Behavioral Economic Treatment to Enhance Rural Living
Phase: NA
Conditions: Alcohol Use, Unspecified
Sponsor: University of Michigan

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Full Study Title: Behavioral Economic Treatment to Enhance Rural Living  
 
IRBMED #: HUM00181940 
 
ClinicalTrials.gov ID: NCT05235971 
 
Principal Investigator: Lara N. Coughlin, PhD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Protocol 
 v.11 04/11/2023 
 
 
 
IRBMED #: HUM00181940 
 
Study Title: BETTER Living 
 
Full Study Title: Behavioral Economic Treatment to Enhance Rural Living 
 
Principal Investigator: Lara N. Coughlin, PhD 
 
Co-Investigators:  
Fred Blow, PhD 
                                 Inbal Nahum-Shani, PhD 
 
 
 
Maureen Walton, PhD, MPH 
 
 
 
Erin Bonar, PhD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Background 
 
     Risky alcohol use (i.e., AUDIT-C1,2 ≥3 in females and ≥4 in males), increases risk for adverse 
health outcomes (e.g., injury,3 impaired driving,3 or alcohol use disorder4). Risky alcohol use is 
wide-spread,5 economically burdensome,6 and under-treated in healthcare settings.7,8 Research 
is needed to develop more effective and scalable interventions with improved reach to reduce 
this public health burden. 
 
Risky drinking in rural regions. Rural drinkers exceed recommended daily alcohol use limits 
at higher rates9 and have greater symptom severity10 than urban/suburban counterparts. 
Compounding the problem, interventions in rural areas are more costly,11 of lower quality,12 and 
less accessible.13 Sparsely populated rural areas face barriers beyond access. To be 
successful, interventions must overcome challenges such as social and geographical isolation, 
limited availability of alternative, healthier behaviors, and resource poor lifestyles.14–17 
Personalized interventions can overcome these barriers by providing relevant content despite 
contextual limitations. Primary care is an excellent setting for identifying risky drinkers eligible 
for mobile health (mHealth) early interventions, reducing the need for more intensive future 
treatment.10,18,19 Remotely-delivered interventions provide feasible, potentially low-cost means 
for reaching rural adults.20 Due to the shrinking digital divide,21,22 cell phone use is nearly 
ubiquitous (91% of rural Americans own cell phones).23 Text message and phone-based 
modalities are recommended for rural interventions where app- and web-based options meet 
technological shortfalls.24 We propose to develop a text-based personalized intervention 
specifically to reduce risky drinking in rural adults.  
 
Risky drinking as a reinforcer pathology. Behavioral economics (BE) is theoretically 
established in addiction research, with strong empirical support and 
objective assessment tools. To date, however, BE has infrequently 
been applied to prevention interventions, yet BE may be critical for a 
new generation of enhanced early interventions for at-risk groups. 
Reinforcer pathology, a BE theory of addiction, posits that 
problematic alcohol use is related to the overvaluation of alcohol 
relative to alternative behaviors and undervaluing future 
reinforcement from alternative behaviors relative to the immediate 
reinforcement of drinking. Reinforcer pathology can be measured 
through two distinct but intersecting processes: excessive demand, 
or the persistently high valuation of a reinforcer measured via the 
Alcohol Purchase Task, and excessive delay discounting, or the 
excessive preference for immediate reinforcement measured via the 
Delay Discounting Task (see Fig. 1). Rigorous prior research, using well controlled, 
experimental studies support the phenomena of increased demand and excessive future 
discounting as hallmarks of addiction.25–30 For example, compared to non-problematic drinkers, 
non-treatment seeking heavy drinkers exhibit greater alcohol demand at a minimum price (i.e., 
demand intensity),31,32 less sensitivity to price increases (i.e., inelastic demand),31,32 and greater 
discounting of the future than non-problematic drinkers.25  
 
Behavioral Economic Treatment to Enhance Rural Living (BETTER Living). Mobile health 
interventions have great potential to increase access and quality of care but have not yet met 
this potential due to a failure to test key theoretical concepts outside of lab settings and in 
clinical populations as well as a need to develop and test interventions using mHealth to 
minimize loss of effectiveness on translation.33 Considerable evidence implicates BE processes 
in the progression and maintenance of disordered substance use; however, development and 

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testing of BE interventions to intervene with and repair reinforcer pathology is very recent.34–3637–
39 These interventions have largely focused on either diminishing demand for alcohol or 
reducing discounting. A critical gap exists in that BE interventions have been studied largely in 
isolation from one another, despite the theoretical basis of reinforcer pathology suggesting a 
need for combined interventions (Fig. 1). Because reinforcer pathology is a multicomponent 
phenomenon, developing multicomponent interventions to target both processes may be most 
effective. Therefore, we propose to develop and assess acceptability/feasibility of two remotely-
delivered intervention components and evaluate the degree to which they modulate 
hypothesized BE processes (i.e., demand and delay discounting) to repair reinforcer pathology 
and curb alcohol use. Both interventions components proposed here, Volitional Choice (VC) and 
Episodic Future Thinking (EFT), include personalized statements suited for mHealth delivery via 
text message.  
Interventions 
EFT identifies and describes positive, non-alcohol related events at future time points to 
facilitate extension of temporal consideration toward future-focused perspectives (e.g., “A month 
from now I’m going to take my kids to the fair where we will eat cotton candy and ride the Ferris 
wheel.”) In laboratory studies, EFT improves alcohol-induced deficits in prospective memory,40 
reduces alcohol consumption,41 and decreases delay discounting and demand intensity,41,42 but 
does not change other demand metrics.41,42 
VC creates structured if-then plans to dismantle context-linked alcohol use. VC, informed by the 
transtheoretical model of behavior change,43 facilitates alternative, healthier choices by 
identifying and linking risky cues with alternative actions.44 (e.g., “If I feel like drinking after a 
stressful day, then I’ll watch Netflix and lift weights instead,” “If I’m home alone and tempted to 
go buy beer, then I will head outside and work on my car instead.”). VC identifies healthier 
alternative strategies to substitute for alcohol use. VC reduces alcohol use in risky drinking 
college students and our prior shows similar reductions in adults.45–47 
VC and EFT statements will be collaboratively personalized with participants during a 
phone-based mid-way session for twice daily text message-based delivery over a 2-week 
period. The collaborative, highly personalized, and deliberate identification of risky drinking 
contexts and alternative strategies, in VC, and positive future events, in EFT, to construct these 
statements is critical in rural environments where alternatives are scarce, resources are limited, 
and isolation both, geographically and socially, is common.14–17 Through iterative, participatory-
based intervention development and refinement (Aim 1) and a pilot randomized controlled trial 
(RCT) in the target rural population to maximize likelihood of future translation (Aim 2), we will 
harness the largely untapped potential of mHealth and address weaknesses of prior BE 
interventions by setting the stage for a future multicomponent intervention proposal to reduce 
risky drinking via repair of reinforcer pathology. 
The guiding framework for this intervention can be found in Figure 1. 
  
Objective 
 
The specific aims of this project are to: 
 
Research Aim 1: Conduct participatory-based intervention development to adapt and refine VC 
and EFT for remote delivery to rural risky drinkers through field and focus testing. 
Research Aim 2: Employ a randomized controlled trial of the intervention components (N=85).  
2a: Evaluate technical feasibility of procedures, intervention components, and mobile 
delivery methods.  
2b: Assess acceptability of intervention components (satisfaction, perceived usefulness, and 
engagement).  
Aim 2 Methods 

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Enrollment 
     Target enrollment is up to 85 adults residing in rural-designated area (e.g., county, zip 
codes) with at-risk alcohol use.  
 
