Abstract
BackgroundDepressive 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.MethodsA 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.DiscussionThis 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 registrationClinical Trials.gov NCT03034343. Trial Registration date 24 January 2017, retrospectively registered.
Highlights
Depressive symptoms are quite prevalent in Primary Care (PC) settings
We considered a standardized difference between arms on the main outcome of d = 0.7, which corresponds to the average effect observed in ten studies comparing Mindfulness-Based Interventions (MBIs) with different wait-list conditions [36] and surpasses the 0.5 standard deviation criterion considered clinically relevant in previous studies [37, 38]
Consistent with the evidence, a large percentage of patients seen in PC services are being treated long-term with antidepressants, showing high relapse rates when trying to stop the medication [67], and many of them are referred to already overloaded specialized mental health services [68]
Summary
Depressive symptoms are quite prevalent in Primary Care (PC) settings. 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. Major Depression is a common mental disorder that produces great functional and social impairment all over the world. It is characterized by sustained states of negative affectivity and diminished positive affectivity. In the Spanish population, prevalence rates of 29.0% have been observed for major depressive disorder and 14.6% for dysthymia in PC services [4]
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