Digital Behavioral Interventions Research Articles

Self-monitoring of blood pressure following a stroke or transient ischaemic attack (TASMIN5S): a randomised controlled trial

BackgroundBlood pressure (BP) control following stroke is important but currently sub-optimal. This trial aimed to determine whether self-monitoring of hypertension with telemonitoring and a treatment escalation protocol, results in lower BP than usual care in people with previous stroke or transient ischaemic attack (TIA).MethodsUnblinded randomised controlled trial, comparing a BP telemonitoring-based intervention with control (usual care) for hypertension management in 12 primary care practices in England. People with previous stroke or TIA with clinic systolic BP 130–180 mmHg, taking ≤ 3 antihypertensive medications and on stable treatment for at least four weeks were randomised 1:1 using secure online system to intervention or control. The BP:Together intervention comprised self-monitoring of blood pressure with a digital behavioural intervention which supported telemonitoring of self-monitored BP with feedback to clinicians and patients regarding medication titration. The planned primary outcome was difference in clinic measured systolic BP 12 months from randomisation but was not available following early study termination due to withdrawal of funding during the COVID-19 pandemic. Instead, in addition to pre-randomised data, routinely recorded BP was extracted from electronic patient records both pre- and post-randomisation and presented descriptively only. An intention to treat approach was taken.ResultsFrom 650 postal invitations, 129 (20%) responded, of whom 95 people had been screened for eligibility prior to the pandemic (November 2019-March 2020) and 55 (58%) were randomised. Pre-randomisation routinely recorded mean BP was 145/78 mmHg in the control (n = 26) and 145/79 mmHg in the self-monitoring (n = 21) groups. Post-randomisation mean BP was 134/73 mmHg in the control (n = 19) and 130/75 mmHg in the self-monitoring (n = 25) groups. Participants randomised to self-monitoring used the intervention for ≥ 7 months in 25/27 (93%) of cases.ConclusionsRecruitment of people with stroke/TIA to a trial comparing a BP self-monitoring and digital behavioural intervention to usual care was feasible prior to the COVID-19 pandemic and the vast majority of those randomised to intervention used it while the trial was running. Routinely recorded blood pressure control improved in both groups. Digital interventions including self-monitoring are feasible for people with stroke/TIA and should be definitively evaluated in future trials.Trial registrationISRCTN57946500 06/09/2019 Prospective.

Design and development of a mobile health intervention for rehabilitation support after knee arthroplasty: TeleRehabilitation after knee ArThroplasty (TReAT) project

BackgroundThe steep increase in knee arthroplasties in lower- and middle-income countries has increased demand for personalised rehabilitation care. Technology-based rehabilitation programs offer potential to replace or augment conventional face-to-face rehabilitation for providing continuum of care. We aimed to systematically develop a theory, evidence-driven, contextualised, and user-centred mobile health platform for people undergoing knee arthroplasty to facilitate monitoring progress during rehabilitation.MethodsWe followed the UK Medical Research Council’s framework and adopted a behaviour design thinking approach, consisting of five steps; (1) conduct multiple literature reviews and cross-sectional surveys to determine the needs and problems experienced during the rehabilitation phase by healthcare professionals and individuals with replaced knees, (2) identify target behaviours along with barriers and facilitators, integrated within the Capability, Opportunity, Motivation-Behaviour (COM-B) framework, (3) identify intervention functions and components, behaviour change techniques, and features for the mobile application, selected after discussions with orthopaedic surgeons, physiotherapists and behavioural experts, (4) develop a prototype application for end-users, and a web-based platform for healthcare professionals, and (5) pilot test the intervention for end-users’ feedback on usability of the application and to identify possible strategies for implementing the intervention package.ResultsUsing the COM-B model, education, training, persuasion, enablement, and modelling were chosen as intervention functions for improving adherence to exercise protocol during early-phase of rehabilitation. The application featured five interlinked components; education, training, goal setting and self-management, communication, and a personalized therapy plan utilising 13 behaviour change techniques. An education booklet, exercise videos, text messaging, video consultation, and a digital tool for measuring range of motion were incorporated into the application. Feedback on the interactive prototype and education material was sought from ten patient volunteers and a physiotherapist. Pilot testing in a convenient sample with broad eligibility criteria (n = 30) indicated importance of digital literacy and dedicated time for remote consultation by healthcare provider within the existing clinical work. Overall, the intervention was well received and valued by the end users.ConclusionThis paper demonstrates the development of a contextualised digital behavioural intervention grounded in behavioural theory and evidence from literature to improve end-user’s engagement with rehabilitation protocols after knee arthroplasty in lower- and middle-income country context.Trial registrationStudy registered prospectively (on 16 February 2023) at Clinical Trials Registry of India (CTRI/2023/02/049792).

