JMIR Publications

ABSTRACT

Background:

Depression poses a major threat to public health with an increasing prevalence in the United States. Mindfulness-Based Cognitive Therapy (MBCT) has been shown to be an effective method for managing depression symptoms and may help fortify efforts to address the current disease burden. The in-person group format of MBCT, however, incurs barriers to care such as expenses, childcare needs, and transportation issues. As a result, alternate delivery modalities can be investigated to overcome the barriers faced by those requiring access to care.

Methods:

This study protocol aims to examine the feasibility and efficacy of virtual-delivered MBCT for the treatment of depression. To attain study aims, two phases will be implemented utilizing a crossover design. A total of 128 eligible participants will be randomized into either an eight-week MBCT intervention group (Group 1) or an eight-week waitlist control group (Group 2). In Phase I (eight weeks), Group 1 will complete the intervention and Group 2 will proceed with treatment as usual (TAU). In Phase II (eight weeks), Group 2 will cross over and complete the intervention and Group 1 will be assigned to TAU. TAU may consist of receiving psychotherapy, pharmacotherapy, or combined treatment. Data collection will be completed at baseline, eight weeks (post-intervention for Group 1, pre-intervention for Group 2), and 16 weeks (follow-up for Group 1, post-intervention for Group 2). The primary outcomes will include 1) current, residual, or chronic depression symptoms and 2) psychiatric distress. Secondary outcomes will include perceived stress and facets of mindfulness. The feasibility will be measured by assessing protocol adherence, retention, attendance, and engagement. Finally, the extent of mindfulness self-practice and executive functioning skills will be assessed as mediators of intervention outcome. Discussion: This trial will contribute to the field examining virtually-delivered, Mindfulness-Based Interventions (MBIs) for improving current, residual, or chronic depression symptoms. It will 1) address the feasibility of virtually-delivered MBCT; 2) contribute to the evidence base regarding MBCT’s efficacy in reducing depression symptoms and psychiatric distress; and 3) assess the impact of MBCT on several important secondary outcomes. Findings from this study will develop further the understanding of the causal pathways between virtually-delivered MBCT and depression symptoms, elucidating the potential for future larger-scale designs. Trial registration: The registration of this trial took place on April 22nd, 2022, on ClinicalTrials.gov (ID: NCT05347719). This occurred prior to the enrollment of any participants. The Sponsor of this trial is Greenville Health Authority (GHA). The Unique Protocol ID for this study is Pro00092709.