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

backgroundThere 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.

objectiveThis 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.

methodsThe 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.

resultsData 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.

conclusionsThe 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 registrationISRCTN Registry 80309011; http://www.isrctn.com/ISRCTN80309011.