Navigating the complexity of User Engagement: need for normative evaluations in digital interventions

Abstract Digital behavioral change interventions (DBCI), leveraging digital technology to promote cognitive behavioral therapy or positive psychology techniques, can potentially revolutionize health promotion. With applications across a spectrum of health behaviors-from managing common mental health disorders to enhancing physical activity, addressing smoking cessation, alcohol use, and weight management-these interventions offer promise for both healthy and clinical populations. However, their effectiveness hinges significantly on user engagement. Digital interventions are prone to attrition due to their self-help and unguided nature, which impedes their translation from research to real-life settings. This talk discusses the findings of a scoping review to shed light on these complexities. Firstly, we explore the various methodologies used to evaluate engagement across studies, hindering effective comparison and understanding. Secondly, we address the lack of systematic assessment of engagement strategies, advocating for experimental research to fill this gap. Lastly, we emphasize the need to establish an optimal level of engagement for desired outcomes, noting that continuous engagement may not always be conducive to behavioral change interventions, which aim to instill lasting changes in individuals. This underscores the importance of comprehensive assessment using both objective and subjective measures. In conclusion, engagement with digital interventions encompasses both quantitative usage metrics and qualitative subjective experiences, highlighting the need for comprehensive assessment beyond the mere evaluation of frequency or duration. Contrary to common belief, increased engagement does not always lead to better outcomes. Too much engagement can lead to exhaustion, while too little can result in inefficiency. Therefore, designing a DBCI that encourages optimal use is essential, fostering a balance that maximizes effectiveness while minimizing adverse effects.

Effectiveness of a digital single-session cognitive behavioral psychoeducational intervention in reducing public stigma associated with psychosis: A randomized controlled trial

Psychosis is a severe mental health condition that is highly stigmatized, significantly increasing the costs of mental healthcare and reducing the productivity of those affected. Due to public stigma, individuals with psychosis often delay seeking professional help, exacerbating the socioeconomic burden of their ill-health. Psychoeducation, delivered in a structured and systematic manner, has been a key part of evidence-based psychological treatments and has been gradually adopted in stigma reduction efforts. This study evaluated the effectiveness of a digital single-session cognitive behavioral psychoeducation intervention in reducing public stigma toward people with psychosis in a collectivist society through a randomized controlled trial. Stigma was assessed using standardized self-report tools at pre-intervention, post-intervention, and 1-month follow-up. A significant reduction was observed in stereotyping, prejudice, and discrimination on seven out of 10 public stigma components post-intervention. However, the desired effects were maintained for only two components at the 1-month follow-up. No significant changes were found in negative emotions, tolerance, and support from pre-intervention to post-intervention. Attribution of responsibility significantly increased after the intervention, contrary to predictions. The findings of this study provide empirical support for the short-term effectiveness of a brief cognitive behavioral psychoeducation intervention in reducing public stigma toward individuals with psychosis while highlighting the potential benefits of delivering this intervention digitally. At the same time, the limitations of individual-level interventions in sustaining long-term effects are discussed from a sociocultural perspective. This study also examined the relevance of these findings in the context of health economics.

