Burnout Syndrome Clinical Trial
— MINDFULNESSOfficial title:
Efficacy of a Mindfulness-Based Intervention ("Breathworks for Stress") Versus Relaxation in the Symptoms of Burnout in Primary Care Providers: A Mixed-Methods Pragmatic Controlled Study
Verified date | March 2019 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The prevalence of the Burnout Syndrome (BS) or symptoms among Primary Health Care (PHC)
providers is high and can affect their quality of life and clinical results.
Mindfulness-based interventions (MBI) have been tested as promising interventions to manage
chronic stress and BS in PHC providers.
The main goal of this study was to compare the efficacy of an eight week MBI (Group 1 or G1)
on burnout symptoms in Brazilian PHC providers, compared to a briefer, four-week
relaxation-based intervention (Group 2 or G2) and to a waiting list control group (Group 3 or
G3). The initial hypothesis was that the MBI is superior to relaxation and to the waiting
list group. A non-randomized controlled trial was performed, with mixed-methods evaluation
(qualitative and quantitative).
Status | Completed |
Enrollment | 142 |
Est. completion date | October 9, 2018 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Volunteers over 18 years old who consent to be randomized to one of two groups, and - have available time to join the research Exclusion Criteria: - Practitioners of mindfulness, meditation yoga or similar in last year, - presence of not controlled greater severity diseases, such as cancer, schizophrenia, epilepsy, or other psychiatric diseases, - alcohol or other drugs addiction or abuse, except tobacco, and - being in acute treatment for psychological or psychiatric problems. All volunteers will undergo a brief initial clinical evaluation to assess whether the conditions of mental and physical health permit participation in groups. |
Country | Name | City | State |
---|---|---|---|
Brazil | Marcelo Marcos Piva Demarzo | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo | Federal University of Rio Grande do Sul |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A mindfulness intervention decreases burnout symptoms | Measured by MBI-GS. | up to 2 months | |
Secondary | A mindfulness intervention decreases negative affect and increases positive affect | After the intervention, measured by PANAS | up to 2 months | |
Secondary | A mindfulness intervention improves self compassion | measured by SCE after intervention. | up to 2 months | |
Secondary | A mindfulness intervention Increases mindfulness state. | measured by FFMQ | up to 2 months | |
Secondary | A mindfulness intervention improves decentering and decrease cognitive rumination | Measured by ES - Experience scale | up to 2 months |
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