Piloting a Novel Social Support Intervention for Addiction Recovery
Phase: NA
Conditions: Alcohol; Harmful Use, Alcohol
Sponsor: Yale University

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
STUDY PROTOCOL
Social Behavioral Template
   
Piloting a novel social support intervention 
for addiction recovery
 Protocol Number
2000035434
 
Protocol Version
7/23/24
10
Clinical Trials Registration Number: NCT# NCT06022107
Confidentiality Statement:
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
2
Synopsis
Purpose
Objectives
Study Population
Number of Participants
We will recruit up to 50 support-providers, and up to 30 support-receivers to use the 
intervention. This sample size is appropriate for a pilot study. We will recruit a subset of these 
participants (10 support-providers and 10 support-receivers) to participate in a follow-up 
qualitative interview.  
The target support-providers are individuals who are involved in addiction recovery community 
(e.g., support group meeting facilitators, volunteers at recovery community centers) or are allies 
of the addiction recovery community. The target support-receivers are adults who engage in 
hazardous drinking and live in Connecticut. 
This study will first determine feasibility and acceptability of inviting addiction recovery 
communities to be support-providers and creating content for this intervention. Second, it will 
determine feasibility and acceptability of individuals who engage in hazardous drinking using 
this intervention (aka support-receivers), and determine preliminary efficacy of this intervention 
on alcohol use and engagement in recovery support services. Third, it will correlate 
characteristics of content created by support-providers with support-receivers’ ratings of the 
content to identify which characteristics are well-received by support-receivers, to guide future 
content creation. 
The purpose of this study is to pilot a novel web-based intervention to help people who engage 
in hazardous drinking cut down or quit drinking. This intervention will be implemented through 
Qualtrics, where each night, participants (referred to as “support-receivers”) will access a 
Qualtrics link containing brief written and video encouragement and information generated by 
people in addiction recovery communities ("support-providers”). The intervention is designed to 
help the user maintain motivation to not drink in the short-run, and build connections with 
addiction recovery communities to sustain their recovery in the long-run. 
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
3
Study Design
Study Duration
Outcome Variables
Locations/Facilities
This entire study will be conducted online. Support-providers will utilize Qualtrics for their portion 
of the study. Support-receivers will meet with a member of the study team at the beginning via 
Zoom or phone call, consent via REDCap, and all subsequent activities will occur via Qualtrics. 
Qualitative interviews will occur over Zoom. 
We will collect data on recruitment and attrition rates of support-providers and support-receivers 
to determine feasibility. To determine acceptability, we will collect quantitative data on how often 
support-receivers engaged with the intervention throughout the month, and qualitative data to 
obtain participants’ views and experiences of the intervention, including barriers and facilitators 
of use. Preliminary efficacy will be assessed using questionnaire measures of substance use 
and engagement in recovery support services administered at the start and end of the 
intervention. We will also characterize the video content created by support-providers and 
correlate them with support-receivers’ ratings of the content, to identify which characteristics are 
well-received by support-receivers, to guide future content creation.
It will take support-providers about 30 minutes to complete their portion of this study. Support-
receivers will complete questionnaires prior to using the intervention (no longer than 1 hour to 
complete), then use the intervention for a few minutes each night for one month, and then 
complete follow-up questionnaires (no longer than 30 minutes to complete) at end of 
intervention use and one month after the end of intervention use. Both support-providers and 
support-receivers can take part in an optional qualitative interview after, which will take no more 
than 30 minutes. Data collection will likely last 1-2 years. 
This is a study to develop and test an intervention that comprises three parts: 1) We will invite 
individuals (support-providers) to provide video and written content for the intervention. 2) We 
will recruit participants who engage in hazardous drinking to be support-receivers and use the 
online intervention daily for a month; they will also fill in questionnaires about their substance 
use and engagement with recovery support services at the beginning and end of the study to 
determine preliminary efficacy. 3) We will then administer qualitative interviews to both support-
providers and support-receivers to gain insight into intervention’s feasibility and acceptability, 
and to identify ways to improve the intervention. 
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
4
Abbreviations
Abbreviation 
Explanation
ARC
Addiction recovery community 
AUD
Alcohol use disorder
QI
Qualitative Interviews 
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
5
Glossary of Terms
Glossary
Explanation
Support-providers (SPs)
These are adults who are from or are allies 
of the addiction recovery community who 
will upload videos/content for the 
intervention.
Support-receivers (SRs)
These are study participants who are adults 
who currently engage in hazardous drinking, 
who will use the intervention. 
Let’s Do Addiction Recovery Together 
(LDART)
Tentative name for the intervention.
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
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Table of Contents
Preface.....................................................................................................................................2
Synopsis ..................................................................................................................................3
Purpose................................................................................................................................3
Objectives.............................................................................................................................3
Study Population ..................................................................................................................3
Number of Participants.........................................................................................................3
Study Design........................................................................................................................3
Study Duration......................................................................................................................3
Outcome Variables...............................................................................................................3
Locations/Facilities...............................................................................................................3
Abbreviations ...........................................................................................................................4
Glossary of Terms....................................................................................................................5
Protocol Revision History.........................................................................................................9
1
Background.....................................................................................................................10
1.1
Background .............................................................................................................10
1.2
Prior Experience (if applicable) ...............................................................................10
2
Rationale/Significance ....................................................................................................11
2.1
Rationale and Study Significance............................................................................11
2.2
Risks........................................................................................................................11
2.3
Anticipated Benefits.................................................................................................11
3
Study Purpose and Objectives .......................................................................................12
3.1
Purpose ...................................................................................................................12
3.2
Hypothesis...............................................................................................................12
3.3
Objectives................................................................................................................12
4
Study Design ..................................................................................................................13
4.1
Study Duration.........................................................................................................15
4.2
Outcome Variables/Endpoints.................................................................................15
4.2.1
Primary Outcome Variables/Endpoints ............................................................15
4.2.2
Secondary and Exploratory Outcome Variables/Endpoints (if applicable).......15
5
Study Participants...........................................................................................................16
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
7
5.1
Study Population .....................................................................................................16
5.2
Number of Participants............................................................................................16
5.3
Eligibility Criteria......................................................................................................16
5.4
Recruitment Procedures .........................................................................................17
5.5
Consent/Assent Procedures/HIPAA Authorization..................................................17
6
Study Methods/Procedures ............................................................................................20
6.1
Study Procedures....................................................................................................20
6.1.1
Data Collection.................................................................................................21
6.2
Method of Assignment/Randomization (if applicable) .............................................21
6.3
Adverse Events Definition and Reporting................................................................21
6.4
Reaction Management ............................................................................................21
6.5
Withdrawal Procedures ...........................................................................................22
6.6
Locations/Facilities ..................................................................................................22
7
Statistical Design ............................................................................................................23
7.1
Sample Size Considerations ...................................................................................23
7.2
Planned Analyses....................................................................................................23
7.2.1
Secondary Objective Analyses (if applicable) ..................................................23
7.2.2
Analysis of Subject Characteristics (if applicable)............................................23
7.2.3
Interim Analysis (if applicable)..........................................................................23
7.3
Data Relevance.......................................................................................................24
7.4
Data Coding.............................................................................................................24
7.5
Data Analysis Tools.................................................................................................24
7.6
Data Monitoring .......................................................................................................24
7.7
Handling of Missing Data.........................................................................................24
8
Data/Specimen Handling and Record Keeping ..............................................................25
8.1
Subject Data Confidentiality ....................................................................................25
8.2
Data Quality Assurance...........................................................................................26
8.3
Data or Specimen Storage/Security ........................................................................26
8.4
Study Records.........................................................................................................26
8.5
Access to Source.....................................................................................................26
8.6
Retention of Records...............................................................................................26
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
8
8.7
Data and Safety Monitoring Plan.............................................................................27
9
Study Considerations......................................................................................................28
9.1
Institutional Review Board (IRB) Review.................................................................28
9.2
Research Personnel Training..................................................................................28
9.3
Study Monitoring......................................................................................................28
9.4
Unanticipated Problems and Protocol Deviations ...................................................29
9.5
Study Discontinuation..............................................................................................30
9.6
Study Completion ....................................................................................................30
9.7
Conflict of Interest Management Plan .....................................................................30
9.8
Funding Source .......................................................................................................31
9.9
Publication Plan.......................................................................................................31
10
Appendices .................................................................................................................32
11
List of Tables...............................................................................................................33
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
9
Protocol Revision History
Version 
Date
Summary of Substantial Changes
V2 6/30/23
As per IRB feedback, SPs are no longer considered human subjects in this 
study, and all such references have been removed.
V3 7/14/23
In order to be able to analyze the videos from SPs, SPs will be considered 
human subjects.
V4 11/27/23
Included study phone as an option for conducting visit 1 remotely, changed a 
questionnaire to short-form version, rearranged when participants would do 
which questionnaire, included NCT#.
V5 1/2/24
SPs no longer will be compensated for recording videos. Additional 
questionnaire added for SR to complete at 3 time points. SRs will be given 
the option to receive a progress report at the end of the study. 
V6 1/23/24
Included measures to screen out scammers posing as potential SR 
participants, option to provide people who do not meet eligibility criteria 
with a resource sheet, expanding SR recruitment to CT more broadly
V7 1/25/24
Additional measure added to screen out scammers: potential SR participant 
will be asked to show some form of ID during the zoom visit to verify their 
identity. This ID will be visually verified by the study team during the zoom 
visit and will not be recorded or saved. 
V8 1/31/24
Disclaimer to be included during Zoom visit 1 with SRs to state that LDART is 
not an established form of addiction treatment and if emergencies arise 
during the study to seek medical care and/or contact 911. Option for SRs to 
leave comments on videos. Additional analyses to be performed on SP 
videos and SR rating data. 
V9 2/22/24
In-person recruitment method added. 
V10 7/23/24
SP compensation increased, SP video collection re-opened. 
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
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1 Background
1.1
Background
1.2
Prior Experience (if applicable) 
The impact of addiction on societies worldwide has been devastating and costly1. Existing 
pharmacological2 and psychological3,4 interventions can be efficacious, but their efficacy is sometimes 
negated if deficits in social determinants of health are not concurrently addressed5-7. Indeed, studies 
have found that social support, especially recovery-oriented support networks, is a consistent 
predictor of addiction recovery8-12. This is particularly true during the first few months of recovery, 
where relapse rates range from 20-85%13,14. Connecting individuals in early recovery to resources in 
the addiction recovery community (ARC), such as support group meetings and recovery community 
centers, is thus crucial for sustaining addiction recovery15-17. 
Despite its importance, accruing social support can be a difficult process for at least two reasons. 
First, finding and accessing recovery support services can be challenging due to individual factors 
(e.g., lack of motivation, anxiety about meeting strangers) and structural factors (e.g., lack of 
comprehensive lists of recovery resources). Second, because this process is time- and effort-
consuming, it requires one to prioritize the long-term benefits of recovery over the short-term benefits 
of substance use18,19 -- an ability that is often compromised in individuals with substance use 
disorders20. Thus it is important to keep individuals motivated during this process, for example by 
having immediate, salient rewards when one reaches their recovery goals. These two barriers can be 
overcome using a combination of community reinforcement approach21 and contingency 
management22, respectively. Although this is a highly effective treatment approach23, few clinicians 
are trained in the former, few treatment centers implement the latter24, and both require individuals to 
be already engaged in formal treatment in order to gain access to these specialized treatments. 
We propose a novel social support intervention that circumvents all of these barriers, tentatively called 
Let’s Do Addiction Recovery Together (LDART). Individuals in early recovery will receive a short pre-
recorded video every night for a month, contingent on them meeting their recovery goal for the day 
(e.g., not drinking, attending a support group meeting). These videos, generated by members of the 
local ARC, have two purposes: 1) to congratulate and motivate the recoveree on their recovery 
journey (in an acutely rewarding way, not unlike monetary rewards in contingency management); 2) to 
introduce and “put a face and a voice” to local recovery support services, thereby reducing 
informational and psychological barriers to engagement. If the daily recovery goal is not met, they will 
receive written words of encouragement and information on a recovery support service, albeit in a 
less engaging and rewarding format. Given that many in early recovery feel socially isolated25, we 
hypothesize that these videos will be a potent social reward and motivator for reaching one’s recovery 
goals, such as reducing substance use and increasing social support. 
Both the PI (McCurdy) and faculty advisor (Potenza) have some experience in developing 
interventions (mHealth apps) and conducting qualitative individuals with adults who engage in 
addictive behavior. Potenza has also been PI on multiple grants involving clinical trials for addiction 
treatment. 
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
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2 Rationale/Significance
2.1
Rationale and Study Significance 
2.2
Risks
2.3
Anticipated Benefits
As mentioned above, getting individuals in early recovery from hazardous alcohol use to stay 
motivated in their recovery can be challenging for a number of reasons, and effective ways of doing 
this (e.g., contingency management, community reinforcement approach) are often difficult to access. 
There is thus a need for low cost and easily accessible interventions to keep individuals motivated 
throughout their recovery. This pilot study will assess feasibility, acceptability, and preliminary efficacy 
of a novel social support intervention that remotely delivers social reinforcements (vis-à-vis videos of 
support from the ARC) contingent on reaching individualized recovery goals to individuals in early 
recovery from alcohol use. The long-term goal of this intervention, if proven to be successful, is to be 
a freely available resource that can run in an automated manner (with the exception of video 
inspection to ensure appropriate quality and content), and scaled both spatially (videos can be 
obtained from people beyond state lines) and temporally (with more videos, this intervention can go 
on for more than one month, thereby further sustaining recovery). 
Overall, participation in this study is thought to involve minimal risk. There is some risk that there may 
be breaches of the SPs’ confidentiality, in that SRs may find ways to share or broadcast the videos 
they receive. However, this is unlikely because i) videos will be uploaded, stored, and viewed via 
Qualtrics, a HIPAA-compliant platform; ii) the option to download the videos will be disabled; iii) SRs 
will be provided with explicit instructions to not share these videos with others; iv) SRs will be advised 
to watch these videos from a private space with no one else around; v) most individuals in the ARC 
are open and explicit about their involvement in such communities, so in the unlikely event that these 
videos are shared, no confidential information will likely be released; vi) Their videos, when integrated 
into the intervention, will only be accessible with a valid participant ID and link, which will prevent 
others from viewing the videos; vii) SPs will be briefed on these potential risks and can make an 
informed decision about participating.
There may be breaches of SRs’ confidentiality. However, this is unlikely as all information they 
provide will be de-identified (they will access their videos using their subject ID) and through Qualtrics, 
which is a secure platform. It is possible that they may experience distress when watching these 
videos, however, these videos will be pre-screened by the study team for quality control. SRs may 
experience distress when filling in questionnaires and taking part in qualitative interviews. However, 
these questionnaires contain minimally (if at all) distressing topics, and the topic of qualitative 
interviews will be entirely on the intervention, so this is an unlikely risk. Additionally, to mitigate this 
concern, they will be informed that they can skip any questions for any reason, and there will be the 
option to “prefer not to answer” on every questionnaire question. 
We anticipate that participation in this study will be beneficial to both SRs and SPs. Participating in a 
study to develop an intervention that may improve treatment outcomes for others with alcohol use 
issues may be considered a benefit. For SPs, being able to give back and help others in recovery is 
a common desire, and this will be a way for them to easily and directly to do. For SRs, They will 
receive supportive and motivating videos and/or information about recovery support services each 
night for a month, which may keep them motivated in their recovery as well as decrease barriers to 
these recovery services. 
This study also would provide the first crucial piece of evidence that such an intervention may be 
helpful for individuals who engage in hazardous alcohol use. This may form the basis of a useful 
adjunct to addiction treatment. 
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
12
3 Study Purpose and Objectives
3.1
Purpose
3.2
Hypothesis
3.3
Objectives
This pilot study will assess feasibility, acceptability, and preliminary efficacy of a novel social support 
intervention (LDART) that remotely delivers social reinforcements contingent on reaching 
individualized recovery goals to individuals in early recovery from hazardous alcohol use. The long-
term goal of this intervention, if proven to be successful, is to be a freely available resource that can 
run in a mostly-automated manner, and scaled both spatially and temporally, that may improve 
alcohol use and quality of life outcomes for individuals who engage in hazardous drinking. 
H1: Collecting videos of support from the addiction recovery community will be feasible and 
acceptable.
H2: Recruitment and retention of SRs will be feasible, and SRs will find the intervention to be 
acceptable. 
H3: There will be a reduction in alcohol use and an increase in engagement with recovery support 
services by SRs post-intervention relative to pre-intervention. 
The primary objectives of this study are to determine whether LDART is feasible, acceptable, and 
efficacious in reducing alcohol use and increasing engagement with recovery support services in 
adults who engage in hazardous alcohol use. 
The secondary objectives are to determine whether video collection is feasible, to identify ways to 
improve this intervention, and to identify components of the videos recorded by SPs that were well-
received by SRs. 
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
13
4 Study Design
Video collection (SPs): We will recruit up to 50 adults who are involved in or are allies of the addiction 
recovery community to participate in this study as SPs. This entire process will occur on their own (i.e., 
without a member of the study team present), but they can email the study team if any questions arise, 
particularly during the consenting process. Everything they need to do will be on the Qualtrics platform. 
First, they will be provided information on the study and screened for eligibility. They will then read the 
information sheet as part of the consenting process and complete a consent quiz. If they agree to 
participate, they will check a box in Qualtrics indicating so; a copy of the information sheet will be emailed 
to them. They will also indicate what they consent to regarding how their videos can be used by the study 
team (e.g., only in this study or in subsequent studies as well, whether they can be shared on the study 
Twitter page or shown at conferences), and how long they are stored. They will then be guided to record 
two short videos to motivate people in recovery. The message in this video will be generic (i.e., no SR 
PHI), as they will have no knowledge of the specific SRs who will view the message. This Qualtrics link will 
be optimized to work on smartphones, to make it easier to record and upload videos directly from their 
phone. SPs will be asked to optionally provide their first name, and information on the recovery work they 
do (e.g., facilitate a support group meeting on Wednesdays at 6pm) and how to access it (e.g., provide the 
zoom link or physical address of the recovery community center). They will fill in a brief demographic 
questionnaire which will not be shared with SRs. Finally, they will be asked under what circumstances the 
study team can contact them (e.g., in the event that their video is selected for use in the intervention, for 
which they will receive a $40 gift card, and/or in the event that their video is voted as one of the best-rated, 
so that the team can send them an additional $100 gift card as a prize if they were in the top 3 or $80 if 
they were 4th or 5th most highly rated.) After our target goal of number of SP videos is collected, we will 
state on the video-uploading website that we will no longer have financial compensation for uploading 
videos, but people are still welcome to do so if they desire. For the second round of video-collection, SPs 
will be compensated with a $50 gift card if their videos is selected for use in the second iteration of LDART.
Pilot intervention (SRs): We will recruit up to 30 adults who engaged in past-year hazardous alcohol use, 
engaged in heavy alcohol use in the past month, and have some interest in cutting down or quitting 
drinking, to be SRs in this study. They will be pre-screened by completing a Qualtrics link or a physical 
copy of the screening document (SR Study Materials). If eligible, they will select a day and time for Visit 1. 
They will also receive an email with more information about the study (SR Study Materials). Visit 1 will 
occur remotely via Zoom or phone call with a member of the study team, and will entail going over the 
consent document (SR compound consent), getting informed consent via REDCap, and filling in some 
questionnaires about their demographics, substance use, and recovery capital (SR questionnaires). This 
visit should last no longer than an hour, and participants will be compensated $30 for their time. 
SRs will then receive a reminder email on the day they decide to begin the intervention (SR Day 0 email; 
Intervention Materials), and will receive their first Qualtrics link via email on the night they decide to start 
participating in the intervention (Intervention Materials), each night for a month (Intervention Materials). In 
these links, they will answer whether they met their recovery goal for the day. If they answer yes, a 
celebratory message from a SP will be shown; if no, an encouraging message from the SP will be shown. 
Participants will rate on a scale of 0-5 how motivating and supportive they found the message to be with 
the option of leaving written feedback on the video. Information provided by the SP about the details of the 
recovery support service they’re affiliated with will also be displayed. SRs will then select their recovery 
goal for the next day (e.g., stay sober, go to a support group meeting). This entire process should take less 
than 5 minutes to complete each night. They will be compensated a maximum of $30 during this month, 
depending on how frequently they engage with the intervention; this will be paid as a lump sum at the end 
of the intervention. On the last day of the intervention, they will complete a few additional questionnaires on 
the Qualtrics link (Intervention Materials). This should take less than 30 minutes to complete, and they will 
be compensated $30 for their time. They will also be emailed a Qualtrics link with questionnaires one 
month after the completion of the intervention (SR questionnaires), which should take about 30 minutes to 
complete, and they will be compensated $30. In the last questionnaire, SRs will be asked whether they 
would like to receive a progress report of their time during the study (SR progress report). 
Gather feedback (SRs and SPs): Participants who indicate that they can be contacted regarding an 
optional 30-minute qualitative interview will be emailed after they upload their video (for SPs), and after 
they complete their 1-month post-intervention questionnaire (for SRs). Participants who consent to being 
contacted and do not complete their portion of their study may also be contacted, to better understand 
barriers to completion. This interview will revolve around feedback on, feasibility and acceptability of the 
intervention, how to improve it, and possible names for the intervention (QI discussion guide) for $20. 
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
14
SP Flow Diagram
Pre-Screening 
Day 1
on Qualtrics
Consenting
Day 1-7
on Qualtrics
Recording 
Day 1-14
on Qualtrics
Optional 
Qualitative 
Interview
Day 2-44
on Zoom
If eligible, read the information sheet, complete consenting quiz,
and consent to agreeing to participate in the study.
Record and upload videos.
Provide information on their recovery service. 
Indicate circumstances under which their videos can be used, and when they can 
be contacted by study team.
Complete brief demographic questionnaire.
Total N: 50
Potential participants access a Qualtrics link to get information on the study 
and to pre-screen using inclusion and exclusion criteria. 
Optional: Qualitative interview with a member of the study team on Zoom.
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APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
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Support-Receiver Flow Diagram
Pre-Screening 
Day -7 to 
Day 1
On Qualtrics
Visit 1
Day 1
On Zoom/phone
Intervention
Day 1-7
until 
Day 29-35
On Qualtrics
Day 29-35
On Qualtrics 
Day 59-75
On Qualtrics 
Optional 
Visit 2
Day 60-105
On Zoom
Indicate if they are interested in participating in optional qualitative interview.
Conduct informed consent process on Zoom with member of study team. 
Complete Qualtrics questionnaires.
Send Qualtrics link for participant to complete 1-month post-intervention 
questionnaire. Option to receive progress report after completion. 
Intervention start date can be the same day as the Zoom visit or up to one week 
after Visit 1. 
Engage with study intervention for 28 days
Send Qualtrics link for participant to complete post-intervention questionnaire. 
Total N: 30
Potential participants access a Qualtrics link or physical copy of the document to 
pre-screen using inclusion and exclusion criteria. If eligible, select day and time for 
Visit 1, and provide contact information so member of study team can provide 
them with more information, send zoom link, and answer any questions they may 
have.
Optional: Qualitative interview with member of study team via Zoom
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APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024
Protocol Number 2000035434
7/23/24 v10
16
4.1
Study Duration
4.2
Outcome Variables/Endpoints
4.2.1
Primary Outcome Variables/Endpoints
4.2.2
Secondary and Exploratory Outcome Variables/Endpoints (if applicable)
We will collect data on recruitment and attrition rates of SPs and SRs to determine feasibility. To 
determine acceptability, we will collect quantitative data on how often SR engaged with the 
intervention throughout the month. Preliminary efficacy will be assessed using questionnaire 
measures of substance use (Timeline Follow Back) and recovery capital (hours spent engaged in 
recovery support services, Assessment of Recovery Capital questionnaire) administered at the start 
and end of the intervention. 
Qualitative data with SPs and SRs after the intervention will identify barriers and facilitators to this 
intervention, and how to optimize it. Content analysis of SP videos will identify themes that they 
believe to be important in communicating to people in recovery. We will characterize the video content 
created by support-providers (e.g., speech rate, eye contact with camera) and correlate them with 
support-receivers’ ratings of the content, to identify which characteristics are well-received by support-
receivers, to guide future content creation.
It will take SPs about 30 minutes to complete their portion of this study, which can be done in one 
sitting or spread out over time. They can additionally take part in a qualitative interview that will take 
30 minutes to complete. 
SRs can complete the pre-screening in less than 10 minutes. Visit 1 occurs via Zoom or phone call 
and should be less than an hour. For 28 days (at a start date of their choosing), they will use the 
intervention for about 5 minutes a day. At the end of the intervention, there will be a questionnaire that 
should take 30 minutes to complete. And one-month post-intervention, there will be another 
questionnaire that should take 30 minutes to complete. Optionally, they can take part in a QI that will 
last about half an hour. So maximum total time for SRs is about 5.5 hours. 
Data collection and analysis will likely last 1-2 years. 
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

