NCT03767907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

1.7 years

First QC Date

December 5, 2018

Last Update Submit

July 19, 2022

Conditions

Keywords

cognitive behavioural therapyonline treatment

Outcome Measures

Primary Outcomes (1)

  • Timeline Follow-Back (TLFB)

    Frequency (days) of substance use over the past 30 days

    30 days

Secondary Outcomes (4)

  • Urine Toxicology Screen

    30 days

  • Addiction Severity Index (ASI)

    30 days

  • WHO Quality of Life (WHOQOL-BREF)

    4 weeks

  • Program and Client Costs-Substance Abuse Treatment (PACC-SAT)

    7 days

Study Arms (2)

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.

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.

Behavioral: Treatment As Usual

Interventions

Interactive content organized into seven modules, illustrating real-life scenarios associated with common risky situations, which illustrate the application of targeted skills and strategies

Also known as: CBT4CBT
Online Cognitive Behavioural Therapy

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

Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to read at sixth grade level
  • Untreated or unstable severe psychiatric or medical disorder
  • Acute suicidal or homicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campbell Family Mental Health Research Institute, CAMH

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Cognitive Behavioral TherapyTherapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lena C. Quilty, PhD

    Campbell Family Mental Health Research Institute, CAMH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 7, 2018

Study Start

October 1, 2018

Primary Completion

June 30, 2020

Study Completion

December 31, 2021

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations