Glycan Profile and Sequence Variants of Certified Ricin Reference Material and Other Ricin Samples Yield Unique Molecular Signature Features.

A certified reference material of ricin (CRM-LS-1) was produced by the EuroBioTox consortium to standardise the analysis of this biotoxin. This study established the N-glycan structures and proportions including their loci and occupancy of ricin CRM-LS-1. The glycan profile was compared with ricin from different preparations and other cultivars and isoforms. A total of 15 different oligomannosidic or paucimannosidic structures were identified in CRM-LS-1. Paucimannose was mainly found within the A-chain and oligomannose constituted the major glycan type of the B-chain. Furthermore, the novel primary structure variants E138 and D138 and four different C-termini of the A-chain as well as two B-chain variants V250 and F250 were elucidated. While the glycan proportions and loci were similar among all variants in CRM-LS-1 and ricin isoforms D and E of all cultivars analysed, a different stoichiometry for isoforms D and E and the amino acid variants were found. This detailed physicochemical characterization of ricin regarding the glycan profile and amino acid sequence variations yields unprecedented insight into the molecular features of this protein toxin. The variable attributes discovered within different cultivars present signature motifs and may allow discrimination of the biotoxin's origin that are important in molecular forensic profiling. In conclusion, our data of in-depth CRM-LS-1 characterization combined with the analysis of other cultivars is representative for known ricin variants.

Effectiveness of a web-based self-help tool to reduce problem gambling: A randomized controlled trial.

Background and Aims: Problem gambling constitutes a public health concern associated with psychopathological comorbidity, substance use, and financial difficulties. Most individuals with gambling problems avoid counseling services due to perceived stigma and their preference for self-reliance. Treatment accessibility could be improved through web-based interventions. Methods: We recruited 360 individuals with gambling problems and randomized them to a web-based intervention (n = 185) or an active control group consisting of a self-help manual for problem gambling (n = 175). The primary outcome was the number of days of gambling in the last 30 days. Secondary outcomes included money spent in the last 30 days, time gambling in the last 7 days, gambling-related problems, consumption of alcohol and cigarettes, and psychopathological comorbidity measured at posttreatment and 6-month follow-up. Results: The primary outcome decreased significantly for both groups, with no significant difference between the groups. There were significant group × time interactions according to the Gambling Symptom Assessment Scale (F = 8.83, p <0 .001), the Problem Gambling Severity Index (F = 3.54, p = 0.030), for cigarettes smoked in the last 7 days (F = 26.68, p < 0.001), the Patient Health Questionnaire-9 (F = 19.41, p <0 .001), and the Generalized Anxiety Disorder-7 (F = 41.09, p <0 .001) favoring the intervention group. We experienced an overall high dropout rate (76%). Conclusions: Win Back Control seems to be an effective low-threshold treatment option for individuals with gambling problems that might otherwise be unapproachable for outpatient treatment services. Nevertheless, the high dropout rate should be considered when interpreting the study results, as they may have introduced a degree of variability.

Predictors of Youth Accessibility for a Mobile Phone-Based Life Skills Training Program for Addiction Prevention.

BACKGROUND: Digital interventions are an emerging and promising avenue for addiction prevention and mental health promotion, but their reach and use are often limited, and little is known about the factors associated with youth accessibility. SmartCoach is a life skills training program for addiction prevention where adolescents are proactively invited for program participation in secondary school classes. The mobile phone-based program provides individualized coaching for a period of 4 months and addresses self-management skills, social skills, and substance use resistance skills. This study examined sociodemographic and other predictors of program participation and program use. METHODS: A total of 476 adolescents in 28 secondary and upper secondary school classes in the German-speaking part of Switzerland were proactively invited for participation in the SmartCoach program. Using generalized linear mixed models (GLMMs), we examined predictors of both program participation and program use at the individual and school class levels. RESULTS: In total, 315 (66.2%) of the present 476 adolescents gave their active consent and provided the necessary information to be included in the program. None of the individual sociodemographic characteristics significantly predicted program participation, however, the participation rate was significantly higher in upper secondary school classes (84%) than secondary school classes (59%). The mean number of interactions with the program was 15.9, i.e., participants took part in almost half of the 34 possible interactions with the SmartCoach program. None of the baseline characteristics on the level of the school class significantly predicted program use. On the level of the individual, the univariate models showed that, compared to the reference category of 14-year-old students, program use was significantly lower for students who were 16 or older. Furthermore, participants with a migration background or an origin from a non-German-speaking country showed significantly lower program use. Finally, students with a medium level of perceived stress showed higher program use compared to those with a low level of stress. Within the final multivariate model for program use, only the variable "origin from a non-German-speaking country" remained significant. CONCLUSIONS: SmartCoach is an attractive offer for young people, in which two out of three young people who are invited in the classroom to participate do so. Among the program participants, the use of the program is acceptable, with an average of almost half of the content being worked on. There is potential for improvement in terms of recruitment, especially in school classes with a lower level of education. The most important starting point for improving program use lies in taking greater account of needs and wishes of students with non-German-speaking countries of origin.

