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NCT03767907 Clinical Trial

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

Substance Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03767907
Other study ID # 073/2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date December 31, 2021

Study information
Verified date July 2022
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date December 31, 2021
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
• Treatment As Usual
Treatment as usual will include standard psychosocial care determined to be appropriate or necessary, on an individual patient basis.

Locations
Country Name City State
Canada Campbell Family Mental Health Research Institute, CAMH Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Timeline Follow-Back (TLFB) Frequency (days) of substance use over the past 30 days 30 days
Secondary Urine Toxicology Screen Determine substance use in past 30 days 30 days
Secondary 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
Secondary 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
Secondary Program and Client Costs-Substance Abuse Treatment (PACC-SAT) Healthcare Costs 7 days
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