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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Substance Dependence

Intervention / Treatment
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* Behavioral: Computer-based Training for Cognitive Behavioural Therapy
* Behavioral: Treatment As Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online Cognitive Behavioural Therapy<br>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<br>* Interactive content organized into seven modules, illustrating real-life scenarios associated with common risky situations, which illustrate the application of targeted skills and strategies<br>* Other names: CBT4CBT;|
| Active Comparator: Treatment as Usual<br>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<br>* Treatment as usual will include standard psychosocial care determined to be appropriate or necessary, on an individual patient basis.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavioural therapy, online treatment