The Craving-Manager smartphone app designed to diagnose substance use/addictive disorders, and manage craving and individual predictors of relapse: a study protocol for a multicenter randomized controlled trial.

Background: The rate of individuals with addiction who are currently treated are low, and this can be explained by barriers such as stigma, desire to cope alone, and difficulty to access treatment. These barriers could be overcome by mobile technologies. EMI (Ecological Momentary Intervention) is a treatment procedure characterized by the delivery of interventions (messages on smartphones) to people in their daily lives. EMI presents opportunities for treatments to be available to people during times and in situations when they are most needed. Craving is a strong predictor of relapse and a key target for addiction treatment. Studies using Ecological Momentary Assessment (EMA) method have revealed that, in daily life, person-specific cues could precipitate craving, that in turn, is associated with a higher probability to report substance use and relapse in the following hours. Assessment and management of these specific situations in daily life could help to decrease addictive use and avoid relapse. The Craving-Manager smartphone app has been designed to diagnose addictive disorders, and assess and manage craving as well as individual predictors of use/relapse. It delivers specific and individualized interventions (counseling messages) composed of evidence-based addiction treatments approaches (cognitive behavioral therapy and mindfulness). The Craving-Manager app can be used for any addiction (substance or behavior). The objective of this protocol is to evaluate the efficacy of the Craving-Manager app in decreasing use (of primary substance(s)/addictive behavior(s)) over 4 weeks, among individuals on a waiting list for outpatient addiction treatment. Methods/design: This multicenter double-blind randomized controlled trial (RCT) will compare two parallel groups: experimental group (full interventional version of the app, 4 weeks, EMA + EMI), versus control group (restricted version of the app, 4 weeks, only EMA). Two hundred and seventy-four participants will be recruited in 6 addiction treatment centers in France. Discussion: This RCT will provide indication on how the Craving-Manager app will reduce addictive use (e.g., better craving management, better stimulus control) in both substance and behavioral addictions. If its efficacy is confirmed, the app could offer the possibility of an easy to use and personalized intervention accessible to the greatest number of individuals with addiction. Clinical Trial Registration: ClinicalTrials.gov: NCT04732676.

Realist evaluation of three programmes aimed at reducing harm and risks associated with alcohol consumption in the Nouvelle Aquitaine region of France: the ECIAE study protocol.

INTRODUCTION: In Europe, alcohol consumption is responsible for many diseases, disabilities, injuries and premature deaths. In France, alcohol consumption represents an important health burden, due to its frequency, scale and the serious damage it causes. One of the keys to addressing the problem would appear to be the adoption of harm and risk reduction approaches. In order to operationalise this strategy, the Nouvelle Aquitaine Regional Health Agency is funding three different programmes to reduce the harm and risks associated with alcohol consumption: Alcochoix, Iaca and ETP (Education Thérapeutique du Patient) Conso-repère. We are interested in understanding how, under what circumstances, through which mechanisms and for which population the different programmes work. METHODS AND ANALYSIS: The ECIAE study (a cross-evaluation of the 3 programs Iaca/Alcochoix/ ETP (Patient Therapeutic Education) is a theory-based evaluation where the realist evaluation method is used to explore effects, intervention mechanisms and the influence of context on outcomes. This realist evaluation is based on multiple case studies in two nested levels. At the first level, each centre implementing the programme will represent a case. At the second level, each programme will represent a case in which a set of activities is conducted to achieve risk reduction objectives. ETHICS AND DISSEMINATION: The project will be carried out in full compliance with existing legislation and international conventions. It was subject to analysis, including a privacy impact assessment conducted by the Data Protection Officer of the University of Bordeaux. The University of Bordeaux has ensured that all the regulatory procedures related to the ECIAE study have been carried out. The dissemination plan includes scientific papers, seminars, a report and recommendation and a public restitution. The study will provide evidence-based results to help health authorities roll out strategies to reduce risks and harm associated with alcohol use.

Realist evaluation of the impact, viability and transferability of an alcohol harm reduction support programme based on mental health recovery: the Vitae study protocol.

INTRODUCTION: Addiction is considered a chronic disease associated with a high rate of relapse as a consequence of the addictive condition. Most of the current therapeutic work focuses on the notion of relapse prevention or avoidance and the control of its determinants. Since only a small portion of patients can access alcohol addiction treatment, it is crucial to find a way to offer new support towards safe consumptions, reductions or cessations. The harm reduction (HR) approach and mental health recovery perspective offers another way to support the patient with alcohol addiction. Vitae is a realist evaluation of the impact, viability and transferability of the IACA! programme, an HR programme based on the principle of psychosocial recovery for people with alcohol use disorders. METHODS AND ANALYSIS: The Vitae study adheres to the theory-driven evaluation framework where the realist evaluation method and contribution analysis are used to explore the effects, mechanisms and influence of context on the outcomes and to develop and adjust an intervention theory. This study is a 12-month, multi-case, longitudinal descriptive pilot study using mixed methods. It is multi-centred, and carried out in 10 addiction treatment or prevention centres. In this study, outcomes are related to the evolution of alcohol use and the beneficiaries trajectory in terms of psychosocial recovery during these 12 months after the start of IACA!. The target number of participants are 100 beneficiaries and 23 professionals. ETHICS AND DISSEMINATION: This research was approved by the Committee for the Protection of Persons Ouest V n°: 21/008-3HPS and was reported to the French National Agency for the Safety of Health Products. All participants will provide consent prior to participation. The results will be reported in international peer-reviewed journals and presented at scientific and public conferences. TRIAL REGISTRATION NUMBERS: NCT04927455; ID-RCB2020-A03371-38.

Effectiveness and Acceptance of a Smartphone-Based Virtual Agent Screening for Alcohol and Tobacco Problems and Associated Risk Factors During COVID-19 Pandemic in the General Population.

Background: During the current COVID-19 pandemic, alcohol, and tobacco are the most available substances for managing stress and can induce a risk of addiction. KANOPEE is a smartphone application available to the general population using an embodied conversational agent (ECA) to screen for experiences of problems with alcohol/tobacco use and to provide follow-up tools for brief intervention. Objectives: This study aimed to determine if the smartphone KANOPEE application could identify people at risk for alcohol and/or tobacco use disorders in the context of the current COVID-19 pandemic, to assess adherence to a 7-day follow-up use diary, and to evaluate trust and acceptance of the application. Methods: The conversational agent, named Jeanne, interviewed participants about perceived problems with the use of alcohol and tobacco since the pandemic and explored risk for tobacco and alcohol use disorder with the five-item Cigarette Dependence Scale (CDS-5) and "Cut Down, Annoyed, Guilty, Eye-opener" (CAGE) questionnaire and experience of craving for each substance. Descriptive, univariate, and multivariate analyses were performed to specify personalized associations with reporting a problem with alcohol/tobacco use; descriptive analysis reported the experience with the intervention and acceptance and trust in the application. Results: From April 22 to October 26, 2020, 1,588 French participants completed the KANOPEE interview, and 318 answered the acceptance and trust scales. Forty-two percent of tobacco users and 27% of alcohol users reported problem use since the pandemic. Positive screening with CDS-5 and CAGE and craving were associated with reported problem use (p < 0.0001). Lockdown period influenced alcohol (p < 0.0005) but not tobacco use (p > 0.05). Eighty-eight percent of users reported that KANOPEE was easy to use, and 82% found Jeanne to be trustworthy and credible. Conclusion: KANOPEE was able to screen for risk factors for substance use disorder (SUD) and was acceptable to users. Reporting craving and being at risk for SUD seem to be early markers to be identified. Alcohol problem use seems to be more reliant on contextual conditions such as confinement. This method is able to offer acceptable, brief, and early intervention with minimal delay for vulnerable people.

Development and validation of a virtual agent to screen tobacco and alcohol use disorders.

BACKGROUND: Substance use disorders are under-detected and not systematically diagnosed or screened for by primary care. In this study, we present the acceptability and validity of an Embodied Conversational Agent (ECA) designed to screen tobacco and alcohol use disorder, in individuals who did not seek medical help for these disorders. METHODS: Individuals were included from June 2016 to May 2017 in the Outpatient Sleep Clinic of the University Hospital of Bordeaux. DSM-5 diagnoses of tobacco and alcohol use disorders were assessed by human interviewers. The ECA interview integrated items from the Cigarette Dependence Scale-5 (CDS-5) for tobacco use disorder screening, and the "Cut Down, Annoyed, Guilty, Eye-opener" (CAGE) questionnaire for alcohol use disorder screening. Paper version of CDS-5 and CAGE questionnaires and acceptability questionnaire was also self-administered. RESULTS: Of the 139 participants in the study (mean age 43.0 [SD = 13.7] years), 71 were women, and 68 were men. The ECA was well accepted by the patients. Paper self-administered CDS-5 and CAGE scores had a strong agreement with the ECA (p < 0.0001). The Receiver Operating Characteristic (ROC) analysis of the ECA interview showed AUC of 0.97 (95% CI, 0.93-1.0) and 0.84 (95% CI, 0.69-0.98) for CDS-5 and CAGE respectively with p-value <0.0001. CONCLUSIONS: This ECA was acceptable and valid to screen tobacco or alcohol use disorder among patients not requesting treatment for addiction. The ECA could be used in hospitals and potentially in primary care settings to help clinicians to better screen their patients for alcohol and tobacco use disorders.