Digital Behavioral Interventions Research Articles

#DryByChristmas: A patient and public involvement study on women's engagement with humorous pelvic floor muscle training digital nudges on social media.

Patient and public involvement (PPI) is essential for women's health research. Little is known about how women engage with humorous social media and behavioural health messaging targeting pelvic floor muscle training (PFMT). This PPI aimed to understand how women engage with a humorous social media campaign encouraging PFMT. The study findings will influence the co-design of a digital intervention to support women's adherence to PFMT. The Guidance for Reporting Involvement of Patients and the Public Version 2 short form was used to report the study's findings. The study examined public engagement with a humorous social media campaign encouraging PFMT in women. A healthcare professional and comedian ran the campaign following the national guidelines for engagement in PFMT. Instagram analytics gave insight into the demographics of the public who engaged, how they engaged and the most popular content. The behaviour change techniques (BCTs) used in the digital nudges that generated the highest levels of engagement were analysed using the Capability Opportunity Motivation Behaviour Change Wheel. The majority (96%) of the population showing the highest levels of engagement were women aged 35-44 years and were based in the United Kingdom (77%). The Instagram account saw an increase in engagement by 12% over the 3-month campaign, with 22,032 users seeing digital nudges and 2645 engaging with the digital nudges. The preferred way of engaging was using Likes (9723). The common themes in the digital nudges that generated the highest levels of engagement were BCTs associated with the 'social influences' theoretical domain framework that targeted the core behaviour opportunity. The study findings suggest humour may improve women's engagement with online PFMT programmes; however, more rigorous research is required to better understand diverse women's experiences of humorous online PFMT nudges. Future studies may use PFMT mobile apps instead of social media to capture true user engagement and adherence to PFMT more accurately. The insights gained from the study will be taken forward to co-design a digital behavioural intervention as part of a larger study. Members of the public were involved in the co-design of a digital health intervention that will be trialled as part of a larger research study. The public was involved using the social media platform Instagram. Public engagement with a humorous social media campaign to encourage women to engage with pelvic floor exercises was captured using Instagram analytics, for example, the timing of engagement.

Distributive randomization: a pragmatic fractional factorial design to screen or evaluate multiple simultaneous interventions in a clinical trial

BackgroundIn some medical indications, numerous interventions have a weak presumption of efficacy, but a good track record or presumption of safety. This makes it feasible to evaluate them simultaneously. This study evaluates a pragmatic fractional factorial trial design that randomly allocates a pre-specified number of interventions to each participant, and statistically tests main intervention effects. We compare it to factorial trials, parallel-arm trials and multiple head-to-head trials, and derive some good practices for its design and analysis.MethodsWe simulated various scenarios involving 4 to 20 candidate interventions among which 2 to 8 could be simultaneously allocated. A binary outcome was assumed. One or two interventions were assumed effective, with various interactions (positive, negative, none). Efficient combinatorics algorithms were created. Sample sizes and power were obtained by simulations in which the statistical test was either difference of proportions or multivariate logistic regression Wald test with or without interaction terms for adjustment, with Bonferroni multiplicity-adjusted alpha risk for both. Native R code is provided without need for compiling or packages.ResultsDistributive trials reduce sample sizes 2- to sevenfold compared to parallel arm trials, and increase them 1- to twofold compared to factorial trials, mostly when fewer allocations than for the factorial design are possible. An unexpectedly effective intervention causes small decreases in power (< 10%) if its effect is additive, but large decreases (possibly down to 0) if not, as for factorial designs. These large decreases are prevented by using interaction terms to adjust the analysis, but these additional estimands have a sample size cost and are better pre-specified. The issue can also be managed by adding a true control arm without any intervention.ConclusionDistributive randomization is a viable design for mass parallel evaluation of interventions in constrained trial populations. It should be introduced first in clinical settings where many undercharacterized interventions are potentially available, such as disease prevention strategies, digital behavioral interventions, dietary supplements for chronic conditions, or emerging diseases. Pre-trial simulations are recommended, for which tools are provided.

The impact of COVID-19 on trial participants' engagement with IBD-BOOST: a digital cognitive behavioural intervention

Background/Aims: The COVID-19 pandemic coincided with a randomised-controlled trial of an online-supported self-management intervention for fatigue, pain and urgency in inflammatory bowel disease (IBD). The aim of the present study was to investigate how the pandemic affected engagement with the IBD-BOOST programme. Methods: Intervention participants were invited to complete an online survey at 6-month follow-up, including both pre-defined and open-ended questions. A mixed methods quantitative and qualitative analyses were conducted. People who had participated in the online intervention (n= 354) were invited to answer questions about the impact of COVID-19 on their ability to engage with the online intervention Results: A total of 171 (48.31%) responded to the survey, with their experiences of the pandemic encompassing both negative and positive impacts on their engagement, as well as those who felt that the pandemic had no impact. For those who reported negative impact (19.30%): the pandemic created additional work and home-life responsibilities, the pandemic-induced emotional and psychological burden contributed to decreased participation, and engagement was reduced due to direct COVID-19 infection. For those who reported a positive impact (9.94%): the pandemic allowed for increased time availability due to pandemic-induced lifestyle changes. For those who felt the pandemic had no impact (50.29%): adaptability helped to maintain their engagement. The remaining 20.47% of participants reported that they were uncertain, or that their involvement varied. Conclusion: For some participants, the pandemic negatively impacted their engagement. However, 60% reported that the pandemic had either no or a positive impact on their engagement with IBD-BOOST, indicating the resilience of online delivery of behavioural interventions.

Feasibility and Acceptability of Digital Behavioral Interventions Among Black and Hispanic Patients With Inflammatory Bowel Disease: A Randomized Pilot Study.

Lay Summary The use of digital behavioral interventions was tested among patients with inflammatory bowel disease with a predominately low-income, Black/Hispanic background who had elevated symptoms of anxiety/depression. Both mood-tracking and cognitive behavioral self-management applications were feasible and acceptable to use, with opportunities for improvement identified.

Developing Message Strategies to Engage Racial and Ethnic Minority Groups in Digital Oral Self-Care Interventions: Participatory Co-Design Approach.

The prevention of oral health diseases is a key public health issue and a major challenge for racial and ethnic minority groups, who often face barriers in accessing dental care. Daily toothbrushing is an important self-care behavior necessary for sustaining good oral health, yet engagement in regular brushing remains a challenge. Identifying strategies to promote engagement in regular oral self-care behaviors among populations at risk of poor oral health is critical. The formative research described here focused on creating messages for a digital oral self-care intervention targeting a racially and ethnically diverse population. Theoretically grounded strategies (reciprocity, reciprocity-by-proxy, and curiosity) were used to promote engagement in 3 aspects: oral self-care behaviors, an oral care smartphone app, and digital messages. A web-based participatory co-design approach was used to develop messages that are resource efficient, appealing, and novel; this approach involved dental experts, individuals from the general population, and individuals from the target population-dental patients from predominantly low-income racial and ethnic minority groups. Given that many individuals from racially and ethnically diverse populations face anonymity and confidentiality concerns when participating in research, we used an approach to message development that aimed to mitigate these concerns. Messages were initially developed with feedback from dental experts and Amazon Mechanical Turk workers. Dental patients were then recruited for 2 facilitator-mediated group webinar sessions held over Zoom (Zoom Video Communications; session 1: n=13; session 2: n=7), in which they provided both quantitative ratings and qualitative feedback on the messages. Participants interacted with the facilitator through Zoom polls and a chat window that was anonymous to other participants. Participants did not directly interact with each other, and the facilitator mediated sessions by verbally asking for message feedback and sharing key suggestions with the group for additional feedback. This approach plausibly enhanced participant anonymity and confidentiality during the sessions. Participants rated messages highly in terms of liking (overall rating: mean 2.63, SD 0.58; reciprocity: mean 2.65, SD 0.52; reciprocity-by-proxy: mean 2.58, SD 0.53; curiosity involving interactive oral health questions and answers: mean 2.45, SD 0.69; curiosity involving tailored brushing feedback: mean 2.77, SD 0.48) on a scale ranging from 1 (do not like it) to 3 (like it). Qualitative feedback indicated that the participants preferred messages that were straightforward, enthusiastic, conversational, relatable, and authentic. This formative research has the potential to guide the design of messages for future digital health behavioral interventions targeting individuals from diverse racial and ethnic populations. Insights emphasize the importance of identifying key stimuli and tasks that require engagement, gathering multiple perspectives during message development, and using new approaches for collecting both quantitative and qualitative data while mitigating anonymity and confidentiality concerns.

Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platform

BackgroundGerm Defence (www.germdefence.org) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19, the intervention needed to be implemented at scale rapidly.MethodsWith NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm (n = 3292) were emailed and asked to disseminate Germ Defence to all adult patients via mobile phone text, email or social media. Usual care arm GP practices (n = 3287) maintained standard management for the 4-month trial period and then asked to share Germ Defence with their adult patients. The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses and suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage and hospital admissions. The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of the intervention by GP practice and by patients was measured via website analytics.ResultsGerm Defence was used 310,731 times. The average website satisfaction score was 7.52 (0–10 not at all to very satisfied, N = 9933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95% CI 0.96, 1.06, p = 0.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0 to 48% of a practice list.ConclusionsWhile the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment.Trial registrationThis trial was registered in the ISRCTN registry (14602359) on 12 August 2020.

