A pilot randomized controlled trial of a cognitive-behavioral therapy guided self-help mobile app for the post-acute treatment of anorexia nervosa: A registered report.

INTRODUCTION: Relapse following acute treatment for anorexia nervosa (AN) is common. Evidence suggests cognitive-behavioral therapy (CBT) may be useful in the post-acute period, but few patients have access to trained providers. mHealth technologies have potential to increase access to high-quality care for AN, including in the post-acute period. The aim of this study is to estimate the preliminary feasibility and effectiveness of a CBT-based mobile intervention plus treatment as usual (TAU), offered with and without an accompanying social networking feature. METHOD: In the current pilot randomized controlled trial, women with AN who have been discharged from acute treatment in the past 2 months (N = 90) will be randomly assigned to a CBT-based mobile intervention plus treatment as usual (TAU), a CBT-based mobile intervention including social networking plus TAU, or TAU alone. We will examine feasibility, acceptability, and preliminary effectiveness of the three conditions in terms of reducing eating disorder psychopathology, reducing frequency of eating disorder behaviors, achieving weight maintenance, reducing depression and suicidal ideation, and reducing clinical impairment. We will examine rehospitalization and full recovery rates in an exploratory fashion. We will also examine whether the mobile intervention and social networking feature change the proposed targets and whether changes in targets are associated with benefit, as well as conduct exploratory analyses to identify within-mobile intervention predictors and moderators of outcome. DISCUSSION: Ultimately, this research may lead to increased access to evidence-based treatment for individuals with AN and prevention of the extreme negative consequences that can result from this serious disorder. PUBLIC SIGNIFICANCE: Relapse after acute treatment for anorexia nervosa is common, and few patients have access to trained providers to support them following acute care. This study will pilot a coached mobile app, including a social networking component, for this population. If ultimately successful, our approach could greatly increase access to evidence-based treatment for individuals with anorexia nervosa and ultimately prevent the extreme negative consequences that can result from this serious disorder.

The Effects of Remote Cognitive Training Combined With a Mobile App Intervention on Psychosis: Double-Blind Randomized Controlled Trial.

BACKGROUND: Impairments in cognition and motivation are core features of psychosis and strong predictors of social and occupational functioning. Accumulating evidence indicates that cognitive deficits in psychosis can be improved by computer-based cognitive training programs; however, barriers include access and adherence to cognitive training exercises. Limited evidence-based methods have been established to enhance motivated behavior. In this study, we tested the effects of web-based targeted cognitive and social cognitive training (TCT) delivered in conjunction with an innovative digital smartphone app called Personalized Real-Time Intervention for Motivational Enhancement (PRIME). The PRIME app provides users with a motivational coach to set personalized goals and secure social networking for peer support. OBJECTIVE: This study investigated whether deficits in cognition and motivation in people with a psychosis spectrum disorder (N=100) can be successfully addressed with 30 hours of TCT+PRIME as compared with 30 hours of a computer games control condition (CG) plus PRIME (CG+PRIME). Here, we describe our study procedures, the feasibility and acceptability of the intervention, and the results on all primary outcomes. METHODS: In this double-blind randomized controlled trial, English-speaking participants completed all cognitive training, PRIME activities, and assessments remotely. Participants completed a diagnostic interview and remote cognitive, clinical, and self-report measures at baseline, posttraining, and at a 6-month follow-up. RESULTS: This study included participants from 27 states across the United States and 8 countries worldwide. The study population was 58% (58/100) female, with a mean age of 33.77 (SD 10.70) years. On average, participants completed more than half of the cognitive training regimen (mean 18.58, SD 12.47 hours of training), and logged into the PRIME app 4.71 (SD 1.58) times per week. The attrition rate of 22% (22/100) was lower than that reported in our previous studies on remote cognitive training. The total sample showed significant gains in global cognition (P=.03) and attention (P<.001). The TCT+PRIME participants showed significantly greater gains in emotion recognition (P<.001) and global cognition at the trend level (P=.09), although this was not statistically significant, relative to the CG+PRIME participants. The total sample also showed significant improvements on multiple indices of motivation (P=.02-0.05), in depression (P=.04), in positive symptoms (P=.04), and in negative symptoms at a trend level (P=.09), although this was not statistically significant. Satisfaction with the PRIME app was rated at 7.74 (SD 2.05) on a scale of 1 to 10, with higher values indicating more satisfaction. CONCLUSIONS: These results demonstrate the feasibility and acceptability of remote cognitive training combined with the PRIME app and that this intervention can improve cognition, motivation, and symptoms in individuals with psychosis. TCT+PRIME appeared more effective in improving emotion recognition and global cognition than CG+PRIME. Future analyses will test the relationship between hours of cognitive training completed; PRIME use; and changes in cognition, motivation, symptoms, and functioning. TRIAL REGISTRATION: ClinicalTrials.gov NCT02782442; https://clinicaltrials.gov/study/NCT02782442.

Understanding self-monitoring to inform a mobile intervention for binge eating and weight management: A proof-of-concept randomized trial.

OBJECTIVE: This study explored consumers' perspectives on self-monitoring, a common feature in behavioral interventions that helps inform consumers' progress and answer their questions, to learn what outcome metrics matter to consumers and whether self-selection of these metrics leads to greater engagement (i.e., compliance, satisfaction) in self-monitoring than monitoring only default options. METHODS: In a proof-of-concept randomized trial, 48 adult participants were randomly assigned to "clinician-determined monitoring" or "clinician + self-determined monitoring" conditions. Before starting monitoring, all participants shared outcomes that would matter to them in a mobile intervention for binge eating and weight management. Then, for 3 weeks, participants in the "clinician-determined" condition monitored their weight and binge-eating episodes, and participants in the "clinician + self-determined" condition monitored these and another metric of their choosing. After, satisfaction and compliance were assessed. RESULTS: Participants identified 116 metrics, grouped into 12 themes, that mattered to them. During monitoring, participants in the "clinician + self-determined" condition monitored 41 metrics. Surprisingly, participants in the "clinician-determined" condition also monitored metrics besides weight and binge eating. This resulted in a failure of our experimental manipulation, which represents a significant limitation of this research. No significant differences emerged in satisfaction or compliance between conditions. DISCUSSION: Although our proof-of-concept trial yielded null quantitative results, findings also suggested binge eating and weight management interventions may benefit from including an individually customizable monitoring option in addition to default metrics, warranting testing in future research. PUBLIC SIGNIFICANCE: Examining consumers' self-monitoring preferences for a mobile intervention for binge eating and weight management revealed a variety of metrics that matter to consumers, although binge eating and weight were still most valued. Findings from our proof-of-concept trial suggest design implications of encouraging an individually customizable monitoring option, in addition to default metrics, which needs to be tested in future research over a longer period and during actual mobile intervention delivery.

Long-term Weight Loss in a Primary Care-Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial.

BACKGROUND: Long-term weight loss in people living with obesity can reduce the risk and progression of noncommunicable diseases. Observational studies suggest that digital coaching can lead to long-term weight loss. OBJECTIVE: We investigated whether an eHealth lifestyle coaching program for people living with obesity with or without type 2 diabetes led to significant, long-term (12-month) weight loss compared to usual care. METHODS: In a randomized controlled trial that took place in 50 municipalities in Denmark, 340 people living with obesity with or without type 2 diabetes were enrolled from April 16, 2018, to April 1, 2019, and randomized via an automated computer algorithm to an intervention (n=200) or a control (n=140) group. Patients were recruited via their general practitioners, the Danish diabetes organization, and social media. The digital coaching intervention consisted of an initial 1-hour face-to-face motivational interview followed by digital coaching using behavioral change techniques enabled by individual live monitoring. The primary outcome was change in body weight from baseline to 12 months. RESULTS: Data were assessed for 200 participants, including 127 from the intervention group and 73 from the control group, who completed 12 months of follow-up. After 12 months, mean body weight and BMI were significantly reduced in both groups but significantly more so in the intervention group than the control group (-4.5 kg, 95% CI -5.6 to -3.4 vs -1.5 kg, 95% CI -2.7 to -0.2, respectively; P<.001; and -1.5 kg/m2, 95% CI -1.9 to -1.2 vs -0.5 kg/m2, 95% CI -0.9 to -0.1, respectively; P<.001). Hemoglobin A1c was significantly reduced in both the intervention (-6.0 mmol/mol, 95% CI -7.7 to -4.3) and control (-4.9 mmol/mol, 95% CI -7.4 to -2.4) groups, without a significant group difference (all P>.46). CONCLUSIONS: Compared to usual care, digital lifestyle coaching can induce significant weight loss for people living with obesity, both with and without type 2 diabetes, after 12 months. TRIAL REGISTRATION: ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915.

A randomized controlled trial of a smartphone-based application for the treatment of anxiety.

AbstractIntroduction: Generalized anxiety disorder (GAD) is prevalent among college students. Smartphone-based interventions may be a low-cost treatment method. Method: College students with self-reported GAD were randomized to receive smartphone-based guided self-help (n = 50), or no treatment (n = 50). Post-treatment and six-month follow-up outcomes included the Depression Anxiety Stress Scales-Short Form Stress Subscale (DASS Stress), the Penn State Worry Questionnaire (PSWQ-11), and the State-Trait Anxiety Inventory-Trait (STAI-T), as well as diagnostic status assessed by the GAD-Questionnaire, 4th edition. Results: From pre- to post-treatment, participants who received guided self-help (vs. no treatment) experienced significantly greater reductions on the DASS Stress (d = -0.408) and a greater probability of remission from GAD (d = -0.445). There was no significant between-group difference in change on the PSWQ-11 (d = -0.208) or STAI-T (d = -0.114). From post to six-month follow-up there was no significant loss of gains on DASS Stress scores (d = -0.141) and of those who had remitted, 78.6% remained remitted. Yet rates of remitted participants no longer differed significantly between conditions at follow-up (d = -0.229). Conclusion: Smartphone-based interventions may be efficacious in treating some aspects of GAD. Methods for improving symptom reduction and long-term outcome are discussed.

Reducing Stress and Enhancing Academic Buoyancy among Adolescents Using a Brief Web-based Program Based on Acceptance and Commitment Therapy: A Randomized Controlled Trial.

Acceptance and commitment therapy programs have rarely been used as preventive tools for alleviating stress and enhancing coping skills among adolescents. This randomized controlled trial examined the efficacy of a novel Finnish web- and mobile-delivered five-week intervention program called Youth COMPASS among a general sample of ninth-grade adolescents (n= 249, 49% females). The intervention group showed a small but significant decrease in overall stress (between-group Cohen's d = 0.22) and an increase in academic buoyancy (d= 0.27). Academic skills did not influence the intervention gains, but the intervention gains were largest among high-stressed participants. The results suggest that the acceptance and commitment based Youth COMPASS program may be well suited for promoting adolescents' well-being in the school context.

Text Messaging to Reduce Alcohol Relapse in Prelisting Liver Transplant Candidates: A Pilot Feasibility Study.

BACKGROUND: Many liver transplantation programs require documented alcohol sobriety prior to United Network for Organ Sharing (UNOS) listing. This pilot study examined the feasibility of the first mobile, alcohol relapse prevention intervention for liver transplant patients with alcoholic liver disease (ALD). METHODS: This was a randomized 8-week pilot feasibility trial of a text message-based alcohol intervention. In-treatment assessment was conducted at 4 weeks (4W), and immediate posttreatment assessment was conducted at 8W. Participants were liver transplant candidates (N = 15) diagnosed with ALD who reported at least 1 drinking episode in the past year. Primary feasibility outcomes were percent of messages responded to and posttreatment intervention satisfaction ratings. Preliminary clinical efficacy outcomes were any biologically confirmed alcohol consumption, stress, abstinence self-efficacy, and alcohol craving. RESULTS: On feasibility outcomes, participants responded to 81% of messages received and reported high rates of intervention satisfaction, looked forward to receiving the messages, and found it easy to complete the intervention. On preliminary efficacy outcomes, zero participants in the text message (TM) had positive urine alcohol tests at 8W. Two of the 6 participants in standard care (SC) tested positive at 8W. No effects were seen on craving. For stress, a condition × time interaction emerged. TM participants had less stress at 4W and 8W compared with SC at baseline. They maintained their stress level during the intervention. For self-efficacy, a trend for condition effect emerged. TM participants had higher self-efficacy than SC participants. CONCLUSIONS: Participants reported high satisfaction with the intervention, looked forward to the messages, and found it easy to complete. Participants who received the intervention had better treatment outcomes than those who received standard care. They maintained higher levels of self-efficacy and lower stress. Mobile alcohol interventions may hold significant promise to help ALD liver transplant patients maintain sobriety.

Purple: a modular system for developing and deploying behavioral intervention technologies.

The creation, deployment, and evaluation of Web-based and mobile-based applications for health, mental health, and wellness within research settings has tended to be siloed, with each research group developing their own systems and features. This has led to technological features and products that are not sharable across research teams, thereby limiting collaboration, reducing the speed of dissemination, and raising the bar for entry into this area of research. This paper provides an overview of Purple, an extensible, modular, and repurposable system created for the development of Web-based and mobile-based applications for health behavior change. Purple contains features required to construct applications and to manage and evaluate research trials using these applications. Core functionality of Purple includes elements that support user management, content authorship, content delivery, and data management. We discuss the history and development of the Purple system guided by the rationale of producing a system that allows greater collaboration and understanding across research teams interested in investigating similar questions and using similar methods. Purple provides a useful tool to meet the needs of stakeholders involved in the creation, provision, and usage of eHealth and mHealth applications. Housed in a non-profit, academic institution, Purple also offers the potential to facilitate the diffusion of knowledge across the research community and improve our capacity to deliver useful and usable applications that support the behavior change of end users.

Effectiveness and uptake of a transdiagnostic emotion regulation mobile intervention among university students: Protocol for a randomized controlled trial.

