Cited by 19Mindfulness and Compassion InterventionsDigital Mental Health InterventionsPsychotherapy Techniques and Applications

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

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Lopez-Montoyo, Alba, Quero, Soledad, Montero-Marin, Jesus, Barcelo-Soler, Alberto, Beltran, Maria, Campos, Daniel, Garcia-Campayo, Javier·2019·BMC Psychiatry

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.

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  • Mindfulness-based approaches have been shown to be effective in managing stress, anxiety, depression, and chronic pain.

    “mindfulness-based approaches have been shown to be effective in managing conditions such as stress, anxiety, depression, and chronic pain.”

    From Exploring patient experiences with a mindfulness course in a general practice setting: a qualitative study. (2025) · cites this paper as [19]

    The Background (page unavailable) says mindfulness-based interventions have demonstrated effectiveness in treating depression and preventing its relapse or recurrence. It does not establish effectiveness for managing stress, anxiety, or chronic pain; those terms appear in reference titles or outcome measures, not as findings reported for those conditions. (LLM, conf=0.87)

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  • MBSR has demonstrated significant benefits in stress, anxiety, depression, and chronic pain and is recommended in several guidelines.

    “the extensively researched MBSR program, has demonstrated significant benefits in these areas [16–23], and are recommended in several guidelines [22, 24, 25].”

    From Exploring patient experiences with a mindfulness course in a general practice setting: a qualitative study. (2025) · cites this paper as [19]

    The Background (page unavailable) reports benefits of mindfulness-based interventions for depression and says NICE guidelines recommend mindfulness-based cognitive therapy for recurrent depression. The Discussion (page unavailable) also notes reported benefits of mindfulness for other disorders. Neither passage establishes the claimed benefits specifically for MBSR across stress, anxiety, depression, and chronic pain, or says that MBSR is recommended in several guidelines. (LLM, conf=0.87)

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  • Our study aligns with existing research evidence that mindfulness is an effective and acceptable alternative or supplement to traditional treatments for stress, anxiety, and depression.

    “Our study aligns with existing research evidence that mindfulness is an effective and acceptable alternative or supplement to traditional treatments for stress, anxiety, and depression [16, 19, 41]”

    From Exploring patient experiences with a mindfulness course in a general practice setting: a qualitative study. (2025) · cites this paper as [19]

    The Background reports that mindfulness-based interventions are effective for depression, and the Clinical implications section discusses them as a possible alternative to antidepressant medication. But this is a study protocol, not evidence from a completed trial; its discussion of an alternative is conditional. The copy does not establish mindfulness as an effective and acceptable alternative or supplement for all three conditions: the explicit acceptability finding in the Background concerns internet-based CBT, not mindfulness. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

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Research works printed but not linked: 1

  1. [70]Andrews G Cuijpers P Craske MG McEvoy P Titov N Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. Baune BT, editor PLoS One 2010 5 10 e13196 10.1371/journal.pone.0013196 20967242 PMC2954140 · DOI · Paper page

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Authors
Lopez-Montoyo, A., Quero, S., Montero-Marin, J., Barcelo-Soler, A., Beltran, M., Campos, D., & Garcia-Campayo, J.
Affiliations
  • Universitat Jaume I (ES)
  • Universidad de Zaragoza (ES)
Corresponding author
Quero, Soledad
Venue
BMC Psychiatry
Published
2019-10-16
Volume
19
Issue
1
Pages
301-301
ISSN
1471-244X (ISSN-L)
OpenAlex
W2980863856
Cited by
19
References
85
Citations by year
2025: 2 · 2023: 4 · 2022: 4 · 2021: 5 · 2020: 4
FWCI
3.80
Type
journal article
Language
en
Open access
Locations
  • BMC Psychiatry (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Repositori UJI (Universitat Jaume I) (publishedVersion, cc-by-sa)
  • LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-sa)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Zaguan (Universidad de Zaragoza) (submittedVersion, cc-by)
Funders
  • European Commission
  • Ministerio de Economía y Competitividad (PI16/)
  • Instituto de Salud Carlos III (PI16/, RD16/0007, PI16/00962)
  • European Regional Development Fund (RD16/0007)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
  • Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
Keywords
depression, mindfulness-based interventions, primary care, online intervention, group therapy, antidepressants, depressive symptoms, quality of life, health care utilization, cost-effectiveness
MeSH terms
Adult, Cost-Benefit Analysis, Depression, Depressive Disorder, Female, Humans, Male, Primary Health Care, Psychiatric Status Rating Scales, Psychotherapy, Brief, Quality of Life, Randomized Controlled Trials as Topic, Treatment Outcome, Mindfulness

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