ClinicalTrials.gg
TerminatedNCT03230669Updated May 7, 2021

Computer-assisted Delivery of Cognitive Behavioral Therapy for Mental Health and Addictions in Canada

An interventional study of cbt4cbt in Substance Abuse, sponsored by University of Prince Edward Island. Terminated at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-07.

Sponsored by University of Prince Edward Island · Not applicable, Interventional, and Treatment

Why this study was terminated
Recruitment and data collection issues

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2016, registered Jul 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Substance Abuse

Keywords

  • substance abuse
  • addiction
  • etherapy
03

In context

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

This study's enrollment of 148 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

University of Prince Edward Island is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Individuals who are currently suicidal, homicidal, or require immediate hospitalization will be excluded.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
148 participants (actual)

Study arms

  • No intervention
    Control

    this arm receives treatment as usual and no intervention.

  • Experimental
    CBT4CBT

    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.

    Other: cbt4cbt

Interventions

  • Othercbt4cbt

    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.

06

What researchers measure

Primary outcomes

  1. primary substance use

    Substance use of individuals of their primary drug (or drug of choice)

    Time frame: 6 months

Secondary outcomes

  1. Secondary substance use

    Substance use of individuals including all drugs which are not their drug of choice

    Time frame: 6 months

  2. Healthcare, social and justice interaction

    Use of healthcare, social and justice services by the individuals

    Time frame: 6 months

  3. CBT4CBT feedback

    Detailed feedback from experimental group individuals on the cbt4cbt program

    Time frame: 8 weeks

07

Study locations

1 site
  • University of Prince Edward Island
    Charlottetown, Prince Edward Island C1A 4P3, Canada
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03230669
Lead sponsor
University of Prince Edward Island
Collaborators
Yale University
Responsible party
Mary Ann MacSwain (Project Coordinator, University of Prince Edward Island) — Principal investigator
First posted
Jul 26, 2017
Start date
Jan 1, 2016
Primary completion
Mar 31, 2018
Completion
Dec 31, 2018
Last update
May 7, 2021

Study contacts

Juergen Krause, phd
principal investigator · University of Prince Edward Island

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion