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

Primary Purpose

Cannabis Use Disorder

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

iCanChange

About this trial

This is an interventional prevention trial for Cannabis Use Disorder

Eligibility Criteria

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

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)

Sites / Locations

Foothills Medical Centre Early Psychosis Intervention Program
Nova Scotia Early Psychosis Program
Clinic Connec-T - Institut universitaire en santé mentale de Montréal
Clinique JAP, Centre hospitalier de l'Université de Montréal
Clinic Notre-Dame des Victoires - Centre de Recherche CERVO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: CHAMPS and mEIS

No Intervention: EIS alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Retention rates

Proportions of participants retained in the trial (completing all endpoint assessments)

Secondary Outcome Measures

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.

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.

Trial parameters

Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study

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.

Full Information

NCT ID

NCT05310981

First Posted

February 3, 2022

Last Updated

December 12, 2022

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Ministere de la Sante et des Services Sociaux

1. Study Identification

Unique Protocol Identification Number

NCT05310981

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

July 6, 2022 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cannabis Use Disorder

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)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: CHAMPS and mEIS

Arm Type

Experimental

Arm Description

Arm Title

No Intervention: EIS alone

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

iCanChange

Intervention Description

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.

Primary Outcome Measure Information:

Title

Completion rates

Description

Time Frame

Week 12

Title

Retention rates

Description

Proportions of participants retained in the trial (completing all endpoint assessments)

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Acceptability (iCC usage data)

Description

Number of iCC modules completed, time spent on each module, time elapsed between module initiation and completion, total time spent on iCC.

Time Frame

Weeks 0-24

Title

Participant satisfaction

Description

Time Frame

Weeks 6, 12 & 24

Title

Trial parameters

Description

Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study

Time Frame

Week -4 to Week 24

Title

Cannabis Use

Description

Time Frame

(-2-0 (baseline) and Week 6, 12 & 24

Other Pre-specified Outcome Measures:

Title

Psychotic Symptoms

Description

Positive and negative symptoms of psychosis (e.g., schizophrenia) will be measured by trained staff with Positive Negative Syndrome Scale (PANSS-6) that has been recently validated in individuals with schizophrenia and shows similar psychometric properties to PANSS-30. PANSS-6 is an interviewer-administered scale, each item is scored from 1-7 based on the presence and severity of symptoms (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme). A total score of 6 reveals no psychotic symptoms and a total score of <14 is considered the cut-off for remission

Time Frame

(-2-0 (baseline) and Week 6, 12 & 24

Title

Cannabis-related problems

Description

Cannabis-related physical, psychological, social, and functioning problems will be assessed with the Marijuana Problems Scale (MPS), which is a 19-item self-report instrument that measures change in problems related to cannabis use over time. The scale contains 19 items that represent potential negative effects of marijuana on social relationships, self-esteem, motivation and productivity, work and finances, physical health, memory impairment, and legal problems. For each item, the participant reports problems related to cannabis use in the last month by choosing one of the following three options: 0=not a problem, 1=a minor problem, 2=a serious problem. A total score is calculated, and higher scores indicate more serious problems with cannabis use.

Time Frame

(-2-0 (baseline) and Week 6, 12 & 24

Title

Cannabis use frequency and abstinence

Description

The frequency of cannabis use (number of days in the previous 14 days weeks) and rates of point prevalence for cannabis abstinence will be assessed with the Timeline Followback (TLFB). The TLFB 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.

Time Frame

(-2-0 (baseline) and Week 6, 12 & 24

Title

Other drug use

Description

Past two weeks other drug use according to the Timeline Follow-Back Questionnaire (TLFB) which is a tool that captures self-reported drug use in the past 14 days. The TLFB will assess the frequency of drug use, and capture self-reported days with abstinence from substance use.

Time Frame

(-2-0 (baseline) and Week 6, 12 & 24

Title

Dependence severity

Description

Severity of cannabis dependence will be measured with the self-administered, the Severity of Dependence Scale (SDS). The SDS contains five items that measure the psychological components of dependence including control over cannabis use, anxiety over missing a dose, worry related to use, desire to stop and difficulties related to stopping using cannabis. Each item is score on a four-point scale (0=never/almost never, 1=sometimes, 2=often, 3=always/nearly always). A total score is calculated, and higher scores indicate higher levels of dependence.