Recruitment Procedures 
Research assistants (RAs) will recruit patients in-person at clinic appointments or 
remotely (phone, text, email or postal mail) after identification via reviewing the EHR for 
participants who may be eligible for the study (waiver of consent and HIPAA waiver are 
requested for this).. Research staff will review records of patients who reside in rural areas  
(e.g., Shiawassee county). Results of record reviews will be kept in a screening log, which 
identifies which records have been reviewed, the preliminary eligibility of the patient, and the 
outcome of the contact with research staff (e.g., approached/called, enrolled, declined, 
ineligible, etc.). Staff review the EHR for indication that the participant may be excluded prior to 
approaching them (e.g., acute psychotic episode and unable to provide consent, currently 
pregnant) in order to limit the number of people approached who would not be eligible. To be 
eligible for screening, the patient must be 18 years or older, understand English, able to provide 
informed consent (medical/physical state does not preclude consent), and reside in rurally 
designated area. For in-person recruitment, RAs will approach patients in the clinic (e.g., waiting 
room) for consent to self-administer a brief web-based screening survey on iPads (paused 
during medical care). For remote recruitment, RAs will reach out to patients by phone, text, 
email or postal mail using a standard recruitment script adapted from previous studies which 
describes our study as one which is focused on health, well-being, and risky behaviors (i.e. use 
of alcohol, consequences of use). Interested participants will be asked to give verbal screening 
informed consent or complete an online screening consent form in Qualtrics (waiver of 
documentation is requested) and, after consent is obtained, will complete a 3-minute 
screening survey. Participants screened in person will receive a gift valuing $1.00 for survey 
completion (e.g., crossword puzzle book, deck of cards, lotion, etc.)  
Participants will also be recruited using flyers. Potentially eligible participants who 
contact the study team will be screened remotely (phone, text, email) for eligibility screening.  
Those meeting eligibility criteria (see below) on the screening survey will be eligible for 
the baseline session. Those interested in participating will have the option to complete an online 
baseline consent form (for remote recruitment) or review the consent with a RA (in person or by 
phone; waiver of documentation is requested). Interested participants will begin baseline 
activities after providing consent. 
      
Study Eligibility Criteria 
Inclusion criteria: (1) adults (ages 18 and older) presenting in primary care and (2) home 
address in a rural area (e.g., zip code, county), and (3) an AUDIT-C score of ≥3 in females or ≥4 
in males and (4) regular access to an internet-enabled device (e.g., smartphone, computer, 
tablet). Exclusion criteria: (1) Does not understand English; (2) currently pregnant; (3) unable to 
provide informed consent due to medical/psychiatric reasons, (4) currently in treatment for a 
substance use disorder. Potential participants may be excluded based on participant best 
interest (e.g., if patient has plans to move out of the country during the study period; adult 
patient with a legal guardian; actively enrolled in another behavioral intervention research study, 
given the potential confounding effect of receiving multiple interventions on study outcomes; or if 
study staff know a patient or their family personally, in order to fully ensure participant privacy), 
with PI approval.     
 
Study Procedures 
After enrolling in the study, participants will complete a ~1 hour baseline session 
(remotely via Qualtrics and/or by phone using a mailed/emailed copy of the survey), including a 

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15–20-minute Timeline Follow-Back (TLFB), a delay discounting task, alcohol purchase task, 
measures about anxiety, depression, food craving, motivation to change alcohol use, 
mindfulness, impaired driving, alcohol use severity, other substance use, consequences of 
alcohol, and consideration of future consequences (see list of measures below). Participants will 
be compensated $30 for completion of the baseline session.  
Following completion of the baseline assessment session, participants will be invited to 
complete a mid-way session by phone or video chat, for which they will be randomized to one of 
four conditions (episodic future thinking, volitional choice, both episodic future thinking and 
volitional choice, or monitoring only). Randomization of participants to condition will be balanced 
by age and sex, and participants will be enrolled in the study after randomization. The mid-way 
session may be audio recorded and will last approximately 30 minutes during which time 
participants will identify personally-relevant reminders, or cues, that they will receive via text-
message over the following 2-week field testing period for all active conditions, in the monitoring 
only condition participants will receive general psychoeducation about alcohol use, mental 
health, resources, and a description of the assessments to be completed over the 2-week field 
testing period. Intervention cues developed by participants (e.g., “If I am thirsty for a beer, then I 
will have a Coke instead”) may be included in the mid-way session as examples for future 
participants to help participants develop personally useful intervention cues. Participants will be 
compensated $30 for completion of the mid-way session.  
During the 2-week field testing period, participants will receive up to 3 text 
messages/day including both assessment messages (e.g., How many drinks did you have 
yesterday?) and intervention messages (i.e., based on the personalized intervention cues 
developed during the mid-way session). Participants will be compensated up to $42 for 
responding to daily messages ($3/message x 1 assessment messages/day x 14 days).  
Following the intervention, participants will be compensated $35 for completing a ~1 
hour post-test/focus testing session, $40 for completing a follow-up assessment at 2-months 
(mirroring baseline assessment), and $25 for completion of all surveys and at least 90% of text-
based assessments. Assessments may be completed by phone/video chat and/or remotely via 
Qualtrics, based on participant preference. Assessment reminders will be sent in a variety of 
ways which may include via e-mail, text message, social media private message, mail and/or 
phone call. 
 
