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olthof et al trials 2021 22 28 https doi org 10 1186 s13063 020 04962 3 study protocol open access ican an internet based intervention to reduce cannabis use study ...

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               Olthof et al. Trials           (2021) 22:28 
               https://doi.org/10.1186/s13063-020-04962-3
                STUDY PROTOCOL                                                                                        Open Access
               ICan, an Internet-based intervention to
               reduce cannabis use: study protocol for a
               randomized controlled trial
                                   1,2*                     1,2,3                     1                          2,3,4
               Marleen I. A. Olthof      , Matthijs Blankers   , Margriet W. van Laar and Anna E. Goudriaan
                 Abstract
                 Background: Heavy cannabis use is associated with adverse physical and mental health effects. Despite available
                 effective treatments, the majority of heavy cannabis users does not seek professional help. Web-based interventions
                 can provide an alternative for cannabis users who are reluctant to seek professional help. Several web-based
                 cannabis interventions are effective in reducing cannabis use; however, the effect sizes are typically small and
                 attrition rates are typically high. This suggests that web-based programs can be an effective cannabis use
                 intervention for some, while others may need additional substance use treatment after completing a web-based
                 intervention. Therefore, it is important that web-based interventions do not solely focus on reducing cannabis use,
                 but also on improving attitudes towards substance use treatment. The Screening Brief Intervention and Referral to
                 Treatment (SBIRT) approach appears to be well suited for the purpose of reducing cannabis use and improving
                 substance use treatment utilization. Based on the SBIRT approach—and based on cognitive behavioral therapy
                 (CBT) and motivational interviewing (MI)—we developed the Internet-based cannabis reduction intervention ICan.
                 Methods/design: This protocol paper presents the design of a randomized controlled trial (RCT) in which we
                 evaluate the effectiveness of the ICan intervention compared to four online modules of educational
                 information on cannabis in a sample of Dutch frequent cannabis users. The primary outcome measure is
                 frequency of cannabis use. Secondary outcome measures include the quantity of cannabis used (grams), the
                 attitudes towards seeking help and the number of participants who enter specialized treatment services for
                 cannabis use-related problems.
                 Discussion: To the best of our knowledge, ICan is the first Internet-based intervention for cannabis users that
                 combines screening, a brief intervention—basedonCBTandMI—and referral to treatment options.
                 Trial registration: The study is registered in the Netherlands Trial Register; identifier NL7668. Registered on 17 April 2019.
                 Keywords: Cannabis,eHealth,SBIRT,Web-basedprogram,Intervention,Substanceusedisorder
               * Correspondence: molthof@trimbos.nl
               1
                Trimbos Institute, Netherlands Institute of Mental Health and Addiction,
               Utrecht, The Netherlands
               2
                Amsterdam UMC, Department of Psychiatry, University of Amsterdam,
               Amsterdam, The Netherlands
               Full list of author information is available at the end of the article
                                              ©The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,
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                                              The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the
                                              data made available in this article, unless otherwise stated in a credit line to the data.
               Olthof et al. Trials           (2021) 22:28                                                                    Page 2 of 12
               Background                                                       Thus, digital interventions for cannabis users can be
               Heavy cannabis use in adolescence and young adulthood          effective and have the potential to overcome some com-
               is associated with various adverse physical and mental         monly reported barriers to treatment-seeking, although
               health effects [1]. These effects include cognitive impair-    effect sizes are generally small. Therefore, they can pos-
               ment and an increased risk of depressive symptoms and          sibly play an important role in bridging the cannabis use
               suicidal ideation [1]. Heavy cannabis users are at risk for    disorder   treatment   gap.   To our knowledge, four
               dependence [2, 3]. A longitudinal study of a cohort of         Internet-based cannabis reduction programs for the
               (near) daily cannabis users found that almost 40% of the       non-clinical population of frequent cannabis users have
               (near) daily cannabis users developed cannabis depend-         been evaluated in randomized controlled trials. The first
               ence (DSM-IV) [3].                                             program, a German program called Quit the shit is based
                 Treatment programs based on cognitive behavioral             on the principles of self-regulation and self-control [18].
               therapy (CBT), motivational interviewing (MI), and con-        The 50-day program has a solution-focused approach
               tingency management are effective in reducing cannabis         and includes weekly interaction with a therapist through
               use [4]. However, the majority of frequent cannabis            instant messaging.
               users does not seek professional help [5, 6]. In the             The second program, the Australian program Reduce
               Netherlands, the number of people receiving treatment          your Use consists of 6 modules based on cognitive, be-
               for cannabis use-related problems increased from 2001          havioral, and motivational principles [19]. The program
               to 2010 and then stabilized until 2015 [7]. In 2015, 11,       is fully self-guided; the participants can go through the
               000 people received treatment for cannabis use-related         modules at their own pace.
