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

Primary Purpose

Marijuana Use, Marijuana Dependence

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Online CBT with MET treatment
CBT without MET treatment
Sponsored by
York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Use focused on measuring Cannabis, CANreduce, Marijuana, Cognitive Behavioural Therapy, Motivational Enhancement Therapy, Online treatment, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of ManitobaRecruiting
  • York UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

CBT with MET treatment group

CBT without MET treatment group

Psychoeducation (Control)

Arm Description

Participants in this arm will be provided with an MET-therapist guided introduction, in addition to the online CBT treatment.

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.

The control group will be provided with psychoeducational resources about cannabis and wellbeing.

Outcomes

Primary Outcome Measures

Change in Cannabis Use
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.

Secondary Outcome Measures

Cannabis-Related Problems
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
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
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
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.

Full Information

First Posted
July 6, 2021
Last Updated
August 25, 2022
Sponsor
York University
Collaborators
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT04965012
Brief Title
Testing the Efficacy of an Online Treatment Program for Heavy Cannabis Use
Official Title
Testing the Efficacy of an Online Evidence-Based Treatment for Heavy Cannabis Use in Canadian Adults: A Randomized Controlled Trial (RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
Collaborators
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Use, Marijuana Dependence
Keywords
Cannabis, CANreduce, Marijuana, Cognitive Behavioural Therapy, Motivational Enhancement Therapy, Online treatment, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
303 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT with MET treatment group
Arm Type
Experimental
Arm Description
Participants in this arm will be provided with an MET-therapist guided introduction, in addition to the online CBT treatment.
Arm Title
CBT without MET treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducation (Control)
Arm Type
No Intervention
Arm Description
The control group will be provided with psychoeducational resources about cannabis and wellbeing.
Intervention Type
Behavioral
Intervention Name(s)
Online CBT with MET treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT without MET treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cannabis Use
Description
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.
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).
Secondary Outcome Measure Information:
Title
Cannabis-Related Problems
Description
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).
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).
Title
Anxiety
Description
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.
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).
Title
Depression
Description
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.
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).
Title
Quality of Life
Description
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew T Keough, PhD
Phone
1-416-736-2100
Ext
33415
Email
keoughmt@yorku.ca
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karli Rapinda, MA
Email
rapindak@myumantioba.ca
First Name & Middle Initial & Last Name & Degree
Harold Wallbridge, Ph.D. C.Psych
Email
Harold.Wallbridge@umanitoba.ca
Facility Name
York University
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Keough, Ph.D. C.Psych
Email
keoughmt@yorku.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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