CANreduce-SP-adding psychological support to web-based adherence-focused guided self-help for cannabis users: study protocol for a three-arm randomized control trial

J I Mestre-Pintó, F Fonseca, M P Schaub, C Baumgartner, M Alias-Ferri, M Torrens, J I Mestre-Pintó, F Fonseca, M P Schaub, C Baumgartner, M Alias-Ferri, M Torrens

Abstract

Background: Cannabis is the most-frequently used illicit drug in Europe. Over the last few years in Spain, treatment demand has increased, yet most cannabis users do not seek treatment despite the related problems. A web-based self-help tool, like CANreduce 2.0, could help these users to control their consumption.

Methods: This study protocol describes a three-arm randomized controlled trial (RCT) comparing the effectiveness of three approaches, in terms of reducing cannabis use among problematic cannabis users, the first two treatment arms including the Spanish version of CANreduce 2.0 (an adherence-focused, guidance-enhanced, web-based self-help tool) (1) with and (2) without psychological support; and the third group (3) treatment as usual (TAU). Study hypotheses will be tested concerning the primary outcome: change in the number of days of cannabis use over the previous week, comparing assessments at 6 weeks and 3 and 6 months follow-up between groups and against baseline. Secondary outcomes related to cannabis use will be tested similarly. Mental disorders will be explored as predictors of adherence and outcomes. Analyses will be performed on an intention-to-treat basis, then verified by complete case analyses.

Discussion: This study will test how effective the Spanish version of CANreduce 2.0 (CANreduce-SP) is at reducing both the frequency and quantity of cannabis use in problematic users and whether adding psychological support increases its effectiveness.

Trial registration: This trial is registered with the Clinical Trials Protocol Registration and Results System (PRS) number: NCT04517474 . Registered 18 August 2020, (Archived by archive.is https://archive.is/N1Y64 ). The project commenced in November 2020 and recruitment is anticipated to end by November 2022.

Keywords: Adherence; CANreduce; Cannabis use disorder; Cognitive behavioural therapy; Guidance; Psychological support; Randomized controlled trial; Reducing cannabis; Self-help tool.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
RCT study flowchart
Fig. 2
Fig. 2
Dashboard for study arms 1 and 2 (translated from Spanish to English for publication purposes only)
Fig. 3
Fig. 3
Module overviews (translated from Spanish to English for publication purposes only)

References

    1. United Nations Office on Drugs and Crime (UNODC) World Drug Report - Booklet 1: Executive Summary. 2020.
    1. Hall W, Stjepanović D, Caulkins J, Lynskey M, Leung J, Campbell G, et al. Public health implications of legalizing the production and sale of cannabis for medicinal and recreational use. Lancet. 2019;394:1580–1590. doi: 10.1016/S0140-6736(19)31789-1.
    1. Cousijn J. Legal cannabis-what’s in it? Addiction. 2021;116(2):231–232. doi: 10.1111/add.15203.
    1. United Nations Office on Drugs and Crime (UNODC) Booklet 4: Cross-cutting issues: evolving trends and new challenges. 2020.
    1. Rotermann M. Looking back from 2020, how cannabis use and related behaviours changed in Canada. Health Rep. 2021;32(4):3–14. doi: 10.25318/82-003-x202100400001-eng.
    1. European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). European Drug Report: trends and developments 2020. 2020. doi:10.2810/420678. Accessed 15 Aug 2021
    1. Álvarez E, Brime B, Llorens N, Molina M, Sánchez E, Sendino R. Informe 2018: Alcohol, tabaco y drogas ilegales en España. Consumo problemático de drogas 2006-2016. Madrid; 2018.
    1. Delegación del Gobierno para el Plan Nacional sobreDrogas . Estrategia Nacional Sobre Adicciones 2017-2024. Madrid: Delegación del Gobierno para el Plan Nacional sobre Drogas; 2017.
    1. Delegación del Gobierno para el Plan Nacional sobreDrogas . Estrategia Nacional sobre Adicciones 2017-2024 - Plan de accion sobre Adicciones 2018-2020. Madrid: Secretaría General Técnica. Centro de Publicaciones Delegación del Gobierno para el Plan Nacional sobre Drogas; 2018.
    1. Stuyt E. The Problem with the Current High Potency THC Marijuana from the Perspective of an Addiction Psychiatrist. Mo Med. 2018;115(6):482–486.
    1. Freeman TP, Winstock AR. Examining the profile of high-potency cannabis and its association with severity of cannabis dependence. Psychol Med. 2015;45:3181–3189. doi: 10.1017/S0033291715001178.
    1. Volkow ND, Baler RD, Compton WM, Weiss SRB. Adverse health effects of marijuana use. N Engl J Med. 2014;370:2219–27. doi: 10.1056/NEJMra1402309.
    1. Delegación del Gobierno para el Plan Nacional sobreDrogas . Memoria 2018 Plan Nacional Sobre Drogas. 2020.
    1. Brezing CA, Levin FR. The current state of pharmacological treatments for cannabis use disorder and withdrawal. Neuropsychopharmacology. 2018;43:173–194. doi: 10.1038/npp.2017.212.
    1. Joshi SV, Stubbe D, Li S-TT, Hilty DM. The use of technology by youth: implications for psychiatric educators. Acad Psychiatry. 2019;43:101–9. doi: 10.1007/s40596-018-1007-2.
    1. Cousijn J, Kuhns L, Larsen H, Kroon E. For better or for worse? A pre–post exploration of the impact of the COVID-19 lockdown on cannabis users. Addiction. 2021 doi: 10.1111/add.15387.
    1. Jones EAK, Mitra AK, Bhuiyan AR. Impact of covid-19 on mental health in adolescents: a systematic review. Int J Environ Res Public Health. 2021;18:1–9. doi: 10.3390/ijerph18052470.
    1. Turna J, Zhang J, Lamberti N, Patterson B, Simpson W, Francisco AP, et al. Anxiety, depression and stress during the COVID-19 pandemic: results from a cross-sectional survey. J Psychiatr Res. 2021;137:96–103. doi: 10.1016/j.jpsychires.2021.02.059.
    1. Bonar EE, Chapman L, McAfee J, Goldstick JE, Bauermeister JA, Carter PM, et al. Perceived impacts of the COVID-19 pandemic on cannabis-using emerging adults. Transl Behav Med. 2021 doi: 10.1093/tbm/ibab025.
    1. Boumparis N, Karyotaki E, Schaub MP, Cuijpers P, Riper H. Internet interventions for adult illicit substance users: a meta-analysis. Addiction. 2017;112:1521–1532. doi: 10.1111/add.13819.
    1. Olmos A, Tirado-Muñoz J, Farré M, Torrens M. The efficacy of computerized interventions to reduce cannabis use: a systematic review and meta-analysis. Addict Behav. 2018;79:52–60. doi: 10.1016/j.addbeh.2017.11.045.
    1. Boumparis N, Loheide-Niesmann L, Blankers M, Ebert DD, Korf D, Schaub MP, et al. Short- and long-term effects of digital prevention and treatment interventions for cannabis use reduction: A systematic review and meta-analysis. Drug Alcohol Depend. 2019;200:82–94. doi: 10.1016/j.drugalcdep.2019.03.016.
    1. Linardon J, Fuller-Tyszkiewicz M. Attrition and adherence in smartphone-delivered interventions for mental health problems: a systematic and meta-analytic review. J Consult Clin Psychol. 2020;88:1–13. doi: 10.1037/ccp0000459.
    1. Schaub MP, Wenger A, Berg O, Beck T, Stark L, Buehler E, et al. A web-based self-help intervention with and without chat counseling to reduce cannabis use in problematic cannabis users: three-arm randomized controlled trial. J Med Internet Res. 2015;17:e232. doi: 10.2196/jmir.4860.
    1. Amann M, Haug S, Wenger A, Baumgartner C, Ebert DD, Berger T, et al. The effects of social presence on adherence-focused guidance in problematic cannabis users: protocol for the CANreduce 2.0 randomized controlled trial. JMIR Res Protoc. 2018;7:e30. doi: 10.2196/resprot.9484.
