Clinical trial NCT05310981: A Cannabis E-intervention for Young Cannabis Users With Early Psychosis (iCC)
Official title: A Randomized Pilot Trial of ICanChange, a Mobile Health Intervention to Reduce Cannabis Use in Young Adults With Psychosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cannabis Use Disorder
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Ministere de la Sante et des Services Sociaux
First posted: 2022-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-arm parallel, open-labelled, pilot randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

Participants must meet all of the following criteria:

1. Young adults age 18 to 35 years old
2. 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.
3. Has been followed at an early psychosis clinic for a minimum of 3 months
4. Diagnosed with a current CUD (any severity), based on Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
5. Currently using cannabis (used cannabis at least once in the past month)
6. Accepting an intervention for CUD to cease or decrease his/her use
7. Able to provide full informed consent
8. Available for the whole duration of the study/able to comply with study procedures
9. Able to comprehend French or English

Exclusion Criteria:

1. Any medical condition that in the opinion of the psychiatrist precludes safe participation in the study or the ability to provide fully informed consent
2. 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
3. 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
4. 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)
5. Currently participating in another specific cannabis use-focused intervention (other than those which are part of the intervention and control arms)

Primary outcomes:
measure: Completion rates
timeFrame: Week 12
measure: Retention rates
timeFrame: Week 12
Secondary outcomes:
measure: Acceptability (iCC usage data)
timeFrame: Weeks 0-24
measure: Participant satisfaction
timeFrame: Weeks 6, 12 & 24
measure: Trial parameters
timeFrame: Week -4 to Week 24
measure: Cannabis Use
timeFrame: (-2-0 (baseline) and Week 6, 12 & 24
Other outcomes:
measure: Psychotic Symptoms
timeFrame: (-2-0 (baseline) and Week 6, 12 & 24
measure: Cannabis-related problems
timeFrame: (-2-0 (baseline) and Week 6, 12 & 24
measure: Cannabis use frequency and abstinence
timeFrame: (-2-0 (baseline) and Week 6, 12 & 24
measure: Other drug use
timeFrame: (-2-0 (baseline) and Week 6, 12 & 24
measure: Dependence severity
timeFrame: (-2-0 (baseline) and Week 6, 12 & 24
measure: Protective behaviours
timeFrame: (-2-0 (baseline) and Week 6, 12 & 24
measure: Confidence in resisting cannabis use
timeFrame: (-2-0 (baseline) and Week 6, 12 & 24
measure: Life satisfaction
timeFrame: (-2-0 (baseline) and Week 6, 12 & 24
measure: Healthcare utilization
timeFrame: (-2-0 (baseline) and Week 6, 12 & 24
measure: Stage of change
timeFrame: (-2-0 (baseline) and Week 6, 12 & 24
measure: Social support
timeFrame: (-2-0 (baseline)
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre Early Psychosis Intervention Program
state: Alberta
city: Halifax
country: Canada
facility: Nova Scotia Early Psychosis Program
state: Nova Scotia
city: Montréal
country: Canada
facility: Clinic Connec-T - Institut universitaire en santé mentale de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Clinique JAP, Centre hospitalier de l'Université de Montréal
state: Quebec
city: Québec
country: Canada
facility: Clinic Notre-Dame des Victoires - Centre de Recherche CERVO
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Didier Jutras-Aswad, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: