and will be administered at the beginning 
of each visit. Scores will be used to evaluate any within-subject changes that may prompt further review. The 
KM instructor will read logs daily and determine if any participant should be followed up with.   
 
STATISTICAL CONSIDERATIONS  
 
6.1 Primary Endpoint 
 
1. Feasibility assessment [Time Frame: every week] 
a. The feasibility of the study design will be measured using the total number of eligible participants, 
and retention rate for each visit, in addition to the one-month follow-up survey of enrolled 
participants. Compliance with individual training will be determined by the mean number of journal 
entries submitted per week in each group, due to previous evidence demonstrating an association 
between amount of homework completed and positive outcomes [40].   
 
6.2 Secondary Endpoint 
 
1. Participant satisfaction [Time Frame: 4 weeks] 
a.  Feedback will be collected the same day as each training visit, using a simple survey designed 
on Qualtrics.  
2. Depression, Anxiety, and Stress Scale (DASS-21) [Time Frame: 8 weeks] 
a. The DASS-21 consists of three self-report scales used to measure depression, anxiety and stress. 
This is a shortened form of the original DASS [36], which contains 42-items but shows no 
improvement over the 3-factor model for the 21-item scale [41]. The DASS-21 has been validated 
in non-clinical samples, and may even be used to measure an overall level of psychological 
distress [42]. In a non-clinical sample of Greek adults 18 years of age and older, the DASS-21 
showed satisfactory reliability, with Cronbach alphas of 0.85, 0.84, and 0.84 for the depression, 
anxiety and stress scales, respectively [43]. There was also high convergent and discriminant 
validity of the three scales in this same sample.   
3. Credibility/Expectancy Questionnaire (CEQ) [Time Frame: 1 week] 
a. Questions on the CEQ are used to measure the credibility of an intervention and treatment 
expectancy in clinical studies [27]. However, due to methodological limitations of comparison 
groups for mindfulness meditation (e.g., waitlist control group doesn’t match intervention in any 

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way), evaluating the credibility of the control group intervention and the expectation of benefit to 
participants in both groups will facilitate the design of better comparison groups than those that 
currently exist.  
 
6.3 Statistical Methods 
 
The total number of eligible participants will be used as a measure of successful recruitment strategies and 
feasibility of enrollment criteria. The mean number of self-report training or journaling days recorded by 
participants and the total number of visits attended by each participant will be used as measures of compliance 
with study procedures. The number of times discomfort is reported by participants with any training procedure 
will be used as a measure of safety. A within-subjects ANOVA will be used to analyze the change in DASS-21 
scores across the training visit weeks, including the total score and scores for all 3 subscales. A 1-Sided t-Test 
will be used to analyze the mean difference in CEQ score between the intervention and control group.  
 
6.4 Sample Size and Power 
 
A power analysis is not applicable for this pilot study due to the small number of subjects intended to be recruited 
solely for the purpose of determining the feasibility of conducting described study procedures.   
 
6.5 Interim Analysis 
 
The study will be stopped for any individual participant if the reported level of discomfort described by the 
participant in their journal entries or meditation logs is considered to be more than minimal by a trained clinical 
psychologist (Co-PI), if their DASS-21 scores increase significantly from one visit to the next, or if they report 
that the study procedures themselves have contributed to any discomfort/distress.    
 
STUDY INTERVENTION  
 
7.1 Koru Mindfulness (KM) Intervention Group 
 
Koru Mindfulness is a 4-week mindfulness meditation training initially designed for the emerging adult population 
(considered < 29 years). The skills are intended to help young adults manage stress, and thus can be advertised 
as an opportunity to learn skills in navigating college without having to mention mindfulness training anywhere 
in recruitment materials. The intervention will be delivered online through Zoom by a certified Koru instructor, 
with the goal of assessing the feasibility of an accessible intervention for college students. Koru is delivered with 
a mix of PowerPoint slides, group training of mindfulness and meditation skills and discussion, and daily logging 
of practice with an application or journal. The training is accompanied by the book The Mindful Twenty-Something 
[44].  
 
