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

Primary Purpose

Psychotic Disorder, Marijuana Use, Young Adult

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CHAMPS
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychotic Disorder focused on measuring Psychosis, Cannabis, Youth

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Foothills Medical Centre Early Psychosis Intervention Program, Unit 24, 1403-29 Street NW
  • Nova Scotia Early Psychosis Program, 3rd Floor, Abbie Lane Bldg 5909 Veterans' Memorial Lane
  • Clinic Connec-T - Institut universitaire en santé mentale de Montréal, 7401 rue Hochelaga
  • Clinique JAP, Centre hospitalier de l'Université de Montréal, 1051, rue Sanguinet
  • Clinic Notre-Dame des Victoires - Centre de Recherche CERVO, 2601 chemin de la Canardière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CHAMPS and EIS

EIS alone

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Completion rates
Proportions of participants completing at least the first four CHAMPS modules or with ongoing participation in EIS.
Retention rates
Proportions of participants retained in the trial (completing all endpoint assessments)

Secondary Outcome Measures

Acceptability (CHAMPS usage data)
Number of CHAMPS modules completed, time spent on each module, time elapsed between module initiation and completion, total time spent on CHAMPS
Participant satisfaction
Score on the Client Satisfaction Questionnaire-I
Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study
Trial parameters
Efficacy (use of cannabis protective behavioral strategies)
Change between endpoint and baseline scores on the Short Form Protective Behavioral Strategies-Marijuana questionnaire.
Efficacy (motivation to change cannabis protective behavioral strategies)
Change between endpoint and baseline scores on the Readiness-to-Change Questionnaire modified for cannabis use

Full Information

First Posted
July 9, 2021
Last Updated
December 9, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Ministere de la Sante et des Services Sociaux
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1. Study Identification

Unique Protocol Identification Number
NCT04968275
Brief Title
A Cannabis Harm Reduction e-Intervention for Young Cannabis Users With Early Psychosis
Acronym
CHAMPS
Official Title
A Randomized Pilot Trial of a Cannabis Harm Reduction e-Intervention (CHAMPS) for Young Adults With Early Psychosis Who Use Cannabis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Ministere de la Sante et des Services Sociaux

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorder, Marijuana Use, Young Adult
Keywords
Psychosis, Cannabis, Youth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CHAMPS and EIS
Arm Type
Experimental
Arm Description
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).
Arm Title
EIS alone
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CHAMPS
Other Intervention Name(s)
Technology-based psychosocial intervention, Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion rates
Description
Proportions of participants completing at least the first four CHAMPS modules or with ongoing participation in EIS.
Time Frame
Week 12
Title
Retention rates
Description
Proportions of participants retained in the trial (completing all endpoint assessments)
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Acceptability (CHAMPS usage data)
Description
Number of CHAMPS modules completed, time spent on each module, time elapsed between module initiation and completion, total time spent on CHAMPS
Time Frame
Weeks -2-0 (baseline) to 10
Title
Participant satisfaction
Description
Score on the Client Satisfaction Questionnaire-I
Time Frame
Weeks 6 and 12
Title
Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study
Description
Trial parameters
Time Frame
Weeks -4 to 18
Title
Efficacy (use of cannabis protective behavioral strategies)
Description
Change between endpoint and baseline scores on the Short Form Protective Behavioral Strategies-Marijuana questionnaire.
Time Frame
Weeks -2-0 (baseline), 6, 12 and 18
Title
Efficacy (motivation to change cannabis protective behavioral strategies)
Description
Change between endpoint and baseline scores on the Readiness-to-Change Questionnaire modified for cannabis use
Time Frame
Weeks -2-0 (baseline), 6, 12 and 18
Other Pre-specified Outcome Measures:
Title
Cannabis-related problems
Description
Total score on the Marijuana Problems Scale
Time Frame
Weeks -2-0 (baseline), 6, 12 and 18
Title
Cannabis use
Description
Past two weeks cannabis use according to the Timeline Follow-Back Questionnaire
Time Frame
Weeks -2-0 (baseline), 6, 12 and 18
Title
Other drug use
Description
Past two weeks other drug use according to the Timeline Follow-Back Questionnaire
Time Frame
Weeks -2-0 (baseline), 6, 12 and 18
Title
Psychotic symptoms
Description
Total score on the Positive and Negative Syndrome Scale
Time Frame
Weeks -2-0 (baseline), 6, 12 and 18
Title
Severity of cannabis dependence
Description
Total score on the Severity of Dependence Scale
Time Frame
Weeks -2-0 (baseline), 6, 12 and 18
Title
Social support
Description
Total score on the Social Provisions Scale
Time Frame
Weeks -2-0 (baseline)
Title
Health service utilization
Description
Past month number of emergency visits and days of hospitalization confirmed by medical record abstraction
Time Frame
Weeks -2-0 (baseline), 6, 12 and 18
Title
Safety (adverse events)
Description
Adverse events and severe adverse events related or not to the study intervention
Time Frame
Weeks 6, 12 and 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Jutras-Aswad, MD, MSc
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre Early Psychosis Intervention Program, Unit 24, 1403-29 Street NW
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Nova Scotia Early Psychosis Program, 3rd Floor, Abbie Lane Bldg 5909 Veterans' Memorial Lane
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E2
Country
Canada
Facility Name
Clinic Connec-T - Institut universitaire en santé mentale de Montréal, 7401 rue Hochelaga
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1N 3M5
Country
Canada
Facility Name
Clinique JAP, Centre hospitalier de l'Université de Montréal, 1051, rue Sanguinet
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Clinic Notre-Dame des Victoires - Centre de Recherche CERVO, 2601 chemin de la Canardière
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 2G3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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