Pilot Trial of Digital Substance Use Disorder Interventions to Prevent Post-release Substance Use Disorder Relapse in Offenders in Correctional Service of Canada Custody
Phase: NA
Conditions: Substance Use Disorder (SUD)
Sponsor: St. Joseph's Healthcare Hamilton

 
 
 
 
 
 
 
 
 
 
 
 
 
Pilot Trial of Digital Substance Use Disorder Interventions to Prevent 
Post-release Substance Use Disorder Relapse in Offenders in 
Correctional Service of Canada Custody (PROCESS) 
 
 
 
 
 
STUDY PROTOCOL 
V4.0 DECEMBER 8th, 2025 
PRINCIPAL INVESTIGATOR: DR. JAMES MACKILLOP  
RESEARCH COORDINATOR: NIKKI PANGBORN 
OTHER RESEARCH STAFF: JESS GILLARD 
                                              KIRAN PUNIA 
                                                      ASHLEY BLAKELY 
                                             EMILY MOTE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROCESS Study Protocol V4.0 December 8th 2025 
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Acknowledgements 
 
This work was supported by a Service Exchange Agreement between the Peter Boris Centre for 
Addictions Research at McMaster University/St. Joseph’s Healthcare Hamilton and Correctional 
Services of Canada. The authors thank the staff of the Research Branch of Correctional Service 
of Canada for their support of the project, especially Sara Johnson, Nicholas Chadwick, and 
Kayla Wanamaker. The authors additionally thank Jane De Jesus at the Peter Boris Centre for 
Addictions Research and Shawn Billington at the Research Institute at St. Joseph’s Healthcare 
Hamilton. 
 
 
 
 

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I. 
Contractual Agreement 
The proposed pilot study is being conducted under the auspices of an ongoing 
memorandum of agreement between the Correctional Service of Canada (CSC) and the Peter 
Boris Centre for Addictions Research (Dr. MacKillop is the Principal Investigator of the parent 
agreement). Both parties have signed a Service Exchange Agreement to govern this 
collaborative research. 
 
 
II. 
Project Summary 
A substantial proportion of individuals currently residing in prison have problems with 
substance use or a substance use disorder (SUD). SUDs can greatly increase an individual’s 
risk for recidivism following release from a correctional institution. Substance use also 
contributes to re-incarceration as it is associated with other illegal activities, such as driving 
while intoxicated. Although research demonstrates that treatment can greatly minimize the risk 
of recidivism, it is rarely accessible for individuals in correctional settings. However, more recent 
findings by the CSC suggests that digital interventions are both promising and effective and can 
help individuals re-integrate into the community. Thus, this pilot study will test the feasibility of 
administering two online-based treatment interventions in individuals recently released from 
prison, with a history of substance use problems, who are prohibited from using substances as 
part of their release terms. Furthermore, we will compare the efficacy of these treatments. 
 
 
III. 
Background and Rationale  
Individuals with SUDs are over represented in the criminal justice system (Butler et al., 
2022; Weekes et al., 2004). This is in part because several psychoactive drugs are illegal, so 
procurement, possession, or distribution are all illegal acts that may lead to incarceration. In 
addition, intoxication is associated with criminal behaviour, ranging from driving while intoxicated 
to physical and sexual assault and homicide. Furthermore, the link between criminal behaviour 
and substance use may be related to environmental factors, such as living in a dangerous 
neighbourhood, which is associated with both criminal behaviour and substance use (e.g., 
Cambron et al., 2020), and psychological traits, such as impulsivity, that are associated with a 
higher likelihood of both criminal behaviour and substance use (e.g., Mathias et al., 2008), a so-
called ‘third variable’. 
Following incarceration, substance use is well known to confer increased risk for 
recidivism (Zgoba et al., 2020), although there is evidence that interventions may be effective 
for decreasing recidivism (Clark, 2024; Olson & Lurigio, 2014). Unfortunately, despite the high 
prevalence of active and historical SUD in incarcerated individuals, a substantial proportion of 
individuals do not receive treatment (Kurdyak et al., 2022). Additionally, treatments that are 
implemented in prison or post-release settings typically comprise drug education or low intensity 
counselling, and are not necessarily evidence-based (Belenko et al., 2013). This is exacerbated 
by the high cost and resource demands of ‘gold standard’ treatments, such as cognitive-
behavioural therapy or the community reinforcement approach (MacKillop et al., 2018). 
 
In this context, it is important to identify alternative treatment modalities that are based 
on sound evidence but are also feasible and scalable for correlational settings. One approach is 
to use digital interventions, which may be implemented in prison settings or post-incarceration. 
In a previous systematic review supported by the CSC (Punia et al., 2025; in preparation), we 

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concluded that digital interventions for SUDs are relatively well established, evidence-based, 
and are comparatively easy to implement in a wide range of settings. Therefore, the goal of the 
proposed protocol is to conduct a pilot study to evaluate the viability of two candidate digital 
substance use interventions for offenders with a history of SUD who have recently been 
released from the custody of the CSC. Such a trial has not been conducted in Canada. 
Specifically, toward reducing substance use relapse and criminal recidivism following release 
from a custodial sentence at the CSC, the overall goals of the pilot study are: 1) to determine 
the feasibility of digital intervention clinical research among CSC post-release offenders; and 2) 
to determine which of the two digital interventions for SUDs may be best suited for a 
subsequent larger scale implementation and evaluation. 
 
 
IV. 
Trial Design and Purpose 
The core trial design is in Table 1 using a Population-Intervention-Comparison-Outcome-
Timeframe (PICOT) framework. Overall, the pilot will examine Computer-based Training for 
Cognitive Behavioral Therapy and Breaking Free Online, the two digital interventions identified 
as most promising in our systematic review. These two interventions will be evaluated in 10-20 
recently released individuals with a history of SUD in terms of feasibility, engagement, perceived 
utility and effectiveness, in general and in comparison, to each other. As a pilot trial, the 
evaluation is not intended to be able to definitively test the interventions relative to each other 
but gather initial descriptive data to establish feasibility and identify one preferred intervention.

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Table 1. PICOT framework for the proposed trial 
Population 
Recently released CSC offenders with a history of substance use 
disorder (i.e., those prohibited from using substances as part of their 
parole terms) entering the community on a probationary basis at 
Community Correctional Centres or Community-based Residential 
Facilities. The sample size is estimated to be 10-20 individuals per 
intervention (N = 20-40).  
Interventions 
1) Breaking Free Online (Telus Health) 
2) Computer-based Training for Cognitive Behavioral Therapy 
(CBT4CBT), by sudtech.org/Yale University 
 
Participation will be voluntary. 
Comparison 
The pilot is essentially two parallel pilot open-label evaluations of the 
interventions, including descriptive comparisons between each.  
Outcomes 
1) Feasibility:  
a. Number of enrolled pilot trial participants, overall and by 
intervention 
2) Engagement: 
a. Number and percentage of modules completed 
3) Perceived Utility:  
a. Mean rating/module and overall (e.g., importance, 
relevance, usefulness) 
4) Effectiveness: 
a. Performance on within-intervention information quizzes 
b. Substance use relapse (as documented by the CCC staff) 
c. Institutional readmission (as documented by CSC) 
Timeframe 
The pilot project will run over a six-month enrollment period. 
 
 
 

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V. 
Population 
The target population is individuals who (1) have previously served custodial services 
in the CSC; (2) have a history of a SUD; (3) are residing in Community Correctional Centres 
(CCCs) or Community-based Residential Facilities (CBRFs); (4) are 18-55 years old. Problems 
with substance use will be determined on the basis that individuals are prohibited from using 
substances according to their parole terms. The programs would be considered to be most 
appropriate to individuals who have been recently released from prison to assist with navigating 
the transition but are fundamentally applicable to any individual in these settings with a history 
of SUD and motivation to participate. 
 