Digital Behavioural Interventions to Reduce Opioid Use in Chronic Non-Cancer Pain Patients: A Systematic Review

Abstract Introduction Opioid medications have become increasingly prevalent in the treatment of chronic non-cancer pain1. This increase in opioid usage has given rise to the ‘Opioid Crisis’ which refers to the significant increase in overdose, addiction, and deaths in the USA and Canada particularly2. Furthermore, the World Health Organisation has declared there to have been approximately 0.5 million deaths in relation to drug use worldwide, with more than 70% of those deaths related to opioids3. Advances in technology have paved the way for the use of digital behavioural interventions, such as mobile applications, virtual reality, and online therapies, to potentially mitigate opioid use in patients suffering from chronic non-cancer pain. These interventions aim to assist individuals in modifying health behaviours to promote overall well-being and may serve as a preventive measure against the detrimental effects of long-term opioid use. Aim This systematic review aimed to evaluate the current evidence regarding the effectiveness of digital behavioural interventions in reducing opioid use among chronic non-cancer pain patients. Methods A comprehensive search was conducted in three electronic databases (MEDLINE, EMBASE, and Web of Science) using specific search terms. Primary outcomes focused on opioid usage measurements, while secondary outcomes pertained to pain measurements. Eligible studies included adult patients with chronic non-cancer pain (excluding cancer/palliative patients) who received opioid prescriptions and engaged in digital behavioural interventions in any setting. Two researchers double-screened eligible studies based on titles and abstracts, excluding duplicates and those not meeting the eligibility criteria. Data extraction was performed, and study quality was assessed using the Cochrane Risk of Bias Tool (double-screened). Ethical approval was not required as this study was a systematic review. Results Out of 30,388 articles identified, six studies conducted in the USA met the inclusion criteria. Risk of bias assessment revealed one study with a low risk, two with some concerns, and the majority with a high risk of bias. The publication dates of the identified papers ranged from 2016 to 2021. There was an overall participant population of 605. The interventions included virtual reality, mobile health applications, web-based cognitive-behavioural therapy, guided audio-visual relaxation, and an electronic health toolkit. Two studies reported a specific reduction in opioid use, while three studies did not provide direct measurements for opioid use. However, these studies indicated a reduction in opioid analgesic usage by reporting either over-the-counter analgesic measures or a Current Opioid Misuse Measure score. Discussion/Conclusion This systematic review was conducted in response to the need for updated pain management strategies. The literature suggests that digital behavioural interventions hold promise for reducing opioid use among chronic non-cancer pain patients. However, due to limitations in the included studies, such as sample size, heterogeneity, and potential bias, further research is needed to fully understand their effectiveness. Future studies should focus on optimising the design and delivery of the interventions tailored to this patient population. Continued research in this area has the potential to address the societal burden of opioid misuse and improve patients' quality of life.

A Randomized Clinical Trial Testing the Effect of Digital Behavioral Interventions on Pain and Mental Health Among Adults with Sickle Cell Disease

Background: Patients with sickle cell disease (SCD) suffer a significant disease burden that affects their psychosocial well-being. Digital cognitive-behavioral therapy (CBT) has been utilized in other patient populations and shown to have clinical benefits. Although evidence-based, non-pharmacological interventions for pain management are widely used in other populations, this is not well studied in SCD. There are currently no large-scale, adequately powered clinical trials that evaluate the effectiveness and dissemination potential of digital behavioral pain management interventions for adults with SCD. Objective: The primary goal was to compare the effectiveness of two mobile-phone-delivered programs: 1) digital CBT program tailored for adults with SCD (CBT); or 2) pain and SCD education (Education) for reducing pain symptoms. The secondary goal was to assess whether baseline depression symptoms moderated the effect of these interventions on pain outcomes. Methods: Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell via Mobile Application (CaRISMA) is a multisite, randomized, pragmatic, comparative effectiveness trial conducted at seven comprehensive sickle cell centers and several community-based organizations in the U.S. The study enrolled adults with SCD who reported chronic pain or using short or long-acting opioids daily. Participants were randomized in a 1:1 ratio to receive either the CBT or Education programs. Both programs utilized identical Facebook Messenger chatbot apps, only the content differed. All intervention participants received health coach support involving weekly phone calls or text messages for a duration of 12 weeks. Participants completed follow up assessments at 3 and 6 months, and daily e-diary entries of 0-10 pain numerical rating scale, mood, and opioid use. The primary outcome was the 6-month change in the PROMIS pain interference. Secondary outcomes included average daily pain intensity for a 2-week period at each time point, change in mean % body area affected by pain (measured by a ‘paintable’ body image within the mobile app), PHQ-9 depression, GAD-7 anxiety, Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) quality of life (social functioning and emotional impact), and Sickle Cell Self-Efficacy Scale (SCSES). Generalized linear mixed models were used to compare changes in 6-month outcomes between study arms after accounting for design variables (study site and baseline depression). Results: Of the 574 participants screened for eligibility, 359 (63%) were consented and randomized (178 to CBT and 181 to Education). Seventy-five percent of participants connected with the chatbot but only 47% completed at least one CBT/education lesson. However, 80% of participants had at least one text message, phone or video session with a health coach. At 6-months, there was a significant decline in pain interference within each arm (CBT [-2.13, 95%CI (-3.42, -0.84)] and Education [-2.66, 95%CI (-3.97, -1.36)]); however, this decline did not differ between arms (p=0.57). There was not a significant 6-month change in daily pain intensity for either arm, however, for % body area covered in pain, both CBT and education conferred a similar relative decrease, 19.2% and 17.1%, respectively. There were significant 6-month improvements within-arms for PHQ-9, GAD-7, and both ASCQ-Me measures, but no between-arm differences emerged. (Table 1). Of these, only the 6-month change in ASCQ-Me emotional impact approached a significant difference between arms with digital CBT conferring slightly greater improvement in scores, 3.51 (95%CI: 2.29, 4.73) compared to education,1.79 (95%CI: .55, 3.04; p=.05). Baseline PHQ depression score (&amp;gt;= 10 vs &amp;lt; 10) did not moderate the effect of treatments on pain interference (p=0.52). Conclusions: Preliminary trial findings suggest that both digital CBT and Education, with health coach support, are effective approaches for management of SCD pain and mental health symptoms. Most participants connected with a health coach and may have derived benefit from this support, however, poor engagement with the digital CBT and education component of the study may have limited the study's ability to detect between arm differences. Secondary analyses will examine the effect of intervention engagement on treatment outcomes.

SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery

BackgroundMood disorders (anxiety, depression), sleep disorders, and catastrophizing lead to increased post-operative pain perception, increase in postoperative opioid consumption, decreased engagement with physical activity, and increased resource utilization in surgical patients. Psychosocial disorders significantly affect postoperative outcome. Unfortunately, studies focused on perioperative psychological assessment and treatment are scarce. We propose to test whether digital cognitive behavioral intervention (dCBI) can help surgical patients. dCBI such as RxWell™ is a proven treatment for mood disorders in medical patients such as reducing depression in patients with inflammatory bowel disease. We hypothesize that RxWell™ will also be effective in surgical patients. This study aims to test whether RxWell™ can improve preoperative mood disorders and subsequently reduce postoperative pain and opioid requirement in patients scheduled for primary total hip and knee arthroplasty (THA, TKA). We named the trial as the SuRxgWell trial.MethodsThis is a randomized, controlled trial that will enroll primary and unilateral THA or TKA patients with anxiety and/or depression symptoms before surgery to receive the SuRxgWell dCBI program and investigate its impact on postoperative outcomes including postoperative pain, anxiety, depression, sleep disorder, and catastrophizing. After signing an informed consent, subjects will be screened using the PROMIS questionnaires, and subjects with a T-score of ≥ 60 on the short Patient-Reported Outcomes Measurement Information System (PROMIS) 4a Anxiety and/or short PROMIS 4a Depression questionnaires will be randomized to either usual care (control group) or the cognitive behavioral intervention, RxWell™, plus usual care (intervention group). The control group will receive information on how to locate tools to address anxiety and depression, whereas the intervention group will have access to SuRxgWell 1 month prior to surgery and up to 3 months after surgery. The allocation will be 3:1 (intervention to control). Investigators will be blinded, but research coordinators approaching patients and research subjects will not.The primary outcome will be day of surgery anxiety or depression symptoms measured with the PROMIS Short Form v1.0 -Anxiety 4a/Depression and Generalized Anxiety Disorder Measure (GAD-7) and Patient Health Questionnaire (PHQ-8). Secondary end points include measuring other health-related quality of life outcomes including sleep disturbance, fatigue, ability to participate in social roles, pain interference, cognitive function, pain catastrophizing, and physical function. Other secondary outcomes include collecting data about preoperative and postoperative pain scores, and pain medication usage, and orthopedic functional recovery at baseline, day of surgery, and 1, 2, and 3 months after the surgery with the Pain Catastrophizing Scale, the Knee injury and Osteoarthritis Outcome Score (KOOS), and Hip injury and Osteoarthritis Outcome Score (HOOS). In addition, subjects will be asked to complete a GAD-7 and PHQ-8 questionnaires bi-weekly (via the RxWell™ app for the interventional group or REDCAP for the control group). Data about postsurgical complications, and resource utilization will also be recorded. We will also receive monthly reports measuring the usage and engagement of RxWell use for each participant randomized to that arm. The primary hypotheses will be assessed with intention-to-treat estimates, and differences in primary outcome will be tested using independent two sample t-tests. This trial is registered to the ClinicalTrials.gov database (NCT05658796) and supported by the DAPM, UPMC Health Plan, and the NIH.DiscussionOur trial will evaluate the feasibility of digital cognitive behavioral intervention as a perioperative tool to improve anxiety and depression before and after major orthopedic surgery in comparison to education. If digital cognitive behavioral intervention proves to be effective, this might have important clinical implications, reducing the incidence of chronic postsurgical pain and improving outcomes.