Background: Going to university is a major life event, which can be stressful and negatively affect mental health. However, it also presents an opportunity to establish a foundation for positive life trajectories. To support university students, a mobile transdiagnostic emotion regulation (ER) intervention has been developed, offering both broad-based (universal) and targeted (indicated) preventative support. ER, a transdiagnostic factor underlying various mental health problems, is a critical intervention target in students, a demographic particularly susceptible to mental health issues. Cultivating ER can help manage immediate stressors and foster long-term wellbeing. This paper describes the study protocol for a Randomized Controlled Trial (RCT) evaluating the effectiveness and uptake of such mobile transdiagnostic ER intervention. Method: The superiority parallel-group RCT involves 250 participants randomized to either the intervention condition (i.e., full access to the mobile intervention, (n = 125) or to a waitlist control condition (n = 125). Primary outcomes include ER skills and stress symptoms. Secondary outcomes include mental health parameters (anxiety, depression, resilience) and intervention uptake (i.e., objective engagement, subjective engagement, ER skills application in real life). Outcomes are assessed at baseline, week 3, 8 and 12, with continuous log-data collection for user engagement. Discussion: This study evaluates the effectiveness and uptake of a transdiagnostic ER mobile intervention for the student population addressing their ER developmental needs. If successful, the results will validate our approach to intervention development and whether focusing on learning transfer (i.e., application of the learnt skills in real-life) and personalization using a recommendation system, can boost the real-world application of skills and intervention impact.

Acceptability and feasibility of a mobile behavioral economic health intervention to reduce alcohol use in adults in rural areas.

Background: At-risk alcohol use is associated with increased adverse health consequences, yet is undertreated in healthcare settings. People residing in rural areas need improved access to services; however, few interventions are designed to meet the needs of rural populations. Mobile interventions can provide feasible, low-cost, and scalable means for reaching this population and improving health, and behavioral economic approaches are promising. Methods: We conducted a pilot randomized controlled trial focused on acceptability and feasibility of a mobile behavioral economic intervention for 75 rural-residing adults with at-risk alcohol use. We recruited participants from a large healthcare system and randomized them to one of four virtually-delivered conditions reflecting behavioral economic approaches: episodic future thinking (EFT), volitional choice (VC), both EFT and VC, or enhanced usual care control (EUC). The intervention included a telephone-delivered induction session followed by two weeks of condition-consistent ecological momentary interventions (EMIs; 2x/day) and ecological momentary assessments (EMAs; 1x/day). Participants completed assessments at baseline, post-intervention, and two-month follow-up, and provided intervention feedback. Results: All participants completed the telephone-delivered session and elected to receive EMI messages. Average completion rate of EMAs across conditions was 92.9%. Among participants in active intervention conditions, 89.3% reported the induction session was helpful and 80.0% reported it influenced their future drinking. We also report initial alcohol use outcomes. Discussion: The behavioral economic intervention components and trial procedures evaluated here appear to be feasible and acceptable. Next steps include determination of their efficacy to reduce alcohol use and public health harms.

Feasibility trial of a technology-based intervention (TI) among men with alcohol dependence from rural settings in India.

This feasibility study utilized two-arm randomized controlled trial (RCT), conducted in a de-addiction unit of tertiary mental care setting, India, between August 2021 and January 2022. Sixty-one participants diagnosed with alcohol dependent syndrome was randomly assigned to receive TI (n = 31) or Treatment as usual (TAU) (n = 30). Participants of both groups were initially assessed for craving, quantity and frequency of alcohol consumption and severity of alcohol use. TI participants received 8 video enabled cue exposure group sessions and periodic mobile phone interventions along with text message reminders after discharge along with routine treatment at de-addiction wards. TAU group participants received only routine treatment. All the participants were followed up over 3 months post-discharge. Results showed that majority (77 %) participants attended all 8-video enabled cue exposure group sessions. Rural men were willing to engage in the program and participated in behavioral rehearsals. Mobile intervention and text messages were accepted. We observed that at 3 months follow-up TI group subjects reported lesser mean craving scores, fewer drinking days, lesser quantity of alcohol consumption and less AUDIT scores compared to TAU group participants. This study provides preliminary support for the hypotheses that it is feasible to implement technology-based alcohol intervention for men with alcohol dependence.

Feasibility, appropriateness, and acceptability of a mobile mindfulness meditation intervention to improve sleep quality among a racially/ethnically diverse population.