Evaluating feasibility, acceptability, and effectiveness of a digital behavioral nutrition intervention in cystic fibrosis care.

Evaluating feasibility, acceptability, and effectiveness of a digital behavioral nutrition intervention in cystic fibrosis care.

Engagement, Acceptability, and Effectiveness of the Self-Care and Coach-Supported Versions of the Vira Digital Behavior Change Platform Among Young Adults at Risk for Depression and Obesity: Pilot Randomized Controlled Trial.

Adolescence and early adulthood are pivotal stages for the onset of mental health disorders and the development of health behaviors. Digital behavioral activation interventions, with or without coaching support, hold promise for addressing risk factors for both mental and physical health problems by offering scalable approaches to expand access to evidence-based mental health support. This 2-arm pilot randomized controlled trial evaluated 2 versions of a digital behavioral health product, Vira (Ksana Health Inc), for their feasibility, acceptability, and preliminary effectiveness in improving mental health in young adults with depressive symptoms and obesity risk factors. A total of 73 participants recruited throughout the United States were randomly assigned to use Vira either as a self-guided product (Vira Self-Care) or with support from a health coach (Vira+Coaching) for 12 weeks. The Vira smartphone app used passive sensing of behavioral data related to mental health and obesity risk factors (ie, activity, sleep, mobility, and language patterns) and offered users personalized insights into patterns of behavior associated with their daily mood. Participants completed self-reported outcome measures at baseline and follow-up (12 weeks). All study procedures were completed via digital communications. Both versions of Vira showed strong user engagement, acceptability, and evidence of effectiveness in improving mental health and stress. However, users receiving coaching exhibited more sustained engagement with the platform and reported greater reductions in depression (Cohen d=0.45, 95% CI 0.10-0.82) and anxiety (Cohen d=0.50, 95% CI 0.13-0.86) compared to self-care users. Both interventions also resulted in reduced stress (Vira+Coaching: Cohen d=-1.05, 95% CI -1.57 to --0.50; Vira Self-Care: Cohen d=-0.78, 95% CI -1.33 to -0.23) and were perceived as useful and easy to use. Coached users also reported reductions in sleep-related impairment (Cohen d=-0.51, 95% CI -1.00 to -0.01). Moreover, participants increased their motivation for and confidence in making behavioral changes, with greater improvements in confidence among coached users. An app-based intervention using passive mobile sensing to track behavior and deliver personalized insights into behavior-mood associations demonstrated feasibility, acceptability, and preliminary effectiveness for reducing depressive symptoms and other mental health problems in young adults. Future directions include (1) optimizing the interventions, (2) conducting a fully powered trial that includes an active control condition, and (3) testing mediators and moderators of outcome effects. ClinicalTrials.gov NCT05638516; https://clinicaltrials.gov/study/NCT05638516.

Digital Intervention for behaviouR changE and Chronic disease prevenTION (DIRECTION): Study protocol for a randomized controlled trial of a web-based platform integrating nutrition, physical activity, and mindfulness for individuals with obesity

Excess body weight, suboptimal diet, physical inactivity, alcohol consumption, sleep disruption, and elevated stress are modifiable risk factors associated with the development of chronic diseases. Digital behavioural interventions targeting these factors have shown promise in improving health and reducing chronic disease risk. The Digital Intervention for behaviouR changE and Chronic disease prevenTION (DIRECTION) study is a parallel group, two-arm, randomized controlled trial evaluating the effects of adding healthcare professional guidance and peer support via group-based sessions to a web-based wellness platform (experimental group, n = 90) compared to a self-guided use of the platform (active control group, n = 90) among individuals with a body mass index (BMI) of 30 to <35 kg/m2 and aged 40–65 years. Obesity is defined by a high BMI. The web-based wellness platform employed in this study is My Viva Plan (MVP)®, which holistically integrates nutrition, physical activity, and mindfulness programs. Over 16 weeks, the experimental group uses the web-based wellness platform daily and engages in weekly online support group sessions. The active control group exclusively uses the web-based wellness platform daily. Assessments are conducted at baseline and weeks 8 and 16. The primary outcome is between-group difference in weight loss (kg) at week 16, and secondary outcomes are BMI, percent weight change, proportion of participants achieving 5% or more weight loss, dietary intake, physical activity, alcohol consumption, sleep, and stress across the study. A web-based wellness platform may be a scalable approach to promote behavioural changes that positively impact health. This study will inform the development and implementation of interventions using web-based wellness platforms and personalized digital interventions to improve health outcomes and reduce chronic disease risk among individuals with obesity.

Real-World Outcomes of a Digital Behavioral Coaching Intervention to Improve Employee Health Status: Retrospective Observational Study.

Chronic noncommunicable diseases (NCDs) account for major disability and premature mortality worldwide, with low- and middle-income countries being disproportionately burdened. Given the negative impact of NCDs on employee performance and work productivity, there is a rising need for stakeholders to identify effective workplace solutions that can improve employee health outcomes. As the workplace becomes more dispersed post pandemic, digital behavioral coaching offers a scalable, personalized, and cost-effective method of managing chronic disease risk factors among employees. This study aimed to retrospectively evaluate the impact of a digital behavioral coaching program on year-to-year changes in employee health status in a cohort of Indonesian employees. This retrospective real-world exploratory analysis of secondary health data followed 774 employees of an Indonesian company who completed company-sponsored health screenings between 2021 and 2022 and were given access to Naluri (Naluri Hidup Sdn Bhd), a holistic digital therapeutics platform offering digital behavioral health coaching and self-help tools. Participants were retrospectively classified as those who received active coaching (n=177), passive coaching (n=108), and no coaching (n=489). Linear mixed-effects models were used to evaluate the year-to-year changes in health outcomes across the 3 employee groups, with post hoc analyses evaluating within-group differences between the 2 time points and between-group differences at follow-up. Significant time×group interaction effects were detected for body weight, BMI, hemoglobin A1c, low-density lipoprotein, total cholesterol, and systolic and diastolic blood pressure. Post hoc pairwise comparisons revealed significant improvements in hemoglobin A1c (mean difference [Mdiff]=-0.14, P=.008), high-density lipoprotein (Mdiff=+2.14, P<.001), and total cholesterol (Mdiff=-11.45, P<.001) for employees in the Active Coaching group between 2021 and 2022, with the other 2 groups reporting deteriorations in multiple health outcomes throughout the 2 time points. At follow-up, those who received active coaching between 2021 and 2022 reported significantly lower body weight (P<.001), BMI (P=.001), low-density lipoprotein (P=.045), and total cholesterol (P<.001) than the No Coaching group. This study demonstrates real-world outcomes and implications supporting the use of workplace digital behavioral coaching in improving employee health status. Given the rising burden of NCDs in the Southeast Asian region, our findings underscore the role that workplace digital health interventions can play in preventing and managing chronic disease risk factors.

Chinese Consumers’ Green Purchase Practices: A Review

This paper reviews current research with significant findings on Chinese consumers' green purchasing behavior in the 2000 to 2023 interval. The main direction of the article is to focus on the factors analyzed in the current research that influence consumers' green purchasing intentions and behaviors, and others include social comparison strategies, advertising appeals, traditional cultural values, and environmental responsibility. The study found that factors such as social comparison strategy, advertising appeal, traditional cultural values, and sense of environmental responsibility have a significant impact on Chinese consumers' green purchasing behavior. In a collectivist society, consumers tend to adjust their purchasing decisions according to the behavioral norms of the social group. Emotionally appealing advertisements are more likely than rationally appealing advertisements to stimulate consumers' environmental awareness and purchase motivation. The concepts of "benevolence" and "propriety" in traditional culture promote green purchasing by emphasizing mutual assistance, responsibility, and compliance with environmental norms, but the "face-saving" culture sometimes leads to superficial environmental behavior. Consumers' sense of environmental responsibility, influenced by education, social norms, and personal values, is an important factor driving green purchasing intentions. Despite consumers' strong willingness to buy green, there are often significant gaps in actual behavior which are attributed to factors such as price, convenience, product availability, and information transparency. Brand authenticity can help enhance consumer trust and emotional connection, thus increasing the likelihood of green product purchases. Government subsidies and the green consumption points system can effectively increase the market share of green products. Future research can further explore the relative importance of each factor and effective strategies to bridge the gap between purchase intention and actual behavior. Meanwhile, new approaches such as digital platforms and behavioral interventions are also worthy of attention to better promote sustainable consumption in China.

Episodic future thinking: A behavioral intervention to promote weight loss in breast cancer survivors.

e22541 Background: Digital behavioral interventions are a scalable method to increase healthy lifestyle engagement. Episodic future thinking (EFT) is a behavior change method where participants mentally simulate positive, detailed, personal, and future-oriented events. EFT targets delay discounting (DD), a behavioral economic principle that measures valuation of long-term, future rewards. Higher DD correlates with bias of immediate gratification and maladaptive health behaviors. EFT can decrease impulsivity and improve body weight (BW) in those with obesity. However, EFT may impact cancer survivors differently. We report results from a phase II trial evaluating the feasibility of 12 week (wk) EFT in overweight/obese BC survivors. Methods: Eligibility included women with non-metastatic BC, BMI ≥ 25 kg/m2 and completion of BC treatment apart from endocrine therapy. All patients (pts) received lifestyle counseling, referral to nutritionist, and logged exercise/diet in MyFitnessPal. Pts were stratified by baseline DD and randomized 1:1 to 12-wk EFT vs control (Episodic Recent Thinking; ERT) in which pts imagine events in the past. Pts received text cues 3x/day during meals. The primary endpoint was adherence to EFT (percentage of smartphone prompts opened and attended to over 12 wk). Secondary endpoints were 12 wk change in BW and DD. A one-sample t-test evaluated adherence in pts regardless of drop-out and compared to an 80% target. A linear mixed effects model was used for secondary endpoints. Results: Pts were recruited from November 2021 - August 2023 (Table 1, n = 46) at The Ohio State University. In total, 17 (74%) in EFT and 19 (83%) in ERT completed the intervention. The average adherence was consistent with the 80% target (EFT 77%, 95% CI = 0.69 - 0.85; ERT 82%; 95% CI = 0.78 - 0.86). BW at 12 wk was available in 17 (74%) EFT and 19 (83%) ERT pts. There was a significant 12 wk change in BW in all pts (-4.0 lbs, 95% CI -6.08 - -1.79, p &lt; 0.001; -2.03%, 95% CI -3.15 - -0.91, p &lt; 0.001) but no significant difference between groups (lbs: -2.28 EFT vs -5.42 ERT, 95% CI -7.41 - 1.14, p = 0.1; %: -1.07 EFT vs -5.20 ERT, 95% CI -4.01 - 0.37, p = 0.1). There was no significant difference in 12 wk change in DD rate between EFT and ERT (ratio 1.56, 95% CI 0.19 - 12.95, p = 0.7). Conclusions: The high adherence supports the feasibility of implementing EFT and engaging digital health for remotely delivered weight loss in BC survivors. BW loss was globally observed, despite low baseline DD in the majority. Further investigation of EFT in combination with lifestyle intervention is needed to formally assess efficacy in this population. Clinical trial information: NCT05012176 . [Table: see text]

A Digital Behavioral Activation Intervention (JuNEX) for Pregnant Women With Subclinical Depression Symptoms: Explorative Co-Design Study.