Time Frame

(-2-0 (baseline) and Week 6, 12 & 24

Title

Protective behaviours

Description

Measured with the self-administered 17-item Protective Behavioral Strategies-Marijuana (PBSM) questionnaire. The PBSM will be used to measure cannabis-related harms in the last 30 days by asking participants to rate on a six-point scale their behaviors (e.g., Avoid using before work or school) related to cannabis use (1=never, 2=rarely, 3=occasionally, 4=sometimes, 5=usually and 6=always). Mean scores will be calculated with higher scores indicating higher risk behaviors.

Time Frame

(-2-0 (baseline) and Week 6, 12 & 24

Title

Confidence in resisting cannabis use

Description

Participant confidence in resisting cannabis use will be measured using the Drug-Taking Confidence Questionnaire (DTCQ), which is an 8-item instrument that has shown reliability and validity in measuring coping self-efficacy. Participants will rate on a 6-point scale (0= not at all confident, 20=20% confident, 40=40%, 60=60% confident, 80=80% confident; and 100=very confident) their confidence to resist cannabis use (i.e., "I would be able to resist the urge to use cannabis…" in 8 different situations e.g. "…. If other people treated me unfairly or interfered with my plans". Participant's confidence in his/her ability to resist cannabis use will be evaluated by calculating a mean score e.g., a confidence score between 0% to 20% reflects little or no confidence at all.

Time Frame

(-2-0 (baseline) and Week 6, 12 & 24

Title

Life satisfaction

Description

The impact of psychosis and CUD on participants' life, we will be measured using the Satisfaction with Life questionnaire (SWL), which is a self-report, 18-item scale that has been validated in participants with schizophrenia and schizophrenia-related disorders. The SWL assesses individual's satisfaction with life pertaining to four domains: living situation (4 items, e.g., "How much do you like the place where you live?"), social relationships (6 items, e.g., How satisfied are you with the number of friends you have?"), work (2 items, e.g., "How satisfied are you with the kind of work that you do?") and self and present life (6 items, e.g., "How satisfied are you with yourself on the whole?"). Items are measured on a five-point Likert scale from "not at all satisfied" to "very satisfied". For each domain a mean score is calculated, and higher scores are indicative of greater satisfaction.

Time Frame

(-2-0 (baseline) and Week 6, 12 & 24

Title

Healthcare utilization

Description

Health service utilization information including number of days of hospitalizations and number of emergency visits in the past 30 days will be collected via self-report from the participant and can be confirmed as needed through the patient medical record abstraction and contact with the case manager.

Time Frame

(-2-0 (baseline) and Week 6, 12 & 24

Title

Stage of change

Description

To capture participants' decision stage of change related to decreasing or stopping cannabis abstinence, we will use the Precaution Adoption Model (PAPM). The PAPM consists of 7 distinct stages of health decision-making: 1) unaware of the health behavior, 2) unengaged in the decision, 3) undecided, 4) decided not to act, 5) decided to act, 6) acting and 7) maintenance. Participants will select one of 6 response options corresponding to PAPM stages 2 to 7: "At this moment, I have not thought about decreasing or stopping using cannabis", "At this moment, I am undecided about decreasing or stopping using cannabis", At this moment I do not want to decrease or stop using cannabis", "At this moment I do want to decrease or stop using cannabis", "I have recently decreased or stopped using cannabis" and "I decreased or stopped using cannabis more than one month ago".

Time Frame

(-2-0 (baseline) and Week 6, 12 & 24

Title

Social support

Description

The availability of social support will be measured with the short form of the Social Provisions Scale (SPS-10) that consists of 2 items per dimension of support (i.e., emotional support or attachment, social integration, reassurance of worth, tangible help, orientation) for a total of 10 items. Items are measured on a four-point Likert scale from "1-totally disagree" to "4-totally agree" and a total score will be calculated. A continuous scale score is computed by summing responses to the 10 questions, with values ranging from 10 to 40. The SPS-10 summary score is not computed for respondents with data missing on any items. Higher scores can be interpreted as having higher levels of social support.

Time Frame

(-2-0 (baseline)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

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

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N2T9

Country

Canada

Facility Name

Nova Scotia Early Psychosis Program

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H2E2

Country

Canada

Facility Name

Clinic Connec-T - Institut universitaire en santé mentale de Montréal

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H1N3M5

Country

Canada

Facility Name

Clinique JAP, Centre hospitalier de l'Université de Montréal

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Facility Name

Clinic Notre-Dame des Victoires - Centre de Recherche CERVO

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1J2G3

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized data sharing procedure will be made developed and made available after completion of the study.

IPD Sharing Time Frame

Within 12 months following the study completion.

IPD Sharing Access Criteria

On request.

Learn more about this trial

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

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