OBJECTIVES: To evaluate the acceptability, appropriateness, and feasibility of using a mindfulness meditation mobile application to improve sleep quality among a diverse group of adults. METHODS: This explanatory qualitative study used online focus group discussions (N = 4 groups with 17 individuals) to collect information about user experiences with a mindfulness meditation mobile application (Headspace) among participants enrolled in the MINDS study. A rapid analyses approach was used to descriptively compare motivators of app use, barriers and facilitators to app use, and perceived tailoring needs across participants. RESULTS: Participants on average were 30 years old, 88% female, and identified as Black/African American (52.9%), White (29.4%), Asian (11.8%), and Hispanic (17.6%). All participants felt the app was acceptable and appreciated the ability to personalize their app experience. Individuals with ≥50% intervention adherence (daily use for 30 days) reported being motivated to use the app because it helped them to fall asleep faster, while the remainder of participants used the app to relax throughout the day and faced external barriers to app use (eg, lack of time) and difficulty with app navigation. Only those participants who used the app exclusively in the evenings reported falling asleep faster and staying asleep. Suggestions for tailoring the app differed by race and age. Only Black/African American participants preferred using an instructor based on their race and gender. CONCLUSION: Using a mobile meditation app to enhance sleep quality is acceptable and feasible, but additional tailoring for Black/African American individuals may improve uptake in this population.

Efficacy of an mHealth self-management intervention for persons living with HIV: the WiseApp randomized clinical trial.

IMPORTANCE: Progression of HIV disease, the transmission of the disease, and premature deaths among persons living with HIV (PLWH) have been attributed foremost to poor adherence to HIV medications. mHealth tools can be used to improve antiretroviral therapy (ART) adherence in PLWH and have the potential to improve therapeutic success. OBJECTIVE: To determine the efficacy of WiseApp, a user-centered design mHealth intervention to improve ART adherence and viral suppression in PLWH. DESIGN, SETTING, AND PARTICIPANTS: A randomized (1:1) controlled efficacy trial of the WiseApp intervention arm (n = 99) versus an attention control intervention arm (n = 101) among persons living with HIV who reported poor adherence to their treatment regimen and living in New York City. INTERVENTIONS: The WiseApp intervention includes the following components: testimonials of lived experiences, push-notification reminders, medication trackers, health surveys, chat rooms, and a "To-Do" list outlining tasks for the day. Both study arms also received the CleverCap pill bottle, with only the intervention group linking the pill bottle to WiseApp. RESULTS: We found a significant improvement in ART adherence in the intervention arm compared to the attention control arm from day 1 (69.7% vs 48.3%, OR = 2.5, 95% CI 1.4-3.5, P = .002) to day 59 (51.2% vs 37.2%, OR = 1.77, 95% CI 1.0-1.6, P = .05) of the study period. From day 60 to 120, the intervention arm had higher adherence rates, but the difference was not significant. In the secondary analyses, no difference in change from baseline to 3 or 6 months between the 2 arms was observed for all secondary outcomes. CONCLUSIONS: The WiseApp intervention initially improved ART adherence but did not have a sustained effect on outcomes.

The Effectiveness of a Mobile Phone-Based Physical Activity Program for Treating Depression, Stress, Psychological Well-Being, and Quality of Life Among Adults: Quantitative Study.

BACKGROUND: Depression is a substantial global health problem, affecting >300 million people and resulting in 12.7% of all deaths. Depression causes various physical and cognitive problems, leading to a 5-year to 10-year decrease in life expectancy compared with the general population. Physical activity is known to be an effective, evidence-based treatment for depression. However, people generally have difficulties with participating in physical activity owing to limitations in time and accessibility. OBJECTIVE: To address this issue, this study aimed to contribute to the development of alternative and innovative intervention methods for depression and stress management in adults. More specifically, we attempted to investigate the effectiveness of a mobile phone-based physical activity program on depression, perceived stress, psychological well-being, and quality of life among adults in South Korea. METHODS: Participants were recruited and randomly assigned to the mobile phone intervention or waitlist group. Self-report questionnaires were used to assess variables before and after treatment. The treatment group used the program around 3 times per week at home for 4 weeks, with each session lasting about 30 minutes. To evaluate the program's impact, a 2 (condition) × 2 (time) repeated-measures ANOVA was conducted, considering pretreatment and posttreatment measures along with group as independent variables. For a more detailed analysis, paired-samples 2-tailed t tests were used to compare pretreatment and posttreatment measurements within each group. Independent-samples 2-tailed t tests were conducted to assess intergroup differences in pretreatment measurements. RESULTS: The study included a total of 68 adults aged between 18 and 65 years, who were recruited both through web-based and offline methods. Of these 68 individuals, 41 (60%) were randomly assigned to the treatment group and 27 (40%) to the waitlist group. The attrition rate was 10.2% after 4 weeks. The findings indicated that there is a significant main effect of time (F1,60=15.63; P=.003; ηp2=0.21) in participants' depression scores, indicating that there were changes in depression level across time. No significant changes were observed in perceived stress (P=.25), psychological well-being (P=.35), or quality of life (P=.07). Furthermore, depression scores significantly decreased in the treatment group (from 7.08 to 4.64; P=.03; Cohen d=0.50) but not in the waitlist group (from 6.72 to 5.08; P=.20; Cohen d=0.36). Perceived stress score of the treatment group also significantly decreased (from 2.95 to 2.72; P=.04; Cohen d=0.46) but not in the waitlist group (from 2.82 to 2.74; P=.55; Cohen d=0.15). CONCLUSIONS: This study provided experimental evidence that mobile phone-based physical activity program affects depression significantly. By exploring the potential of mobile phone-based physical activity programs as a treatment option, this study sought to improve accessibility and encourage participation in physical activity, ultimately promoting better mental health outcomes for individuals with depression and stress.

