The Efficacy of "Foundations," a Digital Mental Health App to Improve Mental Well-being During COVID-19: Proof-of-Principle Randomized Controlled Trial.

BACKGROUND: Against 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. OBJECTIVE: The 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. METHODS: Adults 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. RESULTS: A 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). CONCLUSIONS: This 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 REGISTRATION: OSF Registries osf.io/f6djb; https://osf.io/vm3xq.

Development and Feasibility of a Digital Acceptance and Commitment Therapy-Based Intervention for Generalized Anxiety Disorder: Pilot Acceptability Study.

BACKGROUND: Generalized anxiety disorder (GAD) is characterized by excessive worry that is difficult to control and has high comorbidity with mood disorders including depression. Individuals experience long wait times for diagnosis and often face accessibility barriers to treatment. There is a need for a digital solution that is accessible and acceptable to those with GAD. OBJECTIVE: This paper aims to describe the development of a digital intervention prototype of acceptance and commitment therapy (ACT) for GAD that sits within an existing well-being app platform, BioBase. A pilot feasibility study evaluating acceptability and usability is conducted in a sample of adults with a diagnosis of GAD, self-referred to the study. METHODS: Phase 1 applied the person-based approach (creation of guiding principles, intervention design objectives, and the key intervention features). In Phase 2 participants received the app-based therapeutic and paired wearable for 2 weeks. Self-report questionnaires were obtained at baseline and posttreatment. The primary outcome was psychological flexibility (Acceptance and Action Questionnaire-II [AAQ-II]) as this is the aim of ACT. Mental well-being (Warwick-Edinburgh Mental Well-being Scale [WEMWBS]) and symptoms of anxiety (7-item Generalized Anxiety Disorder Assessment [GAD-7]) and depression (9-item Patient Health Questionnaire [PHQ-9]) were also assessed. Posttreatment usability was assessed via self-report measures (System Usability Scale [SUS]) in addition to interviews that further explored feasibility of the digital intervention in this sample. RESULTS: The app-based therapeutic was well received. Of 13 participants, 10 (77%) completed the treatment. Results show a high usability rating (83.5). Participants found the digital intervention to be relevant, useful, and helpful in managing their anxiety. Participants had lower anxiety (d=0.69) and depression (d=0.84) scores at exit, and these differences were significantly different from baseline (P=.03 and .008 for GAD-7 and PHQ-9, respectively). Participants had higher psychological flexibility and well-being scores at exit, although these were not significantly different from baseline (P=.11 and .55 for AAQ-II and WEMWBS, respectively). CONCLUSIONS: This ACT prototype within BioBase is an acceptable and feasible digital intervention in reducing symptoms of anxiety and depression. This study suggests that this intervention warrants a larger feasibility study in adults with GAD.