Marijuana Use, Psychotic Disorder, Young Adult
Conditions
Keywords
Psychosis, Cannabis, Youth
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.
Interventions
BEHAVIORALCHAMPS
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.
Sponsors
Ministere de la Sante et des Services Sociaux
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Group assignment will not be masked after randomization, but it will be at the data analysis stage.
Intervention model description
two-arm parallel, open-labelled, pilot randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion rates | Week 12 | Proportions of participants completing at least the first four CHAMPS modules or with ongoing participation in EIS. |
| Retention rates | Week 6 | Proportions of participants retained in the trial (completing all endpoint assessments) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study | Weeks -4 to 18 | Trial parameters |
| Acceptability (CHAMPS usage data) | 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 |
| Efficacy (motivation to change cannabis protective behavioral strategies) | Weeks -2-0 (baseline), 6, 12 and 18 | Change between endpoint and baseline scores on the Readiness-to-Change Questionnaire modified for cannabis use |
| Efficacy (use of cannabis protective behavioral strategies) | Weeks -2-0 (baseline), 6, 12 and 18 | Change between endpoint and baseline scores on the Short Form Protective Behavioral Strategies-Marijuana questionnaire. |
| Participant satisfaction | Weeks 6 and 12 | Score on the Client Satisfaction Questionnaire-I |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cannabis-related problems | Weeks -2-0 (baseline), 6, 12 and 18 | Total score on the Marijuana Problems Scale |
| Safety (adverse events) | Weeks 6, 12 and 18 | Adverse events and severe adverse events related or not to the study intervention |
| Cannabis use | Weeks -2-0 (baseline), 6, 12 and 18 | Past two weeks cannabis use according to the Timeline Follow-Back Questionnaire |
| Other drug use | Weeks -2-0 (baseline), 6, 12 and 18 | Past two weeks other drug use according to the Timeline Follow-Back Questionnaire |
| Psychotic symptoms | Weeks -2-0 (baseline), 6, 12 and 18 | Total score on the Positive and Negative Syndrome Scale |
| Severity of cannabis dependence | Weeks -2-0 (baseline), 6, 12 and 18 | Total score on the Severity of Dependence Scale |
| Social support | Weeks -2-0 (baseline) | Total score on the Social Provisions Scale |
| Health service utilization | Weeks -2-0 (baseline), 6, 12 and 18 | Past month number of emergency visits and days of hospitalization confirmed by medical record abstraction |
Countries
Canada
Outcome results
None listed