Measures will include reliable, valid measures from prior work: 
 
Screening measure 
 
Alcohol use frequency, AUDIT-C1,2 
 
Baseline measures 
 
Demographics questionnaire 
 
Gun Carriage 48  
Locations they drink most 
Drug Use Questionnaire 
Rural Identity Scale 
Cognitive Regulation Questionnaire 
 
Baseline, Post-test and Follow-Up measures 
 
Hypothetical delay discounting task 25,28 
Activity Level Questionnaire54 
 
Hypothetical alcohol purchase task 55 
Anxiety scale, GAD-2 57 
 
Depression scale, PHQ-2 58 

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WHOQoL-Brief 
 
Food insecurity 
 
Food cravings scale 59 
 
Nicotine use questionnaire 
 
CUDIT-R 
 
Importance, Self-efficacy, Intention rulers 56 
 
Mindfulness Attention Awareness scale 63 
 
Sleep quality measure 
 
Loneliness measure 
 
Pain, Enjoyment of Life, and General Activity Scale 
 
Impaired Driving 60 
Alcohol use severity, AUDIT 51 
 
Consideration of Future Consequences 62 
 
Drinking Motives Questionnaire (DMQR) 
 
Penn Alcohol Craving Single Item 
Alcohol use frequency, Timeline Follow-back 52,53 
 
Alcohol use consequences, SIP-R 61 
 
Acceptability and satisfaction questions 
 
Daily-level assessments 
 
Prior day alcohol use (daily) 
 
Adaptive brief delay discounting task 64 
 
Substance-free-activities-Brief 
Brief Alcohol Demand Task 65 
 
Data Management and Statistical Design 
 
Data entry methods 
The majority of data in this study are obtained via web-based Qualtrics surveys which 
will be downloaded to secure servers. Qualtrics surveys will be administered by research staff 
over the phone or via text-message. Data entry will take place for participant tracking (e.g., 
assigned condition) using databases on our secure servers, and text-message logs will also be 
entered into databases on our secure internal servers. Manually entered data will be double-
entered and checked during quality-assurance procedures 
 
Data analysis plan 
 
Aim 2. Feasibility and acceptability of the intervention, including retention and engagement, 
participant satisfaction, daily data response rates, and qualitative participant impressions will be 
collected. Descriptive analyses will be used to inform future adjustments to the intervention to 
increase feasibility and acceptability.  
 
Power Analysis: We are not powered for efficacy as the primary goal of this proposal is to 
develop and prepare the intervention through evaluation of feasibility and acceptability for future 
optimization in larger studies.  
  
Effect Size: The novelty of translating the behavioral economically-informed interventions for 
technology-based delivery necessitates preliminary preparatory studies. This study will provide 
acceptability and feasibility data and will assist in identifying preliminary moderators and 
mechanisms of behavior change. We have no basis for listing an expected effect size. Because 
pilot studies are not powered for efficacy, we will examine if the pattern of change is in the 

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desired direction and quantify the uncertainty in effect size estimates using 95% confidence 
intervals.   
 
Data Safety Monitoring Plan 
 
Responsibility for data and safety monitoring 
 
The investigators will be responsible for monitoring the trial and data quality and safety.  
Dr. Coughlin (PI) will ensure that all relevant IRBMED policies, procedures and stipulations are 
being followed and she will be responsible for ensuring that project staff adhere to the UM 
IRBMED policies including the following: (1) All participants will understand, agree to, and 
provide consent before participating;  (2) Strict adherence to a participant’s right to withdraw or 
refuse to answer questions will be maintained; (3) Assessments and interventions will be 
confidential and no names will be directly associated with the obtained research data; (4) 
Identifying information will be kept separate from the coded participant data; (5) All identifying 
information will be kept locked at all times and computer files will be saved with passwords on 
secure servers; and (6) Participants will be informed in the consent form on how to contact the 
PI and IRBMED office with any questions and/or concerns. In directly supervising research staff, 
the investigators will be responsible for monitoring these confidentiality procedures. Quality 
control and reliability of screening, baseline and follow-up data will be monitored via regular 
meetings where data frequencies are examined. 
 
