Background: Digital and mobile health interventions using personalization via reinforcement learning algorithms have the potential to reach large number of people to support physical activity and help manage diabetes and depression in daily life. Objective: The Diabetes and Mental Health Adaptive Notification and Tracking Evaluation (DIAMANTE) study tested whether a digital physical activity intervention using personalized text messaging via reinforcement learning algorithms could increase step counts in a diverse, multilingual sample of people with diabetes and depression symptoms. Methods: From January 2020 to June 2022, participants were recruited from 4 San Francisco, California–based public primary care clinics and through web-based platforms to participate in the 24-week randomized controlled trial. Eligibility criteria included English or Spanish language preference and a documented diagnosis of diabetes and elevated depression symptoms. The trial had 3 arms: a Control group receiving a weekly mood monitoring message, a Random messaging group receiving randomly selected feedback and motivational text messages daily, and an Adaptive messaging group receiving text messages selected by a reinforcement learning algorithm daily. Randomization was performed with a 1:1:1 allocation. The primary outcome, changes in daily step counts, was passively collected via a mobile app. The primary analysis assessed changes in daily step count using a linear mixed-effects model. An a priori subanalysis compared the primary step count outcome within recruitment samples. Results: In total, 168 participants were analyzed, including those with 24% (40/168) Spanish language preference and 37.5% (63/168) from clinic-based recruitment. The results of the linear mixed-effects model indicated that participants in the Adaptive arm cumulatively gained an average of 3.6 steps each day (95% CI 2.45-4.78; P<.001) over the 24-week intervention (average of 608 total steps), whereas both the Control and Random arm participants had significantly decreased rates of change. Postintervention estimates suggest that participants in the Adaptive messaging arm showed a significant step count increase of 19% (606/3197; P<.001), in contrast to 1.6% (59/3698) and 3.9% (136/3480) step count increase in the Random and Control arms, respectively. Intervention effectiveness differences were observed between participants recruited from the San Francisco clinics and those recruited via web-based platforms, with the significant step count trend persisting across both samples for participants in the Adaptive group. Conclusions: Our study supports the use of reinforcement learning algorithms for personalizing text messaging interventions to increase physical activity in a diverse sample of people with diabetes and depression. It is the first to test this approach in a large, diverse, and multilingual sample.

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Background: Women are less physically active, report greater perceived barriers for exercise, and show higher levels of depressive symptoms. This contributes to high global disability. The relationship between perceived barriers for physical activity and depressive symptoms in women remains largely unexplored. The aims of this cross-sectional analysis were to examine the association between physical activity barriers and depressive symptoms, and identify types of barriers in physically inactive community-dwelling women. Methods: Three hundred eighteen physically inactive women aged 25–65 years completed the Barriers to Being Active Quiz (BBAQ) developed by the Centers for Disease Control and Prevention, and the Center for Epidemiological Studies Depression Scale at the baseline visit of the mobile phone-based physical activity education trial. The BBAQ consists of six subscales (lack of time, social influence, lack of energy, lack of willpower, fear of injury, lack of skill, and lack of resources). We used multivariate regression analyses, correcting for sociodemographics. Results: Higher physical activity barriers were associated with greater depressive symptoms scores (linear effect, estimate = 0.75, 95% confidence interval [CI]: 0.39–1.12, p < 0.001). This effect appeared to taper off for the higher barrier scores (quadratic effect, estimate: -0.02, 95% CI: -0.03 to -0.01, p = 0.002). Exploratory analyses indicated that these associations were most driven by the social influence (p = 0.027) and lack of energy subscales (p = 0.017). Conclusions: Higher depression scores were associated with higher physical activity barriers. Social influence and lack of energy were particularly important barriers. Addressing these barriers may improve the efficacy of physical activity interventions in women with higher depressive symptoms. Future research should assess this in a randomized controlled trial.