Blended smartphone intervention for patients in opioid maintenance treatment in Iran: protocol for a randomized controlled trial.

BACKGROUND: The pattern of substance use in Iran is characterized by a high prevalence of opioid use and opioid use disorder (OUD). Although opioid maintenance therapy (OMT) has been introduced in Iran, approximately 50% of people with opioid use disorder remain unreached. Moreover, psychosocial treatment of OUD and common mental health symptoms during OMT is limited. Digital interventions have been shown to improve psychological distress, depression, anxiety, and post-traumatic stress disorder symptoms. In addition, providing psychoeducation and risk reduction counseling to prevent communicable diseases like HIV and infectious hepatitis is common via the Internet. However, despite these promising advances, no smartphone intervention in OMT has been investigated for the treatment of OUD and common comorbid mental health symptoms. OBJECTIVE: We examine the effectiveness of adding a blended smartphone intervention based on community reinforcement approach, motivational interviewing- and cognitive behavioral therapy compared to OMT as usual that aims to improve OMT outcomes and addresses common mental health symptoms in OMT patients in Iran. METHOD: Adults with opioid dependence entering 8 treatment centers in Tehran, Iran will be randomly assigned to receive either OMT plus a smartphone intervention or OMT as usual. The primary outcomes will be the percentage of negative urine tests for illicit, non-prescribed use of opioids (opium, heroin, tramadol) and treatment retention. Secondary outcomes will include the longest period of abstinence from the illicit, non-prescribed use of opioids (opium, heroin, and tramadol) confirmed by urine samples, changes in communicable disease risk-taking behaviors, changes in stress and common mental health symptoms, and client satisfaction. Data analysis will follow the intention-to-treat principle and employ (generalized) linear mixed models. DISCUSSION: This study will provide substantial knowledge for designing effective blended interventions for OUD. Moreover, it will investigate if treatment retention and OMT-related outcomes and common mental health symptoms can be improved by adding a smartphone intervention to OMT. TRIAL REGISTRATION: https://en.irct.ir/trial/53578 .

Mobile App-Based Coaching for Alcohol Prevention among Adolescents: Pre-Post Study on the Acceptance and Effectiveness of the Program "MobileCoach Alcohol".

BACKGROUND: At-risk alcohol use, particularly binge drinking, is widespread among adolescents and young adults in most Western countries. MobileCoach Alcohol is a mobile app-based program for alcohol prevention that provides individualized coaching using a conversational agent. The current study tested the acceptance, use, and evaluation of this newly developed program and explored its potential effectiveness. METHODS: Longitudinal pre-post study among upper secondary and vocational school students in Switzerland. Within the MobileCoach Alcohol prevention program, a virtual coach motivated participants to deal with alcohol sensitively, and provided feedback on alcohol use and strategies to resist alcohol for a period of 10 weeks. Information was provided in weekly dialogs, within contests with other participants, and interactive challenges. By means of a follow-up survey after the end of the 10-week program, indicators of the use, acceptance, and effectiveness of the program were examined. RESULTS: Between October 2020 and July 2022, the program was advertised in upper secondary and vocational schools. Recruiting schools and school classes was difficult due to the COVID-19 containment measures in place during this period. Nevertheless, the program could be implemented in 61 upper secondary and vocational school classes with a total of 954 participating students. Three out of four students who were present in the school classes participated in the MobileCoach Alcohol program and the associated study. Online follow up assessment at week 10 was completed by 272 program participants (28.4%). Based on program use and evaluations by the participants, the overall acceptance of the intervention was good. The proportion of students who engaged in binge drinking was significantly reduced from 32.7% at baseline to 24.3% at follow up. Furthermore, the longitudinal analyses revealed decreases in the maximum number of alcoholic drinks consumed on an occasion and the mean number of standard drinks per month, whereas self-efficacy to resist alcohol increased between baseline and follow up. CONCLUSIONS: The mobile app-based MobileCoach Alcohol program proved to be an attractive intervention, in which the majority of students were interested when proactively recruited at school classes. It allows for individualized coaching in large groups of adolescents and young adults and is promising for reducing at-risk alcohol use.

Efficacy of a Mobile App-Based Coaching Program for Addiction Prevention among Apprentices: A Cluster-Randomized Controlled Trial.

BACKGROUND: Addictive behaviors such as tobacco/e-cigarette smoking, at-risk alcohol consumption, cannabis use or compulsive internet use are common among apprentices. ready4life is a mobile app-based preventive intervention program for apprentices that promotes life skills and reduces risky behavior. The present study tested the efficacy of ready4life for addiction prevention among apprentices in Switzerland within a controlled trial. METHODS: Two-arm, cluster-randomized controlled trial including assessments at baseline and follow-up after 6 months. Participants of the intervention group received coaching by a conversational agent for 16 weeks. The main outcome measure was a composite score for addictive behaviors, which included (1) at-risk drinking, (2) tobacco/e-cigarette smoking, (3) cannabis use and (4) problematic internet use. RESULTS: A total of 2275 students from 159 vocational school classes in Switzerland, were invited for study participation. Of these, 1351 (59.4%) students with a mean age of 17.3 years and a male proportion of 56.6% provided informed consent to participate. The follow up assessment at month 6 was completed by 962 (71.2%) study participants. The results concerning the primary outcome showed a stronger decrease of addictive behaviors between baseline and follow up in the intervention group compared to the control group. In particular, significant effects were observed for at-risk drinking and problematic Internet use, while no significant effects were observed for tobacco/e-cigarette smoking and cannabis use. CONCLUSIONS: The majority of apprentices invited for program participation within vocational schools participated in the ready4life program for addiction prevention. The mobile app-based coaching was effective in reducing risk behaviors such as at-risk drinking and problematic Internet use in a group of adolescents who have an especially high risk of engaging in addictive activities.

Longer-Term Efficacy of a Digital Life-Skills Training for Substance Use Prevention.

INTRODUCTION: The main objective of this study was to test the longer-term and differential efficacy of a mobile phone‒based life-skills training program designed to prevent substance use among adolescents. STUDY DESIGN: A 2-arm, parallel-group, cluster RCT with assessments at baseline and follow-up after 6 and 18 months was conducted. The efficacy of the intervention was compared with that of an assessment-only control condition. SETTING/PARTICIPANTS: A total of 1,473 students with a mean age of 15.4 years were recruited in 2019/2020 within 89 Swiss secondary and upper secondary school classes. INTERVENTION: The automated intervention program included online feedback and individually tailored text messages provided over 22 weeks. The contents were based on social cognitive theory and addressed self-management, social, and substance use resistance skills. MAIN OUTCOME MEASURES: Primary outcomes included 30-day prevalence rates for problem drinking and tobacco use. RESULTS: The 18-month follow-up assessments were completed by 1,232 study (83.6%) participants. Those in the intervention group reported lower tobacco-smoking prevalence than the controls (OR=0.67; 95% CI=0.47, 0.96), but no significant difference in problem drinking (OR=0.84; 95% CI=0.61, 1.17) was observed. Among secondary outcomes, the intervention was effective at reducing cannabis-smoking prevalence (OR=0.55; 95% CI=0.39, 0.76) and cannabis use days (Cohen's d= -0.19; 95% CI= -0.29, -0.09), whereas no effects were observed for quantity of alcohol use, quantity of cigarettes smoked, well-being, or social skills. No significant moderators of the primary outcomes were observed. CONCLUSIONS: An automated mobile phone‒based life-skills training program produced longer-term effectiveness in preventing tobacco smoking and cannabis use, whereas no effects were observed for problem drinking. These results suggest that digitally delivered life-skills training programs are similarly effective and are an easy-to-implement alternative to training conducted within a school curriculum. TRIAL REGISTRATION: This study is registered at ISRCTN41347061 (registration date: 21/07/2018).

Examining differential responses to the Take Care of Me trial: A latent class and moderation analysis.

Given prevalent alcohol misuse-emotional comorbidities among young adults, we developed an internet-based integrated treatment called Take Care of Me. Although the treatment had an impact on several secondary outcomes, effects were not observed for the primary outcome. Therefore, the goal of the current study was to examine heterogeneity in treatment responses. The initial RCT randomized participants to either a treatment or psychoeducational control condition. We conducted an exploratory latent class analysis to distinguish individuals based on pre-treatment risk and then used moderated regressions to examine differential treatment responses based on class membership. We found evidence for three distinct groups. Most participants fell in the "low severity" group (n = 123), followed by the "moderate severity" group (n = 57) who had a higher likelihood of endorsing a previous mental health diagnosis and treatment and higher symptom severity than the low group. The "high severity" group (n = 42) endorsed a family history of alcoholism, and the highest symptom severity and executive dysfunction. Moderated regressions revealed significant class differences in treatment responses. In the treatment condition, high severity (relative to low) participants reported higher alcohol consumption and hazardous drinking and lower quality of life at follow-up, whereas moderate severity (relative to low) individuals had lower alcohol consumption at follow-up, and lower hazardous drinking at end-of-treatment. No class differences were found for participants in the control group. Higher risk individuals in the treatment condition had poorer responses to the program. Tailoring interventions to severity may be important to examine in future research.

Cannabis Use in Adults Who Screen Positive for Attention Deficit/Hyperactivity Disorder: CANreduce 2.0 Randomized Controlled Trial Subgroup Analysis.

