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

Primary Purpose

Substance Abuse

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
cbt4cbt
Sponsored by
University of Prince Edward Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring substance abuse, addiction, etherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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

Sites / Locations

  • University of Prince Edward Island

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

CBT4CBT

Arm Description

this arm receives treatment as usual and no intervention.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary substance use
Substance use of individuals including all drugs which are not their drug of choice
Healthcare, social and justice interaction
Use of healthcare, social and justice services by the individuals
CBT4CBT feedback
Detailed feedback from experimental group individuals on the cbt4cbt program

Full Information

First Posted
July 20, 2017
Last Updated
May 4, 2021
Sponsor
University of Prince Edward Island
Collaborators
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03230669
Brief Title
Computer-assisted Delivery of Cognitive Behavioral Therapy for Mental Health and Addictions in Canada
Official Title
Computer-assisted Delivery of Cognitive Behavioral Therapy for Mental Health and Addictions in Canada
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment and data collection issues
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Prince Edward Island
Collaborators
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
substance abuse, addiction, etherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
this arm receives treatment as usual and no intervention.
Arm Title
CBT4CBT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
cbt4cbt
Intervention Description
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.
Primary Outcome Measure Information:
Title
primary substance use
Description
Substance use of individuals of their primary drug (or drug of choice)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary substance use
Description
Substance use of individuals including all drugs which are not their drug of choice
Time Frame
6 months
Title
Healthcare, social and justice interaction
Description
Use of healthcare, social and justice services by the individuals
Time Frame
6 months
Title
CBT4CBT feedback
Description
Detailed feedback from experimental group individuals on the cbt4cbt program
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Individuals who are currently suicidal, homicidal, or require immediate hospitalization will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen Krause, phd
Organizational Affiliation
University of Prince Edward Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Prince Edward Island
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 4P3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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