EMPower: An online Mind-body wellness Program for adults living with chronic health conditions: A three-armed randomized controlled trial protocol

Abstract

BackgroundSymptoms of depression and anxiety are prevalent among adults with chronic health conditions, contributing to reduced quality of life, morbidity, and mortality. Mind-body wellness interventions (i.e. psychology programming, mindful movement, breathwork, meditation) may impact mental health symptoms, with online delivery offering access and scalability. Whether online mind-body wellness interventions are effective in improving patient outcomes across a broad range of chronic conditions remains uncertain. MethodsThis three-armed, pragmatic, randomized controlled trial will use a nested mixed methods approach to assess the effectiveness of an online mind-body wellness intervention (eMPower), offered at two levels of personnel support, on symptoms of anxiety and depression in adults with chronic health conditions. Inclusion criteria require a self-reported chronic condition and access to an internet-connected device. Eligible participants will be randomized 1:1:1 to [1] waitlist control; [2] eMPower; [3] eMPower + weekly 1-to-1 check-in. The primary analysis will compare the Hospital and Anxiety Depression Scale (HADS) total score between eMPower + weekly 1-to-1 check-in versus controls, with secondary and exploratory outcomes including HADS subscales, health-related quality of life, fatigue, program engagement, and frailty. ConclusionWith online intervention delivery, a range of outcomes, mixed method evaluation, and automated intervention tracking, findings are anticipated to enhance our understanding of how individuals living with chronic health conditions engage with and are impacted by online mind-body wellness programming. Six hundred and fifty-six participants have been enrolled as of April 5, 2024, and 598 patients have completed 12-week follow-up.