BACKGROUND: Prevalence rates for lifetime cannabis use and cannabis use disorder are much higher in people with attention deficit/hyperactivity disorder than in those without. CANreduce 2.0 is an intervention that is generally effective at reducing cannabis use in cannabis misusers. This self-guided web-based intervention (6-week duration) consists of modules grounded in motivational interviewing and cognitive behavioral therapy. OBJECTIVE: We aimed to evaluate whether the CANreduce 2.0 intervention affects cannabis use patterns and symptom severity in adults who screen positive for attention deficit/hyperactivity disorder more than in those who do not. METHODS: We performed a secondary analysis of data from a previous study with the inclusion criterion of cannabis use at least once weekly over the last 30 days. Adults with and without attention deficit/hyperactivity disorder (based on the Adult Attention deficit/hyperactivity disorder Self-Report screener) who were enrolled to the active intervention arms of CANreduce 2.0 were compared regarding the number of days cannabis was used in the preceding 30 days, the cannabis use disorder identification test score (CUDIT) and the severity of dependence scale score (SDS) at baseline and the 3-month follow-up. Secondary outcomes were Generalized Anxiety Disorder score, Center for Epidemiological Studies Depression scale score, retention, intervention adherence, and safety. RESULTS: Both adults with (n=94) and without (n=273) positive attention-deficit/hyperactivity disorder screening reported significantly reduced frequency (reduction in consumption days: with: mean 11.53, SD 9.28, P<.001; without: mean 8.53, SD 9.4, P<.001) and severity of cannabis use (SDS: with: mean 3.57, SD 3.65, P<.001; without: mean 2.47, SD 3.39, P<.001; CUDIT: with: mean 6.38, SD 5.96, P<.001; without: mean 5.33, SD 6.05, P<.001), as well as anxiety (with: mean 4.31, SD 4.71, P<.001; without: mean 1.84, SD 4.22, P<.001) and depression (with: mean 10.25, SD 10.54; without: mean 4.39, SD 10.22, P<.001). Those who screened positive for attention deficit/hyperactivity disorder also reported significantly decreased attention deficit/hyperactivity disorder scores (mean 4.65, SD 4.44, P<.001). There were no significant differences in change in use (P=.08), dependence (P=.95), use disorder (P=.85), attention deficit/hyperactivity disorder status (P=.84), depression (P=.84), or anxiety (P=.26) between baseline and final follow-up, dependent on positive attention-deficit/hyperactivity disorder screening. Attention deficit/hyperactivity disorder symptom severity at baseline was not associated with reduced cannabis use frequency or severity but was linked to greater reductions in depression (Spearman ρ=.33) and anxiety (Spearman ρ=.28). Individuals with positive attention deficit/hyperactivity disorder screening were significantly less likely to fill out the consumption diary (P=.02), but the association between continuous attention deficit/hyperactivity disorder symptom severity and retention (Spearman ρ=-0.10, P=.13) was nonsignificant. There also was no significant intergroup difference in the number of completed modules (with: mean 2.10, SD 2.33; without: mean 2.36, SD 2.36, P=.34), and there was no association with attention deficit/hyperactivity disorder symptom severity (Spearman ρ=-0.09; P=.43). The same was true for the rate of adverse effects (P=.33). CONCLUSIONS: Cannabis users screening positive for attention deficit/hyperactivity disorder may benefit from CANreduce 2.0 to decrease the frequency and severity of cannabis dependence and attenuate symptoms of depression and attention deficit/hyperactivity disorder-related symptoms. This web-based program's advantages include its accessibility for remote users and a personalized counselling option that may contribute to increased adherence and motivation to change among program users. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 11086185; http://www.isrctn.com/ISRCTN11086185.

Comparing a mindfulness- and CBT-based guided self-help Internet- and mobile-based intervention against a waiting list control condition as treatment for adults with frequent cannabis use: a randomized controlled trial of CANreduce 3.0.

BACKGROUND: Though Internet- and mobile-based interventions (IMIs) and mindfulness-based interventions (generally delivered in-situ) appear effective for people with substance use disorders, IMIs incorporating mindfulness are largely missing, including those targeting frequent cannabis use. METHODS: This paper details the protocol for a three-arm randomized controlled trial comparing a mindfulness-based self-help IMI (arm 1) and cognitive-behavioral therapy (CBT)-based self-help IMI (arm 2) versus being on a waiting list (arm 3) in their effectiveness reducing cannabis use in frequent cannabis users. Predictors of retention, adherence and treatment outcomes will be identified and similarities between the two active intervention arms explored. Both active interventions last six weeks and consist of eight modules designed to reduce cannabis use and common mental health symptoms. With a targeted sample size of n = 210 per treatment arm, data will be collected at baseline immediately before program use is initiated; at six weeks, immediately after program completion; and at three and six months post baseline assessment to assess the retention of any gains achieved during treatment. The primary outcome will be number of days of cannabis use over the preceding 30 days. Secondary outcomes will include further measures of cannabis use and use of other substances, changes in mental health symptoms and mindfulness, client satisfaction, intervention retention and adherence, and adverse effects. Data analysis will follow ITT principles and primarily employ (generalized) linear mixed models. DISCUSSION: This RCT will provide important insights into the effectiveness of an IMI integrating mindfulness to reduce cannabis use in frequent cannabis users. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Registry: ISRCTN14971662 ; date of registration: 09/09/2021.

Effects of a minimal-guided on-line intervention for alcohol misuse in Estonia: a randomized controlled trial.

BACKGROUND AND AIMS: Estonia has one of the highest alcohol-attributable mortality rates within the European Union. The aim of this study was to estimate the efficacy of an on-line self-help intervention to reduce problem drinking at the population level. DESIGN: On-line open randomized controlled trial with an 8-week intervention and an active control group (intervention n = 303, control n = 286). Assessments took place at baseline and at 6 months follow-up. SETTING: On- and offline channels were used for population-based recruitment within a nation-wide prevention campaign in Estonia. PARTICIPANTS: Inclusion criteria were age ≥ 18 years, heavy drinking [Alcohol Use Disorders Identification (AUDIT) test score ≥ 8], literacy in Estonian and at least weekly access to the internet; n = 589 participants were randomized (50% male, 1% other; mean age 37.86 years; 45% with higher level of education). INTERVENTION AND COMPARATOR: The intervention consisted of 10 modules based on principles of cognitive-behavioral therapy and motivational interviewing. The active control group received access to a website with a self-test including personalized normative feedback and information for standard alcohol treatment. MEASUREMENTS: The primary outcome was AUDIT scores at 6 months follow-up adjusted for baseline scores. FINDINGS: Intention-to-treat analyses were applied. Missing data were addressed by using baseline observation carried forward (BOCF) and multiple imputation by chained equations (MI); 175 completed follow-up in the intervention group and 209 in the control group. AUDIT score at follow-up was significantly smaller in the intervention [BOCF mean = 13.91, standard deviation (SD) = 7.61, MI mean = 11.03, SD = 6.55] than control group (BOCF mean = 15.30, SD = 7.31; MI mean = 14.30, SD = 7.21), with a group difference of -1.38 [95% confidence interval (CI) = -2.58, -0.18], P = 0.02 for BOCF and -3.26 (95% CI = -2.01, -4.51), P < 0.001 for MI. CONCLUSIONS: A randomized controlled trial has found that an on-line self-help intervention with minimal guidance was effective at reducing problem drinking in Estonia.

Efficacy of a minimally guided internet treatment for alcohol misuse and emotional problems in young adults: Results of a randomized controlled trial.

Many young adults struggle with comorbid alcohol misuse and emotional problems (i.e., depression and anxiety). However, there is currently a paucity of evidence-based, integrated, accessible treatment options for individuals with these comorbidities. The main goal of this study was to examine efficacy of a novel online, minimally guided, integrated program for comorbid alcohol misuse and emotional problems in young adults. Method: The study was an open-label two-arm RCT. Participants (N = 222, M age = 24.6, 67.6% female) were randomized to one of two conditions: the Take Care of Me program (an 8-week, online integrated treatment condition consisting of 12 modules), or an online psychoeducational control condition. Intervention modules incorporated content based on principles of cognitive behavioral therapy and motivational interviewing. Participants completed assessment data at baseline, at the end of treatment (i.e., 8 weeks), and at follow-up (i.e., 24 weeks). Data were analyzed using generalized linear mixed models. Results: We observed that participants in the treatment condition showed larger reductions in depression, hazardous drinking, as well as increases in psychological quality of life and confidence at the end of treatment. We did not find group differences on total alcohol use at follow-up, but participants in the treatment group reduced their hazardous drinking and improved their quality of life at 24-week follow-up. Conclusions: Our study provides promising initial evidence for the first iteration of the comorbid alcohol misuse and emotional problems online program.

The Effectiveness of a Web-Based Self-Help Program to Reduce Alcohol Use Among Adults With Drinking Patterns Considered Harmful, Hazardous, or Suggestive of Dependence in Four Low- and Middle-Income Countries: Randomized Controlled Trial.

BACKGROUND: Given the scarcity of alcohol prevention and use disorder treatments in many low- and middle-income countries (LMICs), the World Health Organization has launched an eHealth portal that includes the web-based self-help program "Alcohol e-Health." OBJECTIVE: We aimed to test the effectiveness of the Alcohol e-Health program in a randomized controlled trial. METHODS: This was a two-arm, individually randomized, and controlled trial across four LMICs comparing the self-help program and a psychoeducation and internet access as usual waiting list. Participants were broadly recruited from community samples in Belarus, Brazil, India, and Mexico from January 2016 through January 2019. The primary outcome measure was change in the Alcohol Use Disorders Identification Test (AUDIT) score with a time frame of 6 months between baseline and follow-up. Secondary outcomes included self-reported numbers of standard drinks over the previous week and cessation of harmful or hazardous drinking (AUDIT score <8). RESULTS: For this study, we recruited 1400 predominantly male (n=982, 70.1%) at least harmful or hazardous alcohol drinkers. The mean age was 37.6 years (SD 10.5). The participants were recruited from Brazil (n=587), Mexico (n=509), India (n=212), and Belarus (n=92). Overall, complete case analysis identified higher AUDIT changes in the intervention group (B=-4.18, 95% CI -5.42 to -2.93, P<.001, d=0.56) that were mirrored by changes in weekly standard drinks (B=-9.34, 95% CI -15.90 to -2.77, P=.005, d=0.28) and cessation rates for harmful or hazardous drinking (χ21=14.56, N=561, P<.001). The supplementary intention-to-treat analyses largely confirmed these initial results. CONCLUSIONS: The expansion of the Alcohol e-Health program to other LMICs with underdeveloped alcohol prevention and treatment systems for alcohol use disorders should be considered after successful replication of the present results. TRIAL REGISTRATION: ISRCTN ISRCTN14037475; https://www.isrctn.com/ISRCTN14037475. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1111/add.14034.