Adapting a mobile app to support patients with anorexia nervosa following post-acute care: perspectives from eating disorder treatment center stakeholders.

Introduction: Anorexia nervosa (AN) is a harmful, life-threatening illness. Patients with severe AN often receive acute treatment but, upon discharge, experience high relapse rates. Evidence-based, outpatient treatment following acute care is critical to preventing relapse; however, numerous barriers (e.g., location, financial limitations, low availability of providers) preclude individuals from accessing treatment. mHealth technologies may help to address these barriers, but research on such digital approaches for those with AN is limited. Further, such technologies should be developed with all relevant stakeholder input considered from the outset. As such, the present study aimed to garner feedback from eating disorder (ED) treatment center providers on (1) the process of discharging patients to outpatient services, (2) their experiences with technology as a treatment tool, and (3) how future mHealth technologies may be harnessed to offer the most benefit to patients in the post-acute period. Methods: Participants (N = 11, from 7 ED treatment centers across the United States) were interviewed. To analyze the data for this study, each interview was manually transcribed and analyzed using components of Braun and Clarke's six-phase thematic analysis framework (Braun & Clarke, 2006). Results: Participants indicated proactively securing outpatient care for their patients, but mentioned several barriers their patients face in accessing evidence-based ED treatment. All participants had some experience using various technologies for treatment (e.g., teletherapy, self-monitoring apps), and mentioned a high level of interest in the development of a new app to be used by patients recently discharged from acute treatment for AN. Participants also offered suggestions of effective and relevant content for a potential app and adjunctive social networking component for post-acute care of AN. Discussion: Overall, participants expressed positive attitudes toward the integration of an app into the care flow, suggesting the high potential benefit of harnessing technology to support individuals recovering from AN.

Optimization of a Transdiagnostic Mobile Emotion Regulation Intervention for University Students: Protocol for a Microrandomized Trial.

BACKGROUND: Many university students experience mental health problems such as anxiety and depression. To support their mental health, a transdiagnostic mobile app intervention has been developed. The intervention provides short exercises rooted in various approaches (eg, positive psychology, mindfulness, self-compassion, and acceptance and commitment therapy) that aim to facilitate adaptive emotion regulation (ER) to help students cope with the various stressors they encounter during their time at university. OBJECTIVE: The goals of this study are to investigate whether the intervention and its components function as intended and how participants engage with them. In addition, this study aims to monitor changes in distress symptoms and ER skills and identify relevant contextual factors that may moderate the intervention's impact. METHODS: A sequential explanatory mixed methods design combining a microrandomized trial and semistructured interviews will be used. During the microrandomized trial, students (N=200) will be prompted via the mobile app twice a day for 3 weeks to evaluate their emotional states and complete a randomly assigned intervention (ie, an exercise supporting ER) or a control intervention (ie, a health information snippet). A subsample of participants (21/200, 10.5%) will participate in interviews exploring their user experience with the app and the completed exercises. The primary outcomes will be changes in emotional states and engagement with the intervention (ie, objective and subjective engagement). Objective engagement will be evaluated through log data (eg, exercise completion time). Subjective engagement will be evaluated through exercise likability and helpfulness ratings as well as user experience interviews. The secondary outcomes will include the distal outcomes of the intervention (ie, ER skills and distress symptoms). Finally, the contextual moderators of intervention effectiveness will be explored (eg, the time of day and momentary emotional states). RESULTS: The study commenced on February 9, 2023, and the data collection was concluded on June 13, 2023. Of the 172 eligible participants, 161 (93.6%) decided to participate. Of these 161 participants, 137 (85.1%) completed the first phase of the study. A subsample of participants (18/172, 10.5%) participated in the user experience interviews. Currently, the data processing and analyses are being conducted. CONCLUSIONS: This study will provide insight into the functioning of the intervention and identify areas for improvement. Furthermore, the findings will shed light on potential changes in the distal outcomes of the intervention (ie, ER skills and distress symptoms), which will be considered when designing a follow-up randomized controlled trial evaluating the full-scale effectiveness of this intervention. Finally, the results and data gathered will be used to design and train a recommendation algorithm that will be integrated into the app linking students to relevant content. TRIAL REGISTRATION: ClinicalTrials.gov NCT05576883; https://www.clinicaltrials.gov/study/NCT05576883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46603.