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The StayWell at Home intervention, a 60-day text-messaging program based on Cognitive Behavioral Therapy (CBT) principles, was developed to help adults cope with the adverse effects of the global pandemic. Participants in StayWell at Home were found to show reduced depressive and anxiety symptoms after participation. However, it remains unclear whether the intervention improved mood and which intervention components were most effective at improving user mood during the pandemic. Thus, utilizing a micro-randomized trial (MRT) design, we examined two intervention components to inform the mechanisms of action that improve mood: 1) text messages delivering CBT-informed coping strategies (i.e., behavioral activation, other coping skills, or social support); 2) time at which messages were sent. Data from two independent trials of StayWell are included in this paper. The first trial included 303 adults aged 18 or older, and the second included 266 adults aged 18 or older. Participants were recruited via online platforms (e.g., Facebook ads) and partnerships with community-based agencies aiming to reach diverse populations, including low-income individuals and people of color. The results of this paper indicate that participating in the program improved and sustained self-reported mood ratings among participants. We did not find significant differences between the type of message delivered and mood ratings. On the other hand, the results from Phase 1 indicated that delivering any type of message in the 3 pm-6 pm time window improved mood significantly over sending a message in the 9 am-12 pm time window. The StayWell at Home program increases in mood ratings appeared more pronounced during the first two to three weeks of the intervention and were maintained for the remainder of the study period. The current paper provides evidence that low-burden text-message interventions may effectively address behavioral health concerns among diverse communities.

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University students have low levels of physical activity and are at risk of mental health disorders. Mobile apps to encourage physical activity can help students, who are frequent smartphone-users, to improve their physical and mental health. Here we report students’ qualitative feedback on a physical activity smartphone app with motivational text messaging. We provide recommendations for the design of future apps. 103 students used the app for 6 weeks in the context of a clinical trial (NCT04440553) and answered open-ended questions before the start of the study and at follow-up. A subsample (n = 39) provided additional feedback via text message, and a phone interview (n = 8). Questions focused on the perceived encouragement and support by the app, text messaging content, and recommendations for future applications. We analyzed all transcripts for emerging themes using qualitative coding in Dedoose. The majority of participants were female (69.9%), Asian or Pacific Islander (53.4%), with a mean age of 20.2 years, and 63% had elevated depressive symptoms. 26% felt encouraged or neutral toward the app motivating them to be more physically active. Participants liked messages on physical activity benefits on (mental) health, encouraging them to complete their goal, and feedback on their activity. Participants disliked messages that did not match their motivations for physical activity and their daily context (e.g., time, weekday, stress). Physical activity apps for students should be adapted to their motivations, changing daily context, and mental health issues. Feedback from this sample suggests a key to effectiveness is finding effective ways to personalize digital interventions.@en

Background: Low physical activity is an important risk factor for common physical and mental disorders. Physical activity interventions delivered via smartphones can help users maintain and increase physical activity, but outcomes have been mixed. Purpose: Here we assessed the effects of sending daily motivational and feedback text messages in a microrandomized clinical trial on changes in physical activity from one day to the next in a student population. Methods: We included 93 participants who used a physical activity app, "DIAMANTE"for a period of 6 weeks. Every day, their phone pedometer passively tracked participants' steps. They were microrandomized to receive different types of motivational messages, based on a cognitive-behavioral framework, and feedback on their steps. We used generalized estimation equation models to test the effectiveness of feedback and motivational messages on changes in steps from one day to the next. Results: Sending any versus no text message initially resulted in an increase in daily steps (729 steps, p = .012), but this effect decreased over time. A multivariate analysis evaluating each text message category separately showed that the initial positive effect was driven by the motivational messages though the effect was small and trend-wise significant (717 steps; p = .083), but not the feedback messages (-276 steps, p = .4). Conclusion: Sending motivational physical activity text messages based on a cognitive-behavioral framework may have a positive effect on increasing steps, but this decreases with time. Further work is needed to examine using personalization and contextualization to improve the efficacy of text-messaging interventions on physical activity outcomes. @en