Digital Adaptive Behavioral Interventions to Improve HIV Prevention and Care: Innovations in Intervention Approach and Experimental Design.

Recent advances in digital technologies can be leveraged to adapt HIV prevention and treatment services to the rapidly changing needs of individuals in everyday life. However, to fully take advantage of these technologies, it is critical to effectively integrate them with human-delivered components. Here, we introduce a new experimental approach for optimizing the integration and adaptation of digital and human-delivered behavioral intervention components for HIV prevention and treatment. Typically, human-delivered components can be adapted on a relatively slow timescale (e.g., every few months or weeks), while digital components can be adapted much faster (e.g., every few days or hours). Thus, the systematic integration of these components requires an experimental approach that involves sequential randomizations on multiple timescales. Selecting an experimental approach should be motivated by the type of adaptive intervention investigators would like to develop, and the scientific questions they have about its construction.

Communicative accessibility and prospective acceptability of a digital behavioural activation intervention for people with aphasia

ABSTRACT Background Behavioural Activation (BA) is a mental health treatment that encourages a person to develop or re-engage in activities that are pleasurable and meaningful to them. It is important to consider the ways such interventions can be made accessible and acceptable to individuals with communication disabilities like aphasia after stroke. Digital technologies may provide a scalable approach to increasing dissemination of BA to this population. Aims The aim of this study was to examine the communicative accessibility and prospective acceptability of a digital BA intervention developed for this population. Methods & Procedures A qualitative research design was used, involving semi-structured interviews with 11 people with aphasia caused by stroke. Data were subject to qualitative content analysis. Outcomes & Results The results suggest that participants found the developed intervention to be both overall accessible and acceptable. Participants suggested improvements that highlighted the importance of considering how an individual’s psychosocial and cognitive experience of stroke aphasia may influence their preferences for intervention layout and content. Conclusions Results of our study reiterated the importance of a user-centred design process to ensure the accessibility and acceptability of digital interventions. This work provides the foundation for ongoing design of the intervention. The continued development may also provide a framework for future development of accessible and acceptable digital interventions not only for those living with aphasia after stroke but others living with acquired language or cognitive disabilities.

Barriers and Enablers to Implementing a Smoke-free Home and Car During Pregnancy: A Qualitative Study Among Expectant Israeli Fathers.

Secondhand smoke exposure during pregnancy is a significant cause of negative health effects. This study aims to identify barriers and facilitators for implementing a smoke-free home and car among expectant Israeli fathers. Twenty-four qualitative semistructured telephone interviews were audio-recorded, transcribed, and analyzed according to a reflexive and collaborative thematic approach. Inclusion criteria were being male, Hebrew speaker, age ≥18 years, smoking at least one cigarette a day, and living with their nonsmoking pregnant spouse. The Capability, Opportunity and Motivation for Behavior (COM-B) model was used as a theoretical model for analysis. Participants reported feeling a strong responsibility for their pregnant spouse's comfort and health, stating that they are doing the best they can to reduce their spouse's secondhand smoke exposure (Motivation). Participants had a low level of knowledge about specific secondhand smoke health consequences, effective strategies to reduce secondhand smoke exposure, with incorrect perceptions about what constitutes exposure (Capability). Couple relationships were not affected by the husband's smoking habits, and participants expressed mutual consideration and understanding (Opportunity). Participants also expressed positive attitudes regarding smoke-free home and car implementation but emphasized that any changes have to be their own decision (Motivation). The present study identified principal Capability, Opportunity and Motivation barriers and facilitators that influence Israeli expectant fathers' decision to implement a smoke-free home and car. Those findings will inform the development of a digital behavioral intervention targeting expectant fathers to reduce prenatal secondhand smoke exposure. Secondhand smoke exposure during pregnancy is a significant cause of negative health effects. Interventions among expectant fathers that focus on creating a smoke-free home and car may be effective because pregnancy has been identified as a "window of opportunity" that generates a strong motivation and creates a sense of urgency to change smoking behavior, while being considered more achievable than smoking cessation. Interventions might be effective if they focus on strengthening the parental responsibility among expectant fathers and emphasize the benefits of a smoke-free home and car, while maintaining male autonomy and increasing skills to effectively implement a smoke-free home and car.