Digital interventions are gaining increasing interest due to their structured nature, ready availability, and self-administered capabilities. Perinatal women have expressed a desire for such interventions. In this regard, behavioral activation interventions may be particularly suitable for digital administration. This study aims to exploratorily investigate and compare the feasibility of the internet-based self-help guided versus unguided version of the Brief Behavioral Activation Treatment for Depression-Revised, an empirically supported in-person behavioral activation protocol, targeting pregnant women with subclinical depression symptoms. A user-centered design is used, whereby data are collected with the intent of evaluating how to adjust the intervention in line with pregnant women's needs. Usability and user engagement were evaluated. A total of 11 Italian pregnant women with subclinical depressive symptoms based on the Patient Health Questionnaire-9 (scoring<15) participated in this study; of them, 6 (55%) women were randomly assigned to the guided group (age: mean 32.17, SD 4.36 years) and 5 (45%) to the unguided group (age: mean 31, SD 4.95 years). The Moodle platform was used to deliver the interventions in an e-learning format. It consisted of 6 core modules and 3 optional modules; the latter aimed at revising the content of the former. In the guided group, each woman had weekly chats with their assigned human guide to support them in the homework revisions. The intervention content included text, pictures, and videos. Semistructured interviews were conducted, and descriptive statistics were analyzed. Collectively, the data suggest that the guided intervention was better accepted than the unguided one. However, the high rates of dropout (at T6: guided group: 3/6, 50%; unguided: 4/5, 80%) suggest that a digital replica of Behavioral Activation Treatment for Depression-Revised may not be feasible in an e-learning format. The reduced usability of the platform used was reported, and homework was perceived as too time-consuming and effort-intensive. Moreover, the 6 core modules were deemed sufficient for the intervention's goals, suggesting that the 3 optional modules could be eliminated. Nevertheless, participants from both groups expressed satisfaction with the content and found it relevant to their pregnancy experiences. Overall, the findings have emphasized both the intervention's merits and shortcomings. Results highlight the unsuitability of replicating an in-person protocol digitally as well as of the use of nonprofessional tools for the implementation of self-help interventions, ultimately making the intervention not feasible. Pregnant women have nonetheless expressed a desire to receive psychological support and commented on the possibilities of digital psychosocial supports, particularly those that are app-based. The information collected and the issues identified here are important to guide the development and co-design of a more refined platform for the intervention deployment and to tailor the intervention's content to pregnant women's needs.

#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.

Predicting Adherence to Behavior Change Support Systems Using Machine Learning: Systematic Review.

There is a dearth of knowledge on reliable adherence prediction measures in behavior change support systems (BCSSs). Existing reviews have predominately focused on self-reporting measures of adherence. These measures are susceptible to overestimation or underestimation of adherence behavior. This systematic review seeks to identify and summarize trends in the use of machine learning approaches to predict adherence to BCSSs. Systematic literature searches were conducted in the Scopus and PubMed electronic databases between January 2011 and August 2022. The initial search retrieved 2182 journal papers, but only 11 of these papers were eligible for this review. A total of 4 categories of adherence problems in BCSSs were identified: adherence to digital cognitive and behavioral interventions, medication adherence, physical activity adherence, and diet adherence. The use of machine learning techniques for real-time adherence prediction in BCSSs is gaining research attention. A total of 13 unique supervised learning techniques were identified and the majority of them were traditional machine learning techniques (eg, support vector machine). Long short-term memory, multilayer perception, and ensemble learning are currently the only advanced learning techniques. Despite the heterogeneity in the feature selection approaches, most prediction models achieved good classification accuracies. This indicates that the features or predictors used were a good representation of the adherence problem. Using machine learning algorithms to predict the adherence behavior of a BCSS user can facilitate the reinforcement of adherence behavior. This can be achieved by developing intelligent BCSSs that can provide users with more personalized, tailored, and timely suggestions.