Cognitive behavioral therapy (CBT) is efficacious to treat depression, however more research is needed to understand its functions among Latinxs. This study analyzed qualitative responses that were paired with a mood rating (1–9 scale) from daily ecological momentary assessments via text-messaging of 52 low-income, Spanish-speaking patients to assess the relationship between word use and changes in mood during group CBT. Based on previous research, we chose 11 linguistic dimensions from the Linguistic Inquiry and Word Count text analysis software that conceptually related to core CBT treatment elements and sociocultural factors of depression in Latinxs. Results showed that the use of words from the categories of Friends, Religion, Positive Emotions, and Leisure (proxy for behavioral activation) were significantly associated with a significant increase in mood. The use of Negative Emotions and Health words were significantly associated with a significant decrease in mood. Post-hoc analysis revealed that Certainty (proxy for cognitive inflexibility) words were related to a significant decrease in mood when Negative Emotional words were present. Findings contribute to our understanding of the role of sociocultural factors and core CBT elements in changes in mood among Latinxs. Lastly, this paper demonstrates the potential for analyzing language content during a digital health intervention to better understand user experiences.@en

Background: Text messaging interventions can be an effective and efficient way to improve health behavioral changes. However, most texting interventions are neither tested nor designed with diverse end users, which could reduce their impact, and there is limited evidence regarding the optimal design methodology of health text messages tailored to low-income, low-health literacy populations and non-English speakers. Objective: This study aims to combine participant feedback, crowdsourced data, and researcher expertise to develop motivational text messages in English and Spanish that will be used in a smartphone app-based texting intervention that seeks to encourage physical activity in low-income minority patients with diabetes diagnoses and depression symptoms. Methods: The design process consisted of 5 phases and was iterative in nature, given that the findings from each step informed the subsequent steps. First, we designed messages to increase physical activity based on the behavior change theory and knowledge from the available evidence. Second, using user-centered design methods, we refined these messages after a card sorting task and semistructured interviews (N=10) and evaluated their likeability during a usability testing phase of the app prototype (N=8). Third, the messages were tested by English- and Spanish-speaking participants on the Amazon Mechanical Turk (MTurk) crowdsourcing platform (N=134). Participants on MTurk were asked to categorize the messages into overarching theoretical categories based on the capability, opportunity, motivation, and behavior framework. Finally, each coauthor rated the messages for their overall quality from 1 to 5. All messages were written at a sixth-grade or lower reading level and culturally adapted and translated into neutral Spanish by bilingual research staff. Results: A total of 200 messages were iteratively refined according to the feedback from target users gathered through user-centered design methods, crowdsourced results of a categorization test, and an expert review. User feedback was leveraged to discard unappealing messages and edit the thematic aspects of messages that did not resonate well with the target users. Overall, 54 messages were sorted into the correct theoretical categories at least 50% of the time in the MTurk categorization tasks and were rated 3.5 or higher by the research team members. These were included in the final text message bank, resulting in 18 messages per motivational category. Conclusions: By using an iterative process of expert opinion, feedback from participants that were reflective of our target study population, crowdsourcing, and feedback from the research team, we were able to acquire valuable inputs for the design of motivational text messages developed in English and Spanish with a low literacy level to increase physical activity. We describe the design considerations and lessons learned for the text messaging development process and provide a novel, integrative framework for future developers of health text messaging interventions.@en

