A Cannabis E-intervention for Young Cannabis Users With Early Psychosis (iCC)

Study Overview
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Brief Summary
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The concerning lack of research related to technology-based psychological interventions in individuals with psychosis and cannabis use disorder (CUD) led to the design a randomized control trial (RCT) with an innovative mobile health e-intervention called ICanChange (iCC). Randomized control trials (RCTs) on well-defined samples (limited to psychosis and CUD) are needed to generate evidence on e-health interventions in individuals with psychosis and CUD. As such, an RCT will be conducted to assess the acceptability and feasibility of administering this e-intervention to young people with psychosis who use cannabis. Besides having scarce cannabis interventions adapted for people with psychosis, there are other barriers to addressing problematic cannabis use, such as the challenging and inadequate access to mental health and substance use services by this population. Implementing these and other approaches in the context of a harm reduction intervention or applying other strategies seeking to minimize cannabis-related harms for people who wish to continue using cannabis may be key in helping individuals set realistic goals that are important and relevant to them.

Detailed Description
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This is a multi-site, two-arm, open-label, pilot randomized control trial, involving 100 young adults diagnosed with psychosis and cannabis use disorder (CUD). Participants will be randomly assigned to either: Arm 1. Early intervention services (EIS): early intervention for psychosis, including standard of care for psychosis and CUD following Canadian guidelines. Arm 2. iCC + modified EIS (mEIS): The iCC is an application-based intervention that includes psychotherapeutic modules based on Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT). Participants in this arm also receive the same services as in EIS, excluding formal psychotherapeutic interventions for CUD. Participants will complete assessments at baseline, and at 6, 12, and 24 weeks from baseline.

Official Title
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A Randomized Pilot Trial of ICanChange, a Mobile Health Intervention to Reduce Cannabis Use in Young Adults With Psychosis

Conditions
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Cannabis Use Disorder

Intervention / Treatment
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* Behavioral: iCanChange


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must meet all of the following criteria: Young adults age 18 to 35 years old 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 Diagnosed with a current CUD (any severity), based on Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria Currently using cannabis (used cannabis at least once in the past month) Accepting an intervention for CUD to cease or decrease his/her use Able to provide full informed consent Available for the whole duration of the study/able to comply with study procedures Able to comprehend French or English Exclusion Criteria: 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 an additional 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 participating in another specific cannabis use-focused intervention (other than those which are part of the intervention and control arms)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two-arm parallel, open-labelled, pilot randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: CHAMPS and mEIS<br>Brief mobile application-based psychological intervention based on the principles of motivational interviewing (MI) and cognitive behavioural therapy (CBT). This e-intervention will be completed by the participant using a smart phone. There will be up to a maximum of 24 individual sessions (which includes 3 booster sessions) each lasting approximately 10-15 minutes. mEIS: iCC will be administered adjunctively to modified EIS (mEIS), which will include all interventions usually provided through EIS except for any specific psychological interventions (MI, CBT, contingency management) for CUD. | Behavioral: iCanChange<br>* iCC is a psychological app based intervention that will be delivered in form of up to 24 brief (10-15 minutes) interactive modules developed based on the principles of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). During the intervention, participants will be offered MI and CBT-based activities (i.e., modules and strategies) aiming at facilitating change in cannabis use. At any point during the intervention, participants can reference modules that had been completed. Due to the frequency of behavioral stage changes in this population (e.g., regression in behavioral stage of change), stage of change will be monitored regularly throughout the intervention. During the follow-up period (i.e., Week 12-24), participants will have continuous access to the smart phone application and all built-in add-ons as described above. During this period, they will have access to 3 booster session.<br>|
| No Intervention: No Intervention: EIS alone<br>Early intervention services will be offered as per standard of care following EIS for psychosis and CUD guidelines, at participating clinical sites. Any visits and services offered in control arm will be considered 'usual care' and administered either through in-person clinic visits, community visits, phone calls, or video calls. Relevant service information will be collected for study purposes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rates | Number of participants who completed the first section of the intervention and at least one module from section 2 related to achieving their cannabis consumption objectives or with ongoing participation in EIS. | Week 12 | 
| Retention rates | Proportions of participants retained in the trial (completing all endpoint assessments) | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability (iCC usage data) | Number of iCC modules completed, time spent on each module, time elapsed between module initiation and completion, total time spent on iCC. | Weeks 0-24 | 
| Participant satisfaction | Score on the Client Satisfaction Questionnaire-I (CSQ-I). The CSQ-I is a modified version of the CSQ-8 measuring global satisfaction with a web-based intervention and and provider reports. Items are scored from 1= does not apply to me to 4= Does totally apply to me. The scores for all eight items will be summed for a total score in the range 8 to 32. To calculate scores on the CSQ-I, sum item responses (range from 8-32). Higher scores indicate higher satisfaction. This collects information on the participant's satisfaction as it relates to the assigned cannabis-focused intervention. | Weeks 6, 12 & 24 | 
| Trial parameters | Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study | Week -4 to Week 24 | 
| Cannabis Use | Frequency and quantity of cannabis use in the last 14 days will be measured using the Timeline Follow Back (TLFB) which is a tool that captures self-reported drug use. The TLFB will assess the frequency of cannabis use, the self-reported days with abstinence from cannabis weekly, as well as type of cannabis products, quantity and dose/concentration in cannabinoids. | (-2-0 (baseline) and Week 6, 12 & 24 |