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Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial

Primary Purpose

Substance Dependence

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Computer-based Training for Cognitive Behavioural Therapy
Treatment As Usual
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Dependence focused on measuring cognitive behavioural therapy, online treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age or older
  2. Fluency in English
  3. Understanding and willingness to comply with study requirements
  4. Meet diagnostic criteria for current substance use disorder
  5. Have used substance in the past 30 days
  6. Treatment-seeking for substance misuse

Exclusion Criteria:

  1. Unable to read at sixth grade level
  2. Untreated or unstable severe psychiatric or medical disorder
  3. Acute suicidal or homicidal ideation

Sites / Locations

  • Campbell Family Mental Health Research Institute, CAMH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Online Cognitive Behavioural Therapy

Treatment as Usual

Arm Description

Computer-based training for cognitive behavioural therapy (CBT4CBT) consists of seven modules, and includes a series of interactive videos presenting characters portrayed by professional actors struggling with real-life situations. These characters first experience a common risky situation or problem and then demonstrate the application of a targeted skill. The program further comprises games and interactive exercises to teach and model effective use of skills and strategies.

Treatment as usual consists of weekly group and/or individual psychotherapy as determined by the clinical team. Psychotherapy will include structured relapse prevention, include cognitive and behavioural techniques, motivational enhancement, mindfulness, and specialized topics (e.g., vocational training, rainbow services) as appropriate.

Outcomes

Primary Outcome Measures

Timeline Follow-Back (TLFB)
Frequency (days) of substance use over the past 30 days

Secondary Outcome Measures

Urine Toxicology Screen
Determine substance use in past 30 days
Addiction Severity Index (ASI)
Substance Use Disorder symptom severity Subscale scores are calculated for 7 domains (medical, employment/support status, alcohol, drug, legal, family/social and psychological). Subscale scores are summed scores ranging from 0-1 with higher scores indicating greater problem severity.
WHO Quality of Life (WHOQOL-BREF)
Quality of Life Subscale scores are calculated for 4 domains (physical health, psychological, social relationships and environment) and for "overall" and "general health" quality of life. Subscale scores have a range of 0 to 100 with higher scores indicating greater quality of life.
Program and Client Costs-Substance Abuse Treatment (PACC-SAT)
Healthcare Costs

Full Information

First Posted
December 5, 2018
Last Updated
July 19, 2022
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT03767907
Brief Title
Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial
Official Title
Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy and cost-effectiveness of a Computer-based Training for Cognitive Behavioural Therapy (CBT4CBT) to treatment as usual in outpatients seeking treatment for substance use disorder.
Detailed Description
Fifty-two adult outpatients seeking treatment for substance use disorder from the Centre for Addiction and Mental Health Addictions Program will be randomized to receive either a computer-based training for cognitive behavioural therapy or treatment as usual for eight weeks. Participants will complete interviews, questionnaires, and other assessments (urine toxicology and physiological assessments) at week 0, at week 8, and at 6 month follow-up). Measures will assess alcohol and drug consumption, substance use disorder symptoms and associated features, quality of life, and healthcare costs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependence
Keywords
cognitive behavioural therapy, online treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Description
Computer-based training for cognitive behavioural therapy (CBT4CBT) consists of seven modules, and includes a series of interactive videos presenting characters portrayed by professional actors struggling with real-life situations. These characters first experience a common risky situation or problem and then demonstrate the application of a targeted skill. The program further comprises games and interactive exercises to teach and model effective use of skills and strategies.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as usual consists of weekly group and/or individual psychotherapy as determined by the clinical team. Psychotherapy will include structured relapse prevention, include cognitive and behavioural techniques, motivational enhancement, mindfulness, and specialized topics (e.g., vocational training, rainbow services) as appropriate.
Intervention Type
Behavioral
Intervention Name(s)
Computer-based Training for Cognitive Behavioural Therapy
Other Intervention Name(s)
CBT4CBT
Intervention Description
Interactive content organized into seven modules, illustrating real-life scenarios associated with common risky situations, which illustrate the application of targeted skills and strategies
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual
Intervention Description
Treatment as usual will include standard psychosocial care determined to be appropriate or necessary, on an individual patient basis.
Primary Outcome Measure Information:
Title
Timeline Follow-Back (TLFB)
Description
Frequency (days) of substance use over the past 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Urine Toxicology Screen
Description
Determine substance use in past 30 days
Time Frame
30 days
Title
Addiction Severity Index (ASI)
Description
Substance Use Disorder symptom severity Subscale scores are calculated for 7 domains (medical, employment/support status, alcohol, drug, legal, family/social and psychological). Subscale scores are summed scores ranging from 0-1 with higher scores indicating greater problem severity.
Time Frame
30 days
Title
WHO Quality of Life (WHOQOL-BREF)
Description
Quality of Life Subscale scores are calculated for 4 domains (physical health, psychological, social relationships and environment) and for "overall" and "general health" quality of life. Subscale scores have a range of 0 to 100 with higher scores indicating greater quality of life.
Time Frame
4 weeks
Title
Program and Client Costs-Substance Abuse Treatment (PACC-SAT)
Description
Healthcare Costs
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Fluency in English Understanding and willingness to comply with study requirements Meet diagnostic criteria for current substance use disorder Have used substance in the past 30 days Treatment-seeking for substance misuse Exclusion Criteria: Unable to read at sixth grade level Untreated or unstable severe psychiatric or medical disorder Acute suicidal or homicidal ideation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena C. Quilty, PhD
Organizational Affiliation
Campbell Family Mental Health Research Institute, CAMH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campbell Family Mental Health Research Institute, CAMH
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.camh.ca/research
Description
Information about research at the Centre for Addiction and Mental Health

Learn more about this trial

Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial

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