Introduction: Cognitive behavioral therapy (CBT) is an established treatment for depression, but its success is often impeded by low attendance. Supportive text messages assessing participants' mood in between sessions might increase attendance to in-clinic CBT, although it is not fully understood who benefits most from these interventions and how. This study examined (1) user groups showing different profiles of study engagement and (2) associations between increased response rates to mood texts and psychotherapy attendance. Methods: We included 73 participants who attended Group CBT (GCBT) in a primary care clinic and participated in a supportive automated text-messaging intervention. Using unsupervised machine learning, we identified and characterized subgroups with similar combinations of total texting responsiveness and total GCBT attendance. We used mixed-effects models to explore the association between increased previous week response rate and subsequent week in-clinic GCBT attendance and, conversely, response rate following attendance. Results: Participants could be divided into four clusters of overall study engagement, showing distinct profiles in age and prior texting knowledge. The response rate to texts in the week before GCBT was not associated with GCBT attendance, although the relationship was moderated by age; there was a positive relationship for younger, but not older, participants. Attending GCBT was, however, associated with higher response rate the week after an attended session. Conclusion: User groups of study engagement differ in texting knowledge and age. Younger participants might benefit more from supportive texting interventions when their purpose is to increase psychotherapy attendance. Our results have implications for tailoring digital interventions to user groups and for understanding therapeutic effects of these interventions. @en

Physical activity (PA) is an effective depression treatment. However, knowledge on how variation in day-to-day PA relates to depression in women is lacking. The purposes of this study were to 1) compare overall objectively measured baseline daily steps and duration of moderate to vigorous PA (MVPA) and 2) examine differences in steps and MVPA on days of the week between women aged 25–65 years, who were physically inactive, with high and low depressive symptoms, enrolled in a run-in period of the mobile phone based physical activity education (mPED) trial. The Center for Epidemiological Studies Depression Scale was used to categorize low/high depressive symptom groups. We used linear mixed-effects models to examine the associations between steps and MVPA and depression-status overall and by day of the week, adjusting for selected demographic variables and their interactions with day of the week. 274 women were included in the final analysis, of which 58 had high depressive symptoms. Overall physical activity levels did not differ. However, day of the week modified the associations of depression with MVPA (p = 0.015) and daily steps (p = 0.08). Women with high depression were characterized by reduced activity at the end of the week (Posthoc: Friday: 791 fewer steps, 95% CI: 73–1509, p = 0.03; 8.8 lower MVPA, 95% CI: 2.16–15.5, p = 0.0098) compared to women with low depression, who showed increased activity. Day of the week might be an important target for personalization of physical activity interventions. Future work should evaluate potential causes of daily activity alterations in depression in women.@en

Background: The COVID-19 pandemic has propelled patient-facing research to shift to digital and telehealth strategies. If these strategies are not adapted for minority patients of lower socioeconomic status, health inequality will further increase. Patient-centered models of care can successfully improve access and experience for minority patients. Objective: This study aims to present the development process and preliminary acceptability of altering in-person onboarding procedures into internet-based, remote procedures for a mobile health (mHealth) intervention in a population with limited digital literacy. Methods: We actively recruited safety-net patients (English- and Spanish-speaking adults with diabetes and depression who were receiving care at a public health care delivery system in San Francisco, United States) into a randomized controlled trial of text messaging support for physical activity. Because of the COVID-19 pandemic, we modified the in-person recruitment and onboarding procedures to internet-based, remote processes with human support. We conducted a preliminary evaluation of how the composition of the recruited cohort might have changed from the pre-COVID-19 period to the COVID-19 enrollment period. First, we analyzed the digital profiles of patients (n=32) who had participated in previous in-person onboarding sessions prior to the COVID-19 pandemic. Next, we documented all changes made to our onboarding processes to account for remote recruitment, especially those needed to support patients who were not very familiar with downloading apps onto their mobile phones on their own. Finally, we used the new study procedures to recruit patients (n=11) during the COVID-19 social distancing period. These patients were also asked about their experience enrolling into a fully digitized mHealth intervention. Results: Recruitment across both pre-COVID-19 and COVID-19 periods (N=43) demonstrated relatively high rates of smartphone ownership but lower self-reported digital literacy, with 32.6% (14/43) of all patients reporting they needed help with using their smartphone and installing apps. Significant changes were made to the onboarding procedures, including facilitating app download via Zoom video call and/or a standard phone call and implementing brief, one-on-one staff-patient interactions to provide technical assistance personalized to each patient's digital literacy skills. Comparing recruitment during pre-COVID-19 and COVID-19 periods, the proportion of patients with digital literacy barriers reduced from 34.4% (11/32) in the pre-COVID-19 cohort to 27.3% (3/11) in the COVID-19 cohort. Differences in digital literacy scores between both cohorts were not significant (P=.49). Conclusions: Patients of lower socioeconomic status have high interest in using digital platforms to manage their health, but they may require additional upfront human support to gain access. One-on-one staff-patient partnerships allowed us to provide unique technical assistance personalized to each patient's digital literacy skills, with simple strategies to troubleshoot patient barriers upfront. These additional remote onboarding strategies can mitigate but not eliminate digital barriers for patients without extensive technology experience.@en

