Feasibility and Preliminary Efficacy of Web-Based and Mobile Interventions for Common Mental Health Problems in Working Adults: Multi-Arm Randomized Pilot Trial

Abstract

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

Implementing Technologies: Assessment of Telemedicine Experiments in the Paris Region: Reasons for Success or Failure of the Evaluations and of the Deployment of the Projects

“…The identification of significant effects requires data collection over a longer period. The time constraints did not allow conducting pilot studies, as is recommended for complex interventions and as is particularly relevant for digital health when participation, delivery, and retention of the intervention are of particular concern [ 21 , 22 ].…”

Feasibility and Preliminary Efficacy of Digital Interventions for Depressive Symptoms in Working Adults: Multiarm Randomized Controlled Trial

“…Unmind is a digital platform designed to help working adults measure, manage, and improve their mental health and well-being and has previously been described in detail [ 30 ]. This study evaluated 3 brief interventions (known as courses) available on the Unmind platform, accessible via web-based or mobile apps, intended to help users manage and improve low mood and depressive symptoms and designed to be completed over the course of several days or weeks ( Figure 1 ).…”

“…Although employees are granted access to Unmind via their employer, it can be used both within and outside the workplace. Unmind has previously been shown to be feasible and acceptable when used by healthy participants to manage symptoms of stress and anxiety or boost resilience [ 30 ], but it has not been evaluated for use by individuals with mild to moderate depression. As depression has been shown to negatively impact intervention engagement [ 31 ], we deemed it necessary to establish acceptability and report on app engagement in this novel study population.…”

Just-in-Time Adaptive Interventions for Depression

“…Since it targets behavioural change, it is defined as 'active' interventions in terms of programme content (Barak et al 2009). While creating the programme content, it has been supported by evidence that individuals can learn on their own (Burns 2015, Wood andJohnson 2021) and that it is effective in reducing the severity of depression (González-Valero et al 2019, Gautam et al 2020, Kürümlüoğlugil and Tanrıverdi 2022, Kaplan et al 2023, interventions such as cognitive behavioural therapy approaches and positive psychology interventions that are suitable for presentation on digital platforms can be used (Cohn et al 2014, Aguilera et al 2021, Economides et al 2022, Klein et al 2023, Lopes et al 2023. Selfhelp interventions are dynamic with the delivery of online activities.…”