 
VI. 
Intervention #1: Breaking Free Online 
 
Breaking Free Online (BFO) is a digital intervention for SUD concerns and mild to 
moderate co-occurring mental health conditions, such as depression and anxiety. It has been 
implemented in a wide array of settings including, to a limited extent, prisons in the UK. In terms 
of modality, BFO can be accessed online or via smartphone, and is self-paced, moving at the 
preferred speed of the individual. In terms of focus, BFO emphasizes relapse prevention and 
behavioural change techniques to address high-risk situations. This includes cognitive 
restructuring and mindfulness-based interventions. Anticipating high risk situations and planning 
to mitigate risk for substance use are also emphasized. Individuals navigate through skills via a 
dashboard and visually track their progress and substance use.  
In terms of criminal justice outcomes, one study included a diverse sample of N = 2,311 
individuals from specialist community-based substance misuse services, inpatient detoxification 
settings, community mental health services, and also prisons (n = 165). Individuals were first 
assessed on biopsychosocial functioning, quality of life, depressive/anxiety symptomology, and 
severity of dependence and were re-assessed eight weeks later. Significant reductions in 
problems with biopsychosocial functioning, depressive/anxiety symptomology, and alcohol/drug 
dependence symptoms were observed. Individuals also reported increases in quality of life and 
recovery progression, albeit to a smaller degree. The degree of change individuals experienced 
was significantly associated with the number of modules completed. For example, reductions in 
anxiety were associated with the number of times participants completed strategies in the 
emotional impact and negative thoughts modules. Changes in quality of life and biopsychosocial 
functioning were also associated with the number of strategies completed, further underscoring 
the dose-dependent response that is associated with completing modules in BFO (Elison et al., 
2017). On balance, the outcomes reported were favourable but only a minority of participants 
were from a prison setting and specific outcomes for that subgroup were not reported. 
A second study included high-risk incarcerated individuals (n = 134) who completed a 
Pillars of Recovery group (an intervention with similar principles as BFO, but completed in 
person with a clinician), whereas low-risk offenders completed BFO (n = 332) (Garvey et al., 
2021). Risk status in this study was based on a score of +50 on the Offender Group 
Reconviction Scale-3. Both groups showed significant increases in quality of life from pre- to 
post-treatment and both also had significant decreases in dependence severity. Additionally, 
both groups showed improvements in biopsychosocial functioning (Garvey et al., 2021). 
Although observational in nature, these results demonstrate that BFO is associated with 
reduced substance use, increasing quality of life and biopsychosocial functioning. In a 
qualitative study in incarcerated adults (Elison et al., 2016), prisoners had a positive impression 
of BFO, highlighting the potential of the program to “build recovery capital” and provide 

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continued care. In addition, the participants reported they liked the structure of the program and 
reported they could translate the skills they learned into the community. 
During the COVID-19 pandemic, a study used data from 2,187 Ohio prison residents 
who engaged with BFO (Elison-Davies et al., 2022). Using the progress check within the 
program as a benchmark, 53% of those who completed a progress check had decreased 
methamphetamine dependence, depression/anxiety, biopsychosocial impairment and increased 
quality of life (Elison-Davies et al., 2022). BFO comprises twelve evidence-based behavioural 
change techniques (BCTs), and those who completed a progress check were found to have 
completed more BCTs components (Elison-Davies et al., 2022). Interestingly, completion of the 
Difficult Situations module was associated with better psychosocial functioning, completion of 
the Unhelpful Behaviours module was associated with decreased substance dependence and 
an increase in mental health and biopsychosocial functioning, and completion of the Lifestyle 
module was associated with benefits for mental health, biopsychosocial functioning, and quality 
of life (Elison-Davies et al., 2022). 
 
Most recently, BFO was evaluated in more than 20,000 offenders in prisons in the United 
States and the United Kingdom (Elison-Davies et al., 2024). In that study, substantive 
differences were present between the two settings, with more favourable outcomes in the British 
sample that had more staff involvement in the implementation. Nonetheless, both samples 
exhibited positive changes in all outcomes and program engagement was significantly 
associated with those changes. These findings suggest that BFO is an effective digital 
intervention for reducing substance use severity, comorbid mental health issues, and further 
provides evidence for the dose-dependent relationship between using the program more 
frequently with certain outcomes such as quality of life. 
On balance, although most of the research uses observational designs, BFO 
nonetheless has notable promise for use in Canadian correctional and post-release settings. 

