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

Overview

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.

Interventions

• Behavioral CBT-based intervention
  * 1st week: Daily self-report on cannabis and tobacco use, myths regarding cannabis use and its health consequences, motives for cannabis use reduction/quitting, psychoeducation concerning withdrawal symptomatology, therapist's recommendation (progressive reduction of cannabis use). * 2nd week: Daily self-report on cannabis and tobacco use, myths regarding cannabis use and its health and behavioral consequences, identification of triggers, alternatives to cannabis use, therapist's recommendation
• Behavioral Self-help guide
  Psychoeducation on cannabis.

Primary outcome measures

• Cannabis abstinence [Time frame: 7-day point prevalence abstinence (PP) at 4-week follow-up (FU), 3-months follow-up (FU), 6-months follow-up (FU)]
• Cannabis reduction [Time frame: 4 weeks follow-up (FU), 3 months follow-up (FU), 6 months follow-up (FU)]
• Acceptability [Time frame: 4-week follow-up (FU)]

Secondary outcome measures (3)

• Changes in legal and illegal substance use [Time frame: 4 weeks follow-up (FU), 3 months follow-up (FU), 6 months follow-up (FU),]
• Changes in cannabis-related problems [Time frame: 4-week follow-up (FU), 3-months follow-up (FU), 6-months follow-up (FU)]
• Improvement in risk of emotional disorders [Time frame: Changes in 4-week follow-up (FU), 6-months follow-up (FU)]

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 2 centers

• Faculty of Psychology, University of Oviedo — Oviedo
• University of Oviedo — Oviedo

Publications

• Derogatis, L.R. (2001). BSI 18, Brief Symptom Inventory 18: Administration, scoring and Procedure Manual. Pearson.
• 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. PMID 20347232
• 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. PMID 10259963

Identifiers

NCT: NCT06733792 · MS-23-PNSD-1 · 2022I002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