    1. Baumgartner C, Schaub MP, Wenger A, Malischnig D, Augsburger M, Walter M, et al. CANreduce 2.0 – the effects of adherence-focused guidance for Internet self-help among cannabis misusers: results of a three-arm randomized controlled trial (Preprint) J Med Internet Res. 2021;23:e27463. doi: 10.2196/27463.
    1. Miller W. Motivational interviewing:preparing people to change addictive behavior. 1. New York: Guilford Press; 1991.
    1. Marlatt A. Relapse prevention:maintenance strategies in the treatment of addictive behaviors. 2. New York: Guilford Press; 2005.
    1. Kanter JW, Puspitasari AJ, Santos MM, Nagy GA. Behavioural activation:history, evidence and promise. Br J Psychiatry. 2012;200:361–363. doi: 10.1192/bjp.bp.111.103390.
    1. Jaffee WB, D’Zurilla TJ. Personality, problem solving, and adolescent substance use. Behav Ther. 2009;40:93–101. doi: 10.1016/j.beth.2008.03.001.
    1. Platt JJ, Husband SD. An overview of problem-solving and social skills approaches in substance abuse treatment. Psychotherapy. 1993;30:276–283. doi: 10.1037/0033-3204.30.2.276.
    1. Tyler TR. Psychological perspectives on legitimacy and legitimation. Annu Rev Psychol. 2006;57:375–400. doi: 10.1146/annurev.psych.57.102904.190038.
    1. Mohr DC, Cuijpers P, Lehman K. Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions. J Med Internet Res. 2011;13:e30. doi: 10.2196/jmir.1602.
    1. Tyler TR. The psychology of legitimacy: a relational perspective on voluntary deference to authorities. Personal Soc Psychol Rev. 1997;1:323–345. doi: 10.1207/s15327957pspr0104_4.
    1. CANreduce. . Accessed 21 Jan 2021.
    1. Hjorthøj CR, Hjorthøj AR, Nordentoft M. Validity of Timeline Follow-Back for self-reported use of cannabis and other illicit substances - systematic review and meta-analysis. Addict Behav. 2012;37:225–233. doi: 10.1016/j.addbeh.2011.11.025.
    1. Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the Timeline Followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014;28:154–162. doi: 10.1037/a0030992.
    1. Annaheim B, Scotto TJ, Gmel G. Revising the Cannabis Use Disorders Identification Test (CUDIT) by means of Item Response Theory. Int J Methods Psychiatr Res. 2010;19:142–155. doi: 10.1002/mpr.308.
    1. Gossop M, Darke S, Griffiths P, Hando J, Powis B, Hall W, et al. The Severity of Dependence Scale (SDS): psychometric properties of the SDS in English and Australian samples of heroin, cocaine and amphetamine users. Addiction. 1995;90:607–614. doi: 10.1046/j.1360-0443.1995.9056072.x.
    1. González-Saiz F, de las Cuevas C, Barrio G, Domingo-Salvany A. Versión española consensuada de la Severity of Dependence Scale (SDS) Med Clin (Barc) 2008;131:797–8. doi: 10.1016/S0025-7753(08)75509-X.
    1. Rubio Valladolid G, Bermejo Vicedo J, Caballero Sánchez-Serrano MC, Santo-Domingo Carrasco J. Validation of the Alcohol Use Disorders Identification Test (AUDIT) in primary care. Rev Clin Esp. 1998;198(1):11–4.
    1. Saunders JB, Aasland OG, Babor TF, De La Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption-II. Addiction. 1993;88:791–804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
    1. Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D. Item Banks for Measuring Emotional Distress From the Patient-Reported Outcomes Measurement Information System (PROMIS®): Depression, Anxiety, and Anger. Assessment. 2011;18:263–283. doi: 10.1177/1073191111411667.
    1. Vilagut G, Forero CG, Castro-Rodriguez JI, Olariu E, Barbaglia G, Astals M, et al. Measurement equivalence of PROMIS depression in Spain and the United States. Psychol Assess. 2019;31:248–254. doi: 10.1037/pas0000665.
    1. Hernandez G, Garin O, Pardo Y, Vilagut G, Pont À, Suárez M, et al. Validity of the EQ–5D–5L and reference norms for the Spanish population. Qual Life Res. 2018;27:2337–2348. doi: 10.1007/s11136-018-1877-5.
    1. Rozental A, Boettcher J, Andersson G, Schmidt B, Carlbring P. Negative effects of internet interventions: a qualitative content analysis of patients’ experiences with treatments delivered online. Cogn Behav Ther. 2015;44:223–236. doi: 10.1080/16506073.2015.1008033.
    1. Graham JW, Olchowski AE, Gilreath TD. How many imputations are really needed? Some practical clarifications of multiple imputation theory. Prev Sci. 2007;8:206–213. doi: 10.1007/s11121-007-0070-9.
    1. Eysenbach G, CONSORT-EHEALTH Group CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011;13:e126. doi: 10.2196/jmir.1923.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Rooke S, Copeland J, Norberg M, Hine D, McCambridge J. Effectiveness of a self-guided web-based cannabis treatment program: randomized controlled trial. J Med Internet Res. 2013;15:e26. doi: 10.2196/jmir.2256.

Source: PubMed

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