Introduction: Digital technologies, including text messaging and mobile phone apps, can be leveraged to increase people's physical activity and manage health. Chatbots, powered by artificial intelligence, can automatically interact with individuals through natural conversation. They may be more engaging than one-way messaging interventions. To our knowledge, physical activity chatbots have not been developed with low-income participants, nor in Spanish—the second most dominant language in the U.S. We recommend best practices for physical activity chatbots in English and Spanish for low-income women. Methods: We designed a prototype physical activity text-message based conversational agent based on various psychotherapeutic techniques. We recruited participants through SNAP-Ed (Supplemental Nutrition Assistance Program Education) in California (Alameda County) and Tennessee (Shelby County). We conducted qualitative interviews with participants during testing of our prototype chatbot, held a Wizard of Oz study, and facilitated a co-design workshop in Spanish with a subset of our participants. Results: We included 10 Spanish- and 8 English-speaking women between 27 and 41 years old. The majority was Hispanic/Latina (n = 14), 2 were White and 2 were Black/African American. More than half were monolingual Spanish speakers, and the majority was born outside the US (>50% in Mexico). Most participants were unfamiliar with chatbots and were initially skeptical. After testing our prototype, most users felt positively about health chatbots. They desired a personalized chatbot that addresses their concerns about privacy, and stressed the need for a comprehensive system to also aid with nutrition, health information, stress, and involve family members. Differences between English and monolingual Spanish speakers were found mostly in exercise app use, digital literacy, and the wish for family inclusion. Conclusion: Low-income Spanish- and English-speaking women are interested in using chatbots to improve their physical activity and other health related aspects. Researchers developing health chatbots for this population should focus on issues of digital literacy, app familiarity, linguistic and cultural issues, privacy concerns, and personalization. Designing and testing this intervention for and with this group using co-creation techniques and involving community partners will increase the probability that it will ultimately be effective.@en

Background: Social distancing and stay-at-home orders are critical interventions to slow down person-to-person transmission of COVID-19. While these societal changes help contain the pandemic, they also have unintended negative consequences, including anxiety and depression. We developed StayWell, a daily skills-based SMS text messaging program, to mitigate COVID-19–related depression and anxiety symptoms among people who speak English and Spanish in the United States. Objective: This paper describes the changes in StayWell participants’ anxiety and depression levels after 60 days of exposure to skills-based SMS text messages. Methods: We used self-administered, empirically supported web-based questionnaires to assess the demographic and clinical characteristics of StayWell participants. Anxiety and depression were measured using the 2-item Generalized Anxiety Disorder (GAD-2) scale and the 8-item Patient Health Questionnaire-8 (PHQ-8) scale at baseline and 60-day timepoints. We used 2-tailed paired t tests to detect changes in PHQ-8 and GAD-2 scores from baseline to follow-up measured 60 days later. Results: The analytic sample includes 193 participants who completed both the baseline and 60-day exit questionnaires. At the 60-day time point, there were significant reductions in both PHQ-8 and GAD-2 scores from baseline. We found an average reduction of –1.72 (95% CI –2.35 to –1.09) in PHQ-8 scores and –0.48 (95% CI –0.71 to –0.25) in GAD-2 scores. These improvements translated to an 18.5% and 17.2% reduction in mean PHQ-8 and GAD-2 scores, respectively. Conclusions: StayWell is an accessible, low-intensity population-level mental health intervention. Participation in StayWell focused on COVID-19 mental health coping skills and was related to improved depression and anxiety symptoms. In addition to improvements in outcomes, we found high levels of engagement during the 60-day intervention period. Text messaging interventions could serve as an important public health tool for disseminating strategies to manage mental health.@en