Data Confidentiality Plans 
  
Our study team will take the following steps to minimize potential confidentiality 
breaches. As done in prior research and deemed HIPAA compliant by the IRBs at University of 
Michigan (U-M) by use of a waiver of HIPAA authorization, minimal clinical data will be collected 
on patients who refuse to participate in the screening survey, and on patients who the research 
assistants fail to contact. The mid-way session and post-test/focus testing interview may be 
audio-recorded to ensure fidelity and audio recordings will be destroyed after the conclusion of 
the study. 
  
For each stage of the proposed research investigation, participants’ names and contact 
information will be stored in a secure, password-protected database, separate from their study 
data and only accessible to members of the research team for research purposes. Any paper 
documents (e.g., patient tracking log) will be stored in locked file cabinets only accessible to 
study staff, separate from study data. Any additional documents with identifying information 
linked to individual ID numbers will be only accessible by study staff and stored separate from 
study data, and in locked file cabinets or in restricted access folders on a secure server (e.g., U-
M Dropbox) and destroyed at study completion. 
 
All study cell phones will be password protected and only accessed by study staff who 
have completed and maintained mandatory training in the protection of human subjects and 
good clinical practices. 
 
Reporting of AEs and SAEs, Management of SAEs and Other Study Risks 
Dr. Coughlin (PI) will be responsible for distinguishing severity of and reporting adverse 
events.  Potential adverse events that could be associated with the research include, but may 
not be limited to: breaches of confidentiality (addressed above), suicide threats, reports of acts 
of violence and child abuse (child abuse will also be reported to Children’s Protective Services 
and the consent form includes information to this effect), complaints about the study or the 
study’s research team, and serious or untoward agitation during any study activity. During the 
informed consent process, participants will be told of the procedures regarding the monitoring of 
study-related adverse events. The timing of the reporting of any at least possibly study-related 
adverse event to the U-M IRBMED will be dependent on the severity of the event, and whether 

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such adverse events were expected (included in the informed consent) and/or related or 
unrelated to the research. According to U-M IRBMED, all adverse events must be reported for 
those defined as: “An adverse event is any experience or abnormal finding that has taken place 
during the course of 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.”  Any serious unexpected and study related adverse events will be reported 
within 48 hours of learning of the event to the Project Officer and to U-M within U-M IRB 
reporting guidelines. Non-threatening potentially serious adverse events that are causally 
related to the research will be reported to the IRBMED within 7 days of learning of the event.  A 
summary of adverse events that occurred during the previous year will be included in the annual 
progress report to NIAAA. 
 
Quality Assurance 
Quality assurance and reliability of screening, baseline, post-intervention, focus testing, and 
follow-up assessments will be monitored by Dr. Coughlin throughout the study via regular 
meetings and observation of the research staff conducting standardized assessments and 
throughout the study via regular meetings. Dr. Coughlin will monitor the quality of the data files 
via supervision of the research assistants and data analyst. Data discrepancies will be corrected 
by a supervisor, based on source documents. The quality of the data will be monitored 
throughout the study. Data will be analyzed using a data analysis program such as R software. 
Data quality will be monitored by random inspection of the completed electronic forms by the 
research assistants and any problems detected will be discussed with Dr. Coughlin. Study staff 
will receive standardized training in conducting assessments and interventions over the 
phone/by video chat. Adherence to assessment protocols will be monitored with supervision 
with Dr. Coughlin. All study staff will receive ongoing training. The mid-way session and focus 
testing/post-test interviews may be audio-recorded for transcription to ensure consistency and 
fidelity. The audio-recordings of the mid-way sessions and focus testing interviews will be 
destroyed after the files are uploaded to a password-protected, secure server with restricted 
access for transcription. Once collected, participant data will remain confidential. Monthly, Dr. 
Coughlin, with the help of a research assistant, will review collected data for accuracy and out of 
range values; ensure that all collected data are backed-up; ensure that all assessment sessions 
are accounted for in the tracking database; update flow chart to ensure accurate numbers of 
assessments recorded as completed, missed, refused, or withdrawn 
 
Study Discontinuation Protocol 
The PI will work directly with NIAAA, in the case that project discontinuation is 
necessary. Should there be clear evidence of harm to the participants due to this trial we will 
cease the trial. Given this is a no more than minimal risk to participants, we do not anticipate 
evidence of harm. As this is a feasibility/acceptability trial, we do not anticipate being able to 
detect a treatment effect and thus do not anticipate stopping the trial due to evidence of futility 
or benefit. 
 
 Protection of Human Subjects 
 
The research conducted in Aim 2 does meet the definition of a clinical trial. A Certificate of 
Confidentiality will be automatically provided by the NIH. All hired members of the research 
team will complete training and receive certification in Human Subjects Research Protection and 
HIPAA regulations, including Good Clinical Practice, and the investigators will keep current 
certifications up to date.  
 
Subject Population, Inclusion/Exclusion Criteria 

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This protocol involves two separate research studies with similar inclusion/exclusion criteria 
and study procedures. Target enrollment for Aim 2 is approximately n=85, which is highly 
feasible given ample patient flow.   
Patients are eligible for screening if they: (1) are adults (ages 18 and older) in primary care 
of a Healthcare system and (2) have a home address in a rural           area (e.g., county or zip 
code). Additional baseline inclusion criteria include: (3) an AUDIT-C score of ≥3 in females or ≥4 
in males and (4) regular access to an internet-enabled device (e.g., smartphone, computer, 
tablet).  
Exclusion criteria: (1) Does not understand English; (2) currently pregnant; (3) unable to 
provide informed consent due to medical/psychiatric reasons, (4) currently in treatment for a 
substance use disorder. Potential Aim 2 participants may be excluded based on participant best 
interest (e.g., if patient has plans to move out of the country during the study period; adult 
patient with a legal guardian; actively enrolled in another behavioral intervention research study, 
given the potential confounding effect of receiving multiple interventions on study outcomes; or if 
study staff know a patient or their family personally, in order to fully ensure participant privacy), 
with PI approval.     
To increase minority representation, we plan to oversample minorities who are African 
American and Hispanic (~20%) by prioritizing recruitment of minority participants (e.g., 
prioritizing screening of minority patients). We expect the racial ethnic composition to be ~74% 
White, 20% Black or African American, 3% Asian, 1% Native American/Alaskan Native, 1% 
Hawaiian/Pacific Islander, and 1% more than one race and 20% Hispanic. To ensure both 
sexes are represented, we will oversample females to enroll approximately equal numbers of 
men and women to be stratified across study conditions.   
 
Recruitment and Consent Procedures 
Prior to approaching participants in both aims, study staff will use preparatory electronic 
health record review to identify potentially eligible participants seen in primary care, including 
UM Brighton Health Center, in the past 2 years (waiver of consent and HIPAA waiver are 
requested for this).  
For Aim 2, participants identified during EHR review may be approached remotely (phone, 
text, email or postal) or in-person at clinic appointments. Potentially eligible participants may 
contact the study team after reviewing/receiving a flyer. For feasibility reasons, we are 
requesting a waiver of informed consent documentation to give participants recruited 
remotely multiple options for providing screening and baseline consent (e.g., verbal consent for 
those completing screen and/or baseline over the phone; completing an online consent form in 
Qualtrics for those self-administering the survey(s) on a personal device). After screening 
consent is obtained, participants will complete a 3-minute screening survey. Those eligible will 
be invited to review the baseline consent. After providing baseline consent, participants will be 
invited to complete a baseline assessment (remotely via Qualtrics and/or by phone/video using 
a mailed/emailed copy of the survey) followed by randomization to study condition (Volitional 
Choice (VC), Episodic Future Thinking (EFT), VC/EFT, or monitoring only), at which point 
participants will be enrolled in the study. All participants will complete a mid-way session by 
phone or video chat prior to the 2-week intervention period. During the 2-week field testing 
period, participants will receive up to 3 text messages/day every day including both assessment 
messages (e.g., How many drinks did you have yesterday?) and intervention messages (i.e., 
based on the personalized intervention cues developed during the mid-way session). Following 
the intervention, participants will complete a post-test and 2-month follow-up assessment and 
will be compensated for their time. 
 
Materials 

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Data will be collected only after participants provide informed consent. Assessment 
instruments have been used widely in other settings and evaluated for their appropriateness 
with adult participants. Four primary sources of data exist for this study: 1) participants will self-
administer or respond via phone/video-administered sessions to questionnaires to gather pre-
intervention, post-intervention, and follow-up data pertaining to demographics, intervention 
acceptability and feasibility, behavioral economic indices (delay discounting and alcohol 
demand), alcohol use, and other risk behaviors (e.g., substance use); 2) interventions may be 
audio recorded for internal quality assurance purposes; 3) daily data will be collected during the 
2-week intervention period pertaining to behavioral economic indices and alcohol use (self-
report); and 4) qualitative data collected during the post-test/focus testing session may be audio 
recorded and transcribed to capture intervention acceptability.  
 
