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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- A mindfulness intervention decreases burnout symptoms
研究概览
简要总结
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).
详细描述
Study Design: a non-randomized pragmatic controlled trial was performed, with mixed-methods investigation.
Population: The target population of the study were PHC professionals from the city of Porto Alegre in the southern region of Brazil.
Sample: PHC professionals from 50 health units. A sample size calculation was performed, considering an effect size of 0.5 (moderate), with a statistical power of 80% and a confidence interval of 95%. Thus, 65 individuals in each group would be necessary, totaling 195 people distributed in the three groups, estimating a drop-out rate of 10%.
Inclusion criteria: 18 years or over, complete primary education at least, be interested in the objectives of this study and have consented to volunteer to participate in one of the three groups of interventions proposed, being a primary health care worker for at least six months and experiencing any kind of stress in relation to work.
Exclusion criteria: Have been practicing mindfulness, meditation, yoga or similar (tai chi chuan, qi gong) in the last six months, presence of diagnosed clinical diseases that would not allow adherence to the study, being in treatment for psychological or psychiatric problems, in the phase of therapeutic adjustment (less than three months of psychological or pharmacological interventions), be on medical leave of absence from work, dependence or abusive use of alcohol or other drugs, except for tobacco.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers over 18 years old who consent to be randomized to one of two groups, and
- •have available time to join the research
排除标准
- •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.
研究组 & 干预措施
1- Mindfulness Intervention
Mindfulness-Based Intervention: The intervention model tested was "Breathworks for Stress".The mindfulness intervention used in the study had a total of eight encounters, lasting 120 minutes, that took place once a week. In order to accommodate employees' schedule. There was a recommendation of daily practice lasting an average of 15 minutes, as well as the suggestion to use the tools in everyday life.
In each session a theme was presented, with distinct practices and well-defined objectives
干预措施: 1- Mindfulness Intervention (Behavioral)
2- Relaxation Intervention
Relaxation-Based Intervention was composed of four meetings, of two hours duration, held every two weeks. The activities involved mutual help conversations about work situations, psychoeducation on stress and various techniques of stress inoculation, such as: diaphragmatic breathing, progressive muscle relaxation, relaxing visualization and stretching. Each session had its own objective to promote the relaxation response effect.
干预措施: 2- Relaxation Intervention (Behavioral)
3- Wait List Control Group
The wait list passive control group did not receive any intervention while the study was been enrolling.
干预措施: 3- Wait List Control Group (Other)
结局指标
主要结局
A mindfulness intervention decreases burnout symptoms
时间窗: up to 2 months
Measured by MBI-GS.
次要结局
- A mindfulness intervention decreases negative affect and increases positive affect(up to 2 months)
- A mindfulness intervention improves self compassion(up to 2 months)
- A mindfulness intervention Increases mindfulness state.(up to 2 months)
- A mindfulness intervention improves decentering and decrease cognitive rumination(up to 2 months)
研究者
Daniela D. Sopezki
Phd
Federal University of São Paulo