User engagement in clinical trials of digital mental health interventions: a systematic review
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SUBMITTER: Elkes J
PROVIDER: S-EPMC11344322 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundDigital mental health interventions (DMHIs), which deliver mental health support via technologies such as mobile apps, can increase access to mental health support, and many studies have demonstrated their effectiveness in improving symptoms. However, user engagement varies, with regard to a user's uptake and sustained interactions with these interventions.ObjectiveThis systematic review aims to identify common barriers and facilitators that influence user engagement with DMHIs.MethodsA systematic search was conducted in the SCOPUS, PubMed, PsycINFO, Web of Science, and Cochrane Library databases. Empirical studies that report qualitative and/or quantitative data were included.ResultsA total of 208 articles met the inclusion criteria. The included articles used a variety of methodologies, including interviews, surveys, focus groups, workshops, field studies, and analysis of user reviews. Factors extracted for coding were related to the end user, the program or content offered by the intervention, and the technology and implementation environment. Common barriers included severe mental health issues that hampered engagement, technical issues, and a lack of personalization. Common facilitators were social connectedness facilitated by the intervention, increased insight into health, and a feeling of being in control of one's own health.ConclusionsAlthough previous research suggests that DMHIs can be useful in supporting mental health, contextual factors are important determinants of whether users actually engage with these interventions. The factors identified in this review can provide guidance when evaluating DMHIs to help explain and understand user engagement and can inform the design and development of new digital interventions.
| S-EPMC8074985 | biostudies-literature
Project description:BackgroundWhile many digital mental health interventions (DMHIs) have been found to be efficacious, patient engagement with DMHIs has increasingly emerged as a concern for implementation in real-world clinical settings. To address engagement, we must first understand what standard engagement levels are in the context of randomized controlled trials (RCTs) and how these compare with other treatments.ObjectiveThis scoping review aims to examine the state of reporting on intervention engagement in RCTs of mobile app-based interventions intended to treat symptoms of depression. We sought to identify what engagement metrics are and are not routinely reported as well as what the metrics that are reported reflect about standard engagement levels.MethodsWe conducted a systematic search of 7 databases to identify studies meeting our eligibility criteria, namely, RCTs that evaluated use of a mobile app-based intervention in adults, for which depressive symptoms were a primary outcome of interest. We then extracted 2 kinds of information from each article: intervention details and indices of DMHI engagement. A 5-element framework of minimum necessary DMHI engagement reporting was derived by our team and guided our data extraction. This framework included (1) recommended app use as communicated to participants at enrollment and, when reported, app adherence criteria; (2) rate of intervention uptake among those assigned to the intervention; (3) level of app use metrics reported, specifically number of uses and time spent using the app; (4) duration of app use metrics (ie, weekly use patterns); and (5) number of intervention completers.ResultsDatabase searching yielded 2083 unique records. Of these, 22 studies were eligible for inclusion. Only 64% (14/22) of studies included in this review specified rate of intervention uptake. Level of use metrics was only reported in 59% (13/22) of the studies reviewed. Approximately one-quarter of the studies (5/22, 23%) reported duration of use metrics. Only half (11/22, 50%) of the studies reported the number of participants who completed the app-based components of the intervention as intended or other metrics related to completion. Findings in those studies reporting metrics related to intervention completion indicated that between 14.4% and 93.0% of participants randomized to a DMHI condition completed the intervention as intended or according to a specified adherence criteria.ConclusionsFindings suggest that engagement was underreported and widely varied. It was not uncommon to see completion rates at or below 50% (11/22) of those participants randomized to a treatment condition or to simply see completion rates not reported at all. This variability in reporting suggests a failure to establish sufficient reporting standards and limits the conclusions that can be drawn about level of engagement with DMHIs. Based on these findings, the 5-element framework applied in this review may be useful as a minimum necessary standard for DMHI engagement reporting.
| S-EPMC9617183 | biostudies-literature
Project description:BackgroundAlthough digital mental health interventions (DMHIs) offer a potential solution for increasing access to mental health treatment, their integration into real-world settings has been slow. A key reason for this is poor user engagement. A growing number of studies evaluating strategies for promoting engagement with DMHIs means that a review of the literature is now warranted. This systematic review is the first to synthesise evidence on technology-supported strategies for promoting engagement with DMHIs.MethodsMEDLINE, EmbASE, PsycINFO and PubMed databases were searched from 1 January 1995 to 1 October 2021. Experimental or quasi-experimental studies examining the effect of technology-supported engagement strategies deployed alongside DMHIs were included, as were secondary analyses of such studies. Title and abstract screening, full-text coding and quality assessment were performed independently by two authors. Narrative synthesis was used to summarise findings from the included studies.Results24 studies (10,266 participants) were included. Engagement strategies ranged from reminders, coaching, personalised information and peer support. Most strategies were disseminated once a week, usually via email or telephone. There was some empirical support for the efficacy of technology-based strategies towards promoting engagement. However, findings were mixed regardless of strategy type or study aim.ConclusionsTechnology-supported strategies appear to increase engagement with DMHIs; however, their efficacy varies widely by strategy type. Future research should involve end-users in the development and evaluation of these strategies to develop a more cohesive set of strategies that are acceptable and effective for target audiences, and explore the mechanism(s) through which such strategies promote engagement.
| S-EPMC9168921 | biostudies-literature
Project description:Digital mental health interventions (DMHIs) present a promising way to address gaps in mental health service provision. However, the relationship between user engagement and outcomes in the context of these interventions has not been established. This study addressed the current state of evidence on the relationship between engagement with DMHIs and mental health outcomes. MEDLINE, PsycINFO, and EmBASE databases were searched from inception to August 1, 2021. Original or secondary analyses of randomized controlled trials (RCTs) were included if they examined the relationship between DMHI engagement and post-intervention outcome(s). Thirty-five studies were eligible for inclusion in the narrative review and 25 studies had sufficient data for meta-analysis. Random-effects meta-analyses indicated that greater engagement was significantly associated with post-intervention mental health improvements, regardless of whether this relationship was explored using correlational [r = 0.24, 95% CI (0.17, 0.32), Z = 6.29, p < 0.001] or between-groups designs [Hedges' g = 0.40, 95% CI (0.097, 0.705), p = 0.010]. This association was also consistent regardless of intervention type (unguided/guided), diagnostic status, or mental health condition targeted. This is the first review providing empirical evidence that engagement with DMHIs is associated with therapeutic gains. Implications and future directions are discussed. Systematic Review Registration: PROSPERO, identifier: CRD 42020184706.
| S-EPMC8599127 | biostudies-literature
Project description:BackgroundDigital interventions offer a solution to address the high demand for mental health promotion, especially when facing physical contact restrictions or lacking accessibility. Engagement with digital interventions is critical for their effectiveness; however, retaining users' engagement throughout the intervention is challenging. It remains unclear what strategies facilitate engagement with digital interventions that target mental health promotion.ObjectiveOur aim is to conduct a scoping review to investigate user engagement strategies and methods to evaluate engagement with digital interventions that target mental health promotion in adults.MethodsThis scoping review adheres to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for scoping reviews. The search was conducted in 7 electronic databases from inception to April 2020. The inclusion criteria for studies were as follows: adult (aged ≥18 years) users of digital interventions for mental health promotion from the general population; any digital intervention for mental health promotion; and user engagement strategies described in the intervention design. We extracted the following data items: study characteristics, digital intervention (type and engagement strategy), evaluation of engagement strategy (method and result specifying whether the strategy was effective at facilitating engagement), and features of engagement (extent of use and subjective experience of users).ResultsA total of 2766 studies were identified, of which 16 (0.58%) met the inclusion criteria. The 16 studies included randomized controlled trials (6/16, 37%), studies analyzing process data (5/16, 31%), observational studies (3/16, 19%), and qualitative studies (2/16, 13%). The digital interventions for mental health promotion were either web based (12/16, 75%) or mobile app based (4/16, 25%). The engagement strategies included personalized feedback about intervention content or users' mental health status; guidance regarding content and progress through e-coaching; social forums, and interactivity with peers; content gamification; reminders; and flexibility and ease of use. These engagement strategies were deemed effective based on qualitative user feedback or responses on questionnaires or tools (4/16, 25%), usability data (5/16, 31%), or both (7/16, 44%). Most studies identified personalized support in the form of e-coaching, peer support through a social platform, personalized feedback, or joint videoconference sessions as an engaging feature.ConclusionsPersonalized support during the intervention, access to social support, and personalized feedback seem to promote engagement with digital interventions for mental health promotion. These findings need to be interpreted with caution because the included studies were heterogeneous, had small sample sizes, and typically did not address engagement as the primary outcome. Despite the importance of user engagement for the effectiveness of digital interventions, this field has not yet received much attention. Further research is needed on the effectiveness of different strategies required to facilitate user engagement in digital interventions for mental health promotion.
| S-EPMC8726056 | biostudies-literature
Project description:BackgroundReal-time digital mental health interventions, primarily enabled by smartphone technology offer continuous, personalised support, that adapts in response to the changing needs of individuals. Despite being prominently explored in populations with psychiatric disorders, there remains a notable gap in the systematic analysis of demographic characteristics, as well as the foundational design decisions or rules that underpin the personalisation of these interventions.Objectives(a) Identifying the prevalent design decisions to enable personalisation within real-time digital mental health interventions, (b) the influence of these design decisions on the clinical outcomes of the interventions, and (c) the demographic characteristics of populations with psychiatric disorders targeted by real-time digital health interventions.MethodsFollowing PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines, a systematic literature review was conducted of peer-reviewed literature focusing on real-time digital interventions in populations with clinically diagnosed psychiatric disorders. We undertook a narrative synthesis to derive the demographics and personalisation design decisions of the interventions and conducted a pooled meta-analysis to evaluate clinical outcomes.ResultsInterventions predominantly targeted female and Caucasian demographics, yielding modest clinical improvements. Our analysis identified nine critical personalisation design decisions concerning measurement, intervention, and interactions with health professional with varying influence on clinical outcomes.ConclusionUnderstanding the complex nuances of design decisions that shape real-time digital health interventions, as well as identifying which patient demographics benefit most, is fundamental for their effective clinical impact and safe use.Prospero registrationPROSPERO CRD42020161663.
| S-EPMC11648022 | biostudies-literature
Project description:BackgroundDigital mental health interventions (DMHIs) to monitor and improve the health of people with psychosis or bipolar disorder show promise; however, user engagement is variable, and integrated clinical use is low.ObjectiveThis prospectively registered systematic review examined barriers and facilitators of clinician and patient engagement with DMHIs, to inform implementation within real-world settings.MethodsA systematic search of 7 databases identified empirical studies reporting qualitative or quantitative data about factors affecting staff or patient engagement with DMHIs aiming to monitor or improve the mental or physical health of people with psychosis or bipolar disorder. The Consolidated Framework for Implementation Research was used to synthesize data on barriers and facilitators, following a best-fit framework synthesis approach.ResultsThe review included 175 papers (150 studies; 11,446 participants) describing randomized controlled trials; surveys; qualitative interviews; and usability, cohort, and case studies. Samples included people with schizophrenia spectrum psychosis (98/150, 65.3% of studies), bipolar disorder (62/150, 41.3% of studies), and clinicians (26/150, 17.3% of studies). Key facilitators were a strong recognition of DMHIs' relative advantages, a clear link between intervention focus and specific patient needs, a simple, low-effort digital interface, human-supported delivery, and device provision where needed. Although staff thought patients would lose, damage, or sell devices, reviewed studies found only 11% device loss. Barriers included intervention complexity, perceived risks, user motivation, discomfort with self-reflection, digital poverty, symptoms of psychosis, poor compatibility with existing clinical workflows, staff and patient fears that DMHIs would replace traditional face-to-face care, infrastructure limitations, and limited financial support for delivery.ConclusionsIdentified barriers and facilitators highlight key considerations for DMHI development and implementation. As to broader implications, sustainable business models are needed to ensure that evidence-based DMHIs are maintained and deployed.Trial registrationPROSPERO CRD42021282871; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=282871.