646-P: Improved Metabolic Outcomes in Individuals with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease after a Digital Intervention

Nonalcoholic fatty liver disease (NAFLD) is a common comorbidity among individuals with type 2 diabetes mellitus (T2DM). The aim of this study was to test the feasibility and efficacy of a digital intervention to improve metabolic outcomes for patients with T2DM and NAFLD. A single-arm study was conducted in Iceland. Participants were provided with a 12-week digital behavioral intervention via the Sidekick app, focused on health education and lifestyle coaching, reducing carbohydrate intake, increasing physical activity, and improving mental health. Individuals with NAFLD and either BMI&amp;gt;30, metabolic syndrome, or T2DM were recruited; here we present a sub-analysis of participants with T2DM. The primary outcome was feasibility, as measured by user retention and engagement; secondary outcomes were changes in anthropometric and clinical measures from baseline to post-program. Out of 38 recruited participants, 19 (50%) had T2DM (mean age 61.1 (SD 10.8) years, 10 (53%) female) and 18/19 (95%) completed the program. The 19 participants were active for a median of 7 days/week (IQR 4.76-7.0). Mean weight reduction was 3.9 kg (SD 4.1, p&amp;lt;0.001) and the average fat mass reduced by 2.4 kg (SD 2.9, p=0.002); a 4.9% relative change (SD 6.3). The median decrease in HbA1c levels was 4.0 mmol/mol (IQR -0.5, 5.0, p=0.05), fasting insulin decreased by 4.8 µU/ml (SD 9.2, p=0.03), and HOMA-IR by 2 mmol/L (SD 3.7, p=0.03). Mean systolic blood pressure reduced by 9.1 mmHg (SD 16.6, p=0.03), and relative liver fat by 18.6% (SD 25.3, p&amp;lt;0.01). These changes were not explained by changes in prescriptions or dosages, nor by self-reported medication adherence, and were not different between patients with or without T2DM. At the end of the 12-week digital intervention, participants with T2DM had improved glucose metabolism, liver fat values and body composition, suggesting that this digital intervention can help individuals with T2DM and NAFLD achieve better metabolic outcomes. Disclosure S. Bjornsdottir: Research Support; Sidekick Health, Reykjavik, Iceland. H. Úlfsdóttir: Employee; Sidekick Health. B. Dobies: Employee; Sidekick Health. E.F. Gudmundsson: Employee; Sidekick Health. K. Sveinsdottir: Employee; Sidekick Health. A.P. Isberg: Employee; Sidekick Health. G. Bjornsdottir: None. S. Sigurdsson: None. V. Gudnason: None.

The Good Talk! A Serious Game to Boost People's Competence to Have Open Conversations About COVID-19: Protocol for a Randomized Controlled Trial.

Vaccine hesitancy is one of the many factors impeding efforts to control the COVID-19 pandemic. Exacerbated by the COVID-19 infodemic, misinformation has undermined public trust in vaccination, led to greater polarization, and resulted in a high social cost where close social relationships have experienced conflict or disagreements about the public health response. The purpose of this paper is to describe the theory behind the development of a digital behavioral science intervention-The Good Talk!-designed to target vaccine-hesitant individuals through their close contacts (eg, family, friends, and colleagues) and to describe the methodology of a research study to evaluate its efficacy. The Good Talk! uses an educational serious game approach to boost the skills and competences of vaccine advocates to have open conversations about COVID-19 with their close contacts who are vaccine hesitant. The game teaches vaccine advocates evidence-based open conversation skills to help them speak with individuals who have opposing points of view or who may ascribe to nonscientifically supported beliefs while retaining trust, identifying common ground, and fostering acceptance and respect of divergent views. The game is currently under development and will be available on the web, free to access for participants worldwide, and accompanied by a promotional campaign to recruit participants through social media channels. This protocol describes the methodology for a randomized controlled trial that will compare participants who play The Good Talk! game with a control group that plays the widely known noneducational game Tetris. The study will evaluate a participant's open conversation skills, self-efficacy, and behavioral intentions to have an open conversation with a vaccine-hesitant individual both before and after game play. Recruitment will commence in early 2023 and will cease once 450 participants complete the study (225 per group). The primary outcome is improvement in open conversation skills. Secondary outcomes are self-efficacy and behavioral intentions to have an open conversation with a vaccine-hesitant individual. Exploratory analyses will examine the effect of the game on implementation intentions as well as potential covariates or subgroup differences based on sociodemographic information or previous experiences with COVID-19 vaccination conversations. The outcome of the project is to promote more open conversations regarding COVID-19 vaccination. We hope that our approach will encourage more governments and public health experts to engage in their mission to reach their citizens directly with digital health solutions and to consider such interventions as an important tool in infodemic management. PRR1-10.2196/40753.

Efficacy of a digital mental health intervention embedded in routine care compared with treatment as usual in adolescents and young adults with moderate depressive symptoms: protocol for randomised controlled trial

IntroductionThere are unmet mental health needs of depressed adolescents and young adults (AYAs) across the USA. Behavioural technology adequately integrated into clinical care delivery has potential to improve care access...

Digital Behavioral Activation Interventions During the Perinatal Period: Scoping Review.

Pregnancy is a complex period that implies many biopsychosocial changes, and the way women adapt to these changes impacts their well-being and the chances of developing mental health problems. During the perinatal period, women have expressed a preference for support delivered on the web. In this regard, interventions such as behavioral activation (BA), which are brief and structured psychosocial interventions, seem particularly suited to be delivered through digital solutions. This study aimed to map the literature investigating digital BA interventions deployed during the perinatal period. We paid particular attention to the methodological underpinnings of the studies, the potential impact of BA interventions on symptoms other than depression, and the existence of differences occurring when these interventions were administered during pregnancy versus the postpartum period. A systematic search compliant with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews) guidelines was conducted considering 5 bibliographic databases; reference lists and key journals were also screened by 2 independent authors following a double-blind approach. A total of 7 studies published between 2013 and 2022 were included. In total, 2 studies were protocols for randomized controlled trials, 5 were empirical studies, and 1 was a qualitative study. All studies focused on the postpartum period, except for 1 that focused on the broader perinatal period. Promising effects on depression symptoms were reported but not on other psychosocial symptoms. Low intervention adherence has emerged, whereas the usability associated with the digital means used to deploy interventions was scarcely addressed; moreover, information on the digital platforms used was poorly reported overall. Our findings highlight the scarcity and preliminary nature of digital BA interventions deployed during the perinatal period, where the focus seems more on treatment rather than prevention. Moreover, future studies should also consider and address usability and user engagement, given their relevance to intervention efficacy.

HIDRATE-PRO: A prospective pilot study evaluating a digital behavioral health intervention to improve bladder-filling compliance in patients with prostate cancer receiving radiation.

70 Background: Prostate cancer (PCa) patients undergoing radiation therapy (RT) need comfortably full bladders during RT to reduce toxicities. Awareness of this state is lacking, and poor compliance is common with standard of care written/verbal instructions, leading to wasted patient value (PV) and inefficient throughput (TE). Herein, we assessed the feasibility and acceptability of a digital behavioral intervention (DBI) to improve bladder filling compliance, methods for quantifying PV, IT, and behavioral biomarkers. Methods: We enrolled 18 non-metastatic PCa patients in a prospective, single-arm pilot study using a DBI. The DBI consists of a smart water bottle and companion app that tracks water consumption. Additionally, visual alerts (water bottle glow and phone notifications) remind the patient to empty his bladder and drink a personalized volume goal (VG) at a set time. The VG is based on simulation bladder volume and reminders are initially set 1.25 hours prior to scheduled RT. Patients were trained to adjust their VG and notification times to achieve comfortably full bladders. Primary endpoint was met if qualitative (QLC) and quantitative compliance (QNC) were both &gt;80%. Other endpoints include acceptability assessed via Service User Technology Acceptability Questionnaire (SUTAQ), engagement (&gt;80% of patients used the device &gt; 50% of the time) and impact of DBI on PV and TE. For QLC, patients were asked if they prepared their bladders before daily RT. QNC was met if bladder volumes on daily CBCT were &gt; 75% of the simulation’s volume. The SUTAQ was given pre- and post-DBI. PV and TE were measured by time spent in clinic and on the linear accelerator (linac), respectively. Biometric data was probed for insights on optimal drinking behaviors. Results: All endpoints were met. QLC was 100% on 375/398 (94.2%) of total treatments, while QNC was 88.9% on 341/398 (85.7%) total treatments. Patients were accepting of DBI with few privacy concerns (4.33/5.00), believe in benefits (4.00/5.00), high satisfaction (4.56/5.00) and high usability (4.24/5.00). Most patients, 15/18 (83.3%), used the DBI on &gt;50% of treatments and met the engagement requirements. Patients with empty bladders (n=43) spent significantly more time (75.14 vs 50.59 minutes, p=0.007) in clinic than patients who came with full bladders (n=355). Similarly, these patients spent nearly twice as long on the linac (21.63 v 12.50 minutes, p&lt;0.001). Shorter time spent drinking correlated with empty bladders (17.07 vs 27.85 min, p=0.027). Conclusions: This digital intervention trial showed high rates of bladder filling compliance and engagement. High patient-value and throughput efficiency was feasibly quantified by shortened clinic times and linac usage, respectively. Future studies are needed to evaluate clinical outcomes, patient experience and cost benefit. Clinical trial information: NCT04946214 .

