Trial reportJMIR mHealth and uHealth2022
The Efficacy of "Foundations," a Digital Mental Health App to Improve Mental Well-being During COVID-19: Proof-of-Principle Randomized Controlled Trial.
Trial report in JMIR mHealth and uHealth, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06455397 (Implementing BEAM), which is not on this map. Cited by 16 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Implementing BEAM: An mHealth Tool to Prevent Mental Health Problems and Improve Developmental Outcomes in Young Children
Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Association between user engagement and clinical outcomes in smartphone apps for depression and anxiety: A systematic review and meta-analysis.Psychiatry research · 2026Pooled it
- Efficacy of stand-alone digital mental health applications for anxiety and depression: A meta-analysis of randomized controlled trials.Journal of psychiatric research · 2023Pooled it
- Analyzing the Effect of Telemedicine on Domains of Quality Through Facilitators and Barriers to Adoption: Systematic Review.Journal of medical Internet research · 2023Pooled it
- Digital mental health intervention for well-being among low-distress workers in small enterprises on a secondary analysis of an RCT.Scientific reports · 2025Trial
- SeniorHealth Tracker application to support the elderly: technological innovation leveraging humanisation.Frontiers in digital health · 2026Article
- Mobile-Based Cognitive Behavioral Therapy for Health Care Workers' Mental Health in Ecuador: Quasi-Experimental Study.JMIR human factors · 2025Article
- Article
- A meta-analysis of persuasive design, engagement, and efficacy in 92 RCTs of mental health apps.NPJ digital medicine · 2025Article
- Systematic review and meta-analysis of adverse events in clinical trials of mental health apps.NPJ digital medicine · 2024Article
- Key considerations for digital decentralised clinical trials from a feasibility study assessing pacing interventions for long COVID.Scientific reports · 2024Article
- Individuals' attitudes toward digital mental health apps and implications for adoption in Portugal: web-based survey.BMC medical informatics and decision making · 2024Article
- Digital interventions to promote psychological resilience: a systematic review and meta-analysis.NPJ digital medicine · 2024Review
- Digital technology and mental health during the COVID-19 pandemic: a narrative review with a focus on depression, anxiety, stress, and trauma.Frontiers in psychiatry · 2023Review
- Leveraging Mobile Health to Manage Mental Health/Behavioral Health Disorders: Systematic Literature Review.JMIR mental health · 2022Review
- Building Emotional Awareness and Mental Health (BEAM): A Pilot Randomized Controlled Trial of an App-Based Program for Mothers of Toddlers.Frontiers in psychiatry · 2022Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 (t
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.