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5 Study Participants
5.1
Study Population
5.2
Number of Participants
5.3
Eligibility Criteria
The target SPs are individuals who are involved in the addiction recovery community (e.g., support 
group meeting facilitators, volunteers at recovery community centers) or allies of the addiction 
recovery community. Target SRs are adults who engage in past-year hazardous drinking (as defined 
as an AUDIT score ≥8), have had at least one heavy drinking day in the past month, and reside in 
Connecticut.
 
We will recruit up to 50 SPs to create content for the intervention, and 30 SRs to use the intervention. 
This sample size is appropriate for a pilot study. We will recruit a subset of these participants (20 
SRs) to participate in a follow-up qualitative interview.  
In order to be eligible for inclusion to be a SP, an individual must meet all of the following criteria:  

18 years of age or older 

Is fluent in English and has a 6th grade reading level or higher 

Either volunteers/works for a recovery support service that is freely available to people with 
addiction (e.g., support groups, recovery community centers) or is an ally/supporter of people 
in recovery.

Has access to a smartphone camera / webcam and microphone 

Is willing to consent to creating a video recording of themselves that will be seen by others.
In order to be eligible for inclusion to be a SR, an individual must meet all of the following criteria:  

18 years of age or older 

Is fluent in English and has a 6th grade reading level or higher 

AUDIT score of ≥8 

Has had at least one heavy drinking day in the past month

Has some desire to cut down or quit their alcohol use

Has a smartphone or computer with access to internet 

Have a geoIP address which indicates being on the East Coast of USA
Any individual who meets any of the following criteria will be excluded from participation in this study: 

Has vulnerable population status (e.g., pregnant people, prisoners)

Is at the time of study participation receiving in-patient psychiatric treatment involving 
hospitalization
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5.4
Recruitment Procedures
 
SPs will be recruited using word-of-mouth and physical and digital (i.e., PDF sent via email) flyers at 
organizations in Connecticut related to addiction recovery (e.g., Connecticut Community for Addiction 
Recovery, SMART Recovery, Recovery Dharma). Flyers may also be shared via the study twitter page 
(@TeamLDART). SRs will be recruited via those methods, and using physical flyers in the general New 
Haven community (e.g., liquor stores, convenience stores) and emails from YCCI to their recruitment 
database. The flyers are included under Recruitment Materials. There will be separate flyers for recruiting 
SPs and SRs, with QR codes and links that connect to corresponding Qualtrics pre-screening forms. GeoIP 
addresses will be collected in Qualtrics eligibility screen survey to verify that potential SR participants are 
indeed in the Connecticut area, to prevent scammers from enrolling in the study. Potential participants will 
be informed on the first page of the Qualtrics eligibility screen that their GeoIP address will be collected by 
completing the survey. Participants who are not eligible for the study will be offered to be emailed a PDF of 
community resources (please see document List of Addiction Recovery Organizations) if desired. In-person 
recruitment may occur at community events (e.g., health fairs) where information sheets on recovery 
organizations may be given out, and a physical copy of the eligibility screen is given to potential 
participants. This completed paperwork will be kept by the study PI to ensure their confidentiality. This 
information will be transcribed by the study team into the Qualtrics eligibility screener and the physical 
copies will be shredded right after.
Recruitment for follow-up qualitative interviews will utilize participants who were either SPs or SRs and 
indicated that they would like to be contacted for the interview. 
APPROVED BY THE YALE UNIVERSITY IRB 8/9/2024

