Cannabis Use Among Adults in Cigarette Smoking Cessation Treatment in Ontario, Canada: Prevalence and Association With Tobacco Cessation Outcome, 2015-2021.

Objectives. To examine cannabis use prevalence and its association with tobacco cessation among adults enrolled in cigarette smoking cessation treatment before and after Canada legalized recreational cannabis in October 2018. Methods. The sample comprised 83 206 adults enrolled in primary care-based cigarette smoking cessation treatment between 2015 and 2021 in Ontario, Canada. Past-30-day cannabis use was self-reported at enrollment and cigarette smoking abstinence at 6-month follow-up. Results. Past-30-day prevalence of cannabis use increased from 20.2% in 2015 to 37.7% in 2021. The prevalence increased linearly both before and after legalization. Cannabis and tobacco co-use was associated with lower odds of self-reported cigarette smoking abstinence at 6-month follow-up than tobacco use only (24.4% vs 29.3%; odds ratio [OR] = 0.78; 95% confidence interval [CI] = 0.75, 0.81). This association was attenuated after adjustment for covariates (OR = 0.93; 95% CI = 0.89, 0.97) and weakened slightly over time. Conclusions. Cannabis use prevalence almost doubled from 2015 to 2021 among primary care patients in Ontario seeking treatment to quit cigarettes and was associated with poorer quit outcomes. Further research into the impact of cannabis policy on cannabis and tobacco co-use is warranted to mitigate harm. (Am J Public Health. 2024;114(1):98-107. https://doi.org/10.2105/AJPH.2023.307445).

Outcomes Among People With Schizophrenia Participating in General-Population Smoking Cessation Treatment: An Observational Study.

OBJECTIVE: People with schizophrenia are much more likely than others to smoke tobacco, raising risks of disease and premature mortality. These individuals are also less likely to quit successfully after treatment, but the few existing clinical and observational studies have been limited by small sample sizes, and have generally considered specialized treatment approaches. In this analysis, we examine outcomes, service use, and potential explanatory variables in a large sample of people with schizophrenia treated in a general-population cessation program. METHOD: Our sample comprised 3,011 people with schizophrenia and 77,790 controls receiving free nicotine replacement therapy through 400 clinics and health centres. We analysed self-reported 7-day abstinence or reduction at 6-month follow-up, as well as the number of visits attended and self-reported difficulties in quitting. We adjusted for demographic, socioeconomic, and health variables, and used multiple imputation to address missing data. RESULTS: Abstinence was achieved by 16.2% (95% confidence interval [CI], 14.5% to 17.8%) of people with schizophrenia and 26.4% (95% CI, 26.0% to 26.7%) of others (absolute difference = 10.2%; 95% CI, 8.5% to 11.9%; P < 0.001). After adjustment, this difference was reduced to 7.3% (95% CI, 5.4% to 9.3%; P < 0.001). Reduction in use was reported by 11.8% (95% CI, 10.3% to 13.3%) and 12.5% (95% CI, 12.2% to 12.8%), respectively; this difference was nonsignificant after adjustment. People with schizophrenia attended more clinic visits (incidence rate ratio [IRR] = 1.15, 95% CI = 1.12% to 1.18%, P < 0.001) and reported more difficulties related to "being around other smokers" (odds ratio [OR] = 1.28; 95% CI, 1.11% to 1.47%; P = 0.001). CONCLUSION: There is abundant demand for tobacco cessation treatment in this population. Outcomes were substantially poorer for people with schizophrenia, and this difference was not explained by covariates. Cessation remained much better than for unaided quit attempts, however, and engagement was high, demonstrating that people with schizophrenia benefit from nonspecialized pharmacological treatment programs.

Disruptions in Primary Care among People with Schizophrenia in Ontario, Canada, During the COVID-19 Pandemic.

OBJECTIVE: To investigate how primary care access, intensity and quality of care changed among patients living with schizophrenia before and after the onset of the COVID-19 pandemic in Ontario, Canada. METHODS: This cohort study was performed using primary care electronic medical record data from the University of Toronto Practice-Based Research Network (UTOPIAN), a network of > 500 family physicians in Ontario, Canada. Data were collected during primary care visits from 2643 patients living with schizophrenia. Rates of primary care health service use (in-person and virtual visits with family physicians) and key preventive health indices indicated in antipsychotic monitoring (blood pressure readings, hemoglobin A1c, cholesterol and complete blood cell count [CBC] tests) were measured and compared in the 12 months before and after onset of the COVID-19 pandemic. RESULTS: Access to in-person care dropped with the onset of the COVID-19 pandemic. During the first year of the pandemic only 39.5% of patients with schizophrenia had at least one in-person visit compared to 81.0% the year prior. There was a corresponding increase in virtual visits such that 78.0% of patients had a primary care appointment virtually during the pandemic period. Patients prescribed injectable antipsychotics were more likely to continue having more frequent in-person appointments during the pandemic than patients prescribed only oral or no antipsychotic medications. The proportion of patients who did not have recommended tests increased from 41.0% to 72.4% for blood pressure readings, from 48.9% to 60.2% for hemoglobin A1c, from 57.0% to 67.8% for LDL cholesterol and 45.0% to 56.0% for CBC tests during the pandemic. CONCLUSIONS: There were substantial decreases in preventive care after the onset of the pandemic, although primary care access was largely maintained through virtual care. Addressing these deficiencies will be essential to promoting health equity and reducing the risk of poor health outcomes.

Effects of COVID-19-Related Disruptions on Service Use in a Large Smoking Cessation Program.

INTRODUCTION: The COVID-19 pandemic caused a rapid shift to virtual care, with largely unknown consequences for accessibility. The purpose of this study is to examine pandemic-related changes in use of care for smoking cessation. AIMS AND METHODS: We conducted a secondary analysis 65 565 enrollments in a large smoking cessation program in Ontario, Canada. We used piecewise mixed-effects regression to examine how weeks nicotine replacement therapy (NRT) received, as well as counseling provided and visits attended, varied with date of enrollment over three time periods: more than 6 months before the pandemic began; the 6 months before the pandemic; and the pandemic period itself. We then examined changes in the associations between use of care and participant characteristics by fitting a model including a set of interactions between time and other variables. Based on an omnibus test of these interactions, we then tested individual terms, using the Holm method to control the family-wise error rate. RESULTS: From the start of the pandemic in March 2020, the total weeks of NRT provided rose significantly and then declined, while the amount of counseling fell. Associations between NRT use and participant characteristics changed significantly after the pandemic onset. Individual models showed that people with lower income, living in areas of higher marginalization, unable to work, and reporting higher levels of depressive symptoms all received NRT for a longer time during the pandemic period. CONCLUSIONS: The pandemic led to small but significant changes in the amount of services used per enrollment. The transition to remote care appears to have reduced the effects of socioeconomic and health barriers. IMPLICATIONS: The amount of care used by participants in tobacco cessation treatment is known to be associated with health and sociodemographic characteristics. Most of these associations did not change markedly following the pandemic-related switch to virtual care in 2020; however, the effects of some economic and health barriers seem to have lessened, perhaps because of a likely reduction in transport and time requirements of treatment.

The Impact of a Clinical Decision Support System for Addressing Physical Activity and Healthy Eating During Smoking Cessation Treatment: Hybrid Type I Randomized Controlled Trial.

BACKGROUND: People who smoke have other risk factors for chronic diseases, such as low levels of physical activity and poor diet. Clinical decision support systems (CDSSs) might help health care practitioners integrate interventions for diet and physical activity into their smoking cessation programming but could worsen quit rates. OBJECTIVE: The aims of this study are to assess the effects of the addition of a CDSS for physical activity and diet on smoking cessation outcomes and to assess the implementation of the study. METHODS: We conducted a pragmatic hybrid type I effectiveness-implementation trial with 232 team-based primary care practices in Ontario, Canada, from November 2019 to May 2021. We used a 2-arm randomized controlled trial comparing a CDSS addressing physical activity and diet to treatment as usual and used the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to measure implementation outcomes. The primary outcome was self-reported 7-day tobacco abstinence at 6 months. RESULTS: We enrolled 5331 participants in the study. Of these, 2732 (51.2%) were randomized to the intervention group and 2599 (48.8%) to the control group. At the 6-month follow-up, 29.7% (634/2137) of respondents in the intervention arm and 27.3% (552/2020) in the control arm reported abstinence from tobacco. After multiple imputation, the absolute group difference was 2.1% (95% CI -0.5 to 4.6; F1,1000.42=2.43; P=.12). Mean exercise minutes changed from 32 (SD 44.7) to 110 (SD 196.1) in the intervention arm and from 32 (SD 45.1) to 113 (SD 195.1) in the control arm (group effect: B=-3.7 minutes; 95% CI -17.8 to 10.4; P=.61). Servings of fruit and vegetables changed from 2.64 servings to 2.42 servings in the intervention group and from 2.52 servings to 2.45 servings in the control group (incidence rate ratio for intervention group=0.98; 95% CI 0.93-1.02; P=.35). CONCLUSIONS: A CDSS for physical activity and diet may be added to a smoking cessation program without affecting the outcomes. Further research is needed to improve the impact of integrated health promotion interventions in primary care smoking cessation programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04223336 https://www.clinicaltrials.gov/ct2/show/NCT04223336. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19157.

