Substance AbuseNCT03230669
Computer-assisted Delivery of Cognitive Behavioral Therapy for Mental Health and Addictions in Canada
A study testing cbt4cbt in people with Substance Abuse, run by University of Prince Edward Island at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- cbt4cbt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 struggling with substance abuse (the definition of 'abuse' is determined by their counselor).
- Individuals who are 18 years of age or older
- Individuals who have used their substance of choice within the past 28 days.
Who cannot join
- Individuals who are currently suicidal, homicidal, or require immediate hospitalization will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Prince Edward Island
Charlottetown, Prince Edward Island, C1A 4P3
About this study
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.
Read the detailed 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).
- Conditions
- Substance Abuse
- Being tested
- cbt4cbt
- Keywords
- substance abuse, addiction, etherapy
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cbt4cbtOther
This arm receives treatment as usual and in addition are given access to an online therapy, cbt4cbt. If placed in this group, individuals are asked to use the online therapy for a minimum of 30 minutes each week for the trial duration of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | this arm receives treatment as usual and no intervention. |
| CBT4CBT | Experimental | This arm receives treatment as usual and in addition are given access to an online therapy, cbt4cbt. If placed in this group, individuals are asked to use the online therapy for a minimum of 30 minutes each week for the trial duration of 8 weeks. Receives: Other: cbt4cbt |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary substance use
Substance use of individuals of their primary drug (or drug of choice)
Measured: 6 months
Secondary outcomes (3)
Secondary substance use
Substance use of individuals including all drugs which are not their drug of choice
Measured: 6 months
Healthcare, social and justice interaction
Use of healthcare, social and justice services by the individuals
Measured: 6 months
CBT4CBT feedback
Detailed feedback from experimental group individuals on the cbt4cbt program
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Jan 2016
- Primary completion31 Mar 2018
- Study completion31 Dec 2018
Why it stopped: Recruitment and data collection issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Prince Edward Island
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Mary Ann MacSwain, University of Prince Edward Island
- Investigators
- Juergen Krause, phd, Principal investigator, University of Prince Edward Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230669
- Sponsor's protocol ID
- 6006626
- Status last verified
- May 2021
- First submitted
- 20 Jul 2017
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-assisted Delivery of Cognitive Behavioral Therapy for Mental Health and Addictions in Canada
- ClinicalTrials.gov ID
- NCT03230669
- Acronym / sponsor ID
- 6006626
- Conditions
- Substance Abuse
- Keywords
- substance abuse, addiction, etherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment and data collection issues
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of Prince Edward IslandUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –this arm receives treatment as usual and no intervention. |
| CBT4CBT | Experimental | Other: cbt4cbtThis arm receives treatment as usual and in addition are given access to an online therapy, cbt4cbt. If placed in this group, individuals are asked to use the online therapy for a minimum of 30 minutes each week for the trial duration of 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 struggling with substance abuse (the definition of 'abuse' is determined by their counselor).
- Individuals who are 18 years of age or older
- Individuals who have used their substance of choice within the past 28 days.
Key exclusion criteria (1 listed)
- Individuals who are currently suicidal, homicidal, or require immediate hospitalization will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cbt4cbtThis arm receives treatment as usual and in addition are given access to an online therapy, cbt4cbt. If placed in this group, individuals are asked to use the online therapy for a minimum of 30 minutes each week for the trial duration of 8 weeks. | Other | CBT4CBT |
Primary outcome
primary substance use
Time frame: 6 months
Substance use of individuals of their primary drug (or drug of choice)
3 secondary outcomes
Secondary substance use
Time frame: 6 months
Healthcare, social and justice interaction
Time frame: 6 months
CBT4CBT feedback
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Recruitment and data collection issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juergen Krause, phd principal investigator
University of Prince Edward Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cbt4cbt in people with Substance Abuse, run by University of Prince Edward Island at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment and data collection issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary substance use (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.