Mobile Phone-Based Nutrition Education Targeting Pregnant and Nursing Mothers in Sri Lanka.

INTRODUCTION: A woman's nutrition during pregnancy and nursing affects the mother and the growing child. Similarly, the first two years of a child's life are critical to their growth and development and are facilitated by optimum nutrition. Women's nutrition-related knowledge, attitudes, and practices influence household food and nutrition security. Mobile health (mHealth) is a potentially effective health intervention in pandemic situations when physical gatherings are restricted. OBJECTIVES: To examine the effectiveness of a mobile phone-based nutrition education intervention targeting pregnant and nursing mothers in six Sri Lankan divisional secretariat areas. METHOD: This intervention was evaluated using a before and after within-subjects design. The intervention included 19 messages over four weeks sent via mobile phone, covering nutrition themes such as pregnancy care, infant and young child-feeding, diet, family care for mother and child, and cash management. The intervention was evaluated based on a quantitative survey using a structured interviewer-administered questionnaire and qualitative interviews using a semi-structured questionnaire. The study population was pregnant and nursing mothers. The objective of the qualitative interviews was to identify how respondents used messages and how satisfied they were with the project. The outcome measures were awareness/knowledge, attitudes, social norms, self-efficacy, behaviour intentions, and practices of pregnant and nursing mothers. Trained enumerators collected data using a mobile phone. RESULTS: A total of 996 pregnant and nursing mothers participated in the pre-assessment survey, of which 720 completed the post-assessment. Most were nursing mothers (84.2% pre- and 78.9% post-assessment). Participants provided positive feedback on the intervention. Knowledge/awareness (t = -18.70, p < 0.01) and attitudes (t = -2.00, p < 0.05) increased when exposed to the intervention. Favourable improvements in the practices were also observed. Mothers' practices related to breastfeeding and 24-h dietary diversity showed a statistically significant improvement. However, social norms and behaviour intentions did not significantly improve. The qualitative component also revealed favourable responses. CONCLUSION AND RECOMMENDATIONS: The mobile intervention improved participants' knowledge, awareness, attitude, and practices, but not social norms or behaviour intentions. This approach is recommended to be used on a larger scale in community settings. In addition, mobile technology could drive intervention in pandemic-related situations.

m-RESIST, a Mobile Therapeutic Intervention for Treatment-Resistant Schizophrenia: Feasibility, Acceptability, and Usability Study.

BACKGROUND: In the European Union, around 5 million people are affected by psychotic disorders, and approximately 30%-50% of people with schizophrenia have treatment-resistant schizophrenia (TRS). Mobile health (mHealth) interventions may be effective in preventing relapses, increasing treatment adherence, and managing some of the symptoms of schizophrenia. People with schizophrenia seem willing and able to use smartphones to monitor their symptoms and engage in therapeutic interventions. mHealth studies have been performed with other clinical populations but not in populations with TRS. OBJECTIVE: The purpose of this study was to present the 3-month prospective results of the m-RESIST intervention. This study aims to assess the feasibility, acceptability, and usability of the m-RESIST intervention and the satisfaction among patients with TRS after using this intervention. METHODS: A prospective multicenter feasibility study without a control group was undertaken with patients with TRS. This study was performed at 3 sites: Sant Pau Hospital (Barcelona, Spain), Semmelweis University (Budapest, Hungary), and Sheba Medical Center and Gertner Institute of Epidemiology and Health Policy Research (Ramat-Gan, Israel). The m-RESIST intervention consisted of a smartwatch, a mobile app, a web-based platform, and a tailored therapeutic program. The m-RESIST intervention was delivered to patients with TRS and assisted by mental health care providers (psychiatrists and psychologists). Feasibility, usability, acceptability, and user satisfaction were measured. RESULTS: This study was performed with 39 patients with TRS. The dropout rate was 18% (7/39), the main reasons being as follows: loss to follow-up, clinical worsening, physical discomfort of the smartwatch, and social stigma. Patients' acceptance of m-RESIST ranged from moderate to high. The m-RESIST intervention could provide better control of the illness and appropriate care, together with offering user-friendly and easy-to-use technology. In terms of user experience, patients indicated that m-RESIST enabled easier and quicker communication with clinicians and made them feel more protected and safer. Patients' satisfaction was generally good: 78% (25/32) considered the quality of service as good or excellent, 84% (27/32) reported that they would use it again, and 94% (30/32) reported that they were mostly satisfied. CONCLUSIONS: The m-RESIST project has provided the basis for a new modular program based on novel technology: the m-RESIST intervention. This program was well-accepted by patients in terms of acceptability, usability, and satisfaction. Our results offer an encouraging starting point regarding mHealth technologies for patients with TRS. TRIAL REGISTRATION: ClinicalTrials.gov NCT03064776; https://clinicaltrials.gov/ct2/show/record/NCT03064776. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2017-021346.

