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

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.

Study Overview

• Status: Completed
• Conditions: Substance Dependence
• Intervention / Treatment: Behavioral: Computer-based Training for Cognitive Behavioural Therapy; Behavioral: Treatment As Usual

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 2S1
      • Campbell Family Mental Health Research Institute, CAMH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Online Cognitive Behavioural Therapy; 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.	Behavioral: Computer-based Training for Cognitive Behavioural Therapy; Interactive content organized into seven modules, illustrating real-life scenarios associated with common risky situations, which illustrate the application of targeted skills and strategies; Other Names: CBT4CBT
ACTIVE_COMPARATOR: Treatment as Usual; 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.	Behavioral: Treatment As Usual; Treatment as usual will include standard psychosocial care determined to be appropriate or necessary, on an individual patient basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeline Follow-Back (TLFB)	Frequency (days) of substance use over the past 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine Toxicology Screen	Determine substance use in past 30 days	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.	30 days
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.	4 weeks
Program and Client Costs-Substance Abuse Treatment (PACC-SAT)	Healthcare Costs	7 days

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: Lena C. Quilty, PhD, Campbell Family Mental Health Research Institute, CAMH

Publications and helpful links

Helpful Links

• Information about research at the Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (ACTUAL): December 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: cognitive behavioural therapy; online treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 073/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No