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VII. 
Intervention #2: Computer-based Training for Cognitive Behavioral Therapy 
Computer-based Training for Cognitive-Behavioral Therapy (CBT4CBT) was developed by 
Dr. Kathleen Carroll at Yale University, and is a web-based version of Cognitive Behavioural 
Therapy (CBT) for SUDs (Carroll et al., 2008). CBT4CBT does not require any prior computer 
experience or reading skills (the text is read by a narrator) and incorporates multimedia style 
with computer educational games, graphic designs, animation, quizzes, interactive videos and 
audio voice-overs, modelling and imparting knowledge on skills and strategies (Carroll et al., 
2008, 2014; Mallorquí-Bagué et al., 2023). In terms of structure, CBT4CBT has six modules 
including understanding and changing patterns of substance use, coping with craving, refusing 
offers of drugs and alcohol, problem solving skills, identifying and changing thoughts about 
drugs and alcohol, and improving decision-making skills (Carroll et al., 2008). Each module 
begins with introducing the key concepts, portraying a short video describing an individual being 
offered drugs or needing to cope with challenges surrounding substance use (Carroll et al., 
2008). Following this, core skills to avoid substance use are introduced by the characters 
highlighting the importance of CBT skills (Carroll et al., 2008). Knowledge and skills gained in 
the modules are reinforced in additional videos that enable participants to view supplementary 
videos depicting characters engaging in assertive versus aggressive versus passive 
communication (Carroll et al., 2008). Additionally, each module contains a short vignette and an 
interaction video with a narrator providing knowledge on utilizing skills that assisted them to 
avoid substance use and the application of skills to address other issues (Carroll et al., 2008). 
Last, each module consists of a narrator reviewing all skills and strategies acquired, 
demonstration of homework completion and provides an assignment with a reminder sheet 
(Carroll et al., 2008). 
In terms of the efficacy in randomized controlled trials, Carroll et al. (2008) found 
participants in the CBT4CBT group had significantly reduced positive urine drug screen tests for 
any drugs (Carroll et al., 2008). Those in the CBT4CBT group also had a longer periods of 
abstinence while in treatment in comparison to those in treatment as usual (Carroll et al., 2008), 
although no differences were found between the two groups (CBT4CBT and treatment-as-usual 
[TAU]) for overall self-reported abstinence for all illicit drugs, alcohol, and cocaine (Carroll et al., 
2008, 2014). While investigating treatment outcomes, it was reported that cocaine use 
outcomes were more favourable among the CBT4CBT group in comparison to treatment as 
usual alone, with significant abstinence from cocaine observed in the intention to treat sample in 
the CBT4CBT group (Carroll et al., 2014). As noted, decreased consumption of cocaine was 
observed among those assigned to the CBT4CBT group in comparison to treatment as usual 
from baseline until the 6 month follow-up (Carroll et al., 2014). 
In terms of correctional settings, one study specifically focused on alcohol use disorder 
(AUD) and a quarter of the sample was referred for treatment by the criminal justice system 
(Kiluk et al., 2016). Evaluating treatment retention and completion, 63 of 68 individuals initiated 
treatment by attending at least 1 session and 52% completed the treatment protocol (Kiluk et 
al., 2016). Participants in either of the CBT4CBT groups had a higher likelihood to complete the 
treatment protocol compared to those in treatment as usual (Kiluk et al., 2016) and the large 
majority of the participants (88.4%) indicated completion of at least 1 of the 6 homework 
assignments (Kiluk et al., 2016). The primary and secondary indicators of drinking at the 6 
month follow-up suggested an increase in the percentage of days abstinent (PDA) and a 
decrease in percentage of heavy drinking days (PHDD) across all three groups: TAU, TAU + 
CBT4CBT, and CBT4CBT + brief monitoring (Kiluk et al., 2016). In addition, an overall increase 
in abstinence was found during the 8-week period in the TAU + CBT4CBT group as compared 
to TAU (Kiluk et al., 2016). Furthermore, a decline in heavy drinking was significant for 
participants in the TAU + CBT4CBT group, but not in the CBT4CBT + monitoring group (Kiluk et 

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al., 2016). Lastly, 91% of the participants completed the final 6-month follow-up and an overall 
decline in heavy drinking was present (Kiluk et al., 2016). Most recently, investigating the 
feasibility of CBT4CBT in residential treatment among women with SUDs, Kelpin et al. (2022) 
found that those in the CBT4CBT group had a decreased likelihood of relapse, increased time 
to relapse, and lesser number of days of endorsing substance use over the 3-month follow-up in 
comparison to a TAU group. 
Given its electronic structure, program engagement is one candidate mechanism of 
efficacy. Evaluating this as measured by adherence to the program, Tetrault et al. (2020) found 
that of N = 30 participants in CBT4CBT, 77% completed at least one CBT4CBT session and of 
those who completed at least one session 78% completed some homework. Further, it was 
shown that participants preferred to complete CBT4CBT in diverse settings as 44% completed 
sessions at home, 44% at the clinic, and 12% completed both at home and in the clinic (Tetrault 
et al., 2020). Reasons reported for accessing CBT4CBT in the clinic was that it provided a 
quieter environment without distraction as compared to their homes. Notably, diverse electronic 
platforms were also used, as 61% accessed CBT4CBT on a desktop, 22% on a laptop, 26% on 
a tablet, and 26% on a smart phone (Tetrault et al., 2020), suggesting accessibility via multiple 
modalities is a strength of the program. 
On balance, although not validated in correctional or post-release settings, its sizable 
evidence base makes CBT4CBT a promising digital SUD intervention in criminal justice 
contexts. 
 