Objective: Providing behavioral health interventions via smartphones allows these interventions to be adapted to the changing behavior, preferences, and needs of individuals. This can be achieved through reinforcement learning (RL), a sub-area of machine learning. However, many challenges could affect the effectiveness of these algorithms in the real world. We provide guidelines for decision-making. Materials and Methods: Using thematic analysis, we describe challenges, considerations, and solutions for algorithm design decisions in a collaboration between health services researchers, clinicians, and data scientists. We use the design process of an RL algorithm for a mobile health study "DIAMANTE"for increasing physical activity in underserved patients with diabetes and depression. Over the 1.5-year project, we kept track of the research process using collaborative cloud Google Documents, Whatsapp messenger, and video teleconferencing. We discussed, categorized, and coded critical challenges. We grouped challenges to create thematic topic process domains. Results: Nine challenges emerged, which we divided into 3 major themes: 1. Choosing the model for decision-making, including appropriate contextual and reward variables; 2. Data handling/collection, such as how to deal with missing or incorrect data in real-time; 3. Weighing the algorithm performance vs effectiveness/implementation in real-world settings. Conclusion: The creation of effective behavioral health interventions does not depend only on final algorithm performance. Many decisions in the real world are necessary to formulate the design of problem parameters to which an algorithm is applied. Researchers must document and evaulate these considerations and decisions before and during the intervention period, to increase transparency, accountability, and reproducibility.@en

Digital health, including the use of mobile health apps, telemedicine, and data analytics to improve health systems, has surged during the COVID-19 pandemic. The social and economic fallout from COVID-19 has further exacerbated gender inequities, through increased domestic violence against women, soaring unemployment rates in women, and increased unpaid familial care taken up by women—all factors that can worsen women's health. Digital health can bolster gender equity through increased access to health care, empowerment of one's own health data, and reduced burden of unpaid care work. Yet, digital health is rarely designed from a gender equity perspective. In this Viewpoint, we show that because of lower access and exclusion from app design, gender imbalance in digital health leadership, and harmful gender stereotypes, digital health is disadvantaging women—especially women with racial or ethnic minority backgrounds. Tackling digital health's gender inequities is more crucial than ever. We explain our feminist intersectionality framework to tackle digital health's gender inequities and provide recommendations for future research.@en

Background: Regular physical activity (PA) is crucial for well-being; however, healthy habits are difficult to create and maintain. Interventions delivered via conversational agents (eg, chatbots or virtual agents) are a novel and potentially accessible way to promote PA. Thus, it is important to understand the evolving landscape of research that uses conversational agents. Objective: This mixed methods systematic review aims to summarize the usability and effectiveness of conversational agents in promoting PA, describe common theories and intervention components used, and identify areas for further development. Methods: We conducted a mixed methods systematic review. We searched seven electronic databases (PsycINFO, PubMed, Embase, CINAHL, ACM Digital Library, Scopus, and Web of Science) for quantitative, qualitative, and mixed methods studies that conveyed primary research on automated conversational agents designed to increase PA. The studies were independently screened, and their methodological quality was assessed using the Mixed Methods Appraisal Tool by 2 reviewers. Data on intervention impact and effectiveness, treatment characteristics, and challenges were extracted and analyzed using parallel-results convergent synthesis and narrative summary. Results: In total, 255 studies were identified, 7.8% (20) of which met our inclusion criteria. The methodological quality of the studies was varied. Overall, conversational agents had moderate usability and feasibility. Those that were evaluated through randomized controlled trials were found to be effective in promoting PA. Common challenges facing interventions were repetitive program content, high attrition, technical issues, and safety and privacy concerns. Conclusions: Conversational agents hold promise for PA interventions. However, there is a lack of rigorous research on long-term intervention effectiveness and patient safety. Future interventions should be based on evidence-informed theories and treatment approaches and should address users' desires for program variety, natural language processing, delivery via mobile devices, and safety and privacy concerns.@en