Co-design Tensions Between Parents, Children, and Researchers Regarding Mobile Health Technology Design Needs and Decisions: Case Study.

BACKGROUND: Just-in-time adaptive interventions (JITAIs) in mobile health are an intervention design that provides behavior change support based on an individual's changing and dynamic contextual state. However, few studies have documented how end users of JITAI technologies are involved in their development, particularly from historically marginalized families and children. Less is known for public health researchers and designers of the tensions that occur as families negotiate their needs. OBJECTIVE: We aimed to broaden our understanding of how historically marginalized families are included in co-design from a public health perspective. We sought to address research questions surrounding JITAIs; co-design; and working with historically marginalized families, including Black, Indigenous, and people of color (BIPOC) children and adults, regarding improving sun protection behaviors. We sought to better understand value tensions in parents' and children's needs regarding mobile health technologies and how design decisions are made. METHODS: We examined 2 sets of co-design data (local and web-based) pertaining to a larger study on mobile SunSmart JITAI technologies with families in Los Angeles, California, United States, who were predominantly of Latinx and multiracial backgrounds. In these co-design sessions, we conducted stakeholder analysis through perceptions of harms and benefits and an assessment of stakeholder views and values. We open coded the data and compared the developed themes using a value-sensitive design framework by examining value tensions to help organize our qualitative data. Our study is formatted through a narrative case study that captures the essential meanings and qualities that are difficult to present, such as quotes in isolation. RESULTS: We presented 3 major themes from our co-design data: different experiences with the sun and protection, misconceptions about the sun and sun protection, and technological design and expectations. We also provided value flow (opportunities for design), value dam (challenges to design), or value flow or dam (a hybrid problem) subthemes. For each subtheme, we provided a design decision and a response we ended up making based on what was presented and the kinds of value tensions we observed. CONCLUSIONS: We provide empirical data to show what it is like to work with multiple BIPOC stakeholders in the roles of families and children. We demonstrate the use of the value tension framework to explain the different needs of multiple stakeholders and technology development. Specifically, we demonstrate that the value tension framework helps sort our participants' co-design responses into clear and easy-to-understand design guidelines. Using the value tension framework, we were able to sort the tensions between children and adults, family socioeconomic and health wellness needs, and researchers and participants while being able to make specific design decisions from this organized view. Finally, we provide design implications and guidance for the development of JITAI mobile interventions for BIPOC families.

Direct Outreach in Bars and Clubs to Enroll Cigarette Smokers in Mobile Cessation Services: Exploratory Study.

BACKGROUND: Cigarette smoking and alcohol use are well known to be concomitant behaviors, but there is a lack of studies related to recruitment of smokers for mobile cessation services at places where alcohol is consumed, such as bars and clubs. Adapting recruitment strategies to expand the reach of cessation programs to where tobacco users are located may help decrease the health-equity gap in tobacco control by improving reach and enrollment of underserved smokers residing in low-income and rural areas who are not reached by traditional cessation services. OBJECTIVE: The purpose of this exploratory study was to assess the feasibility of direct outreach in bars, clubs, and restaurants to recruit smokers to Quitxt, our mobile smoking cessation service. Quitxt is delivered through SMS text messaging or Facebook Messenger. METHODS: We collaborated with an advertising agency to conduct in-person recruitment of young adult smokers aged 18-29 years, focusing on urban and rural Spanish-speaking Latino participants, as well as English-speaking rural White and African American participants. Street team members were recruited and trained in a 4-hour session, including a brief introduction to the public health impacts of cigarette smoking and the aims of the project. The street teams made direct, face-to-face contact with smokers in and near smoking areas at 25 bars, clubs, and other venues frequented by young smokers in urban San Antonio and nearby rural areas. RESULTS: The 3923 interactions by the street teams produced 335 (8.5%) program enrollments. Most participants were English speakers with a mean age of 29.2 (SD 10.6) years and smoked a mean of 8.5 (SD 6.2) cigarettes per day. Among users who responded to questions on gender and ethnicity, 66% (70/106) were women and 56% (60/107) were Hispanic/Latino. Among users ready to make a quit attempt, 22% (17/77) reported 1 tobacco-free day and 16% (10/62) reported maintaining cessation to achieve 1 week without smoking. The response rate to later follow-up questions was low. CONCLUSIONS: Direct outreach in bars and clubs is a useful method for connecting young adult cigarette smokers with mobile cessation services. However, further research is needed to learn more about how mobile services can influence long-term smoking cessation among those recruited through direct outreach, as well as to test the use of incentives in obtaining more useful response rates.