Accepted for/Published in: JMIR Formative Research
Date Submitted: Oct 8, 2021
Date Accepted: Nov 20, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Feasibility and preliminary efficacy of web-based and mobile interventions for common mental health problems in working adults: a multi-arm randomised 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 aimed to evaluate the feasibility and preliminary efficacy of a digital mental health platform for the workplace, that incorporates evidence-based practices such as cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT). Three brief, unguided interventions designed to address stress, anxiety, and resilience, respectively, were evaluated. The primary aim was to determine the feasibility of the study methods and interventions in preparation for a definitive randomised controlled trial (RCT).
Methods:
The study employed a fully remote, parallel, multi-arm, external pilot RCT, with three 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 an online participant platform. Primary outcomes included objective and self-report measures of feasibility, acceptability, engagement, transferability, relevance, and negative effects. Secondary outcomes included four self-report measures of mental health and wellbeing, completed at baseline (t0), post-intervention (t1) and 1-month follow-up (t2). Secondary outcomes were analysed 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 to March 2021. A total of 383 working adult participants meeting trial eligibility were randomised, of which 356 (93.0%) were retained at t2. Objective engagement data showed that 67.8% of all participants randomised to an intervention arm completed their intervention. 87.1% of participants reported being “satisfied” or “very satisfied” with their intervention, and 87.1% 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 Hedge’s 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 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 are noted. Preliminary efficacy findings suggest the study interventions may result in improved mental health outcomes when offered to working adults. Clinical Trial: International Standard Randomized Controlled Trial Number (ISRCTN) 80309011; http://www.isrctn.com/ISRCTN80309011.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.