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Testing the Efficacy of an Online Treatment Program for Heavy Cannabis Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04965012
Recruitment Status : Recruiting
First Posted : July 16, 2021
Last Update Posted : August 31, 2022
Sponsor:
Collaborator:
University of Manitoba
Information provided by (Responsible Party):
Matthew Keough, York University

Tracking Information
First Submitted Date  ICMJE July 6, 2021
First Posted Date  ICMJE July 16, 2021
Last Update Posted Date August 31, 2022
Actual Study Start Date  ICMJE August 25, 2022
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2021)
Change in Cannabis Use [ Time Frame: Participants will be assessed using the DFAQ-CU at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2). ]
The Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU; Cuttler & Spradlin, 2017) is a self-report inventory of cannabis use that will be used as the primary assessment of cannabis use. The frequency (i.e., number of days per week) and quantity (i.e., grams) of cannabis use subscales will be used. There is mixed evidence as to whether frequency or quantity better predicts cannabis-related severity, thus information on both will be analyzed.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2021)
  • Cannabis-Related Problems [ Time Frame: Participants will be assessed using the CUDIT-R at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2). ]
    The Cannabis Use Disorders Identification Test-Revised (CUDIT-R; Adamson et al., 2010), is an 8-item self-report questionnaire that will be used to assess problematic cannabis misuse characteristic of Cannabis Use Disorder (CUD).
  • Anxiety [ Time Frame: Participants will be assessed using the GAD-7 at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2). ]
    The General Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006) is a 7-item self-report anxiety questionnaire that will be used to assess overall anxiety severity.
  • Depression [ Time Frame: Participants will be assessed using the PHQ-9 at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2). ]
    The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) is a 9-item self-report of depression symptoms that will be used to assess overall depression severity.
  • Quality of Life [ Time Frame: Participants will be assessed using the WHOQOL-BREF at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2). ]
    The World Health Organization Quality of Life Assessment (WHOQOL-BREF; WHOQOL Group, 1998) is a 26-item self-report measure that will be used to assess quality of life.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing the Efficacy of an Online Treatment Program for Heavy Cannabis Use
Official Title  ICMJE Testing the Efficacy of an Online Evidence-Based Treatment for Heavy Cannabis Use in Canadian Adults: A Randomized Controlled Trial (RCT)
Brief Summary

Cannabis is a frequently-used psychoactive substance. While the majority of individuals can use cannabis without experiencing problems, a small minority of people develop cannabis problems. Despite the small-to-medium reported effect sizes of cognitive behavioural therapy (CBT) and motivational enhancement therapy (MET) treatments for cannabis misuse, many cannabis users do not seek treatment. Online CBT/MET programs have the potential to be cost-effective and accessible, and offer a less stigmatizing option for treatment. These programs may also help capture cannabis users who experience subclinical problems, who are not captured by traditional treatment. Existing treatment programs also need to be adapted to maximize participant retention and increase treatment completion, as many current cannabis use treatment programs have significant drop-out rates. Hence, the goal of the proposed randomized controlled trial (RCT) is to examine the efficacy of an online evidence-based CBT/MET treatment program. Outcomes of a combined CBT/MET treatment program will be compared to a CBT-only treatment program and a waitlist control. This research will provide insight into the novel contribution of MET to online CBT treatment programs for cannabis misuse.

The researchers are hoping to recruit 303 participants for this study from Central and Eastern Canada. Participants will be randomly assigned to one of the treatment groups (i.e., CBT with MET, CBT without MET) or the psychoeducational control group. Individuals in either treatment group will be given 6 weeks to work through 8 online modules. Throughout the modules, participants will identify goals related to cannabis use, learn strategies to cope with cannabis cravings, triggers, and social pressures and learn to prevent relapse. Participants randomly assigned to the control (i.e., psychoeducation) will receive links to websites that provide general psychoeducation about cannabis use and wellbeing. All participants will complete online assessment measures at baseline, end of treatment, and at follow up approximately one month later (i.e., 0 weeks, 6 weeks, 10 weeks) in order to assess the efficacy of the treatment. At the end of the study, individuals in the control group will be given access to the CBT without MET treatment.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A three-arm RCT will be conducted to evaluate the proposed online intervention. Eligible participants will be randomized to the CBT with MET condition, the CBT without MET condition, or the psychoeducational control (i.e., control) condition.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Marijuana Use
  • Marijuana Dependence
Intervention  ICMJE
  • Behavioral: Online CBT with MET treatment
    The CBT with MET treatment condition will begin with an MET-therapist guided introduction to the program and first module. After this guided introduction, they will have access to the remaining 7 treatment modules and have 6 weeks to complete them. The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing. Through module engagement, participants will identify goals related to cannabis use, learn strategies to cope with cravings, triggers, and social pressures, and learn to how prevent relapse. Participants will work through modules sequentially.
  • Behavioral: CBT without MET treatment
    The CBT without MET treatment condition will begin with a brief non-MET trained research assistant welcome to the program, and will not include working through the first module together. After this welcome, they will have access to the 8 treatment modules and have 6 weeks to complete them. The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing. Through module engagement, participants will identify goals related to cannabis use, learn strategies to cope with cravings, triggers, and social pressures, and learn to how prevent relapse. Participants will work through modules sequentially.
Study Arms  ICMJE
  • Experimental: CBT with MET treatment group
    Participants in this arm will be provided with an MET-therapist guided introduction, in addition to the online CBT treatment.
    Intervention: Behavioral: Online CBT with MET treatment
  • Experimental: CBT without MET treatment group
    Participants in this arm will be provided with a brief non-MET research assistant-led welcome to the program, in addition to the online CBT treatment.
    Intervention: Behavioral: CBT without MET treatment
  • No Intervention: Psychoeducation (Control)
    The control group will be provided with psychoeducational resources about cannabis and wellbeing.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2021)
303
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages 18+
  • Living in Manitoba or Ontario, Canada
  • Reporting moderate difficulties with cannabis as indicated by a score of 8 or more on the Cannabis Use Disorders Identification Test - Revised (CUDIT-R; Adamson et al., 2010)
  • Fluency in English
  • Having weekly Internet access with a device that allows for video connection
  • Self-report at least a 6 out of 10 on a Likert-type scale for motivation to reduce cannabis use (i.e., how important it is to reduce cannabis use)

Exclusion Criteria:

  • Self-reported engagement in other psychological or pharmacological treatments for cannabis use
  • Elevated suicidality, as defined by scoring greater than minimal risk on a screener
  • Current serious psychiatric disorders or history of psychosis, schizophrenia, bipolar disorder
  • Are a woman who is currently pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matthew T Keough, PhD 1-416-736-2100 ext 33415 keoughmt@yorku.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04965012
Other Study ID Numbers  ICMJE YM8974384y57393848938nv8493478
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Matthew Keough, York University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE York University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Manitoba
Investigators  ICMJE Not Provided
PRS Account York University
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP