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

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ClinicalTrials.gov Identifier: NCT03767907
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Lena Quilty, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Substance Dependence Behavioral: Computer-based Training for Cognitive Behavioural Therapy Behavioral: Treatment As Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Online Cognitive Behavioural Therapy for Addiction: Efficacy and Cost-Effectiveness in a Pragmatic Clinical Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : October 1, 2020

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 Name: 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.




Primary Outcome Measures :
  1. Timeline Follow-Back (TLFB) [ Time Frame: 30 days ]
    Frequency (days) of substance use over the past 30 days


Secondary Outcome Measures :
  1. Urine Toxicology Screen [ Time Frame: 30 days ]
    Determine substance use in past 30 days

  2. Addiction Severity Index (ASI) [ Time Frame: 30 days ]

    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.


  3. WHO Quality of Life (WHOQOL-BREF) [ Time Frame: 4 weeks ]

    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. Program and Client Costs-Substance Abuse Treatment (PACC-SAT) [ Time Frame: 7 days ]
    Healthcare Costs



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767907


Contacts
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Contact: Lena C. Quilty, PhD 416-535-8501 ext 34313 Lena.Quilty@camh.ca
Contact: Lena C. Quilty, PhD

Locations
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Canada, Ontario
Campbell Family Mental Health Research Institute, CAMH Recruiting
Toronto, Ontario, Canada, M5S 2S1
Contact: Lena C. Quilty, PhD    416-535-8501 ext 34313    Lena.Quilty@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Lena C. Quilty, PhD Campbell Family Mental Health Research Institute, CAMH

Additional Information:
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Responsible Party: Lena Quilty, Senior Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03767907     History of Changes
Other Study ID Numbers: 073/2018
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lena Quilty, Centre for Addiction and Mental Health:
cognitive behavioural therapy
online treatment

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders