Background There is growing interest in digital platforms as a means of implementing scalable, accessible, and cost-effective mental health interventions in the workplace. However, little is known about the efficacy of such interventions when delivered to employee groups. Objective This study aims to evaluate the feasibility and preliminary efficacy of a digital mental health platform for the workplace, which incorporates evidence-based practices such as cognitive behavioral therapy and acceptance and commitment therapy. A total of 3 brief, unguided interventions designed to address stress, anxiety, and resilience, respectively, are evaluated. The primary aim is to determine the feasibility of the study methods and interventions in preparation for a definitive randomized controlled trial. Methods The study used a fully remote, parallel, multi-arm, external pilot randomized controlled trial, with 3 intervention arms and a no-intervention control group. Participants were working adults representative of the general UK population with respect to age, sex, and ethnicity who were recruited from a web-based participant platform. Primary outcomes included objective and self-report measures of feasibility, acceptability, engagement, transferability, relevance, and negative effects. Secondary outcomes included 4 self-report measures of mental health and well-being, completed at baseline (time point 0 [t0]), postintervention (time point 1 [t1]), and the 1-month follow-up (time point 2 [t2]). Secondary outcomes were analyzed via linear mixed-effects models using intention-to-treat principles. Preregistered criteria for progression to a definitive trial were evaluated. Results Data were collected between January and March of 2021. A total of 383 working adult participants meeting trial eligibility were randomized, of whom 356 (93%) were retained at t2. Objective engagement data showed that 67.8% (196/289) of participants randomized to an intervention arm completed their intervention. Overall, 87.1% (203/233) of participants reported being satisfied or very satisfied with their intervention and rated the quality of their intervention as good or excellent. All intervention groups reported significantly greater improvements than the control group on at least one secondary outcome at t1, with between-group Hedges g effect sizes for the pooled interventions ranging from 0.25 (95% CI 0.05-0.46) to 0.43 (95% CI 0.23-0.64). All the improvements were maintained at t2. Conclusions The study methods were feasible, and all preregistered criteria for progression to a definitive trial were met. Several minor protocol amendments were noted. Preliminary efficacy findings suggest that the study interventions may result in improved mental health outcomes when offered to working adults. Trial Registration ISRCTN Registry 80309011; http://www.isrctn.com/ISRCTN80309011

Background: Depressive symptoms are highly prevalent and have broad ranging negative implications. Digital interventions are increasingly available in a workplace context, but supporting evidence is limited. This study evaluated the feasibility, acceptability and preliminary efficacy of three digital interventions for depressive symptoms in a sample of UK based working adults experiencing subthreshold or mild to moderate symptoms. Methods: This was a parallel, multi-arm, pilot randomised controlled trial. Participants were allocated to one of three digital interventions or a wait list control group and had three weeks to complete 6-8 short self-guided sessions. Online assessments were conducted at weeks 0, 3 and 7. The interventions are available on the Unmind platform and draw on evidence based psychological therapies. Feasibility and acceptability were assessed using engagement and feedback data, efficacy outcomes were assessed using validated measures of mental health, wellbeing, and functioning, and linear mixed models.Results: 405 participants were randomised and 92% were retained. 97% initiated their allocated intervention and 67% completed all sessions. 81% rated the quality as excellent or good, and 80% were satisfied or very satisfied. All groups showed significant, maintained improvements in wellbeing, functioning, and depressive and anxiety symptoms vs control (p<0.05). Hedges g effect sizes were predominantly in the small to medium range. Limitations: This was a pilot study meaning efficacy findings require replication in a definitive trial. Conclusions: All interventions were feasible and acceptable, and findings indicate that their use can improve depressive symptoms, wellbeing and functioning. Pre-defined criteria for a definitive trial were met.

Study Objectives Many adults without a diagnosed sleep disorder report poor sleep. Recently, there has been a dramatic increase in the use of app-based audio tools to aid sleep by the general public, yet there is a paucity of evidence on whether such tools are efficacious. This study evaluated the feasibility and preliminary efficacy of two categories of audio tools, comprising music and narrated stories, featured on the Unmind app. Methods We conducted an online, parallel, multi-arm, external pilot randomized controlled trial, with two intervention arms and a waitlist (WL) control group. Participants were working adults who were screened for poor sleep. Feasibility was assessed via objective and self-report measures. Preliminary efficacy was evaluated via self-report measures of sleep disturbance, work productivity, and other mental health outcomes, captured at baseline (t0) and following a 4-week intervention period (t1), and analyzed using mixed effects models with intention-to-treat principles. Results 300 participants were randomized, and 92% were retained at t1. 90.5% of participants completed at least one intervention session. 82.1% reported being ‘satisfied’ or ‘very satisfied’ with their intervention, and 84.3% rated their intervention as ‘good’ or ‘excellent’. The between-group Hedges’ g effect size for sleep disturbance was 0.92 [0.63 – 1.22] and 1.09 [0.80 – 1.39] for the two interventions compared to the WL group. Conclusions Both interventions are feasible and acceptable. Preliminary efficacy findings suggest that audio tools designed to aid sleep could have widespread financial and public health implications, and should be investigated in a definitive trial.

Background Depressive symptoms are highly prevalent and have broad-ranging negative implications. Digital interventions are increasingly available in the workplace context, but supporting evidence is limited. Objective This study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of 3 digital interventions for depressive symptoms in a sample of UK-based working adults experiencing mild to moderate symptoms. Methods This was a parallel, multiarm, pilot randomized controlled trial. Participants were allocated to 1 of 3 digital interventions or a waitlist control group and had 3 weeks to complete 6 to 8 short self-guided sessions. The 3 interventions are available on the Unmind mental health app for working adults and draw on behavioral activation, cognitive behavioral therapy, and acceptance and commitment therapy. Web-based assessments were conducted at baseline, postintervention (week 3), and at 1-month follow-up (week 7). Participants were recruited via Prolific, a web-based recruitment platform, and the study was conducted entirely on the web. Feasibility and acceptability were assessed using objective engagement data and self-reported feedback. Efficacy outcomes were assessed using validated self-report measures of mental health and functioning and linear mixed models with intention-to-treat principles. Results In total, 2003 individuals were screened for participation, of which 20.22% (405/2003) were randomized. A total of 92% (373/405) of the participants were retained in the study, 97.4% (295/303) initiated their allocated intervention, and 66.3% (201/303) completed all sessions. Moreover, 80.6% (229/284) of the participants rated the quality of their allocated intervention as excellent or good, and 79.6% (226/284) of the participants were satisfied or very satisfied with their intervention. All active groups showed improvements in well-being, functioning, and depressive and anxiety symptoms compared with the control group, which were maintained at 4 weeks. Hedges g effect sizes for depressive symptoms ranged from −0.53 (95% CI −0.25 to −0.81) to −0.74 (95% CI −0.45 to −1.03). Conclusions All interventions were feasible and acceptable, and the preliminary efficacy findings indicated that their use may improve depressive symptoms, well-being, and functioning. The predefined criteria for a definitive trial were met. Trial Registration International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN13067492; https://www.isrctn.com/ISRCTN13067492

Many adults without a diagnosed sleep disorder report poor sleep. Recently, there has been a dramatic increase in the use of app-based audio tools to aid sleep by the general public, yet there is a paucity of evidence on whether such tools are efficacious. This study evaluated the feasibility and preliminary efficacy of two categories of audio tools, comprising music and narrated stories, featured on the Unmind app. We conducted a web-based, parallel, multi-arm, external pilot randomized controlled trial, with two intervention arms and a waitlist (WL) control group. Participants were working adults who were screened for poor sleep. Feasibility was assessed via objective and self-report measures. Preliminary efficacy was evaluated via self-report measures of sleep disturbance, work productivity, and other mental health outcomes, captured at baseline (t0) and following a 4-week intervention period (t1), and analyzed using mixed effects models with intention-to-treat principles. 300 participants were randomized, and 92% were retained at t1. 90.5% of participants completed at least one intervention session. 82.1% reported being ‘satisfied’ or ‘very satisfied’ with their intervention, and 84.3% rated their intervention as ‘good’ or ‘excellent’. The between-group Hedges’ g effect size for sleep disturbance was 0.92 [0.63 – 1.22] and 1.09 [0.80 – 1.39] for the two interventions compared to the WL group. Both interventions are feasible and acceptable. Preliminary efficacy findings suggest that audio tools designed to aid sleep could have widespread financial and public health implications, and should be investigated in a definitive trial.