Multicentre, England-wide randomised controlled trial of the ‘Foundations’ smartphone application in improving mental health and well-being in a healthcare worker population

Abstract

Background Healthcare workers (HCWs) have faced considerable pressures during the COVID-19 pandemic. For some, this has resulted in mental health distress and disorder. Although interventions have sought to support HCWs, few have been evaluated. Aims We aimed to determine the effectiveness of the ‘Foundations’ application (app) on general (non-psychotic) psychiatric morbidity. Method We conducted a multicentre randomised controlled trial of HCWs at 16 NHS trusts (trial registration number: EudraCT: 2021-001279-18). Participants were randomly assigned to the app or wait-list control group. Measures were assessed at baseline, after 4 and 8 weeks. The primary outcome was general psychiatric morbidity (using the General Health Questionnaire). Secondary outcomes included: well-being; presenteeism; anxiety; depression and insomnia. The primary analysis used mixed-effects multivariable regression, presented as adjusted mean differences (aMD). Results Between 22 March and 3 June 2021, 1002 participants were randomised (500:502), and 894 (89.2%) followed-up. The sample was predominately women (754/894, 84.3%), with a mean age of 44⋅3 years (interquartile range (IQR) 34–53). Participants randomised to the app had a reduction in psychiatric morbidity symptoms (aMD = −1.39, 95% CI −2.05 to −0.74), improvement in well-being (aMD = 0⋅54, 95% CI 0⋅20 to 0⋅89) and reduction in insomnia (adjusted odds ratio (aOR) = 0⋅36, 95% CI 0⋅21 to 0⋅60). No other significant findings were found, or adverse events reported. Conclusions The app had an effect in reducing psychiatric morbidity symptoms in a sample of HCWs. Given it is scalable with no adverse effects, the app may be used as part of an organisation's tiered staff support package. Further evidence is needed on long-term effectiveness and cost-effectiveness.

Effectiveness of a mental health stepped-care programme for healthcare workers with psychological distress in crisis settings: a multicentre randomised controlled trial

“…During the COVID-19 pandemic, some RCTs used online and phone-based emotion regulation interventions similar to the first step of our programme, namely DWM. Their effects on anxiety and depression symptoms were either non-existent8 11 13 or limited to the completion of a unique mindfulness training session 6 7. This contrasts with our positive findings with the DWM at 6 weeks from baseline, probably because it was more intense both in terms of duration (5 weeks vs 2–4 weeks) and level of support (weekly follow-up calls vs unguided self-help) 35 36.…”

“…However, most have used short psychological interventions with no previous evidence, included small sample sizes (mostly limited to nurses) and used short follow-up periods. Two studies reported positive results on anxiety symptoms, but only immediately after a single mindfulness training session,6 7 and one reported a decrease in general psychiatric comorbidity at 8 weeks from baseline using a smartphone app but did not find any effects on anxiety or depression symptoms 13…”

“…In Spain, one of the earliest pandemic hotspots worldwide, one in four HCWs had a probable major depressive disorder and one in five had a probable anxiety disorder or PTSD by late 2020 5. Only a few randomised controlled trials (RCTs) have focused on HCWs’ anxiety and depression symptoms during the COVID-19 pandemic 6–13. However, most have used short psychological interventions with no previous evidence, included small sample sizes (mostly limited to nurses) and used short follow-up periods.…”

Psychological interventions for healthcare professionals during the COVID‐19 pandemic: A systematic review

“…Five studies used web applications to deliver psychological interventions (Fiol‐DeRoque et al., 2021; Ghazanfarpour et al., 2021; Gnanapragasam et al., 2022; Gupta et al., 2021; Otared et al., 2021). Two studies did not show significant differences between groups for the primary outcomes (Fiol‐DeRoque et al., 2021; Gupta et al., 2021).…”

“…Gnanapragasam et al. (2022) used the Foundations smartphone application, the main aim of this tool was to promote well‐being habits and behaviour change, promoting mental well‐being, improving sleep and managing stress. Participants in the application group presented a significant reduction of psychiatric morbidity symptoms (aMD = −1.39, 95% CI = −2.05 to −0.74, p < 0.001) as well as a significant increase in well‐being (aMD = 0.54, 95% CI = 0.20–0.89, p = 0.002) compared to control group.…”