 
VIII. 
Comparison 
This pilot study is a two-parallel open-label (unblinded) feasibility trial of the two 
interventions. We will use a cross-sectional design, with N=10-20 participants randomly 
assigned to each intervention. We will descriptively compare our feasibility outcomes (i.e., 
average number of modules completed and overall utility ratings) between the interventions and 
consider other factors, such as ease of implementation, duration/burden, and cost. For example, 
one intervention has an additional module compared to the other and if the ratings are 
descriptively similar, we would interpret the shorter intervention to be more viable. 
Fundamentally, as a pilot/feasibility study with a small sample size, the goal is to assess 
patterns of responses toward selecting a particular intervention for future research, without 
drawing statistically significant conclusions about differences in efficacy, and to confirm the 
overall feasibility of both treatment interventions in our study population. 
 
 
IX. 
Outcomes 
The first outcome is feasibility because a fundamental question is whether clinical 
research on digital interventions can be undertaken in CCCs/CBRFs. That is, any subsequent 
larger-scale research in these settings is predicated on the feasibility of working with staff and 
residents there. In terms of operational definitions, feasibility will be defined as the number of 
enrolled pilot trial participants, overall in the study and by intervention program. Based on 
evidence that the content module completion is a critical mechanism for benefit from these 
digital programs (Elison-Davies et al., 2022; Tetrault et al., 2020), the second outcome will be 
the number of modules completed (i.e., engagement). Third, to evaluate the acceptability and 
tolerability of the programs for the target population, we will examine the perceived utility by the 
program participants who will rate each module in terms of its importance for preventing 

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substance use, relevance to their situation, and usefulness as a post-release resource, via 
purpose-built questionnaires. Finally, although the project is a pilot study, it will nonetheless 
collect data on how effective the programs are, defined as a) how well participants perform on 
the content quizzes within the interventions; b) whether substance use lapses were identified by 
the CCC/CBRF staff; and whether institutional readmission took place as a result of substance 
use or substance-implicated recidivism as documented by CSC. 
 
X. 
Assessments and Study Procedures 
Assessments (Table 2) for this study will include self-report questionnaires collected via 
the St Joseph’s REDCap on study iPads. Study personnel will travel to CCC’s and CBRF’s to 
complete the informed consent process with interested participants. They will be subsequently 
randomized into the BFO or CBT4CBT treatment intervention, complete a battery of 
questionnaires, and have their treatment account set up. All assessments and treatment 
modules will be completed on the study iPads in-person, with study personnel present to 
provide any necessary assistance. Additionally, iPads will be set up to block the use of all other 
apps and websites aside from REDCap, BFO, and CBT4CBT. Three months following 
completion of the treatment intervention, we will submit a request to the CSC to send 
information about participants’ status of relapse and re-incarceration following treatment. CSC 
staff will only receive a list of names for which this data is requested, but will not have access to 
data collected by our study team or that collected through the treatment intervention. This query 
will be submitted via an encrypted email using a password-protected Excel sheet containing the 
participant names and requested information. The CSC will send back the information 
containing only the Subject ID numbers, thereby unlinking it from any personal identifiers. 
Randomization will be conducted in an Excel sheet. To do so, a column was created with 
both treatment types split evenly, assuming N=40 participants. A separate column generated 
random numbers using the RAND() function, and the Treatment column was subsequently 
sorted by the randomly-generated numbers from smallest to largest. Subject ID’s will be 
inputted into a separate column as participants are enrolled. 
 
Table 2. Self-Report Questionnaire Measures 
Construct 
Scale/Questionnaire 
Demographics 
Self-report demographics questionnaire assessing age, gender, 
race/ethnicity, education, socioeconomic status, etc.  
 
Treatment Utility  
A 4-item scale where participants rate how important, relevant, 
helpful/useful, and likely they are to recommend the treatment 
program and modules. These will be administered after each 
individual module, and following completion of the treatment 
intervention.  
Substance Use 
Behaviour 
a Brief Assessment of Recovery Capital (BARC) 
Description: 10-item assessment of an individual’s personal and 
interpersonal tools/resources available for recovery from substance 
use. 
 
a Commitment to Sobriety Scale (CSS) 
Description: 5-item self-report assessment of how committed an 
individual is to maintaining sobriety.  

