Effectiveness of a brief psychological mindfulness-based intervention for the treatment of depression in primary care: study protocol for a randomized controlled clinical trial

Abstract

Abstract Background Depressive symptoms are quite prevalent in Primary Care (PC) settings. The treatment as usual (TAU) in PC is pharmacotherapy, despite the high relapse rates it produces. Many patients would prefer psychotherapy, but specialized services are overloaded. Studies that apply Mindfulness-Based Interventions (MBIs) for the treatment of depression have obtained significant improvements. Brief low-intensity approaches delivered from PC could be a promising approach. This study aims to compare a low-intensity mindfulness intervention for the treatment of depression in PC using different intervention formats – a face-to-face MBI delivered in a group and the same MBI individually applied on the Internet – to a control group that will receive PC medical treatment as usual. Methods A randomized controlled clinical trial will be conducted in PC, with about 120 depressed patients allocated (1:1:1) to three groups: “face-to-face MBI + TAU”, “Internet-delivered MBI + TAU”, and “TAU alone”. The MBI programs will be composed of four modules. The primary outcome will be depressive symptoms, measured through the Beck Depression Inventory, assessed at pre- and post-treatment and 6- and 12-month follow-ups. Other outcomes will be mindfulness, happiness, affectivity, quality of life, and the use of healthcare services. Intention-to-treat analysis using linear mixed models adjusted for baseline scores and routine sociodemographic analysis that could show baseline differences will be conducted. Per-protocol secondary outcome analyses will also be performed. Discussion This is the first Spanish RCT to apply a low-intensity face-to-face MBI (plus TAU) to treat depression in PC settings compared to TAU (alone). Moreover, this study will also make it possible to evaluate the same MBI program (plus TAU), but Internet-delivered, considering their cost-effectiveness. Positive results from this RCT might have an important impact on mental health settings, helping to decrease the overload of the system and offering treatment alternatives beyond antidepressant medication through high-quality, flexible PC interventions. Trial registration Clinical Trials.gov NCT03034343. Trial Registration date 24 January 2017, retrospectively registered.