Computer-assisted Delivery of Cognitive Behavioral Therapy for Mental Health and Addictions in Canada
Phase: NA
Conditions: Substance Abuse
Sponsor: University of Prince Edward Island

PEI REB - Research Protocol Guidelines  
 
 
 
      Version 1 dated July 20, 2017 
 
Page 1 of 6 
 
 
Prince Edward Island 
RESEARCH ETHICS  BOARD 
 
Research Protocol Guidelines 
 
 
1. 
INTRODUCTORY INFORMATION: 
 
 
Project Title: Computer-assisted delivery of cognitive behavioral therapy for mental 
health and addictions in Canada 
 
 
Local Principal Investigator: Juergen Krause 
 Institution/Department/Divisional: Faculty of Business 
 Affiliation: UPEI  
 Address and Telephone : 550 University Ave, Charlottetown PEI, C1A 4P3 
Number: 902-566-0340, 
Fax Number,  
Email Address: jukrause@upei.ca 
 
 
Co/Sub/Associate Investigators: Michelle Patterson 
Institution/Department/Divisional  Affiliation: Centre for Health and Community Research 
Address:  550 University Ave, Charlottetown PEI, C1A 4P3 
Telephone Number: 902-566-0334 
 
Kathleen Carroll 
Yale School of Medicine 
New Haven, CT 
kathleen.carroll@yale.edu 
 
 
 
Anticipated Duration of Study: April 01, 2019 
 
 
Name of Study Sponsor or Funding Agency (if applicable): CIHR 
 
 
 
 
Local Site(s) of Research: Prince Edward Island, New Brunswick, Ontario 
 
 
Version Number and Date: 1, 7/12/2017 
 
 
2. 
SUMMARY:  
 
Computer-based Training for Cognitive Behavioural Therapy (CBT4CBT) is a new on-
line addiction treatment developed by Dr Kathleen Carroll at the Yale School of Medicine in 
New Haven, Connecticut. CBT4CBT consists of seven one-hour long online sessions that teach 
key concepts, including dealing with cravings, problem solving, and decision making skills, to 
help users reduce substance abuse. CBT4CBT has been rigorously tested throughout various 
communities in the United States with great success and is currently being rolled out throughout 

PEI REB - Research Protocol Guidelines  
 
 
 
      Version 1 dated July 20, 2017 
 
Page 2 of 6 
 
the States. The therapeutic approach of CBT4CBT is unique as its efficacy, durability and cost-
savings have been proven in several rigorous clinical trials and will be magnified by the fact that 
the program can be delivered in Canada, allowing for increased and continual improvements in 
population health. CBT4CBT has been accepted by both patients and addiction treatment 
personnel alike and has won numerous clinical innovation awards. 
  
A collaboration has now been formed between Dr Carroll and Drs Michelle Patterson and 
Juergen Krause of the UPEI Centre for Health and Community Research (CHCR) that will bring 
CBT4CBT to Canada. While CBT4CBT has previously been tested in urban areas, there are 
many advantages to offering computer-based training to more rural populations (such as PEI). 
These more remote areas frequently suffer from a lack of services, as well as a lack of continuity 
with the services currently offered. CBT4CBT may very well provide that needed continuity to 
Addictions treatment and has also been shown to improve retention.  
 
