Dataset Information

Efficacy of the Digital Therapeutic Mobile App BioBase to Reduce Stress and Improve Mental Well-Being Among University Students: Randomized Controlled Trial.

ABSTRACT: BACKGROUND:University students in the United Kingdom are experiencing increasing levels of anxiety. A program designed to increase awareness of one's present levels of well-being and suggest personalized health behaviors may reduce anxiety and improve mental well-being in students. The efficacy of a digital version of such a program, providing biofeedback and therapeutic content based on personalized well-being metrics, is reported here. OBJECTIVE:The aim of this study was to test the efficacy and sustained effects of using a mobile app (BioBase) and paired wearable device (BioBeam), compared with a waitlist control group, on anxiety and well-being in university students with elevated levels of anxiety and stress. METHODS:The study employed a randomized, waitlist-controlled trial with assessments at baseline, 2 weeks, postintervention (4 weeks), and follow-up (6 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored >14 points on the Depression, Anxiety, and Stress Scale-21 items (DASS-21) stress subscale or >7 points on the DASS-21 anxiety subscale, (3) owned an iOS mobile phone, (4) did not have any previous psychiatric or neurological conditions, (6) were not pregnant at the time of testing, and (7) were able to read and understand English. Participants were encouraged to use BioBase daily and complete at least one course of therapeutic content. A P value ?.05 was considered statistically significant. RESULTS:We found that a 4-week intervention with the BioBase program significantly reduced anxiety and increased perceived well-being, with sustained effects at a 2-week follow-up. Furthermore, a significant reduction in depression levels was found following the 4-week usage of BioBase. CONCLUSIONS:This study shows the efficacy of a biofeedback digital intervention in reducing self-reported anxiety and increasing perceived well-being in UK university students. Results suggest that digital mental health interventions could constitute a novel approach to treat stress and anxiety in students, which could be combined or integrated with existing therapeutic pathways. TRIAL REGISTRATION:Open Science Framework (OSF.io) 2zd45; https://osf.io/2zd45/.

SUBMITTER: Ponzo S

PROVIDER: S-EPMC7171562 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Efficacy of the Digital Therapeutic Mobile App BioBase to Reduce Stress and Improve Mental Well-Being Among University Students: Randomized Controlled Trial.

Ponzo Sonia S Morelli Davide D Kawadler Jamie M JM Hemmings Nicola Rose NR Bird Geoffrey G Plans David D

JMIR mHealth and uHealth 20200406 4

<h4>Background</h4>University students in the United Kingdom are experiencing increasing levels of anxiety. A program designed to increase awareness of one's present levels of well-being and suggest personalized health behaviors may reduce anxiety and improve mental well-being in students. The efficacy of a digital version of such a program, providing biofeedback and therapeutic content based on personalized well-being metrics, is reported here.<h4>Objective</h4>The aim of this study was to test ...[more]

PMID: 31926063

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Project description:BackgroundAgainst a long-term trend of increasing demand, the COVID-19 pandemic has led to a global rise in common mental disorders. Now more than ever, there is an urgent need for scalable, evidence-based interventions to support mental well-being.ObjectiveThe aim of this proof-of-principle study was to evaluate the efficacy of a mobile-based app in adults with self-reported symptoms of anxiety and stress in a randomized control trial that took place during the first wave of the COVID-19 pandemic in the United Kingdom.MethodsAdults with mild to severe anxiety and moderate to high levels of perceived stress were randomized to either the intervention or control arm. Participants in the intervention arm were given access to the Foundations app for the duration of the 4-week study. All participants were required to self-report a range of validated measures of mental well-being (10-item Connor-Davidson Resilience scale [CD-RISC-10], 7-item Generalized Anxiety Disorder scale [GAD-7], Office of National Statistics Four Subjective Well-being Questions [ONS-4], World Health Organization-5 Well-Being Index [WHO-5]) and sleep (Minimal Insomnia Scale [MISS]) at baseline and at weeks 2 and 4. The self-reported measures of perceived stress (10-item Perceived Stress Score [PSS-10]) were obtained weekly.ResultsA total of 136 participants completed the study and were included in the final analysis. The intervention group (n=62) showed significant improvements compared to the control group (n=74) on measures of anxiety, with a mean GAD-7 score change from baseline of -1.35 (SD 4.43) and -0.23 (SD 3.24), respectively (t134=1.71, P=.04); resilience, with a mean change in CD-RISC score of 1.79 (SD 4.08) and -0.31 (SD 3.16), respectively (t134=-3.37, P<.001); sleep, with a mean MISS score change of -1.16 (SD 2.67) and -0.26 (SD 2.29), respectively (t134=2.13, P=.01); and mental well-being, with a mean WHO-5 score change of 1.53 (SD 5.30) and -0.23 (SD 4.20), respectively (t134=-2.16, P=.02), within 2 weeks of using Foundations, with further improvements emerging at week 4. Perceived stress was also reduced within the intervention group, although the difference did not reach statistical significance relative to the control group, with a PSS score change from baseline to week 2 of -2.94 (SD 6.84) and -2.05 (SD 5.34), respectively (t134= 0.84, P=.20).ConclusionsThis study provides a proof of principle that the digital mental health app Foundations can improve measures of mental well-being, anxiety, resilience, and sleep within 2 weeks of use, with greater effects after 4 weeks. Foundations therefore offers potential as a scalable, cost-effective, and accessible solution to enhance mental well-being, even during times of crisis such as the COVID-19 pandemic.Trial registrationOSF Registries osf.io/f6djb; https://osf.io/vm3xq.