               problems, while according to the most recent estimates           The third program, the Swiss program Can Reduce,is
               (2007–2009) 30,000 people met the criteria for cannabis        based on CBT, MI, and behavioral self-management
               dependence [7, 8]. Several studies have identified pos-        [20]. The effectiveness of the program with and without
               sible explanations for the low numbers of cannabis users       guidance has been tested. The guidance consists of two
               entering treatment specifically, and for substance users       chat sessions with a trained counselor. The chat sessions
               in general. Commonly reported barriers for seeking             have a duration of 20–30min.
               treatment are the desire to solve one’s own problems,            The fourth program, the Swedish program Cannabish-
               the feeling that treatment is not necessary, not being         jälpen, is also based on CBT and MI principles [21]. The
               ready to stop using cannabis, being unaware of treat-          program consists of 13 modules. Participants are advised
               ments options, not being able to attend treatment during       to complete one or two modules per week. At the begin-
               office hours, and stigma associated with substance use         ning of the program, a therapist sends a welcome mes-
               disorder treatment [9, 10].                                    sage to the participant including personalized feedback
                 Internet-based programs can overcome some of these           on the baseline assessment. Throughout the program,
               barriers and thereby provide an alternative for frequent       the participant can contact the therapist if desired.
               cannabis users who are unwilling to enter substance use          The Cannabishjälpen program and the unguided ver-
               treatment [11]. Internet-based programs are character-         sion of the Can Reduce program were not effective in re-
               ized by a high degree of anonymity; this can minimize          ducing cannabis use frequency (compared to the waiting
               the fear of being stigmatized [12]. Besides, they are easily   list control condition) [20, 21]. The other programs—
               accessible, as users can access the programs from any lo-      Quit the Shit, Reduce your Use and the guided version of
               cation at any time of day. In addition, the programs can       Can Reduce—were effective in reducing cannabis use
               be followed at their own pace, which heightens (per-           [18–20]. However, the effect sizes were small and attri-
               ceived) feasibility of following the program. Internet-        tion was high. These small effect sizes and high attrition
               based programs require less therapist time per patient         rates suggest that online programs can provide an alter-
               than face-to-face treatments; therefore, they may also be      native for some, but not for all cannabis users who are
               more cost-effective [13].                                      reluctant to enter substance use treatment. Therefore, it
                 Studies show that Internet-based programs for canna-         seems important that online programs do not solely
               bis users are effective. Boumparis et al. recently pub-        focus on reducing cannabis use, but also on improving
               lished a systematic review with meta-analyses on digital       attitudes towards substance use treatment. If a cannabis
               prevention and treatment interventions to reduce canna-        user fails to reduce his use after completing the online
               bis use [14]. The meta-analyses showed a small but sig-        program, he may be willing to start/engage in substance
               nificant effect in favor of digital interventions compared     use disorder treatment.
               to control conditions (waiting list, psycho-education or         The Screening Brief Intervention and Referral to
               assessment only) [14]. These results are in line with re-      Treatment (SBIRT) approach appears to be well suited
               sults found in earlier meta-analyses on Internet and           for the purpose of improving substance use treatment
               computer-based interventions for cannabis use [15–17].         utilization. The SBIRT approach was developed in the
               Olthof et al. Trials           (2021) 22:28                                                                         Page 3 of 12
               1960s [22]. The SBIRT approach enables universal                 the most recent version of the Consolidated Standards
               screening in a variety of settings, targeting not only           of Reporting Trials (CONSORT) guidelines [24]. The
               those who are already dependent but also those who are           study is registered in the Netherlands Trial Register;
               not seeking help for their substance use [23]. The               identifier NL7668. Ethical approval to carry out this
               screening procedure typically results in three possible          study was obtained from an accredited medical research
               outcomes: no risk, moderate risk, or high risk for sub-          and ethics committee in the Netherlands (Medical Re-
               stance use problems. Substance users at moderate risk            search Ethics Committees United, NL67449.100.18). The
               for substance use problems receive a brief intervention.         study is designed and will be performed in compliance
               The brief intervention usually consists of one or more           with the Declaration of Helsinki, seventh revision.
               sessions with a health care professional. The goal of
               these sessions is to raise awareness about the risks asso-       Study procedures
               ciated with the substance use and to increase motivation         Figure 1 shows the CONSORT flow diagram of the trial.
               to reduce or stop this behavior [23]. Substance users at         Applicants interested to participate fill out an online
               high risk for cannabis use problems are referred to spe-         screening questionnaire to determine if they meet all of
               cialized substance use treatment. The main goal of the           the inclusion criteria and none of the exclusion criteria.
               referral to treatment is to identify an appropriate treat-       Applicants who are eligible to participate receive the pa-
               ment program and to facilitate participation of the sub-         tient information letter and the informed consent form.
