Clinical trial NCT06733792: A Mobile App to Reduce and/or Quit Cannabis Use
Official title: Efficacy of a Digitalized Selective Prevention Program (App - "CANQUIT") to Reduce and/or Quit Cannabis Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis Dependence
Keywords: Cannabis
App-based intervention
Young adults
Selective prevention
CBT
Contingency Management
Lead sponsor: University of Oviedo
Sponsor class: OTHER
Collaborators: name: Delegación del Gobierno para el Plan Nacional sobre Drogas
First posted: 2024-12-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to develop an App-based intervention (CANQUIT) aimed at regular cannabis users. The efficacy of this intervention will be evaluated in the short-term (1-month follow-up) and long-term (3- and 6-months follow-ups) using a sample of 120 participants. Participants will be randomly assigned to the experimental arm (App-assisted CBT-based intervention) or the control (App-assisted self-help guide). The study will also estimate the economic impact of the intervention by considering the benefit-cost ratio (BCR) and net benefit (in €) associated with the total cost of the program. The goal is to provide evidence that can inform policy decisions regarding cannabis use and minimize the negative consequences on the physical and mental health of young adults in Spain. This study aims to offer a cost-effective prevention strategy that minimize the negative consequences on the physical and mental health of young adults in Spain.

Detailed description: The aim of this study is to evaluate the efficacy and cost-effectiveness in the short (1-month) and long-term (3 and 6 months) of a digitalized intervention (CANQUIT) to reduce and/or quit cannabis among young Spanish adults.

CANQUIT is a 4-week digitalized CBT-based intervention aimed at reducing or ceasing cannabis use among regular cannabis users (at least 1 occasion of cannabis use in the previous month). It is specifically tailored to young adults (18-30 years old). CANQUIT will be available to download both on Apple Store (iOS) and Play Store (Android). Upon completion of the baseline assessment, participants will be randomly assigned 2:1 to either an experimental arm (60 participants: App-assisted CBT-based intervention) or control (60 participants: App-assisted self-help guide). Participants in the experimental arm will be exposed to seven weekly modules, which include: 1) psychoeducation regarding the benefits of ceasing cannabis use, its short and long-term effects and myths associated with its consumption, 2) training in emotion regulation strategies, stimulus control (i.e., alternatives to cannabis use), 3) behavioral activation strategies, and 4) relapse prevention (i.e., assertiveness and problem-solving abilities). Participants will also register daily consumption of cannabis (number of joints) and receive weekly recommendations regarding cannabis use reduction. To ensure adherence to treatment, CANQUIT includes gamification via direct contact with a mental health professional and social interaction with others (through an online chat).

Alternatively, participants allocated to the control group will receive a self-help guide with information based on the contents of the App. This guide will be also available through the App. As in the experimental arm, participants in the control group will also complete 1-month, 3-months and 6-months follow-ups through the App.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 30 years old.
* At least one occasion of cannabis use in the last month.
* Access to smartphones (iOS or Android).
* Access to Internet.

Exclusion Criteria:

-

Primary outcomes:
measure: Cannabis abstinence
timeFrame: 7-day point prevalence abstinence (PP) at 4-week follow-up (FU), 3-months follow-up (FU), 6-months follow-up (FU)
measure: Cannabis reduction
timeFrame: 4 weeks follow-up (FU), 3 months follow-up (FU), 6 months follow-up (FU)
measure: Acceptability
timeFrame: 4-week follow-up (FU)
Secondary outcomes:
measure: Changes in legal and illegal substance use
timeFrame: 4 weeks follow-up (FU), 3 months follow-up (FU), 6 months follow-up (FU),
measure: Changes in cannabis-related problems
timeFrame: 4-week follow-up (FU), 3-months follow-up (FU), 6-months follow-up (FU)
measure: Improvement in risk of emotional disorders
timeFrame: Changes in 4-week follow-up (FU), 6-months follow-up (FU)
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Faculty of Psychology, University of Oviedo
state: Asturias
city: Oviedo
country: Spain
facility: University of Oviedo
state: Asturias
Study officials:
References:
citation: Derogatis, L.R. (2001). BSI 18, Brief Symptom Inventory 18: Administration, scoring and Procedure Manual. Pearson.
citation: Adamson SJ, Kay-Lambkin FJ, Baker AL, Lewin TJ, Thornton L, Kelly BJ, Sellman JD. An improved brief measure of cannabis misuse: the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). Drug Alcohol Depend. 2010 Jul 1;110(1-2):137-43. doi: 10.1016/j.drugalcdep.2010.02.017. Epub 2010 Mar 26.
citation: Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.