Smoking behavior and symptoms of depression and anxiety among young adult backpackers: Results from a short longitudinal study.

Levels of smoking and smoking initiation have been found to increase during the transition to adulthood. Symptoms of depression and anxiety may both precede or follow smoking behavior, yet there is equivocal evidence regarding the direction of this relationship. The aim of the current study was to examine the direction of this relationship in a group of young adult backpackers who traveled to social environments which are permissive of smoking. The current study involved a quasi-experimental design examining 199 (52% men, mean age 24.27, SD = 1.05 years at time 1) young adults, before, during and following a backpacking experience of at least six months. Regression analyses was used to examine the association between smoking and symptoms of depression and anxiety over time. Relative to smoking levels before the journey, a significant transient increase in smoking was found during the journey. The increase in smoking during the journey predicted increases in both depressive and anxiety symptoms following the journey. The reverse direction models were not significant. Our study suggests that social contexts which are permissive of smoking, such as backpacking, increase young adult smoking behavior. Mood symptoms did not contribute to the observed increase in smoking behavior but, inversely, increases in smoking contributed to heightened mood symptoms. Additional longitudinal studies are needed to explore the role that smoking behavior plays in young adults' mental health.

Identifying contexts and mechanisms in multiple behavior change interventions affecting smoking cessation success: a rapid realist review.

BACKGROUND: Smoking continues to be a leading cause of preventable chronic disease-related morbidity and mortality, excess healthcare expenditure, and lost work productivity. Tobacco users are disproportionately more likely to be engaging in other modifiable risk behaviours such as excess alcohol consumption, physical inactivity, and poor diet. While hundreds of interventions addressing the clustering of smoking and other modifiable risk behaviours have been conducted worldwide, there is insufficient information available about the context and mechanisms in these interventions that promote successful smoking cessation. The aim of this rapid realist review was to identify possible contexts and mechanisms used in multiple health behaviour change interventions (targeting tobacco and two or more additional risk behaviours) that are associated with improving smoking cessation outcome. METHODS: This realist review method incorporated the following steps: (1) clarifying the scope, (2) searching for relevant evidence, (3) relevance confirmation, data extraction, and quality assessment, (4) data analysis and synthesis. RESULTS: Of the 20,423 articles screened, 138 articles were included in this realist review. Following Michie et al.'s behavior change model (the COM-B model), capability, opportunity, and motivation were used to identify the mechanisms of behaviour change. Universally, increasing opportunities (i.e. factors that lie outside the individual that prompt the behaviour or make it possible) for participants to engage in healthy behaviours was associated with smoking cessation success. However, increasing participant's capability or motivation to make a behaviour change was only successful within certain contexts. CONCLUSION: In order to address multiple health behaviours and assist individuals in quitting smoking, public health promotion interventions need to shift away from 'individualistic epidemiology' and invest resources into modifying factors that are external from the individual (i.e. creating a supportive environment). TRIAL REGISTRATION: PROSPERO registration number: CRD42017064430.

COVID-19 and persons with substance use disorders: Inequities and mitigation strategies.

The COVID-19 pandemic disproportionately disrupts the daily lives of marginalized populations. Persons with substance use disorders are a particularly vulnerable population because of their unique social and health care needs. They face significant harm from both the pandemic itself and its social and economic consequences, including marginalization in health care and social systems. Hence, we discuss: (1) why persons with substance use disorders are at increased risk for infection with COVID-19 and a severe illness course; (2) anticipated adverse consequences of COVID-19 in persons with substance use disorders; (3) challenges to health care delivery and substance use treatment programs during and after the COVID-19 pandemic; and (4) the potential impact on clinical research in substance use disorders. We offer recommendations for clinical, public health, and social policies to mitigate these challenges and to prevent negative outcomes.

Understanding Engagement with a Physical Health Service: A Qualitative Study of Patients with Severe Mental Illness.