Acceptability and preliminary effectiveness of a single-arm 12-week digital behavioral health intervention in patients with knee osteoarthritis

BackgroundDigital health interventions may improve osteoarthritis (OA) management. This study evaluated the acceptability and preliminary effectiveness of a multimodal digital nutrition, exercise, and mindfulness intervention in adults with knee OA.MethodsAdults with advanced knee OA and an orthopaedic referral were invited to self-enroll in a pragmatic 12-week single-arm intervention. OA-focused nutrition and exercise resources were delivered weekly by email, and secondary components accessed on-demand (web-platform, webinars, and nutrition consultation). Acceptability was assessed by qualitative interview data and completion rates. Preliminary effectiveness on clinical outcomes was assessed by change in health-related quality of life, well-being, mindfulness, self-efficacy, and interest in total knee arthroplasty (TKA) between baseline and 12-weeks.ResultsN = 102 patients self-enrolled (73.5% female, age 64 ± 7 years, body mass index 32.9 ± 7.3 kg/m2); n = 53 completed the 12-week intervention (71.7% female, age 65 ± 7 years, body mass index 33.4 ± 6.3 kg/m2). Acceptability was demonstrated by positive perceptions of tailored intervention resources. In study completers, health-related quality of life components of pain and physical functioning domains improved at 12-weeks [change in SF36 4.4 (95%CI 0.2–8.6), p = 0.016, and 6.7 (95%CI 2.7–10.7), p < 0.001, respectively]. Self-efficacy for managing daily activities improved [change in PROMIS T-score 4.4 (95%CI 2.8–6.0), p < 0.001].ConclusionA 12-week digital multimodal intervention for knee OA was acceptable to patients and shows preliminary effectiveness in improving self-efficacy, aspects of quality of life, and decreasing interest in TKA. Digital behavioral interventions for knee OA may be an acceptable approach to improve patient outcomes and OA self-management while potentially reducing utilization of costly health system resources.

Development of a Digital Behavioral Intervention to Reduce the Consumption of Sugar-Sweetened Beverages Among Rural Appalachian Adults: Multiphased, Human-Centered Design Approach

To avoid the low engagement and limited efficacy of digital behavioral health interventions, robust human-centered design (HCD) processes are needed. The primary objective of this study was to describe a flexible, step-by-step HCD process to develop digital behavioral health interventions by illustrating iSIPsmarter as an example. iSIPsmarter is a digital intervention for reducing the consumption of sugar-sweetened beverages (SSBs) that comprises 6 internet-based cores metered out over time to deliver the program content, an integrated SMS text message strategy to engage users in reporting SSB behaviors, and an electronic cellular-enabled scale for in-home weighing. The secondary objective is to illustrate the key components and characteristics of iSIPsmarter that resulted from the HCD process. The methods were guided by the Model for Internet Interventions and by best practices in HCD and instructional design processes (eg, rapid prototype development and think-aloud protocol). The 3-phased (ie, contextual, prototype testing, end user testing phases) process followed in this study included a series of 13 semistructured one-on-one interviews with 7 advisory team participants from the targeted Appalachian user group. The interviews were content coded by 2 researchers and then deductively coded to the suggested areas of digital behavioral health interventions. The participants provided rich perspectives pertaining to iSIPsmarter's appearance, behavioral prescriptions, burdens, content, delivery, message, participation, and assessment. These inputs included requests for built-in flexibility to account for varying internet and SMS text message accessibility among users; ideas to resolve the issues and problems encountered when using the prototypes, including those related to navigation and comprehension of content; ideas to enhance personalized feedback to support motivation and goal setting for SSB consumption and weight; and feedback to refine the development of realistic and relatable vignettes. The participants were able to interact with multiple prototype drafts, allowing researchers to capture and incorporate feedback related to the iSIPsmarter dashboard, daily SSB and weight diaries, action planning, core content, interactions, and vignettes. Using scientific models and established processes is critical for building robust and efficacious interventions. By applying an existing model and HCD and instructional design processes, we were able to identify assumptions and address the key areas of the iSIPsmarter intervention that were hypothesized to support users' engagement and promote behavior change. As evidenced by the rich feedback received from the advisory team members and the resulting iSIPsmarter product, the HCD methodology was instrumental in the development process. Although the final iSIPsmarter content is specific to improving SSB consumption behaviors among adults in rural areas, the intent is that this HCD process will have wide applications in the development of digital behavioral health interventions across multiple geographic and behavioral contexts.

Using Digital Health Technology to Prevent and Treat Diabetes.

Using Digital Health Technology to Prevent and Treat Diabetes.