A Mobile Phone-Based Life-Skills Training Program for Substance Use Prevention Among Adolescents: Cluster-Randomized Controlled Trial.

BACKGROUND: Life skills are abilities for adaptive and positive behavior that enable individuals to deal effectively with the demands and challenges of everyday life. Life-skills training programs conducted within the school curriculum are effective in preventing the onset and escalation of substance use among adolescents. However, their dissemination is impeded due to their large resource requirements. Life-skills training provided via mobile phones may provide a more economic and scalable approach. OBJECTIVE: The goal of this study was to test the appropriateness (ie, acceptance, use, and evaluation) and short-term efficacy of a mobile phone-based life-skills training program to prevent substance use among adolescents within a controlled trial. METHODS: The study design was a two-arm, parallel-group, cluster-randomized controlled trial with assessments at baseline and follow-up assessments after 6 and 18 months. This report includes outcomes measured up to the 6-month follow-up. The efficacy of the intervention was tested in comparison to an assessment-only control group. The automated intervention program SmartCoach included online feedback and individually tailored text messages provided over 22 weeks. The contents were based on social cognitive theory and addressed self-management skills, social skills, and substance use resistance skills. Linear mixed models and generalized linear mixed models, as well as logistic or linear regressions, were used to investigate changes between baseline and 6-month follow-up in the following outcomes: 30-day prevalence rates of problem drinking, tobacco use, and cannabis use as well as quantity of alcohol use, quantity of cigarettes smoked, cannabis use days, perceived stress, well-being, and social skills. RESULTS: A total of 1759 students from 89 Swiss secondary and upper secondary school classes were invited to participate in the study. Of these, 1473 (83.7%) students participated in the study; the mean age was 15.4 years (SD 1.0) and 55.2% (813/1473) were female. Follow-up assessments at 6 months were completed by 1233 (83.7%) study participants. On average, program participants responded to half (23.6 out of 50) of the prompted activities. Program evaluations underlined its appropriateness for the target group of secondary school students, with the majority rating the program as helpful and individually tailored. The results concerning the initial effectiveness of this program based on 6-month follow-up data are promising, with three of nine outcomes of the intention-to-treat analyses showing beneficial developments of statistical significance (ie, quantity of alcohol use, quantity of tobacco use, and perceived stress; P<.05) and another three outcomes (ie, problem drinking prevalence, cannabis use days, and social skills) showing beneficial developments of borderline significance (P<.10). CONCLUSIONS: The results showed good acceptance of this intervention program that could be easily and economically implemented in school classes. Initial results on program efficacy indicate that it might be effective in both preventing or reducing substance use and fostering life skills; however, data from the final 18-month follow-up assessments will be more conclusive. TRIAL REGISTRATION: ISRCTN Registry ISRCTN41347061; https://doi.org/10.1186/ISRCTN41347061.

"Take Care of You" - Efficacy of integrated, minimal-guidance, internet-based self-help for reducing co-occurring alcohol misuse and depression symptoms in adults: Results of a three-arm randomized controlled trial.

BACKGROUND: Depression and harmful alcohol use are two of the top five leading causes of years of life lost to disability in high-income countries. Integrated treatment targeting both at the same time is often considered more complicated and difficult and, therefore, more expensive. Consequently, integrated internet-based interventions could be a valuable addition to traditional care. METHODS: A three-arm randomized controlled trial was conducted comparing the effectiveness of (1) an integrated, minimal-guidance, adherence-focused self-help intervention designed to reduce both alcohol use and depression symptoms (AFGE-AD); (2) a similar intervention designed to reduce alcohol use only (AFGE-AO), and (3) internet access as usual (IAU) as a control condition, in at least moderately depressed alcohol misusers from February 2016-March 2020. We recruited 689 alcohol misusers (51.6 % males, mean age = 42.8 years) with at least moderate depression symptoms not otherwise in treatment from the general population. Six months after baseline, 288 subjects (41.8 %) were reachable for the final assessment. RESULTS: All interventions yielded reduced alcohol-use after six months (AFGE-AD: -16.6; AFGE-AO: -19.8; IAU: -13.2). Those who undertook active-interventions reported significantly fewer standard drinks than controls (AFGE-AD: p = .048, d=0.10; AFGE-AO: p = .004, d=0.20). The two active-intervention groups also reported significantly less severe depression symptoms than controls (AFGE-AD: p = .006, d=0.41; AFGE-AO: p = .008, d=0.43). Testing revealed noninferiority between the two interventions. CONCLUSIONS: This study documented sustained effectiveness of the first integrated, fully internet-based self-help intervention developed for the reduction of both alcohol use and depression symptoms in at least moderately depressed adult alcohol misusers recruited from the general population.