3. 
BACKGROUND, RATIONALE AND STATEMENT OF RESEARCH 
QUESTION(S): 
 
CBT4CBT will be the first computer-based, cognitive behavioural therapy program for 
Addictions treatment to be offered in Canada. CBT4CBT has been rigorously tested in urban 
populations in the United States but this collaboration will be the first pilot trial in First Nation 
and other rural communities in Canada. Prince Edward Island has a self-proclaimed need for 
innovative new substance abuse treatments and CBT4CBT may provide the continuity and 
retention to traditional therapy programs that current available treatment options often lack. This 
study will allow CBT4CBT to be tested in several Prince Edward Island communities to gage its 
efficacy and effectiveness. The results and feedback received from the pilot study will allow the 
program to be adapted for Canadian populations in order to optimize its positive outcomes within 
Canada. 
CBT4CBT has been tested in urban populations in the United States in three rigorous 
randomized clinical trials with great success. The nature of CBT4CBT suggests it would also be 
beneficial in rural and remote populations which are common across Canada. Computer based 
treatments are cost-effective and although their nature necessitates human participants they have 
minimal risk associated with them. As the first computer based training for  Addictions in 
Canada this research project could have broad implications for treatment in Addictions across 
our country. 
Analysis techniques will be based on those used in previous CBT4CBT trials conducted by our 
collaborator, Dr Carroll. 
The primary substance abuse outcomes (self-reported abstinence) will be assessed throughout the 
study and through a six month follow-up. Additional outcomes will include use of other services 
(medical, legal), patient and provider satisfaction, as well as the costs of implementing the 
program. Each week, the counsellors will deliver a questionnaire (provided by the CHCR) which 
covers this range of topics to their patient participating in the trial. The data will be analyzed 
with a focus on feasibility (retention in both conditions, levels of substance abuse, health 
problems, and cost by condition).  
 
 

PEI REB - Research Protocol Guidelines  
 
 
 
      Version 1 dated July 20, 2017 
 
Page 3 of 6 
 
4. 
SUBJECT SELECTION: 
 
Participants will be recruited from Prince Edward Island; Lennox Island Health Centre 
and Abegweit Health Centre, Mount Herbert Provincial Addictions Treatment Facility Transition 
Unit and Methadone clinic, Holland College Student Services, University of Prince Edward 
Island Student Services, Charlottetown Methadone Clinic and Prince County Hospital. At 
RECAP  in New Brunswick and Ontario Shores Mental Health Centre in Ontario. 
A total of 240 Participants will be recruited during years 1-2 and an additional 440 participants 
will be recruited during years 3-4 ending in April 2019. 
Counsellors already employed by the Centres will recruit participants who are willing to consent 
to a randomized trial of CBT4CBT. In order to create as representative a sample as possible, the 
inclusion criteria will be fairly broad, including any consenting individual who reports substance 
abuse in the past thirty days. Individuals who are currently suicidal, homicidal, or require 
immediate hospitalization will be excluded.  
The participants will be patients who have reported substance abuse in the past thirty days. For 
the initial trial, all participating individuals will be over eighteen years of age and be approved to 
participate by their addictions counsellors.  
Counsellors will ask individuals seeking treatment for substance abuse if they would be 
interested in learning about and participating in a substance abuse treatment project. If yes, 
participants will be introduced to the study Research Assistant who will go through the consent 
form(attached) with them. The Research Assistant will orally read the forms if necessary and 
individuals will be informed of their right to withdraw from the program should the need arise. 
 
5. 
RESEARCH PLAN: 
The individuals recruited for this study will each fall into one or more subgroup of the trial 
(transitioning patients [ inpatient to outpatient], youth [18-24 years], maintained on methadone, 
and indigenous individuals) and will be analyzed individually as well as collectively by 
compiling results from all sites. A subgroup analysis based on gender is also planned to 
investigate any differences in outcomes between male and female participants, these two groups, 
historically, can show significant differences in response to mental health and addictions 
treatment. 
Participants will be randomized to either test or control groups. Participants in the control group 
will receive treatment as usual (the conventional treatment offered at that site) and will also meet 
with the Research Assistant during week 4 and week 8 to complete questionnaires (attached) 
either in hard copy or online on a tablet provided. These participants will also be contacted six 
months after their eight-week participation in the trial ended to complete a follow-up 
questionnaire. 
Participants randomized to the test group will receive treatment as usual but will also be asked to 
spend at least thirty minutes per week using the program. CBT4CBT use by each participant will 
be monitored throughout the trial to ensure that this requirement is being met. They may choose 
to do this on location at the site or from their personal computer/tablet. The individuals in this 
arm of the trial will also meet with a Research Assistant once a week for eight weeks to complete 
questionnaires and will be contacted six months after their eight-week participation in the trial 
ended to complete a follow-up questionnaire. These questionnaires can be completed online. 
Each participant will be asked to participate in the eight-week long treatment period regardless of 
group (test or control). In addition to participants’ treatment as usual, this will involve a 

