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

NCT04968275 | Completed DMC

• 1 other identifier: 20.433
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 5

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.

Conditions

Psychotic Disorder; Marijuana Use; Young Adult

Keywords

Psychosis; Cannabis; Youth

Outcome Measures

Primary Outcomes (2)

• Completion rates

  Proportions of participants completing at least the first four CHAMPS modules or with ongoing participation in EIS.

  Week 12

• Retention rates

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

  Week 6

Secondary Outcomes (5)

• Acceptability (CHAMPS usage data)

  Weeks -2-0 (baseline) to 10

• Participant satisfaction

  Weeks 6 and 12

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

  Weeks -4 to 18

• Efficacy (use of cannabis protective behavioral strategies)

  Weeks -2-0 (baseline), 6, 12 and 18

• Efficacy (motivation to change cannabis protective behavioral strategies)

  Weeks -2-0 (baseline), 6, 12 and 18

Other Outcomes (8)

• Cannabis-related problems

  Weeks -2-0 (baseline), 6, 12 and 18

• Cannabis use

  Weeks -2-0 (baseline), 6, 12 and 18

• Other drug use

  Weeks -2-0 (baseline), 6, 12 and 18

Study Arms (2)

CHAMPS and EIS

EXPERIMENTAL

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).

Behavioral: CHAMPS

EIS alone

NO INTERVENTION

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.

Interventions

CHAMPS BEHAVIORAL

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.

Also known as: Technology-based psychosocial intervention, Psychotherapy

CHAMPS and EIS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Ministere de la Sante et des Services Sociaux: collaborator

Study Sites (5)

Foothills Medical Centre Early Psychosis Intervention Program, Unit 24, 1403-29 Street NW

Calgary, Alberta, T2N 2T9, Canada

Location

Nova Scotia Early Psychosis Program, 3rd Floor, Abbie Lane Bldg 5909 Veterans' Memorial Lane

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Clinic Connec-T - Institut universitaire en santé mentale de Montréal, 7401 rue Hochelaga

Montreal, Quebec, H1N 3M5, Canada

Location

Clinique JAP, Centre hospitalier de l'Université de Montréal, 1051, rue Sanguinet

Montreal, Quebec, H2X 3E4, Canada

Location

Clinic Notre-Dame des Victoires - Centre de Recherche CERVO, 2601 chemin de la Canardière

Québec, Quebec, G1J 2G3, Canada

Location

Related Publications (1)

• Coronado-Montoya S, Abdel-Baki A, Cote J, Crockford D, Dubreucq S, Fischer B, Lachance-Touchette P, Lecomte T, L'Heureux S, Ouellet-Plamondon C, Roy MA, Tatar O, Tibbo P, Villeneuve M, Wittevrongel A, Jutras-Aswad D. Evaluation of a Cannabis Harm Reduction Intervention for People With First-Episode Psychosis: Protocol for a Pilot Multicentric Randomized Trial. JMIR Res Protoc. 2023 Dec 18;12:e53094. doi: 10.2196/53094.

  PMID: 38109196 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Marijuana Use; Marijuana Abuse

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Didier Jutras-Aswad, MD, MSc

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Group assignment will not be masked after randomization, but it will be at the data analysis stage.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-arm parallel, open-labelled, pilot randomized controlled trial

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: August 23, 2021
• Primary Completion: September 30, 2023
• Study Completion: October 24, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CA (5)