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5.5
Consent/Assent Procedures/HIPAA Authorization
All participants will be competent adults who willingly provide their agreement to participate prior to research 
participation during the informed consent process.
SPs: If a participant is eligible, they will access the Qualtrics link containing the consent document (SP 
information sheet). The consent process will occur on their own (i.e., without a member of the study team 
present). They can take as much time as they want to read and review the document, to consult with others 
regarding the decision to participate, and to contact the study team if they have questions. Participants will be 
informed that participation is voluntary and that they may withdraw from the study at any time, even after 
consenting to participate. They may also rescind their consent regarding how their video is used at any time, and 
be provided with instructions on how to do so. Participants will also be provided with contact information for the 
study PIs and the IRB in the event they have additional concerns. Participants will then complete a consent quiz 
(SP information sheet) to ensure informed consent. If they answer all questions correctly and agree to the terms, 
they will check a box indicating that they agree to participate. They will input their email address to receive a copy 
of the consent document. 
SR pilot intervention: Visit 1 will occur in a password-protected Zoom room or on the phone with a member of the 
study team. Participants will be advised to have this zoom meeting in a private room. Participants will be asked to 
show some form of identification (e.g., driver’s license) to verify their identity and/or some other proof that they 
are based in Connecticut (to protect against scammers). This PHI will not be recorded or stored. Each participant 
will be sent a link to the REDCap consent form (SR compound consent). A member of the study team will explain 
the research study to the participant, read the IRB-approved consenting document containing details on the study 
intervention, procedures and risks, and answer any questions that may arise. The participant will have the 
opportunity to carefully review the consent form and ask questions prior to consenting. The participant will have 
the opportunity to discuss the study with their family or surrogates or think about it prior to agreeing to participate. 
Participants will be informed that participation is voluntary and that they may withdraw from the study at any time, 
even after consenting to participate. They may also choose not to answer any question for any reason. 
Participants will also be provided with contact information for the study PIs and the IRB in the event they have 
additional concerns. Participants will then be asked to summarize their understanding of the study and its risks, 
and the study team member will ensure that they sufficiently understand the study. If the participant agrees to 
participate, they will electronically sign the consent form on REDCap, and receive an electronic copy of the 
consent document for their records via email. The study intervention will not be administered prior to receiving 
informed consent. 
Follow-up qualitative interviews: The consenting process will occur over Zoom with a member of the study team. 
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6 Study Methods/Procedures
6.1
Study Procedures
SP protocol: After consent is complete, they will click on a Qualtrics link (SP video-recording link) to record two 
short videos to motivate someone to keep reaching their daily recovery goal. This Qualtrics link will work on 
smartphones such that the SP can record and upload videos directly from their smartphone. If used on a 
computer, the SP will have to record the video using software such as Photo Booth on Mac or Windows Camera 
on PC, and then upload the video as a file to Qualtrics. SPs will also be asked to optionally provide information on 
the recovery work they do (e.g., facilitate a support group meeting on Wednesdays at 6pm) and how to access it 
(e.g., provide the zoom link or physical address of the recovery community center), and a brief demographic 
questionnaire. Finally, they will be asked under what circumstances the study team can contact them. 
SR pilot intervention: Upon completion of the pre-screening form, a zoom meeting or phone call will be scheduled 
with a member of the study team for Visit 1. Participants will first be asked the same questions that they filled in in 
the eligibility screen to see if their answers match up. This is to verify the authenticity of the potential participant. 
This visit will first introduce the study intervention to the participant, with the disclaimer that the intervention is not 
an established form of treatment and that if emergencies arise while participating in the study, to seek treatment or 
call 911. Then, a member of the study team will go over the consent document if they are interested in 
participating. getting informed consent via REDCap, and filling in questionnaires about their demographics, 
substance use, and recovery capital (SR Questionnaires). Their preference for what time to receive emails/text 
reminders to log onto LDART each night will be recorded. The visit should last no longer than an hour, and 
participants will be compensated with a $30 electronic gift card for their time. SRs will then receive an email to a 
Qualtrics link on the night they want to begin the intervention (SR Day 0, Intervention Materials). On the days 
immediately before and after using the intervention (i.e., Day 1 and Day 28), participants will complete the 
Timeline Follow Back for alcohol use and recovery services, which is built into the Qualtrics intervention. Each 
night for a month, they will open the Qualtrics link to answer to indicate whether they met their recovery goal for 
the day. If they answer yes, a celebratory message from a SP will be shown; if no, an encouraging message from 
a SP will be shown. Video messages will be shown on some nights and written ones (i.e., transcription of the 
video) on others. Participants will rate how motivating and supportive they found the message to be with the option 
of leaving written feedback on the video. Information provided by the SP about the details of their recovery support 
service will also be displayed. They will then select their recovery goal for the next day (e.g., stay sober, go to a 
support group meeting). This entire process should take less than 5 minutes to complete each night. They will be 
compensated a maximum of $30 during this time, depending on how frequently they engage with the intervention; 
this will be paid as a lump sum at the end of the intervention. 
On the last day of the intervention, they will complete a few additional questionnaires on the Qualtrics link (e.g., 
acceptability assessments of the intervention; SR Day 28, Intervention Materials). This should take less than 30 
minutes, and they will be compensated $30 for their time. They will also be emailed a Qualtrics link with a subset 
of questionnaires they filled in at the beginning one month after the completion of the intervention, which should 
take about 30 minutes to complete, and they will be compensated $30 for their time. In the last questionnaire, SRs 
will be asked whether they would like to receive a progress report of their time during the study (SR progress report). 
This will include a summary of their time using LDART (e.g., number of goals achieved, types of goals achieved), and 
information on their drinking, recovery support, and quality of life (all data obtained from their questionnaires). If 
participants who choose to receive it, we will email them the PDF.
Qualitative Interviews: After uploading their videos (SPs) or after completing the one-month post-intervention 
questionnaires (SRs), they may be invited to participate in the QI, which will be a zoom meeting with a member of 
the study team that will last about half an hour. Questions will revolve around feasibility and acceptability of the 
intervention, how to improve it, and possible names for the intervention (QI discussion guide). Participants will be 
compensated $20 for their time.
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6.1.1
Data Collection
Video recordings and information on recovery services from SPs will be collected and stored on 
Qualtrics, which is a secure site. The majority of data from SRs will be collected via standard and 
validated questionnaires sent to the participant via Qualtrics. Participants will input their unique ID 
number when filling in all questionnaires, so all questionnaire data will be de-identified. Qualtrics links 
for SRs with videos made by support-providers will only be accessible with a valid participant ID and 
link, which will prevent others from viewing the video. 
QIs will be semi-structured using the discussion guide (included in Supporting Documents), and 
recordings of the meeting will be collected using the embedded function in Zoom. Audio transcripts of 
the QIs will be de-identified (i.e., no names will appear in the transcript, only ID numbers).
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6.2