               stance user in the program [23]. The SBIRT approach              Participants have up to 30days to decide if they want to
               seems suitable to be computerized.                               participate. If they have any questions regarding the
                 Based on the SBIRT approach and based on cognitive             study or intervention, they can contact a member of the
               behavioral therapy and motivational interviewing, we de-         research team by phone, email, or face-to-face. They can
               veloped the Internet-based cannabis reduction interven-          also contact an independent expert whose contact details
               tion ICan. ICan is an easy to use progressive web app.           are listed in the patient information letter. Applicants
               ICan includes adherence focused guidance to minimize             who decide to participate in the study are asked for
               drop-out rates. Users of the ICan app receive weekly             necessary personal data. After the participants have
               WhatsApp messages from a coach to encourage them to              sent us their signed informed consent form digitally,
               use the app. The guidance is minimal to ensure that the          they are directed to the baseline questionnaire. The
               intervention remains easily accessible. This protocol            electronic data capture platform Castor will be used
               paper presents the design of the randomized controlled           for the randomization and allocation procedure and
               trial (RCT) in which we evaluate the effectiveness of the        to conduct the online questionnaires. The research
               ICan intervention.                                               data are stored separately from the participants’ per-
                                                                                sonal data. Only the four authors of this study proto-
               Methods                                                          col will have access to the keys to join the research
               Aims and hypotheses                                              data tables with the personal data tables. After the
               The aim of this study is to test the effectiveness of the        participants have completed the baseline question-
               Internet-based intervention ICan compared to four online         naire, they will be allocated to one of two trial arms
               modules of educational information on cannabis in a sample       (1:1) using variable block randomization. Participants
               of Dutch frequent cannabis users. We address the following       will be informed that they will be assigned to one of
               research questions: (1) Is the ICan intervention more effect-    two programs, both focusing on cannabis moderation.
               ive in reducing cannabis use than the control condition? (2)     Depending on the outcome of the allocation proced-
               IstheICaninterventionmoreeffectiveinimprovingpositive            ure, an email will be sent to the participants contain-
               attitudes towards seeking professional help for cannabis use-    ing an access code to either the ICan intervention or
               related problems than the control condition?                     the online control program (four online modules of
                                                                                educational information on cannabis). Participants will
               Study design                                                     be blind to the condition they are in.
               Asingle blind randomized controlled trial will be carried          The follow-up measurements will take place 6weeks,
               out with a duration of 6months in an online setting.             3months, and 6months post randomization. Self-reported
               The trial will be two armed (ICan intervention x four            outcome measures are used to reduce the risk of experi-
               online modules of educational information on cannabis).          menter bias. If participants do not complete the online
               Participants will be assessed on cannabis-related out-           follow-up questionnaires, they will first receive an auto-
               come measures at T0 (baseline, before randomization),            matic email reminder; subsequently, they will receive
               T1 (6weeks post randomization), T2 (3months post                 WhatsApp (audio) messages to encourage them to fill in
               randomization), and T3 (6months post randomization).             the questionnaires. All participants receive the same (audio)
               The trial will be conducted and reported according to            messages to reduce the risk of bias.
              Olthof et al. Trials           (2021) 22:28                                                            Page 4 of 12
               Fig. 1 Trial flow
                After completing the 3months’ follow-up question-       they were allocated to. If desired, they can cross over to
              naire and after completing the 6months’ follow-up ques-   the other condition.
              tionnaire, the participants will receive a €20 gift card by All spontaneously reported adverse events will be re-
              email. Even if participants discontinue their use of the  corded. All serious adverse events will be reported to the
              intervention prematurely, they will be followed up. Only  accredited MREC (Medical Research Ethics Committee)
              if participants explicitly state that they do not want to that approved the protocol. Given the limited risks asso-
              participate in the study anymore, data collection will be ciated with a text-based self-help intervention, no Data
              stopped. After completing the last follow-up question-    Safety Monitoring Board or Safety Committee will be
              naire, the participants are informed about the condition  established for this study.
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...Olthof et al trials https doi org s study protocol open access ican an internet based intervention to reduce cannabis use for a randomized controlled trial marleen i matthijs blankers margriet w van laar and anna e goudriaan abstract background heavy is associated with adverse physical mental health effects despite available effective treatments the majority of users does not seek professional help web interventions can provide alternative who are reluctant several in reducing however effect sizes typically small attrition rates high this suggests that programs be some while others may need additional substance treatment after completing therefore it important do solely focus on but also improving attitudes towards screening brief referral sbirt approach appears well suited purpose utilization cognitive behavioral therapy cbt motivational interviewing mi we developed reduction methods design paper presents rct which evaluate effectiveness compared four online modules educational inform...

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