Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03230669 |
| Other study ID # |
6006626 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2016 |
| Est. completion date |
December 31, 2018 |
Study information
| Verified date |
May 2021 |
| Source |
University of Prince Edward Island |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 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.
Description:
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).