Method of Assignment/Randomization (if applicable) 
6.3
Adverse Events Definition and Reporting
6.4
Reaction Management
6.5
Withdrawal Procedures
6.6
Locations/Facilities
Participants may withdraw from the study at any time. If they request to have their data not used in 
the analysis, their data will be destroyed. If not, their data will be kept in de-identified form. SPs may 
withdraw their consent to use their videos at any time, and their videos will be deleted and no longer 
used as part of the intervention. 
The entire study will be conducted via Zoom, Qualtrics and REDCap.
It is possible that SRs may experience distress when watching these videos. However, these videos 
will be pre-screened by the study team for quality control. SRs may experience distress when filling in 
questionnaires and taking part in qualitative interviews. However, these questionnaires contain 
minimally (if at all) distressing topics, and the topic of qualitative interviews will be entirely on the 
intervention, so this is an unlikely risk. Additionally, to mitigate this concern, they will be informed that 
they can skip any questions for any reason, and there will be the option to “prefer not to answer” on 
every questionnaire question. If participants experience severe emotional distress as a result of their 
participation in this research, the study team will refer them to mental health resources where 
appropriate.
N/A
An adverse event (AE) means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related. There are no expected AEs 
for this study. The PIs will apprise study personnel of all AEs that occur during the conduct of this 
research project via email as they are reviewed by the PIs. The protocol’s research monitor(s), the 
Yale School of Medicine Office of Student Research, and regulatory and decision-making bodies will 
be informed of AEs such as a participant threatening harm to themselves or others within 5 days of 
the event becoming known to the PIs. An AE or suspected adverse reaction is considered "severe" if, 
in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a 
life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or 
significant incapacity or substantial disruption of the ability to conduct normal life functions, or a 
congenital anomaly/birth defect. Participants who experience a significant psychiatric or medical 
problem requiring overnight hospitalization at an acute care facility will also be considered as having 
experienced a severe AE (SAE). All SAEs will result in the completion of an SAE Form that will be 
submitted to the Yale IRB within 5 days, and events that are serious or life-threatening and 
unanticipated (or anticipated but occurring with a greater frequency than expected) and possibly, 
probably, or definitely related require prompt reporting. The procedures for SAE reporting include 
written documentation related to the adverse event and specific forms detailing the event. 
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7 Statistical Design
7.1
Sample Size Considerations
Sample size for the intervention was inferred from other pilot studies of behavioral interventions. 
Sample size for qualitative interviews was derived from prior qualitative work conducted by members 
of the research team.  
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7.2
Planned Analyses
7.2.1
Secondary Objective Analyses (if applicable)
Intervention: Standard statistical analyses will be used to determine preliminary efficacy (e.g., random 
effects regression models) of continuously measured primary (percentage of days abstinent) and 
secondary (percentage of heavy drinking days) outcomes, measured at three time points (prior to 
intervention, post-intervention, and one-month post-intervention). 
Video ratings done by SRs will be correlated with features of the SP videos to determine what 
components of the videos are associated with the video having motivational and supportive 
properties. We will only analyze videos in which SPs consent to their videos being used “in research 
publications where the content of their videos and information is analyzed”. 
Some examples of video features include the content of the video (e.g., higher proportion of 
sentences conveying esteem social support), audio (e.g., higher voice pitch variability), and visual 
(e.g., percent time making eye contact with the camera). To quantify content, videos will be manually 
transcribed by the PI to extract textual data. This transcript will be de-identified by removing all names 
of people and recovery organizations. Some examples of types of qualitative analyses that will be 
performed include content analysis on the textual data using the Social Support Behavior Code 
(Cutrona & Suhr, 1992) as a coding scheme, where sentences will be labeled as information, network, 
esteem, and/or emotional support. A text analysis application called Linguistic Inquiry and Word 
Count (LIWC, Boyd et al., 2022) will also be utilized to characterize the text based on various 
psychosocial constructs. For example, the word “cried” is classified in the affect category amongst 
others. Use of self-disclosure or stigmatizing language will be coded in binary (absent/present). 
Audio data will be extracted from videos using software such as Adobe Premiere Pro. Quantitative 
analyses on audio data include using speech analysis software like Praat (Boersma, 2001) to extract 
audio features such as speech rate (a measure of how quickly the person in the video speaks), 
variability in waveform amplitude (as a measure of variability of how loudly one speaks) and variability 
in fundamental frequency (as a measure of how monotonous or prosidic the voice is). Examples of 
analyses of visual data include manual coding of percent time the person in the video spends looking 
at the camera versus visibly reading off a script, spontaneous blink rate (as a proxy of dopaminergic 
tone and arousal), and use of software such as OpenFace (Baltrusaitis et al., 2016) to quantify facial 
action units such as frequency of raising eyebrows and smiling. We may also use other software to 
quantify the colorfulness of the video and may qualitatively describe the background location where 
the video is set (e.g., fake zoom background, person’s living room). 
For most of the analyses described, at least two members of the study team will serve as 
coders/raters, and inter-rater reliability will be determined to ensure consistency. After these analyses 
have been completed, descriptive statistics will be used to summarize the characteristics. Statistical 
analyses will also be used to determine whether video characteristics differ as a function of 
demographics of the people in the videos. (For example, are men more likely to have monotonous 
speech patterns than women?) Then, after the rating data from are collected, correlational analyses 
will be performed to identify associations between content/audio/visual video variables and rating 
scores. Qualitative analyses of comments left by SRs about videos may also be incorporated to 
inform what SRs like and dislike about the videos. 
QI: All participants’ data will be analyzed unless otherwise specified by the participant. Data collected 
from QIs of support-providers will be analyzed separately from QIs of support-receivers.
N/A 
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7.2.2
Analysis of Subject Characteristics (if applicable)
7.2.3
Interim Analysis (if applicable)
7.3
Data Relevance
7.4
Data Coding
7.5
Data Analysis Tools
7.6
Data Monitoring
The quantitative and qualitative data collected in this study will provide the first pieces of evidence of 
LDART’s feasibility, acceptability, and preliminary efficacy, which will determine how to improve upon 
the intervention. 
QI: Two coders on the study team will develop code books independently, drawing from themes 
observed in the transcripts. The two coders will then merge their code books, resolving any 
discrepancies by mutual agreement and with input from other researchers. 
For most qualitative (e.g., describe the background scene in the video) and quantitative analyses 
(e.g., how often does SP look directly at the camera?) of SP videos, we will have two coders on the 
study team rate these variables independently, and discrepancies will be resolved by mutual 
agreement and input from other members of the study team. 
Statistical analyses will be performed using software such as MPlus, SPSS and Prism. Video 
quantification will be performed using software such as NVivo, Praat, and OpenFace. All QI analyses 
will be done in NVivo. 
The PIs (Dr. McCurdy and Potenza) are responsible for monitoring the data, ensuring protocol 
compliance, and conducting safety reviews. Data pertaining to recruitment, retention, follow-up rates, 
completeness, and availability of primary outcome data will be discussed at least monthly. 
N/A 
We do not intend to have an interim analysis. Instead, we propose to monitor screening data, baseline 
demographics, retention data, serious adverse events data, and any other data that will help in the 
assessment of the study. Based on these data, we can determine if changes in recruitment or study 
termination are necessary. 
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7.7
Handling of Missing Data
 