Participants will be encouraged to practice daily any of the mindfulness and meditation skills that were previously 
learned. To incentivize compliance with training, monetary incentives will be given to individuals who practice >3 
days/week and those who practice >5 days/week.  
 
7.1 Navigating College (NC) Control Group  
 
The NC training is designed to match the KM training in at least the total duration of the training, the duration of 
each individual visit, the practice of daily training of a skill, class structure, and instructor. The skills taught are 
directly related to the topics discussed in the Freshman Survival Guide: Soulful Advice for Studying, Socializing, 
and Everything In Between [19]. 
 

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Participants will be encouraged to write in their paper journal or online (via Qualtrics) for about 10 minutes every 
day. Prompts with suggested topics for reflection will be provided.  
 
STUDY INTERVENTION ADMINISTRATION   
 
8.1 Administration for Training Groups 
 
After Visit 1, participants will be randomized to either the intervention or control group using a randomized 
number computer generator (e.g., 01-18 assigned to mindfulness meditation group). The NC and KM training 
instructor will be blinded to the group each participant is randomly assigned to, and participants will be assigned 
a unique ID to put as their name for their Zoom profile and on questionnaires. This number will be given (and 
recorded) by a research assistant. During training visits, all videos (except the instructor’s) will be turned off.  
 
SAFETY MANAGEMENT  
 
 
We do not anticipate participant safety to be an issue in this study. Proposed procedures do pose a risk of 
harm if safety protocols are not followed carefully. To ensure participant safety, all participants will be 
thoroughly screened by trained personnel for the presence of conditions that could pose a threat to the subject. 
All research personnel will be trained in blood collection by finger prick. Daily practice logs will give participants 
a safe space to share any discomfort experienced during training. If participants in the KM group are 
experiencing extreme discomfort during weeks when visits 2-6 take place, due to resurfacing of traumatic 
experiences, subjects will be withdrawn from the study and given resources to alleviate distress. Logs will be 
checked daily. Any adverse event related to the training or blood collection will be immediately reported to the 
Principal and Co-Investigators.  
 
DATA COLLECTION AND MANAGEMENT  
 
We will obtain a certificate of confidentiality for this study. A participant's personal information could be linked 
with their study data. To minimize this risk, no one outside of the research team will have access to 
participants’ data. Participants’ data will only be identified in all computer analyses with their ID numbers. Any 
paperwork that includes participants’ names or other personal information will be stored in a locked file cabinet 
in the locked lab. All data will be archived without personal identifiers, using only ID numbers. Emails to 
participants will be encrypted.  
 
RECRUITMENT STRATEGY 
 
Participants will be recruited through IRB-approved flyers distributed within the University of North Carolina at 
Chapel Hill community, and through first-year Psychology courses that give class credit in exchange for 
participation in research studies. No Protected Health Information (PHI) will be accessed prior to contacting 
participants. Potential subjects who respond to these advertisements will be contacted initially via telephone or 
encrypted email. If contacted via email, subjects will be scheduled for an initial telephone screening to 
determine eligibility status. Those meeting inclusion criteria based on the phone interview will be scheduled for 
all study visits.  
 
CONSENT PROCESS 
 
 
Individuals who show initial interest in the study are contacted via phone or e-mail by study personnel and 
once consent is verbalized, the individual is asked about psychiatric and neurological health, medications, use 
of psychoactive substances, the presence of study-specific contra-indications, and prior experience with 
meditation. Participants will be emailed the consent form to review before the first study visit. Upon arrival to 
the first study visit, the research assistant will review the consent form with participants, ask whether the risks 

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and benefits of the study are understood, and answer any questions. Participants will then read and sign the 
informed consent form.  
 
PLANS FOR PUBLICATION  
 
The data collected from this pilot study may be included in papers based on full scale follow-up studies.    
 
 
 
 
 
 
 
 
 
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APPENDIX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2. The relationship between alcohol misuse, attentional capture, and acting with awareness. Among 
individuals with low or average levels of alcohol misuse in the past year, greater levels of acting with awareness 
(one facet of the FFMQ) is associated with reduced attentional capture among individuals who misused alcohol 
before age 21. FFMQ, Five Facet Mindfulness Questionnaire. 
Figure 1. Study design.  

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