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Substance Use History 
Description: examining participants’ substance use prior to their 
most recent incarceration (i.e., what substances they used, how 
often, how often they were under the influence, and whether they 
have been incarcerated as a result of substance use). 
 
a Penn Craving Scale (PCS) 
Description: 5-item self-report scale assessing recent drug/alcohol 
cravings. 
 
a General Motivation to Change Questionnaire (GMCQ) 
Description: 3-item assessment of how motivation an individual is to 
quit or cut down on their substance use. 
Incarceration History 
Self-report questionnaire about the individual’s most recent criminal 
offence and the length of their sentencing. 
a These scales will be administered at baseline (upon enrolment into the study) as well as 
following treatment completion. 
 
 
 
XI. 
Timeframe 
The project will be executed as part of the 2025-2026 Annual Deliverables Plan for the 
Memorandum of Understanding between CSC and the Peter Boris Centre for Addictions 
Research. The first three months will be used for finalizing the protocol, determining the target 
CCC/CBRFs and establishing working relationships with those settings, and obtaining ethical 
review board approvals. BFO and CBT4CBT include 6 and 7 modules, respectively; thus, we 
anticipate each participant to complete treatment in 4-6 weeks at a minimum rate of 1-2 
modules per week. Data collection and analyses will be executed over six months and the 
results will be reported during the final three months.  
 
 
XII. 
Participant Recruitment  
 
Participants will be recruited from CCCs and CBRFs. Study flyers will be advertised in 
the facility and interested participants can contact the team expressing their interest in 
participating, or otherwise inform staff in the facilities who will generate a list of interested 
participants to provide to study personnel. This process will be repeated as needed until the 
target sample of N=20-40 participants is reached.  
 
 
XIII. 
Analyses  
 
Our feasibility outcomes will be analyzed using basic descriptive measures to assess the 
number of participants enrolled and the total and average number of modules completed for 
each intervention. We will use independent sample t-tests to analyze differences in the 
perceived utility between treatment interventions, as well as differences in our feasibility 

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outcomes. Secondary outcomes such as recidivism and relapse rates will also be preliminarily 
compared between treatment groups using independent sample t-tests, and differences in 
baseline and post-treatment assessments of substance use will be examine using a 2x2 
analysis of variance (ANOVA).  
 
 
XIV. 
Incentives and Costs  
CSC policy prohibits provision of incentives to incarcerated individuals. Participation will 
be voluntary, with no monetary incentives, and no benefits to the participants beyond the 
experience of contributing to research and participating in the intervention. This will be clearly 
explained to participants and is considered to have no risk of coercion. There will also be no 
costs to participants.  
 
 
XV. 
Potential Risks  
This study does have several potential risks, and we have implemented several 
procedures to minimize these risks. Prior to enrolling in the study, all participants will be given a 
detailed overview of the study and will provide written informed consent. Participants will be 
reminded that taking part in the study is voluntary and that they can withdraw at any time 
without penalty.  
We anticipate the following potential risks: 
1. Risks associated with discomfort / distress in answering personal questions: 
Participants could potentially experience some discomfort resulting from answering 
some of the personal questions throughout treatment, which ask about previous 
substance use, triggers for use, and mental health symptoms. Participants will be 
informed that they can stop treatment at any time point. To further reduce any potential 
discomfort, participants will be debriefed at the end of treatment, including an opportunity 
to raise any concerns that they may have about their experience in the study. 
2. Risks associated with breach of confidentiality / loss of privacy: A potential risk is 
loss of privacy due to inadvertent disclosure of personal information which could lead to 
embarrassment or damage to reputation. In addition, we are using two online-based 
therapeutic interventions which collect participant’s data. Both BFO and CBT4CBT are 
compliant with PIPEDA. Their full privacy statements can also be found online. Any 
personal data we are viewing will be stored on password-protected servers and paper-
based data will only be transported by trusted study personnel directly to our research 
centre, where it will be stored in a locked office and locked cabinet. Additionally, 
participants will be assigned a unique Subject ID number that will be kept separate from 
their name. Finally, results will only be disseminated in aggregate form with no 
participant names.   
3. Risks for legal disclosure of information: It is possible that a court may find privilege 
to the information collected about participants’ substance use, if it was subpoenaed. To 
avoid legal repercussions, we will not collect information about participants’ recent 
substance use patterns. Information collected via treatment and questionnaires will 
relate to craving, coping, and general recovery, rather than current substance use. 
Participants will be informed of this possibility in the consent form to ensure they 
understand all legal risks associated with completing the study. Furthermore, they will be 

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reminded that their participation, including answering any questions in the study, is 
completely voluntary.  
 
 
XVI. 
Study Budget 
A detailed study budget has been uploaded with the REB application.  
 
 

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