Intervention: In cases where significant amounts of missing data occur (>5%), multiple imputation in 
SPSS will be conducted. QIs: QIs will continue until there are data for each of the questions in the 
discussion guide. If no one interviewed has personal experience with a particular topic, that will be 
noted in the results. 
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8 Data/Specimen Handling and Record 
Keeping
8.1
Subject Data Confidentiality
8.2
Data Quality Assurance
8.3
Data or Specimen Storage/Security
Participant confidentiality and privacy are strictly held in confidence by the participating 
investigators, their staff, and the sponsor(s)/funding agency. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict confidence. HIPAA 
guidelines for data collection, management and monitoring will be followed in this study. All personnel 
involved in this study have already been certified by the Yale Human Investigation Committee as 
having completed training in the protection of the rights of human subjects who participate in 
research. Therefore, the study protocol, documentation, data, and all other information generated will 
be held in strict confidence. All research activities will be conducted in as private a setting as possible 
(via Zoom, in a private physical space). Representatives of the Institutional Review Board (IRB), 
regulatory agencies or study sponsor/funding agency may inspect all documents and records required 
to be maintained by the investigator for the participants in this study. The study site will permit access 
to such records. 
Video recordings of SPs will be stored and shared with SRs also via Qualtrics, a HIPAA-approved 
platform. Audio and video recordings of participants during QIs will be recorded using Zoom. The files 
will be saved on a secure USB hard drive and Yale Secure Box. Audio files will be transcribed and 
stored in de-identified form. Video files may be retained for nonverbal analyses, and deleted within 5 
years after data collection is complete. 
The study participant's contact information will be securely stored at each study site for internal 
use during the study (stored in Qualtrics and Yale Secure Box folder). At the end of the study, all 
records will continue to be kept in a secure location for as long a period as dictated by the reviewing 
IRB, institutional policies, regulatory, or sponsor/funding agency requirements. Study participant 
research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted 
to and stored on study computers. This will not include the participant's contact or identifying 
information. Rather, individual participants and their research data will be identified by a unique study 
identification number. The study data entry and study management systems used will be secured and 
password protected. At the end of the study, all study databases will be de-identified and archived on 
Yale secure systems.
The entire study will be conducted by the same study PI (McCurdy) to ensure consistency. The study 
PI will consult with and be mentored by the other PI (Potenza) who has extensive experience with 
conducting clinical trials and interventions for addiction. The QIs will be transcribed verbatim by a 
professional transcription service. Trained research staff will serve as secondary transcriptionists and 
will review all audio recordings and transcripts and make corrections as needed. 
Data will be stored on password-protected, Yale-managed computers and secure online storage 
spaces e.g., Yale Secure Box and Qualtrics. Data will be de-identified with unique codes and a key in 
a document separate from the data. Specifically, confidentiality of sensitive or health-related 
information collected via surveys will be accomplished by assigning unique numeric identifiers to each 
subject, and exclusively using these numbers on all electronic data records which contain sensitive 
information. For example, demographic data in Qualtrics will be labeled using participants’ unique 
numeric identifier (assigned to them at the time of enrollment) to keep their identifying information and 
their survey responses separate. Transcripts of QIs will not include names of participants but rather 
their numeric identifiers. Analysis of PHI (e.g., full-face SP videos) will occur on password-protected 
Yale-issued work computers. 
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8.4
Study Records
8.5
Access to Source
8.6
Retention of Records
8.7
Data and Safety Monitoring Plan 
Records will be maintained for 5 years after study completion. 
The study PI (McCurdy) will be responsible for maintaining all study documentation (protocols, 
consent forms, surveys, etc). These files will only be accessible to other members of the study team, 
via Secure Box. 
Only members of the research team will have access to the data, recordings, and related transcripts. 
The principal investigators (PIs) are responsible for monitoring the data, assuring protocol 
compliance, and conducting the safety reviews quarterly. During the review process, the PIs will 
evaluate whether the study should continue unchanged, require modification/amendment, or 
terminate enrollment.  The PIs and the IRB have the authority to stop or suspend the study or require 
modifications. 
This protocol presents minimal risks to the subjects. Unanticipated Problems Involving Risks to 
Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the unlikely event 
that such events occur, Reportable Events (which are events that are serious or life-threatening and 
unanticipated, or anticipated but occurring with a greater frequency than expected, and 
possible/probably/definitely related) or UPIRSOs that may require a temporary or permanent 
interruption of study activities will be reported immediately (if possible, followed by a written report 
within 5 calendar days of the PIs becoming aware of the event to the IRB and any appropriate funding 
and regulatory agencies. The PIs will apprise study personnel of all UPIRSOs and AEs that occur 
during the conduct of this research project via email as they are reviewed by the PIs. The protocol’s 
research monitor(s), the Yale School of Medicine Office of Student Research, and regulatory and 
decision-making bodies will be informed of AEs such as a participant threatening harm to themselves 
or others within 5 days of the event becoming known to the PIs. 
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9 Study Considerations
9.1
Institutional Review Board (IRB) Review
9.2
Research Personnel Training
9.3
Study Monitoring 
The study PI (McCurdy) has expertise in working with individuals with addiction and individuals in the 
ARC in a research and volunteer setting and conducting qualitative interviews. She is mentored by a 
PI (Potenza) who has extensive experience in running clinical trials for addiction treatment and 
various other relevant expertise.
The protocol will be submitted to the IRB for review and approval. Approval of the protocol must be 
obtained before initiating any research activity. Any change to the protocol will require an approved 
IRB amendment before implementation. The IRB will have final determination whether informed 
consent and HIPAA authorization are required. Study closure will be submitted to the IRB after all 
research activities have been completed. Other study events (e.g. data breaches, protocol deviations) 
will be submitted per Yale policies.
The PIs will monitor the study, and the PIs will meet fortnightly to discuss study progress. 
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9.4
Unanticipated Problems and Protocol Deviations
9.5
Study Discontinuation
9.6
Study Completion
A protocol deviation is any noncompliance with the protocol. The noncompliance may be either on the 
part of the participant, the investigator, or the study site staff. As a result of deviations, corrective 
actions are to be developed by the site and implemented promptly.
It is the responsibility of the site investigator to identify and report deviations within 5 working days of 
identification of the protocol deviation. All deviations must be addressed in study source documents, 
reported to the study sponsor, and the reviewing Institutional Review Board (IRB) per their policies.
Unanticipated problems involving risks to participants or others include, in general, any incident, 
experience, or outcome that meets all of the following criteria:

Unexpected in terms of nature, severity, or frequency given (a) the research procedures that 
are described in the protocol-related documents, such as the Institutional Review Board 
(IRB)-approved research protocol and informed consent document; and (b) the characteristics 
of the participant population being studied;

Related or possibly related to participation in the research ("possibly related" means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by 
the procedures involved in the research); and

Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized.
If the study team becomes aware of an unanticipated problem (e.g. data breach, protocol deviation), 
the event will be reported to the IRB via IRES.
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;

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 will be reported to the IRB within 5 days of the investigator becoming aware of the event.
The study may be discontinued if there are unexpected circumstances, for example in which multiple 
researchers are unable to continue the project (e.g., due to health emergencies). 
The study is expected to be completed in approximately two years, around September 2025. The IRB 
will be notified of study completion via Yale’s IRES website. 
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9.7
Conflict of Interest Management Plan 
9.8
Funding Source
9.9
Publication Plan
The PIs are responsible for publishing the results of this study. 
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, 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 trial. The study 
leadership in conjunction with the appropriate conflict of interest review committee 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. All investigators will 
follow the applicable conflict of interest policies.
This work is funded by Division 50 (Society of Addiction Psychology) of the American Psychological 
Association.
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10 Appendices
Appendix #
Title
Section
Topic
1
Literature cited for 
Background
1.1
References
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Appendix 1
1
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2
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3
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4
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5
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7
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8
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9
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12
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(2021).
13
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14
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15
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16
Kelly, J. F., Stout, R., Zywiak, W. & Schneider, R. A 3-Year Study of Addiction 
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17
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Front Psychol 10, 1052, doi:10.3389/fpsyg.2019.01052 (2019).
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18
Turner, J. K., Athamneh, L. N., Basso, J. C. & Bickel, W. K. The phenotype of 
recovery V: Does delay discounting predict the perceived risk of relapse among 
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19
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20
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21
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22
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23
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24
Proctor, S. L. Rewarding recovery: the time is now for contingency management for 
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(2022).
25
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