OBJECTIVE: Individuals with severe mental illness (SMI) are disproportionally affected by medical comorbidities, resulting in poor physical health and premature death. Despite this, care for chronic medical conditions is suboptimal, and there is limited research that explores this phenomenon from the patient's perspective. The aim of this study was to identify barriers and facilitators of engagement with a physical health service experienced by individuals with SMI. METHODS: Adults with SMI were recruited from a large psychiatric hospital and offered referral to a physical health service focused on the prevention and treatment of obesity and diabetes. Interviews were conducted at referral, 3, and 6 months. Data from 56 interviews of 24 participants were analyzed using the framework method to identify factors influencing engagement. RESULTS: Barriers to engagement were identified at individual, medical program, and health system levels. Factors influencing the individual experience included difficulty in care coordination, affective symptomatology, and ability to bond with providers. Factors at the program level included difficulty adjusting to the clinic environment and the inability to achieve treatment goals. Factors at the system level included challenges in attending multiple appointments in a fragmented health system, lack of social support, and financial constraints. CONCLUSIONS: This qualitative study suggests that traditional models of medical care for chronic conditions pose challenges for many individuals with SMI and contribute to health disparities. Adaptation of medical care to populations with SMI and close collaboration between medical and mental health services are necessary to improve medical care and, subsequently, health outcomes.

Technology-Enabled Collaborative Care for Type-2 Diabetes and Mental Health (TECC-D): Findings From a Mixed Methods Feasibility Trial of a Responsive Co-Designed Virtual Health Coaching Intervention.

Introduction: Type-2 diabetes (T2D) is a complex chronic condition associated with a lower quality of life due to disease specific distress. While there is growing support for personalized diabetes programs, care for mental health challenges is often fragmented and limited by access to psychiatry, and integration of care. The use of communication technology to improve team based collaborative care to bridge these gaps is promising but untested. Methods: We conducted an explanatory sequential mixed methods study to assess the feasibility and acceptability of the co-designed Technology-Enabled Collaborative Care for Diabetes and Mental Health (TECC-D) program. Participants included adults aged ≥18 years who had a clinical diagnosis of T2D, and self-reported mental health concerns. Results: 31 participants completed the 8-week virtual TECC-D program. Findings indicate that the program is feasible and acceptable and indicate that there is a role for virtual diabetes and mental health care. Discussion: The TECC-D program, designed through an iterative co-design process and supported by innovative, responsive adaptations led to good uptake and satisfaction. Conclusion: The TECC-D model is a feasible and scalable care solution that empowers individuals living with T2D and mental health concerns to take an active role in their care.

A computer-assisted telephone collaborative care intervention provided by lay providers for the treatment of comorbid depression and at-risk drinking: Analysis of a randomized controlled trial.

INTRODUCTION: Virtual collaborative care for people with comorbid depression and at-risk drinking lacks strong evidence. Our aim was to assess the impact of 12 months of telephone collaborative care (tCC) versus enhanced usual care (eUC) on depression and drinking. METHODS: We performed a secondary analysis of the Primary care Assessment and Research of a Telephone intervention for Neuropsychiatric conditions with Education and Resources study (PARTNERs), a blinded randomized controlled trial. We examined 144 participants with comorbid depression and at-risk drinking, of which 129 were from the original sample whose data have been published, and 15 were studied since the original report had been published. PARTNERs compared eUC consisting of usual care plus assessment of symptoms at baseline, and 4, 8, and 12 months later vs. tCC consisting of eUC plus telephone-based coaching and symptom monitoring provided by a lay mental health technician to patients supervised by a psychiatrist. The study assessed depression response and remission using logistic regression; we assessed trajectory of drinking using Generalized-estimating equations (GEE). Baseline factors associated with likelihood of not exceeding number of drinks at 12 months were identified using decision trees. RESULTS: tCC produced a faster decline in the number of drinks than eUC (Wald Χ2 = 9.47, p = 0.02). However, drinking and depression outcomes did not differ significantly between the two groups at the end of treatment. Higher alcohol consumption at baseline (≥18 standard drinks per week in the tCC group and ≥11 standard drinks per week in the eUC group) was associated with a higher likelihood of having at-risk drinking after 12 months of treatment. CONCLUSIONS: Our findings suggest that, compared to eUC, tCC may accelerate drinking reductions in patients with comorbid depression and at-risk drinking. Both treatments were equally effective at the end of treatment for both depression and drinking outcomes.

Guidelines and recommendations about virtual mental health services from high-income countries: a rapid review.

OBJECTIVES: This study reviewed existing recommendations for virtual mental healthcare services through the quadruple aim framework to create a set of recommendations on virtual healthcare delivery to guide the development of Canadian policies on virtual mental health services. DESIGN: We conducted a systematic rapid review with qualitative content analysis of data from included manuscripts. The quadruple aim framework, consisting of improving patient experience and provider satisfaction, reducing costs and enhancing population health, was used to analyse and organise findings. METHODS: Searches were conducted using seven databases from 1 January 2010 to 22 July 2022. We used qualitative content analysis to generate themes. RESULTS: The search yielded 40 articles. Most articles (85%) discussed enhancing patient experiences, 55% addressed provider experiences and population health, and 25% focused on cost reduction. Identified themes included: screen patients for appropriateness of virtual care; obtain emergency contact details; communicate transparently with patients; improve marginalised patients' access to care; support health equity for all patients; determine the cost-effectiveness of virtual care; inform patients of insurance coverage for virtual care services; increase provider training for virtual care and set professional boundaries between providers and patients. CONCLUSIONS: This rapid review identified important considerations that can be used to advance virtual care policy to support people living with mental health conditions in a high-income country.

Healthcare providers' perspectives on implementing a brief physical activity and diet intervention within a primary care smoking cessation program: a qualitative study.

BACKGROUND: Post-smoking-cessation weight gain can be a major barrier to quitting smoking; however, adding behavior change interventions for physical activity (PA) and diet may adversely affect smoking cessation outcomes. The "Picking up the PACE (Promoting and Accelerating Change through Empowerment)" study assessed change in PA, fruit/vegetable consumption, and smoking cessation by providing a clinical decision support system for healthcare providers to utilize at the intake appointment, and found no significant change in PA, fruits/vegetable consumption, or smoking cessation. The objective of this qualitative study was to explore the factors affecting the implementation of the intervention and contextualize the quantitative results. METHODS: Twenty-five semi-structured interviews were conducted with healthcare providers, using questions based on the National Implementation Research Network's Hexagon Tool. The data were analyzed using the framework's standard analysis approach. RESULTS: Most healthcare providers reported a need to address PA and fruit/vegetable consumption in patients trying to quit smoking, and several acknowledged that the intervention was a good fit since exercise and diet could improve smoking cessation outcomes. However, many healthcare providers mentioned the need to explain the fit to the patients. Social determinants of health (e.g., low income, food insecurity) were brought up as barriers to the implementation of the intervention by a majority of healthcare providers. Most healthcare providers recognized training as a facilitator to the implementation, but time was mentioned as a barrier by many of healthcare providers. Majority of healthcare providers mentioned allied health professionals (e.g., dieticians, physiotherapists) supported the implementation of the PACE intervention. However, most healthcare providers reported a need for individualized approach and adaptation of the intervention based on the patients' needs when implementing the intervention. The COVID-19 pandemic was found to impact the implementation of the PACE intervention based on the Hexagon Tool indicators. CONCLUSION: There appears to be a need to utilize a flexible approach when addressing PA and fruit/vegetable consumption within a smoking cessation program, based on the context of clinic, the patients' it is serving, and their life circumstances. Healthcare providers need support and external resources to implement this particular intervention. NAME OF THE REGISTRY: Clinicaltrials.gov. TRIAL REGISTRATION NUMBER: NCT04223336. DATE OF REGISTRATION: 7 January 2020 Retrospectively registered. URL OF TRIAL REGISTRY RECORD: https://classic. CLINICALTRIALS: gov/ct2/show/NCT04223336 .

The Role of Personality Risk and Protective Factors in Living with Covid-19: A Longitudinal Study.

Earlier research has shown the significant role of personality in serving as risk or protective factors in psychological wellbeing. However, it is less clear the extent to which personality plays in coping with the Covid-19 pandemic. The aim of the current study was to examine the role of a personality risk factors such as self-criticism, and personality strengths such as efficacy and intrinsic motivation representing resilience in predicting psychological outcomes in response to the Covid-19 pandemic. As part of a broader longitudinal study, personality measures were assessed at ages 23 and 29, and Covid-19-related outcomes were measured at age 41 on a subsample of 83 Israeli participants, who were approached after the first lockdown that was implemented (April 2020). Findings showed that self-criticism measured at age 23 anticipated greater Covid-19-related distress and lower satisfaction at age 41. Decrease in self-criticism from age 23 to 29, which indicates developmental progress toward maturity, explained lower non-adaptive emotional reactions at age 41- lower distress and lower anxiety. In addition, a higher level of intrinsic motivation at age 29 explained a greater likelihood to expect post pandemic growth. Findings highlight the role of personality in addressing unexpected stressful events such as the current Covid-19 pandemic.

Factors Associated With Initiation of Antidepressant Medication in Adults With Type 1 and Type 2 Diabetes: A Primary Care Retrospective Cohort Study in Ontario, Canada.

OBJECTIVES: Depression in patients with diabetes mellitus is common and associated with poorer outcomes. This study aims to identify demographic, socioeconomic and medical factors associated with the initiation of antidepressant medication after a diagnosis of diabetes in adult patients without a previous prescription for antidepressants. We also examined frequency of primary care visits in the year after antidepressant initiation compared with the year before treatment began. METHODS: This was a retrospective cohort study using routinely collected electronic medical record data spanning January 2011 to December 2019 from the University of Toronto Practice-based Research Network (UTOPIAN) Data Safe Haven. Our primary outcome was a first prescription for an antidepressant in patients with diabetes. We used a mixed-effects logistic regression model to identify sociodemographic and medical factors associated with this event. RESULTS: Among 22,750 patients with diabetes mellitus, 3,055 patients (13.4%) began taking an antidepressant medication. Increased odds of antidepressant initiation were observed in younger patients (odds ratio [OR], 1.77; 95% confidence interval [CI], 1.39 to 2.26), females (OR, 1.60; 95% CI, 1.46 to 1.7), those receiving insulin treatment (OR, 1.59; 95% CI, 1.43 to 1.78) and cases of polypharmacy (OR, 3.67; 95% CI, 3.29 to 4.11). There was an increase in the mean number of primary care visits from 4.6 to 5.9 per year after antidepressant initiation. CONCLUSIONS: In patients with diabetes, age, sex and medical characteristics were associated with the initiation of antidepressants. These patients accessed primary care more frequently. Screening and prevention of depression, particularly in these subgroups, could reduce its personal and systemic burdens.

Coordinating smoking cessation treatment with menstrual cycle phase to improve quit outcomes (MC-NRT): study protocol for a randomized controlled trial.

BACKGROUND: Women experience greater difficulty achieving smoking abstinence compared to men. Recent evidence suggests that hormonal fluctuations during different phases of the menstrual cycle can contribute to lower smoking abstinence rates following a quit attempt among women. However, these findings are limited by small sample sizes and variability among targeted smoking quit dates. This clinical trial aims to clarify whether targeting the quit date to the follicular or luteal phase of the menstrual cycle can improve smoking abstinence. METHODS: Participants will enroll in an online smoking cessation program providing nicotine replacement therapy (NRT) and behavioral support. We will randomize 1200 eligible individuals to set a target quit date: (1) during the mid-luteal phase, (2) during the mid-follicular phase, or (3) 15-30 days after enrollment with no regard to the menstrual cycle phase (usual practice). Participants will receive a 6-week supply of combination NRT consisting of a nicotine patch plus their choice of nicotine gum or lozenge. Participants will be instructed to start using NRT on their target quit date. Optional behavioral support will consist of a free downloadable app and brief videos focusing on building a quit plan, coping with cravings, and relapse prevention, delivered via e-mail. Smoking status will be assessed via dried blood spot analysis of cotinine concentration at 7 days, 6 weeks, and 6 months post-target quit date. DISCUSSION: We aim to overcome the limitations of previous studies by recruiting a large sample of participants and assigning target quit dates to the middle of both the follicular and luteal phases. The results of the trial can further elucidate the effects of the menstrual cycle on smoking cessation outcomes and whether it is beneficial to combine menstrual cycle phase timing strategies with accessible and low-cost NRT. TRIAL REGISTRATION: ClinicalTrials.gov NCT05515354. Registered on August 23, 2022.

Technology-Supported Integrated Care Innovations to Support Diabetes and Mental Health Care: Scoping Review.

BACKGROUND: For individuals living with diabetes and its psychosocial comorbidities (eg, depression, anxiety, and distress), there remains limited access to interprofessional, integrated care that includes mental health support, education, and follow-up. Health technology, broadly defined as the application of organized knowledge or skill as software, devices, and systems to solve health problems and improve quality of life, is emerging as a means of addressing these gaps. There is thus a need to understand how such technologies are being used to support, educate, and help individuals living with co-occurring diabetes and mental health distress or disorder. OBJECTIVE: The purpose of this scoping review was to (1) describe the literature on technology-enabled integrated interventions for diabetes and mental health; (2) apply frameworks from the Mental Health Commission of Canada and World Health Organization to elucidate the components, type, processes, and users of technology-enabled integrated interventions for diabetes and mental health; and (3) map the level of integration of interventions for diabetes and mental health. METHODS: We searched 6 databases from inception to February 2022 for English-language, peer-reviewed studies of any design or type that used technology to actively support both diabetes and any mental health distress or disorder in succession or concurrently among people with diabetes (type 1 diabetes, type 2 diabetes, and gestational diabetes). Reviewers screened citations and extracted data including study characteristics and details about the technology and integration used. RESULTS: We included 24 studies described in 38 publications. These studies were conducted in a range of settings and sites of care including both web-based and in-person settings. Studies were mostly website-based (n=13) and used technology for wellness and prevention (n=16) and intervention and treatment (n=15). The primary users of these technologies were clients and health care providers. All the included intervention studies (n=20) used technology for clinical integration, but only 7 studies also used the technology for professional integration. CONCLUSIONS: The findings of this scoping review suggest that there is a growing body of literature on integrated care for diabetes and mental health enabled by technology. However, gaps still exist with how to best equip health care professionals with the knowledge and skills to offer integrated care. Future research is needed to continue to explore the purpose, level, and breadth of technology-enabled integration to facilitate an approach to overcome or address care fragmentation for diabetes and mental health and to understand how health technology can further drive the scale-up of innovative integrated interventions.

AI Conversational Agent to Improve Varenicline Adherence: Protocol for a Mixed Methods Feasibility Study.

BACKGROUND: Varenicline is a pharmacological intervention for tobacco dependence that is safe and effective in facilitating smoking cessation. Enhanced adherence to varenicline augments the probability of prolonged smoking abstinence. However, research has shown that one-third of people who use varenicline are nonadherent by the second week. There is evidence showing that behavioral support helps with medication adherence. We have designed an artificial intelligence (AI) conversational agent or health bot, called "ChatV," based on evidence of what works as well as what varenicline is, that can provide these supports. ChatV is an evidence-based, patient- and health care provider-informed health bot to improve adherence to varenicline. ChatV has been programmed to provide medication reminders, answer questions about varenicline and smoking cessation, and track medication intake and the number of cigarettes. OBJECTIVE: This study aims to explore the feasibility of the ChatV health bot, to examine if it is used as intended, and to determine the appropriateness of proceeding with a randomized controlled trial. METHODS: We will conduct a mixed methods feasibility study where we will pilot-test ChatV with 40 participants. Participants will be provided with a standard 12-week varenicline regimen and access to ChatV. Passive data collection will include adoption measures (how often participants use the chatbot, what features they used, when did they use it, etc). In addition, participants will complete questionnaires (at 1, 4, 8, and 12 weeks) assessing self-reported smoking status and varenicline adherence, as well as questions regarding the acceptability, appropriateness, and usability of the chatbot, and participate in an interview assessing acceptability, appropriateness, fidelity, and adoption. We will use "stop, amend, and go" progression criteria for pilot studies to decide if a randomized controlled trial is a reasonable next step and what modifications are required. A health equity lens will be adopted during participant recruitment and data analysis to understand and address the differences in uptake and use of this digital health solution among diverse sociodemographic groups. The taxonomy of implementation outcomes will be used to assess feasibility, that is, acceptability, appropriateness, fidelity, adoption, and usability. In addition, medication adherence and smoking cessation will be measured to assess the preliminary treatment effect. Interview data will be analyzed using the framework analysis method. RESULTS: Participant enrollment for the study will begin in January 2024. CONCLUSIONS: By using predetermined progression criteria, the results of this preliminary study will inform the determination of whether to advance toward a larger randomized controlled trial to test the effectiveness of the health bot. Additionally, this study will explore the acceptability, appropriateness, fidelity, adoption, and usability of the health bot. These insights will be instrumental in refining the intervention and the health bot. TRIAL REGISTRATION: ClinicalTrials.gov NCT05997901; https://classic.clinicaltrials.gov/ct2/show/NCT05997901. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53556.

A Motivational Interviewing Chatbot With Generative Reflections for Increasing Readiness to Quit Smoking: Iterative Development Study.

BACKGROUND: The motivational interviewing (MI) approach has been shown to help move ambivalent smokers toward the decision to quit smoking. There have been several attempts to broaden access to MI through text-based chatbots. These typically use scripted responses to client statements, but such nonspecific responses have been shown to reduce effectiveness. Recent advances in natural language processing provide a new way to create responses that are specific to a client's statements, using a generative language model. OBJECTIVE: This study aimed to design, evolve, and measure the effectiveness of a chatbot system that can guide ambivalent people who smoke toward the decision to quit smoking with MI-style generative reflections. METHODS: Over time, 4 different MI chatbot versions were evolved, and each version was tested with a separate group of ambivalent smokers. A total of 349 smokers were recruited through a web-based recruitment platform. The first chatbot version only asked questions without reflections on the answers. The second version asked the questions and provided reflections with an initial version of the reflection generator. The third version used an improved reflection generator, and the fourth version added extended interaction on some of the questions. Participants' readiness to quit was measured before the conversation and 1 week later using an 11-point scale that measured 3 attributes related to smoking cessation: readiness, confidence, and importance. The number of quit attempts made in the week before the conversation and the week after was surveyed; in addition, participants rated the perceived empathy of the chatbot. The main body of the conversation consists of 5 scripted questions, responses from participants, and (for 3 of the 4 versions) generated reflections. A pretrained transformer-based neural network was fine-tuned on examples of high-quality reflections to generate MI reflections. RESULTS: The increase in average confidence using the nongenerative version was 1.0 (SD 2.0; P=.001), whereas for the 3 generative versions, the increases ranged from 1.2 to 1.3 (SD 2.0-2.3; P<.001). The extended conversation with improved generative reflections was the only version associated with a significant increase in average importance (0.7, SD 2.0; P<.001) and readiness (0.4, SD 1.7; P=.01). The enhanced reflection and extended conversations exhibited significantly better perceived empathy than the nongenerative conversation (P=.02 and P=.004, respectively). The number of quit attempts did not significantly change between the week before the conversation and the week after across all 4 conversations. CONCLUSIONS: The results suggest that generative reflections increase the impact of a conversation on readiness to quit smoking 1 week later, although a significant portion of the impact seen so far can be achieved by only asking questions without the reflections. These results support further evolution of the chatbot conversation and can serve as a basis for comparison against more advanced versions.

Technology-Enabled Collaborative Care for Concurrent Diabetes and Distress Management During the COVID-19 Pandemic: Protocol for a Mixed Methods Feasibility Study.

BACKGROUND: The COVID-19 pandemic disrupted the delivery of diabetes care and worsened mental health among many patients with type 2 diabetes (T2D). This disruption puts patients with T2D at risk for poor diabetes outcomes, especially those who experience social disadvantage due to socioeconomic class, rurality, or ethnicity. The appropriate use of communication technology could reduce these gaps in diabetes care created by the pandemic and also provide support for psychological distress. OBJECTIVE: The purpose of this study is to test the feasibility of an innovative co-designed Technology-Enabled Collaborative Care (TECC) model for diabetes management and mental health support among adults with T2D. METHODS: We will recruit 30 adults with T2D residing in Ontario, Canada, to participate in our sequential explanatory mixed methods study. They will participate in 8 weekly web-based health coaching sessions with a registered nurse, who is a certified diabetes educator, who will be supported by a digital care team (ie, a peer mentor, an addictions specialist, a dietitian, a psychiatrist, and a psychotherapist). Assessments will be completed at baseline, 4 weeks, and 8 weeks, with a 12-week follow-up. Our primary outcome is the feasibility and acceptability of the intervention, as evident by the participant recruitment and retention rates. Key secondary outcomes include assessment completion and delivery of the intervention. Exploratory outcomes consist of changes in mental health, substance use, and physical health behaviors. Stakeholder experience and satisfaction will be explored through a qualitative descriptive study using one-on-one interviews. RESULTS: This paper describes the protocol of the study. The recruitment commenced in June 2021. This study was registered on October 29, 2020, on ClinicalTrials.gov (Registry ID: NCT04607915). As of June 2022, all participants have been recruited. It is anticipated that data analysis will be complete by the end of 2022, with study findings available by the end of 2023. CONCLUSIONS: The development of an innovative, technology-enabled model will provide necessary support for individuals living with T2D and mental health challenges. This TECC program will determine the feasibility of TECC for patients with T2D and mental health issues. TRIAL REGISTRATION: ClinicalTrials.gov NCT04607915; https://clinicaltrials.gov/ct2/show/NCT04607915. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39724.