Potential Risks 
The proposed study poses minimal risks. Every effort will be made to ensure that study 
participants are protected from risks. The major risk for participants in this study is the violation 
of confidentiality. This risk is due to the disclosure of personal information regarding the use of 
alcohol and other substances and is heightened due to the audio recording of the mid-way 
session and focus testing/post-test interview and possible completion of the mid-way session 
over video chat. The informed consent will contain a statement about exceptions to 
confidentiality which include if the participant expresses suicidality, homicidality, or the physical 
or sexual abuse of a child. We expect that participants will not disclose such information as part 
of completing the study activities since our assessments and intervention do not specifically 
inquire about these topics, but should information to this effect be shared, we will provide 
appropriate referrals to resources and follow appropriate reporting procedures. Study staff will 
review limits of confidentiality at enrollment, will always notify participants when mandatory 
reporting or breaking of confidentiality is required, and will only disclose the minimum 
information necessary as required by law.   
We expect that participants will not disclose such information in the context of a mobile 
health study, but should information to this effect be shared as part of study interaction via in-
person, phone, or text-based communication with study staff, Dr. Coughlin, in consultation with 
her mentors, will provide appropriate referrals to hotlines and local county resources and follow 
appropriate reporting procedures. We will notify participants when/if we must make any 
mandatory reports based on information they disclose and we will only disclose the minimum 
information necessary. Participants will be informed in the consent documentation about the 
procedures taken to maintain and protect their confidentiality. We will inform participants that 
during their participation, the text messages are saved for data collection purposes and will be 
stored on our internal, restricted-access servers in password protected databases. Participants 
under legal drinking age (those 18 to 20 years old) will be also informed of potential risks of 
joining a study collecting information about illegal alcohol use including that information about 
alcohol use will be collected remotely (participants report number of drinks per day in a text 
message) and stored on password-protected servers.         
We will also encourage participants to use a password/code on their phones and to view 
study assessments and intervention text-messages in private spaces. Participants who 
complete the midway session by video chat will be informed that they can choose the program 
most convenient for them to complete video procedures, including HIPAA-compliant programs, 
and that the study cannot control changes in future policies and potential secret recording with 
release of audio or video interaction from other programs (e.g., Skype, Facetime). Participants 
will also be informed that we will take steps necessary to secure their data. Survey data 
collected will be stored in secure, password-protected databases on the secure U-M network 
(e.g., U-M Dropbox). When completing intervention sessions or sending text-messages, staff 
will do so in private spaces and use privacy screens where others who are not part of the 

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research team could not see the data. Study cell phones used to send text-messages will be 
password protected. The computerized surveys are designed and administered using Qualtrics 
Research Suite through the University of Michigan (http://www.qualtrics.com/), which meets the 
HIPAA standards, and is where data will be stored based on study ID securely and separate 
from any identifying information.   
Participants could potentially experience emotional discomfort as a result of being asked 
personal questions or because of intervention content. All participants will receive crisis/referral 
information via a national resource listing that will be shared in person or emailed/mailed (based 
on participant preference) during remote recruitment to all participants at the time of the 
baseline session assessment. The resource list will include national resources including suicide 
hotlines/text-lines, mental health and substance use treatment, etc. All participants will also be 
notified that they are free to terminate the assessments at any time or refuse to respond to any 
item. 
 
Protection Against Risk 
To minimize the risk of violating confidentiality, research staff will make every effort to 
ensure that study data are always kept confidential. Staff training procedures 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 U-M Program for Education and Evaluation in 
Responsible Research and Scholarship system and will complete CITI Good Clinical Practice 
Training. Staff will be trained to conduct phone- and video-based sessions where no one can 
overhear the conversation. Consent documents will fully explain the study procedures, potential 
risks, and potential benefits.  
Unique identification numbers will be assigned to participants. Any data forms will be 
coded with this number, rather than with a name. The audio-recordings of the mid-way sessions 
and focus testing/post-test interviews will be destroyed after the files are uploaded to a 
password-protected, secure server with restricted access for transcription. Computer data files 
will be saved with passwords on a secured network, and will not contain names, birthdates, etc. 
See “Data Confidentiality Plans” above for further information on protection of participants’ data.   
Furthermore, because of the sensitive nature of the data collected, this study is covered by a 
Certificate of Confidentiality from the NIH to protect the confidentiality of our data from legal 
requests. Finally, specific information collected during this research study will not be available 
for use outside of research purposes. Likewise, specific information collected during this 
research study will not be available to family or friends or others outside of the study team, only 
staff members who need to know personal identifying information will have access to this 
information. All data will be collected specifically for use on this project. 
 