Project description:BACKGROUND:Although the availability and use of mobile mental health apps has grown exponentially in recent years, little data are available regarding their efficacy. OBJECTIVE:This study aimed to evaluate the effectiveness of an app developed to promote stress management and well-being among working women compared with a control app. METHODS:Female employees at a private hospital were invited to participate in the study via mailing lists and intranet ads. A total of 653 individuals self-enrolled through the website. Eligible participants were randomized between control (n=240) and intervention (n=250) groups. The well-being mobile app provides an 8-week program with 4 classes per week (including a brief theoretical portion and a 15-min guided practice). The active control app also provided 4 assessments per week that encouraged participants to self-observe how they were feeling for 20 min. We also used the app to conduct Web-based questionnaires (10-item Perceived Stress Scale and 5-item World Health Organization Well-Being Index) and ask specific questions to assess subjective levels of stress and well-being at baseline (t1), midintervention (t4=4 weeks after t1) and postintervention (t8=8 weeks after t1). Both apps were fully automated without any human involvement. Outcomes from the control and intervention conditions at the 3 time points were analyzed using a repeated measures analysis of variance. RESULTS:Among the randomized participants (n=490), 185 participants were excluded at the 4-week follow-up and another 79 at the 8-week follow-up because of noncompliance with the experimental protocol. Participants who did not complete t4 and t8 assessments were equally distributed between groups (t4: control group=34.6% [83/240] and intervention group=40.8% [102/250]; P=.16; t8: control group=29.9% [47/157] and intervention group=21.6% [32/148]; P=.10). Both groups showed a significant increase in general well-being as a function of time (F2,426=5.27; P=.006), but only the intervention group presented a significant increase in work-related well-being (F2,426=8.92; P<.001), as well as a significant reduction in work-related and overall stress (F2,426=5.50; P=.004 and F2,426=8.59; P<.001, respectively). CONCLUSIONS:The well-being mobile app was effective in reducing employee stress and improving well-being. TRIAL REGISTRATION:Clinicaltrials.gov NCT02637414; https://clinicaltrials.gov/ct2/show/NCT02637414.

Project description:BackgroundCollege students are increasingly reporting common mental health problems, such as depression and anxiety, and they frequently encounter barriers to seeking traditional mental health treatments. Digital mental health interventions, such as those delivered via the Web and apps, offer the potential to improve access to mental health treatment.ObjectiveThis study aimed to review the literature on digital mental health interventions focused on depression, anxiety, and enhancement of psychological well-being among samples of college students to identify the effectiveness, usability, acceptability, uptake, and adoption of such programs.MethodsWe conducted a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (registration number CRD42018092800), and the search strategy was conducted by a medical research librarian in the following databases: MEDLINE (Ovid), EMBASE (Elsevier), PsycINFO (EbscoHost), the Cochrane Library (Wiley), and Web of Science (Thomson Reuters) from the date of inception to April 2019. Data were synthesized using a systematic narrative synthesis framework, and formal quality assessments were conducted to address the risk of bias.ResultsA total of 89 studies met the inclusion criteria. The majority of interventions (71/89, 80%) were delivered via a website, and the most common intervention was internet-based cognitive behavioral therapy (28, 31%). Many programs (33, 37%) featured human support in the form of coaching. The majority of programs were either effective (42, 47%) or partially effective (30, 34%) in producing beneficial changes in the main psychological outcome variables. Approximately half of the studies (45, 51%) did not present any usability or acceptability outcomes, and few studies (4, 4%) examined a broad implementation of digital mental health interventions on college campuses. Quality assessments revealed a moderate-to-severe risk of bias in many of the studies.ConclusionsResults suggest that digital mental health interventions can be effective for improving depression, anxiety, and psychological well-being among college students, but more rigorous studies are needed to ascertain the effective elements of these interventions. Continued research on improving the user experience of, and thus user engagement with, these programs appears vital for the sustainable implementation of digital mental health interventions on college campuses.

Dataset Information

Efficacy of the Digital Therapeutic Mobile App BioBase to Reduce Stress and Improve Mental Well-Being Among University Students: Randomized Controlled Trial.

Publications

Efficacy of the Digital Therapeutic Mobile App BioBase to Reduce Stress and Improve Mental Well-Being Among University Students: Randomized Controlled Trial.

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