| S-EPMC11791459 | biostudies-literature
Project description:BackgroundNew approaches to the treatment of depression are necessary for patients who do not respond to current treatments or lack access to them because of barriers such as cost, stigma, and provider shortage. Digital interventions for depression are promising; however, low patient engagement could limit their effectiveness.ObjectiveThis systematic literature review (SLR) assessed how participant adherence to and engagement with digital interventions for depression have been measured in the published literature, what levels of adherence and engagement have been reported, and whether higher adherence and increased engagement are linked to increased efficacy.MethodsWe focused on a participant population of adults (aged ≥18 years) with depression or major depressive disorder as the primary diagnosis and included clinical trials, feasibility studies, and pilot studies of digital interventions for treating depression, such as digital therapeutics. We screened 756 unique records from Ovid MEDLINE, Embase, and Cochrane published between January 1, 2000, and April 15, 2022; extracted data from and appraised the 94 studies meeting the inclusion criteria; and performed a primarily descriptive analysis. Otsuka Pharmaceutical Development & Commercialization, Inc (Princeton, New Jersey, United States) funded this study.ResultsThis SLR encompassed results from 20,111 participants in studies using 47 unique web-based interventions (an additional 10 web-based interventions were not described by name), 15 mobile app interventions, 5 app-based interventions that are also accessible via the web, and 1 CD-ROM. Adherence was most often measured as the percentage of participants who completed all available modules. Less than half (44.2%) of the participants completed all the modules; however, the average dose received was 60.7% of the available modules. Although engagement with digital interventions was measured differently in different studies, it was most commonly measured as the number of modules completed, the mean of which was 6.4 (means ranged from 1.0 to 19.7) modules. The mean amount of time participants engaged with the interventions was 3.9 (means ranged from 0.7 to 8.4) hours. Most studies of web-based (34/45, 76%) and app-based (8/9, 89%) interventions found that the intervention group had substantially greater improvement for at least 1 outcome than the control group (eg, care as usual, waitlist, or active control). Of the 14 studies that investigated the relationship between engagement and efficacy, 9 (64%) found that increased engagement with digital interventions was significantly associated with improved participant outcomes. The limitations of this SLR include publication bias, which may overstate engagement and efficacy, and low participant diversity, which reduces the generalizability.ConclusionsPatient adherence to and engagement with digital interventions for depression have been reported in the literature using various metrics. Arriving at more standardized ways of reporting adherence and engagement would enable more effective comparisons across different digital interventions, studies, and populations.
| S-EPMC10457707 | biostudies-literature
Project description:Many young people (YP) are diagnosed with mental illnesses and require support. Web-based mental health interventions (W-MHIs) have been increasingly utilized by YP, healthcare providers, and parents due to reasons including convenience and anonymity. W-MHIs are effective in improving mental health in YP. However, real-world engagement with W-MHIs remains low. Therefore, understanding barriers/facilitators of user engagement with W-MHIs is necessary to promote W-MHIs and help users gain optimal benefits through higher engagement. This review aims to identify barriers/facilitators of user engagement with W-MHIs in YP aged 10-24 years. A systematic search of five databases for English language, peer-reviewed publications was conducted between January 2010 and February 2023. Studies examining factors influencing user engagement with W-MHIs, described as barriers or facilitators, were included. Study quality was assessed using the Mixed Methods Appraisal Tool. A narrative synthesis was performed. Of 4088 articles identified, 69 studies were included. Barriers/facilitators were reported by young people (63 studies), providers (17 studies), and parents/caregivers (8 studies). YP perceived that usefulness and connectedness were the most common facilitators, whereas low-perceived need was the most reported barrier. Both providers and parents reported that perceived usefulness for YP was the most common facilitator, whereas concerns about program effectiveness and privacy were noted as barriers. This review found that program- and individual-related factors were important determinants of engagement with W-MHIs. This review provides guidance on the future design and development of new interventions, narrowing the gap between existing W-MHIs and unmet needs of users.
| S-EPMC11805866 | biostudies-literature
Project description:Mental health problems in the workplace are common and have a considerable impact on employee wellbeing and productivity. Mental ill-health costs employers between £33 billion and £42 billion a year. According to a 2020 HSE report, roughly 2,440 per 100,000 workers in the UK were affected by work-related stress, depression, or anxiety, resulting in an estimated 17.9 million working days lost. We performed a systematic review of randomised controlled trials (RCTs) to assess the effect of tailored digital health interventions provided in the workplace aiming to improve mental health, presenteeism and absenteeism of employees. We searched several databases for RCTs published from 2000 onwards. Data were extracted into a standardised data extraction form. The quality of the included studies was assessed using the Cochrane Risk of Bias tool. Due to the heterogeneity of outcome measures, narrative synthesis was used to summarise the findings. Seven RCTs (eight publications) were included that evaluated tailored digital interventions versus waiting list control or usual care to improve physical and mental health outcomes and work productivity. The results are promising to the advantage of tailored digital interventions regarding presenteeism, sleep, stress levels, and physical symptoms related to somatisation; but less for addressing depression, anxiety, and absenteeism. Even though tailored digital interventions did not reduce anxiety and depression in the general working population, they significantly reduced depression and anxiety in employees with higher levels of psychological distress. Tailored digital interventions seem more effective in employees with higher levels of distress, presenteeism or absenteeism than in the general working population. There was high heterogeneity in outcome measures, especially for work productivity; this should be a focus of attention in future studies.
| S-EPMC9931277 | biostudies-literature