Research staff will be trained to respond to any emotional distress and to refer 
participants to appropriate resources as necessary.  All participants are free to terminate the 
study at any time. Participants can also  refuse to respond to any questionnaire item; although 
some survey items will require a response (e.g., to determine study eligibility), participants who 
self-administer the survey can choose to exit the survey if they would prefer not to answer these 
questions. Further, the risk of potential coercion is minimized by using standard recruitment 
scripts to avoid undue influence.  All baseline eligible participants will also receive substance 
use and mental health resources in a community resource brochure at baseline. 
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. 
Staff will receive training in crisis assessment and risk management procedures in the unlikely 
event that participants reveal suicidal and/or homicidal ideation, or child physical/sexual abuse 
during study interactions (including via text-message). If staff becomes aware of any of these 
issues, they will follow our standard risk assessment guidelines for attempting to contact 

13 
 
participants remotely (e.g., message/text/email hotline number and by phone). In cases of 
psychiatric distress, staff are trained in strategies that include contacting the individual non-
judgmentally, using active listening skills, and empathically encouraging use of referral 
information or other coping skills. Staff will immediately page Dr. Coughlin or one of Dr. 
Coughlin’s mentors for consultation in cases where participants express moderate or acute risk. 
Staff will also be trained to manage responses to potentially inappropriate messages from 
participants (e.g., asking on dates, sending explicit image).    
 
Vulnerable Subjects 
We will enroll adults residing in rural areas with risky drinking. Vulnerable subjects (e.g., 
fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals) are not 
targeted for recruitment in this proposed research. This protocol does not allow for currently 
pregnant women to be included in the study, because some women may not know they are 
pregnant or may not disclose their pregnancy, information regarding the risks of alcohol use 
during pregnancy and a special notation of a local substance use treatment center that has 
specialized women’s program (e.g., Odyssey House) will be provided in the resource brochure 
provided to all participants at screening. All women who report that they are pregnant and who 
are using alcohol will be referred this substance use treatment program. This protocol does not 
include the participation of minors (<18 years old) whose developmental stage would require 
different intervention content.  
 
Potential Benefits of the Proposed Research to Human Subjects and Others 
Participation in the proposed study could potentially benefit participants in a few 
important ways. First, it is possible that the assessments may be beneficial to all participants by 
asking them to review their substance use. Therefore, these assessments may actually serve 
as a very minimal intervention (as could any study with questions that prompt participants to 
consider and monitor their risky behaviors). Second, all participants will receive referral 
information for substance use and mental health treatment. In sum, potential benefits for the 
research outweigh the risks for the participants. Further, with regard to benefits to others, in the 
event that the intervention tested in the present study is efficacious, the potential benefits to 
society involve reducing the public health burden associated with alcohol use by way of 
healthcare expenditures, reductions in impaired driving/motor vehicle crashes, etc. and 
increasing available services for rural-residing individual with risky alcohol use. 
 
Importance of Knowledge to be Gained 
 
     Excessive alcohol use is the 3rd leading preventable cause of death in the U.S., and is 
associated with significant economic burden and negative health-related consequences that are 
undertreated in rural areas. By refining and evaluating acceptability and feasibility of two 
remotely-delivered intervention components using remote text message delivery, the study will 
contribute to the development of a well-specified, novel mobile health intervention for rural risky 
drinkers. Given the high rates of mobile phone ownership, if the efficacy is established, this 
intervention will have great promise for increasing access to alcohol intervention services for 
rural individuals, thereby benefiting public health. The risks to participants are reasonable in 
relation to the importance of this knowledge to be gained and potential public health impact of 
developing an effective treatment to reduce the use of and consequences associated with 
alcohol use among rural adults. 
 
 
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