Substance DependenceNCT03767907
Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial
A study testing Computer-based Training for Cognitive Behavioural Therapy and Treatment As Usual in people with Substance Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Dependence
- What is being tested?
- Computer-based Training for Cognitive Behavioural Therapy and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to read at sixth grade level
- Untreated or unstable severe psychiatric or medical disorder
- Acute suicidal or homicidal ideation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Campbell Family Mental Health Research Institute, CAMH
Toronto, Ontario, M5S 2S1
About this study
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.
Read the 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.
- Conditions
- Substance Dependence
- Being tested
- Computer-based Training for Cognitive Behavioural Therapy, Treatment As Usual
- Keywords
- cognitive behavioural therapy, online treatment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based Training for Cognitive Behavioural TherapyBehavioural
Also called CBT4CBT
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 UsualBehavioural
Treatment as usual will include standard psychosocial care determined to be appropriate or necessary, on an individual patient basis.
| Study group | Role | What they receive |
|---|---|---|
| Online Cognitive Behavioural Therapy | Experimental | 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. Receives: Behavioral: Computer-based Training for Cognitive Behavioural Therapy |
| Treatment as Usual | Active comparator | 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. Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Follow-Back (TLFB)
Frequency (days) of substance use over the past 30 days
Measured: 30 days
Secondary outcomes (4)
Urine Toxicology Screen
Determine substance use in past 30 days
Measured: 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.
Measured: 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.
Measured: 4 weeks
Program and Client Costs-Substance Abuse Treatment (PACC-SAT)
Healthcare Costs
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Oct 2018
- Primary completion30 Jun 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance DependenceStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Quilty, Centre for Addiction and Mental Health
- Investigators
- Lena C. Quilty, PhD, Principal investigator, Campbell Family Mental Health Research Institute, CAMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767907
- Sponsor's protocol ID
- 073/2018
- Status last verified
- Jul 2022
- First submitted
- 5 Dec 2018
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel A, Corman M, de Oliveira C, Mason J, Some N, Downie D, Jain E, Patterson M, Cunningham JA, George TP, Le Foll B, Quilty LC. Computer-Based Training for Cognitive Behavioural Therapy for Substance Use Disorder: A Randomized Controlled Trial Including Quantitative and Qualitative Health and Economic Outcomes: Formation informatisee pour la therapie cognitivo-comportementale pour les troubles lies a l'usage de substances : un essai randomise controle y compris les resultats quantitatifs et qualitatifs en matiere de sante et d'economie. Can J Psychiatry. 2025 Jan;70(1):9-20. doi: 10.1177/07067437241255100. Epub 2024 May 24.
PubMed 38783836
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT03767907
- Acronym / sponsor ID
- 073/2018
- Conditions
- Substance Dependence
- Keywords
- cognitive behavioural therapy, online treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Cognitive Behavioural Therapy | Experimental | Behavioral: Computer-based Training for Cognitive Behavioural TherapyComputer-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 | Active comparator | Behavioral: Treatment As UsualTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to read at sixth grade level
- Untreated or unstable severe psychiatric or medical disorder
- Acute suicidal or homicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-based Training for Cognitive Behavioural TherapyAlso: CBT4CBTInteractive content organized into seven modules, illustrating real-life scenarios associated with common risky situations, which illustrate the application of targeted skills and strategies | Behavioural | Online Cognitive Behavioural Therapy |
| Treatment As UsualTreatment as usual will include standard psychosocial care determined to be appropriate or necessary, on an individual patient basis. | Behavioural | Treatment as Usual |
Primary outcome
Timeline Follow-Back (TLFB)
Time frame: 30 days
Frequency (days) of substance use over the past 30 days
4 secondary outcomes
Urine Toxicology Screen
Time frame: 30 days
Addiction Severity Index (ASI)
Time frame: 30 days
WHO Quality of Life (WHOQOL-BREF)
Time frame: 4 weeks
Program and Client Costs-Substance Abuse Treatment (PACC-SAT)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 38783836Patel A, Corman M, de Oliveira C, Mason J, Some N, Downie D, Jain E, Patterson M, Cunningham JA, George TP, Le Foll B, Quilty LC. Computer-Based Training for Cognitive Behavioural Therapy for Substance Use Disorder: A Randomized Controlled Trial Including Quantitative and Qualitative Health and Economic Outcomes: Formation informatisee pour la therapie cognitivo-comportementale pour les troubles lies a l'usage de substances : un essai randomise controle y compris les resultats quantitatifs et qualitatifs en matiere de sante et d'economie. Can J Psychiatry. 2025 Jan;70(1):9-20. doi: 10.1177/07067437241255100. Epub 2024 May 24.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena C. Quilty, PhD principal investigator
Campbell Family Mental Health Research Institute, CAMH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based Training for Cognitive Behavioural Therapy and Treatment As Usual in people with Substance Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeline Follow-Back (TLFB) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.