PEI REB - Research Protocol Guidelines  
 
 
 
      Version 1 dated July 20, 2017 
 
Page 4 of 6 
 
commitment of approximately 10 minutes as a weekly average from participants in the control 
group, and approximately 45 minutes as a weekly average from participants in the test group. 
Please see the consent form table outlining the time commitments in more detail. 
This trial design will mirror the designs in the trials already successfully conducted in the United 
States. Once an individual consents to participate, the counsellor will contact the Research 
Assistant who will meet with the individual and assign them a participant number generated 
using Randomizer.org (Geoffrey C. Urbaniak, 2015). This number will have been previously 
assigned to either test or control. The participant will be notified about the trial arm that they are 
placed into so that their participation may commence. 
A Research Assistant will deliver the questionnaires to the trial participants. Questionnaires may 
be answered in hard copy or online in private. This removes the pressure from the participants to 
'improve' in the eyes of their counsellor. Other than the addition of sections specifically relating 
to the CBT4CBT program, the questionnaires between groups will be identical. 
As mentioned above, three previous/pilot studies in urban areas of the U.S. have been performed 
(Carroll et al., 2008, 2009, 2014). The trial described herein will follow a very similar design. 
Questionnaires, data analysis and protocols are based on those previously used by our 
collaborator in the US and have all been tailored to better suit Canadian populations. Based on 
the significant success that Dr Carroll had using these outcomes, tools and protocols we are 
confident in their reliability and validity. 
Individuals who consent to this trial will be notified at the beginning of the trial that they have 
the right to remove themselves from the trial at any time. They also have the right to contact their 
counsellor or either co-investigator (phone numbers and emails provided on the consent form) at 
any time should they have questions or concerns. The counsellors also hold the ability to remove 
any of their patients from the trial at any time if they see fit. 
 
 
6. 
ANALYSIS OF DATA: 
 
Statistical analysis techniques previously used by the Co-Investigator Dr Carroll and her 
team will be performed on the generated data from this trial (Carroll et al., 2008, 2009, 2014). 
These include one and two-way analysis of variance (ANOVA's) where appropriate.  This will 
ensure a relevant analysis approach is used for the field of addictions treatment research as well 
as ensuring that the generated results may be compared with those previously established at other 
sites. 
The power calculations performed to calculate the sample size are based on three similar 
published trials of CBT4CBT in urban populations in the US. Primary outcome measurements of 
this trial will be a subset of measurements collected in these previous trials. We believe retention 
and follow up rates will be similar if not higher than the previous trials as PEI has a less transient 
community than most urban centers like Connecticut. Based on the three previous trials (Carroll 
et al., 2008, 2009, 2014), the average drug use measurement (measured by the percent days 
abstinence from all drugs) in the test groups was 75% and control group 66%  with a common 
standard deviation of 24% at the end of the eight week trial. Retention during the eight week trial 
was on average 77% and follow-up success was approximately 87% six months post trial. These 
values were used to calculate the sample size of 30 (for each group) to achieve statistical 
significance with an alpha of 0.5 and a power of 0.8 for subgroup analysis of the initial trials on 
PEI, and an alpha 0.05 of and a power of 0.8 for combined analysis (i.e. combining results from 

PEI REB - Research Protocol Guidelines  
 
 
 
      Version 1 dated July 20, 2017 
 
Page 5 of 6 
 
all 240 participants across the four trial settings). Power calculations to achieve statistical 
significance with an alpha of 0.05 and a power of 0.9 were calculated for the large-scale 
effectiveness trials and a sample size of 110 was found. 
Primary outcomes measured include retention, changes in drug use, changes in health (e.g. 
medical visits, family and social satisfaction, etc.) and program implementation costs. The 
outcomes to be determined are identical in the four parallel trials to foster comparability across 
populations. 
Secondary outcomes measured include feedback from patients and counsellors. This information 
will be used to refine CBT4CBT as an ideal treatment approach for each relevant population. 
Analysis of this data will be on a qualitative level. Drs Krause, Patterson and Carroll place a high 
priority on patient feedback and advisement and are in agreement that the patients who 
participate in these trials can contribute to quality improvement at both the individual and 
collective level. The populations in which CBT4CBT will be implemented throughout this 
program may have differing needs and desires for substance abuse treatment. Dr. Carroll and her 
team to date have created three versions of the CBT4CBT program (drug abuse, alcohol only 
abuse, and a culturally specific version for Spanish speaking individuals in the U.S.). With the 
feedback from this initial trial, we aim to create potentially revised versions of the CBT4CBT 
program, which are tailored to better suit Canadian, specifically First Nation, youth, and 
rural/remote environments.  
7. 
RISKS AND BENEFITS: 
 
CBT4CBT has been shown to hold no more than minimal risk for all participants. In all 
previous trials, no adverse effects were demonstrated. For this implementation, all participants 
will be referred to the trial at the sole discretion of their counsellor and anyone who is deemed 
suicidal, homicidal, has an undiagnosed psychiatric disorder, or is requiring immediate 
hospitalization will be excluded. If at any point throughout the trial a participant wishes to 
withdraw, or if the counsellor feels they should be withdrawn from the trial, exposure to 
CBT4CBT will be immediately withdrawn. 
CBT4CBT has demonstrated excellent results in improving retention and in allowing participants 
to significantly reduce their substance abuse. The goal of these initial trials is to have CBT4CBT 
become a standard treatment option in Mental Health and Addictions treatment programs 
throughout Canada by providing refined, or potentially new, versions of the program to 
populations across the country. This may significantly increase the success of addictions 
treatment across Canada and in turn largely benefit our society as a whole. 
Participants in the ‘test’ group who respond well to CBT4CBT will have the opportunity to 
continue accessing the program at their leisure (using their provided login information) beyond 
the time frame of the study. Participants in the ‘control’ group may have the opportunity to 
access CBT4CBT once the trial is complete and assuming that positive effects of CBT4CBT are 
verified on PEI. 
 
 
8. 
CONFIDENTIALITY: 
 
The CHCR team currently work with Health PEI and the PEI Department of Health and 
Wellness on a CIHR-funded initiative which built the UPEI Secure Island Data Repository on 
the UPEI campus which holds de-identified PEI health records as well as any research-generated 
data from clinical trials such as this one.Therefore, the non-identifiable data generated 

PEI REB - Research Protocol Guidelines  
 
 
 
      Version 1 dated July 20, 2017 
 
Page 6 of 6 
 
throughout this study will be stored, after collected and analysed, on secure servers in the UPEI 
Secure Data Facility.  Only CHCR researchers (via password protection and key codes to the 
room) will have access to the data. All Data will be retained for a minimum of five years.  
 
 
 
9. 
LIABILITY: 
 
N’A 
 
10. 
DISCLOSURE OF ANY FINANCIAL COMPENSATION: 
 
N/A 
 
11. 
REFERENCES: 
 
 
Attached 
 
12. 
APPENDICES: 
 
Questionnaires or measuring instruments and appropriate copyright release (if applicable) 
should be  
included as appendices to the proposal when appropriate. 
 
 
 
Any advertisements intended for use to recruit participants should be submitted for 
review. 
 
 
Please see the General Guidelines (Section 3.11) concerning Advertisements. 
 
 
Administrative Requirements for Research Protocols: 
● Please use a font-size large enough to be legible (12pt Times New Roman font is 
preferred). 
Protocols may be returned if this criterion is not met. 
 
● Please include page numbers, as well as a version number and date on your proposal 
(which must be revised whenever the proposal is amended) and any appended data 
collection tools or measures. 
 
 
 
 
Additional Considerations: 
• 
Submissions based on a grant proposal (e.g. CIHR, PEI Research Fund), the level 
of data might not in all instances provide enough information about the 
methodology to meet the REB’s requirements for  ethical and scientific review.  
In these cases the grant proposal should be supplemented by further information 
based on the guidelines of the this REB. 
• 
All documentation that will be provided to family doctors, participants, 
participant relatives and caregivers (including study introductory letters) must be 
reviewed and approved by the REB prior to use.