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A Cannabis Harm Reduction e-Intervention for Young Cannabis Users With Early Psychosis (CHAMPS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04968275
Recruitment Status : Enrolling by invitation
First Posted : July 20, 2021
Last Update Posted : December 13, 2022
Sponsor:
Collaborator:
Ministere de la Sante et des Services Sociaux
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information
First Submitted Date  ICMJE July 9, 2021
First Posted Date  ICMJE July 20, 2021
Last Update Posted Date December 13, 2022
Actual Study Start Date  ICMJE August 23, 2021
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2021)
  • Completion rates [ Time Frame: Week 12 ]
    Proportions of participants completing at least the first four CHAMPS modules or with ongoing participation in EIS.
  • Retention rates [ Time Frame: Week 6 ]
    Proportions of participants retained in the trial (completing all endpoint assessments)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2021)
  • Acceptability (CHAMPS usage data) [ Time Frame: Weeks -2-0 (baseline) to 10 ]
    Number of CHAMPS modules completed, time spent on each module, time elapsed between module initiation and completion, total time spent on CHAMPS
  • Participant satisfaction [ Time Frame: Weeks 6 and 12 ]
    Score on the Client Satisfaction Questionnaire-I
  • Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study [ Time Frame: Weeks -4 to 18 ]
    Trial parameters
  • Efficacy (use of cannabis protective behavioral strategies) [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
    Change between endpoint and baseline scores on the Short Form Protective Behavioral Strategies-Marijuana questionnaire.
  • Efficacy (motivation to change cannabis protective behavioral strategies) [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
    Change between endpoint and baseline scores on the Readiness-to-Change Questionnaire modified for cannabis use
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 19, 2021)
  • Cannabis-related problems [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
    Total score on the Marijuana Problems Scale
  • Cannabis use [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
    Past two weeks cannabis use according to the Timeline Follow-Back Questionnaire
  • Other drug use [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
    Past two weeks other drug use according to the Timeline Follow-Back Questionnaire
  • Psychotic symptoms [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
    Total score on the Positive and Negative Syndrome Scale
  • Severity of cannabis dependence [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
    Total score on the Severity of Dependence Scale
  • Social support [ Time Frame: Weeks -2-0 (baseline) ]
    Total score on the Social Provisions Scale
  • Health service utilization [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
    Past month number of emergency visits and days of hospitalization confirmed by medical record abstraction
  • Safety (adverse events) [ Time Frame: Weeks 6, 12 and 18 ]
    Adverse events and severe adverse events related or not to the study intervention
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Cannabis Harm Reduction e-Intervention for Young Cannabis Users With Early Psychosis
Official Title  ICMJE A Randomized Pilot Trial of a Cannabis Harm Reduction e-Intervention (CHAMPS) for Young Adults With Early Psychosis Who Use Cannabis
Brief Summary Cannabis users who experienced a psychosis are particularly vulnerable to cannabis-related harms, which can include worse psychotic symptoms and more hospitalizations. Unfortunately, few psychosocial interventions exist that aim to decrease these harms. Instead, most focus on ceasing cannabis use which is rarely appealing to cannabis users. Furthermore, face-to-face psychotherapy often remains inaccessible to people with psychosis mostly due to lack of trained clinicians. Alternatives such as e-interventions have the potential to increase access to treatment and decrease clinicians' workload. Among cannabis harm reduction approaches are the protective behavioural strategies. These strategies do not encourage nor discourage cannabis use. Instead, they recommend behaviours for safer cannabis use. For example, these strategies include: 1) avoid driving a car under the influence of cannabis, 2) avoid mixing cannabis with other drugs and 3) purchase cannabis only from a trusted source. In the present pan-Canadian study, we will test the first e-intervention called CHAMPS (Cannabis Harm-reducing App for Managing Practices Safely) for cannabis harm reduction adapted for young adult cannabis users who experienced a psychosis. CHAMPS is a smartphone application that includes 17 strategies for safer cannabis use, a personalized consumption goal and a consumption journal. The goals of this study are 1) to confirm whether CHAMPS is acceptable to participants and 2) to test whether it works, notably by positively impacting participants' health and cannabis consumption habits.
Detailed Description

This multicentric, two-arm, open-labelled, pilot randomized controlled trial involves 100 young cannabis users who experienced a psychosis and are followed in an early intervention service (EIS) in Canada. Participants will be randomized in a 1:1 ratio to one of two interventions:

  • CHAMPS and EIS
  • EIS alone

The smartphone application CHAMPS contains six modules (each lasting 15-20 min, weeks 1 to 6) and a booster session (20 min, week 10) based on motivational interviewing and harm reduction approaches. EIS consists of standard of care and psychoeducation material on cannabis use offered in first episode psychosis clinics and administered through in-person visits and/or phone or video calls.

All participants will be assessed for a follow-up at weeks 6, 12 and 18. Data on mental health, substance use, cannabis dependence severity, cannabis-related problems, quality of life and health care service utilization will be obtained through questionnaires and medical charts.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
two-arm parallel, open-labelled, pilot randomized controlled trial
Masking: None (Open Label)
Masking Description:
Group assignment will not be masked after randomization, but it will be at the data analysis stage.
Primary Purpose: Prevention
Condition  ICMJE
  • Psychotic Disorder
  • Marijuana Use
  • Young Adult
Intervention  ICMJE Behavioral: CHAMPS
CHAMPS provides personalized feedback on participants' cannabis use behaviors and supports strategies to change such behaviors. It comprises six modules measuring the use of cannabis protective behavioural strategies, exploring the possible benefits of changing cannabis practices and setting and monitoring the reach of a SMART cannabis use goal.
Other Names:
  • Technology-based psychosocial intervention
  • Psychotherapy
Study Arms  ICMJE
  • Experimental: CHAMPS and EIS
    The Cannabis Harm-reducing App for Managing Practices Safely (CHAMPS) is a brief harm reduction e-intervention based on the principles of motivational interviewing and harm reduction approaches. This e-intervention will be completed by the participant using a smart phone. There will be a total of six individual sessions each lasting 15-20 min. There will be one booster session offered at 4 weeks post-intervention to review goal setting, evaluate motivation around changing cannabis use practices. This e-intervention will be administered adjunctively to psychosis early intervention services (EIS).
    Intervention: Behavioral: CHAMPS
  • No Intervention: EIS alone
    Early intervention services (EIS) for psychosis will be offered as per standard of care at participating clinical sites. Theses services vary but typically include pharmacotherapy and individual and/or group psychotherapy. Any visits and services offered in the EIS arm will be considered 'usual care' and administered either through in-person clinic visits, phone calls, or video calls. Relevant service information will be collected for study purposes.
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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 19, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Participants must meet all following inclusion criteria:

  • diagnosed with any psychotic disorder, which can include schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, delusional disorder, psychotic disorder not otherwise specified, brief psychotic disorder and substance-induced psychotic disorder;
  • has been followed at an early psychosis clinic for a minimum of 3 months;
  • currently using cannabis (at least one time in the past 4 weeks);
  • is open to changing cannabis-related practices;
  • able to provide full informed consent;
  • available for the whole study duration and able to comply with study procedures;
  • able to comprehend French or English.

Participants are excluded if any of these exclusion criteria is met:

  • pregnancy, nursing or any medical condition that in the opinion of the psychiatrist precludes safe participation in the study or the ability to provide fully informed consent;
  • any disabling, unstable or acute mental condition that in the opinion of the psychiatrist precludes safe participation in the study or the ability to provide fully informed consent;
  • any legal/judicial status/issue, pending legal action, or other reasons in the opinion of the study team that might prevent completion of the study;
  • presence of a substance use disorder that, in the opinion of the psychiatrist, precludes safe participation in the study (e.g., very unstable or severe substance use disorder);
  • currently seeking psychological or pharmacological treatment for cannabis use disorder to cease or decrease his/her use;
  • currently participating in another specific cannabis-focused intervention.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04968275
Other Study ID Numbers  ICMJE 20.433
Has Data Monitoring Committee Yes
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: Undecided
Current Responsible Party Centre hospitalier de l'Université de Montréal (CHUM)
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre hospitalier de l'Université de Montréal (CHUM)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ministere de la Sante et des Services Sociaux
Investigators  ICMJE
Principal Investigator: Didier Jutras-Aswad, MD, MSc Centre hospitalier de l'Université de Montréal (CHUM)
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date December 2022

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