Background: Social distancing is a crucial intervention to slow down person-to-person transmission of COVID-19. However, social distancing has negative consequences, including increases in depression and anxiety. Digital interventions, such as text messaging, can provide accessible support on a population-wide scale. We developed text messages in English and Spanish to help individuals manage their depressive mood and anxiety during the COVID-19 pandemic. Objective: In a two-arm randomized controlled trial, we aim to examine the effect of our 60-day text messaging intervention. Additionally, we aim to assess whether the use of machine learning to adapt the messaging frequency and content improves the effectiveness of the intervention. Finally, we will examine the differences in daily mood ratings between the message categories and time windows. Methods: The messages were designed within two different categories: behavioral activation and coping skills. Participants will be randomized into (1) a random messaging arm, where message category and timing will be chosen with equal probabilities, and (2) a reinforcement learning arm, with a learned decision mechanism for choosing the messages. Participants in both arms will receive one message per day within three different time windows and will be asked to provide their mood rating 3 hours later. We will compare self-reported daily mood ratings; self-reported depression, using the 8-item Patient Health Questionnaire; and self-reported anxiety, using the 7-item Generalized Anxiety Disorder scale at baseline and at intervention completion. Results: The Committee for the Protection of Human Subjects at the University of California Berkeley approved this study in April 2020 (No. 2020-04-13162). Data collection began in April 2020 and will run to April 2021. As of August 24, 2020, we have enrolled 229 participants. We plan to submit manuscripts describing the main results of the trial and results from the microrandomized trial for publication in peer-reviewed journals and for presentations at national and international scientific meetings. Conclusions: Results will contribute to our knowledge of effective psychological tools to alleviate the negative effects of social distancing and the benefit of using machine learning to personalize digital mental health interventions. Trial Registration: ClinicalTrials.gov NCT04473599; https://clinicaltrials.gov/ct2/show/NCT04473599 International Registered Report Identifier (IRRID): DERR1-10.2196/23592@en

Introduction Depression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual's behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention. Methods and analysis In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up. Ethics and dissemination The Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings. Trial registration number NCT03490253; pre-results.

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Purpose of review: Digital mental health (DMH) interventions provide opportunities to alleviate mental health disparities among marginalized populations by overcoming traditional barriers to care and putting quality mental health services in the palm of one’s hand. While progress has been made towards realizing this goal, the potential for impactful change has yet to be realized. This paper reviews current examples of DMH interventions for certain marginalized and underserved groups, namely, ethnic and racial minorities including Latinx and African-Americans, rural populations, individuals experiencing homelessness, and sexual and gender minorities. Recent findings: Strengths and opportunities, along with the needs and considerations, of each group are discussed as they pertain to the development and dissemination of DMH interventions. Our review focuses on several DMH interventions that have been specifically designed for marginalized populations with a culturally sensitive approach along with other existing interventions that have been tailored to fit the needs of the target population. Overall, evidence is beginning to show promise for the feasibility and acceptability of DMH inter ventions for these groups, but large-scale efficacy testing and scaling potential are still lacking. Summary: These examples of how DMH can potentially positively impact marginalized populations should motivate developers, researchers, and practitioners to work collaboratively with stakeholders to deliver DMH interventions to these underserved populations in need.@en