CANreduce 2.0 Adherence-Focused Guidance for Internet Self-Help Among Cannabis Users: Three-Arm Randomized Controlled Trial.

BACKGROUND: Despite increasing demand for treatment among cannabis users in many countries, most users are not in treatment. Internet-based self-help offers an alternative for those hesitant to seek face-to-face therapy, though low effectiveness and adherence issues often arise. OBJECTIVE: Through adherence-focused guidance enhancement, we aimed to increase adherence to and the effectiveness of internet-based self-help among cannabis users. METHODS: From July 2016 to May 2019, cannabis users (n=775; male: 406/575, 70.6%, female: 169/575, 29.4%; age: mean 28.3 years) not in treatment were recruited from the general population and were randomly assigned to (1) an adherence-focused guidance enhancement internet-based self-help intervention with social presence, (2) a similar intervention with an impersonal service team, and (3) access to internet as usual. Controls who were placed on a waiting list for the full intervention after 3 months underwent an assessment and had access to internet as usual. The primary outcome measurement was cannabis-use days over the preceding 30 days. Secondary outcomes included cannabis-dependence severity, changes in common mental disorder symptoms, and intervention adherence. Differences between the study arms in primary and secondary continuous outcome variables at baseline, posttreatment, and follow-up were tested using pooled linear models. RESULTS: All groups exhibited reduced cannabis-use days after 3 months (social presence: -8.2 days; service team: -9.8 days; internet as usual: -4.2 days). The participants in the service team group (P=.01, d=.60) reported significantly fewer cannabis-use days than those in the internet as usual group; the reduction of cannabis use in the social presence group was not significant (P=.07, d=.40). There was no significant difference between the 2 intervention groups regarding cannabis-use reduction. The service team group also exhibited superior improvements in cannabis-use disorder, cannabis-dependence severity, and general anxiety symptoms after 3 months to those in the internet as usual group. CONCLUSIONS: The adherence-focused guidance enhancement internet-based self-help intervention with an impersonal service team significantly reduced cannabis use, cannabis-use disorder, dependence severity, and general anxiety symptoms. TRIAL REGISTRATION: ISRCTN Registry ISRCTN11086185; http://www.isrctn.com/ISRCTN11086185.

Efficacy of a smartphone-based coaching program for addiction prevention among apprentices: study protocol of a cluster-randomised controlled trial.

BACKGROUND: A large proportion of apprentices shows addictive behaviours like cigarette smoking, alcohol, cannabis, or compulsive Internet use, others do not show such behaviours at all. ready4life is a smartphone application-based coaching program for apprentices, which takes into account the heterogeneity of adolescent addictive behaviour by promoting life skills and reducing risk behaviours. The main objective of the planned study is to test the efficacy of ready4life for addiction prevention among apprentices in Switzerland within a controlled trial. METHODS/DESIGN: The efficacy of the ready4life coaching program will be tested in comparison to an assessment only control group, within a cluster-randomised controlled trial with one follow-up assessment after 6 months. At the beginning of the program, participants of the intervention group will receive an individual profile, showing areas in which they have sufficient resources and in which there is a need for coaching. Based on this feedback, they can select two out of the following six program modules: stress, social skills, Internet use, tobacco/e-cigarettes, cannabis, and alcohol. Participants of the intervention group will receive individualised coaching by a conversational agent (chatbot) for a period of four months. The coaching relies on motivational and social-cognitive principles of behaviour change. Within weekly dialogues, the coach provides individually tailored information in different formats, such as videoclips, texts, or pictures. Study participants will be 1318 apprentices with a minimum age of 15, recruited in approximately 100 vocational school classes in Switzerland. Primary outcome will be a composite measure for addictive behaviours including (1) at risk-drinking, (2) tobacco/e-cigarette smoking, (3) cannabis use, and (4) problematic Internet use. DISCUSSION: The study will reveal whether this universally implementable but individually tailored intervention approach is effective in preventing the onset and escalation of addictive behaviors among apprentices. TRIAL REGISTRATION: ISRCTN59908406 (registration date: 21/10/2020).

The concept of buying-shopping disorder: Comparing latent classes with a diagnostic approach for in-store and online shopping in a representative sample in Switzerland.

BACKGROUND AND AIMS: Buying-shopping disorder and its transferability to the online sector is controversial. This study investigates in-store and online shopping patterns by comparing data-based modeling to a diagnostic cut-off approach. Further aims were to test model equivalence for gender and identify socio-demographic risk factors. METHODS: In a representative survey, the Bergen Shopping Addiction Scale (BSAS) was applied, using both an online and in-store version. Latent class analyses were followed by multinomial logistic regression analyses to investigate socio-demographic variables. Measurement invariance across genders was tested with multi-group comparisons. RESULTS: With N = 1,012, 3-class solutions provided the best model fit for both in-store and online shopping. Most individuals (76, 86%) were grouped in non-addicted classes, followed by risky (21, 11%) and addicted classes (both 3%). Twenty-eight percent of individuals in the online addicted shopping class remained unidentified using the cut-off. For online shopping, only lower age and education differentiated classes significantly. DISCUSSION: Results indicate a close link between online and in-store shopping, albeit with distinguishing features. The cut-off yielded findings discrepant from class probabilities. That buying-shopping disorder mainly affects younger women of lower educational level must be questioned, given the limited associations identified. CONCLUSIONS: It is important not only to consider different settings of pathological shopping, but also to focus on groups that may not have appeared at risk in previous investigations (e.g., men, older age). The BSAS cut-off warrants further research.

Testing the efficacy of a minimal-guidance online self-help intervention for alcohol misuse in Estonia: study protocol of a randomized controlled trial.

BACKGROUND: Despite an initial steep decrease in alcohol misuse among Estonians through structural intervention means and the scaling up of alcohol counselling in the mid-2000's, most of the country's alcohol misuse indicators remain clearly higher than European averages. Consequently, an online self-help program was launched as part of an initial behavioral intervention initiative to foster progress in alcohol prevention on a population level. METHODS: A two-arm randomized controlled trial (RCT) has been designed to compare the efficacy of a culturally-adapted minimal-guidance online self-help program, the 8-week "Selge" online program against a control condition that consists of a self-administered test of alcohol use and advice regarding usual treatment in Estonia. A target sample of 600 individuals will be recruited and randomly assigned to either condition. The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI). Participants in the control group will have access to the full treatment after they complete their final follow-up assessment. The primary outcome will be change in the Alcohol Use Disorders Identification Test (AUDIT) score between the 6-month follow-up and baseline assessments. Secondary outcomes will include the number of standard drinks consumed and alcohol-free days, drinking motives and motivation for change, as well as changes in mental health. Assessments will be completed at baseline, at the end of treatment, and at 6 months follow-up. Data analysis will follow the intention-to-treat principle and employ (generalised) linear mixed models. DISCUSSION: The "Selge" program is the first and only internet program for the intervention of alcohol misuse in Estonia. If proven effective, it will foster progress in the intervention of alcohol misuse in the Estonian population and be implemented as a standard program amidst the continuum of intervention and care. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48753339 registered 04/06/2019 retrospectively.

Efficacy of a web-based self-help tool to reduce problem gambling in Switzerland: study protocol of a two-armed randomised controlled trial.

INTRODUCTION: The past-year prevalence of problem gambling worldwide averages 2.3%. Switzerland exhibits a slightly lower past-year prevalence rate, of 1.1%, among adults. Only a minority of these adults attend outpatient treatment. Surveyed problem gamblers have explained that they wanted to handle the problem on their own. The option of a web-based self-help programme could potentially reach those users who hesitate to approach treatment centres and help them to reduce or stop their problem gambling. The effectiveness of such web-based interventions has been shown in other countries. METHODS AND ANALYSIS: This two-armed randomised controlled trial (RCT) will examine the efficacy of a web-based self-help intervention, relative to an active control condition with a self-help manual, at reducing problem gambling. The active intervention programme, spanning 8 weeks, consists of nine modules developed to reduce gambling and attenuate psychopathological comorbidity, including depression, anxiety and stress-related disorder symptoms, relying on motivational interviewing and cognitive behavioural therapy. With a target sample size of 352, questionnaire data will be collected at baseline, and at 8 and 24 weeks after baseline. Primary outcomes will be the number of days one has gambled in the last 30 days. Secondary outcomes will include money and time spent on gambling activities, changes in gambling-related problems (Problem Gambling Severity Index, Gambling Symptom Assessment Scale), use of alcohol and cigarettes, and psychopathological comorbidity. All data analysis will comply with the intention-to-treat principle. ETHICS AND DISSEMINATION: The RCT will be conducted in accordance with the Declaration of Helsinki; the consort eHealth Guidelines for studies on medical devices; the European Directive on medical devices 93/42/EEC, Swiss Law and Swiss Regulatory Authority requirements. The study was approved by the ethics committee of the Canton of Zurich. Results will be published in a scientific peer-reviewed journal. Participants will be informed via e-mail about study results via a lay-person-friendly summary of trial findings. TRIAL REGISTRATION NUMBER: Current Controlled Trials registry (ISRCTN16339434).