Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC)

BackgroundCannabis use is the most prevalent among adolescents and young adults; frequent consumption is associated with cannabis use disorder (CUD) and psychosis, with a high prevalence (up to 50%) of CUD in individuals with first-episode psychosis (FEP). Early Intervention...

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Main Authors: Ovidiu Tatar, Amal Abdel-Baki, Anne Wittevrongel, Tania Lecomte, Jan Copeland, Pamela Lachance-Touchette, Stephanie Coronado-Montoya, José Côté, David Crockford, Simon Dubreucq, Sophie L'Heureux, Clairélaine Ouellet-Plamondon, Marc-André Roy, Philip G Tibbo, Marie Villeneuve, Didier Jutras-Aswad
Format: Article
Language:English
Published: JMIR Publications 2022-11-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2022/11/e40817
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author Ovidiu Tatar
Amal Abdel-Baki
Anne Wittevrongel
Tania Lecomte
Jan Copeland
Pamela Lachance-Touchette
Stephanie Coronado-Montoya
José Côté
David Crockford
Simon Dubreucq
Sophie L'Heureux
Clairélaine Ouellet-Plamondon
Marc-André Roy
Philip G Tibbo
Marie Villeneuve
Didier Jutras-Aswad
author_facet Ovidiu Tatar
Amal Abdel-Baki
Anne Wittevrongel
Tania Lecomte
Jan Copeland
Pamela Lachance-Touchette
Stephanie Coronado-Montoya
José Côté
David Crockford
Simon Dubreucq
Sophie L'Heureux
Clairélaine Ouellet-Plamondon
Marc-André Roy
Philip G Tibbo
Marie Villeneuve
Didier Jutras-Aswad
author_sort Ovidiu Tatar
collection DOAJ
description BackgroundCannabis use is the most prevalent among adolescents and young adults; frequent consumption is associated with cannabis use disorder (CUD) and psychosis, with a high prevalence (up to 50%) of CUD in individuals with first-episode psychosis (FEP). Early Intervention Services (EIS) for psychosis include face-to-face psychosocial interventions for CUD, because reducing or discontinuing cannabis use improves clinical and health care service use outcomes. However, multiple barriers (eg, staff availability and limited access to treatment) can hinder the implementation of these interventions. Mobile health (mHealth) interventions may help circumvent some of these barriers; however, to date, no study has evaluated the effects of mHealth psychological interventions for CUD in individuals with FEP. ObjectiveThis study describes the protocol for a pilot randomized controlled trial using a novel mHealth psychological intervention (iCanChange [iCC]) to address CUD in young adults with FEP. iCC was developed based on clinical evidence showing that in individuals without psychosis, integrating the principles of cognitive behavioral therapy, motivational interviewing, and behavioral self-management approaches are effective in improving cannabis use–related outcomes. MethodsConsenting individuals (n=100) meeting the inclusion criteria (eg, aged 18-35 years with FEP and CUD) will be randomly allocated in a 1:1 ratio to the intervention (iCC+modified EIS) or control (EIS) group. The iCC is fully automatized and contains 21 modules that are completed over a 12-week period and 3 booster modules available during the 3-month follow-up period. Validated self-report measures will be taken via in-person assessments at baseline and at 6, 12 (end point), and 24 weeks (end of trial); iCC use data will be collected directly from the mobile app. Primary outcomes are intervention completion and trial retention rates, and secondary outcomes are cannabis use quantity, participant satisfaction, app use, and trial recruiting parameters. Exploratory outcomes include severity of psychotic symptoms and CUD severity. For primary outcomes, we will use the chi-square test using data collected at week 12. We will consider participation in iCC acceptable if ≥50% of the participants complete at least 11 out of 21 intervention modules and the trial feasible if attrition does not reach 50%. We will use analysis of covariance and mixed-effects models for secondary outcomes and generalized estimating equation multivariable analyses for exploratory outcomes. ResultsRecruitment began in July 2022, and data collection is anticipated to be completed in July 2024. The main results are expected to be submitted for publication in 2024. We will engage patient partners and other stakeholders in creating a multifaceted knowledge translation plan to reach a diverse audience. ConclusionsIf feasible, this study will provide essential data for a larger-scale efficacy trial of iCC on cannabis use outcomes in individuals with FEP and CUD. Trial RegistrationClinicalTrials.gov NCT05310981; https://www.clinicaltrials.gov/ct2/show/NCT05310981 International Registered Report Identifier (IRRID)PRR1-10.2196/40817
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spelling doaj.art-f16a0956b067411b839b5b0d6d1d27462023-08-28T23:20:25ZengJMIR PublicationsJMIR Research Protocols1929-07482022-11-011111e4081710.2196/40817Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC)Ovidiu Tatarhttps://orcid.org/0000-0003-1886-6390Amal Abdel-Bakihttps://orcid.org/0000-0003-3333-9652Anne Wittevrongelhttps://orcid.org/0000-0002-1620-1953Tania Lecomtehttps://orcid.org/0000-0002-0340-3759Jan Copelandhttps://orcid.org/0000-0002-6525-7929Pamela Lachance-Touchettehttps://orcid.org/0000-0002-8774-877XStephanie Coronado-Montoyahttps://orcid.org/0000-0003-2491-5689José Côtéhttps://orcid.org/0000-0002-0617-2861David Crockfordhttps://orcid.org/0000-0001-9938-7388Simon Dubreucqhttps://orcid.org/0000-0002-4423-543XSophie L'Heureuxhttps://orcid.org/0000-0001-7849-5179Clairélaine Ouellet-Plamondonhttps://orcid.org/0000-0001-7450-4496Marc-André Royhttps://orcid.org/0000-0002-0123-6651Philip G Tibbohttps://orcid.org/0000-0002-2070-6495Marie Villeneuvehttps://orcid.org/0000-0002-0248-1181Didier Jutras-Aswadhttps://orcid.org/0000-0002-8474-508X BackgroundCannabis use is the most prevalent among adolescents and young adults; frequent consumption is associated with cannabis use disorder (CUD) and psychosis, with a high prevalence (up to 50%) of CUD in individuals with first-episode psychosis (FEP). Early Intervention Services (EIS) for psychosis include face-to-face psychosocial interventions for CUD, because reducing or discontinuing cannabis use improves clinical and health care service use outcomes. However, multiple barriers (eg, staff availability and limited access to treatment) can hinder the implementation of these interventions. Mobile health (mHealth) interventions may help circumvent some of these barriers; however, to date, no study has evaluated the effects of mHealth psychological interventions for CUD in individuals with FEP. ObjectiveThis study describes the protocol for a pilot randomized controlled trial using a novel mHealth psychological intervention (iCanChange [iCC]) to address CUD in young adults with FEP. iCC was developed based on clinical evidence showing that in individuals without psychosis, integrating the principles of cognitive behavioral therapy, motivational interviewing, and behavioral self-management approaches are effective in improving cannabis use–related outcomes. MethodsConsenting individuals (n=100) meeting the inclusion criteria (eg, aged 18-35 years with FEP and CUD) will be randomly allocated in a 1:1 ratio to the intervention (iCC+modified EIS) or control (EIS) group. The iCC is fully automatized and contains 21 modules that are completed over a 12-week period and 3 booster modules available during the 3-month follow-up period. Validated self-report measures will be taken via in-person assessments at baseline and at 6, 12 (end point), and 24 weeks (end of trial); iCC use data will be collected directly from the mobile app. Primary outcomes are intervention completion and trial retention rates, and secondary outcomes are cannabis use quantity, participant satisfaction, app use, and trial recruiting parameters. Exploratory outcomes include severity of psychotic symptoms and CUD severity. For primary outcomes, we will use the chi-square test using data collected at week 12. We will consider participation in iCC acceptable if ≥50% of the participants complete at least 11 out of 21 intervention modules and the trial feasible if attrition does not reach 50%. We will use analysis of covariance and mixed-effects models for secondary outcomes and generalized estimating equation multivariable analyses for exploratory outcomes. ResultsRecruitment began in July 2022, and data collection is anticipated to be completed in July 2024. The main results are expected to be submitted for publication in 2024. We will engage patient partners and other stakeholders in creating a multifaceted knowledge translation plan to reach a diverse audience. ConclusionsIf feasible, this study will provide essential data for a larger-scale efficacy trial of iCC on cannabis use outcomes in individuals with FEP and CUD. Trial RegistrationClinicalTrials.gov NCT05310981; https://www.clinicaltrials.gov/ct2/show/NCT05310981 International Registered Report Identifier (IRRID)PRR1-10.2196/40817https://www.researchprotocols.org/2022/11/e40817
spellingShingle Ovidiu Tatar
Amal Abdel-Baki
Anne Wittevrongel
Tania Lecomte
Jan Copeland
Pamela Lachance-Touchette
Stephanie Coronado-Montoya
José Côté
David Crockford
Simon Dubreucq
Sophie L'Heureux
Clairélaine Ouellet-Plamondon
Marc-André Roy
Philip G Tibbo
Marie Villeneuve
Didier Jutras-Aswad
Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC)
JMIR Research Protocols
title Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC)
title_full Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC)
title_fullStr Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC)
title_full_unstemmed Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC)
title_short Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC)
title_sort reducing cannabis use in young adults with psychosis using icanchange a mobile health app protocol for a pilot randomized controlled trial recap icc
url https://www.researchprotocols.org/2022/11/e40817
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