Efficacy of a Mindfulness-Based Intervention Versus Relaxation in Primary Care Burnout Providers.
Condition: Burnout Syndrome
MeSH terms: Burnout, Psychological
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.

      Recruitment and procedures: The study was publicized among all PHC units using informative
      pamphlets, and PHC managers were informed personally by the first author (DS) about the goals
      of the project. The professionals were dismissed during working hours for the meetings that
      took place in places available and previously scheduled with the heads of health services.
      All the volunteers were previously submitted to the study´s criteria for participation. Those
      who were interested underwent a brief evaluation using the Beck´s Depression Inventory (BDI),
      Self Reported Questionnaire (SRQ-20) (common mental disorders) and Self Reported
      Questionnaire (SRQ-A) (alcohol use) scales to exclude severe symptoms (suicidal ideation and
      alcohol abuse). After inclusion, volunteers were able to choose between the three participant
      groups of the study (mindfulness, relaxation, or waiting list). We did not randomize the
      professionals in order to make the study more feasible and pragmatic. Specifically, in a
      pilot study we had observed that the professionals were highly resistant to being randomly
      allocated to the study groups.

      Ethics: This study was conducted according to the Declaration of Helsinki and was submitted
      to three Research Ethics Committees, respecting all the criteria for the execution of
      research with human beings.

      All participants agreed to participate in the study and signed the Free and Informed Consent
      prior to any study procedure.

      A drop-out was defined as a participant who completed fewer than four sessions.

      Measures:

      Added to sociodemographic data, the Maslach Burnout Inventory - General Survey) (MBI-GS ) was
      used to identify symptoms of BS, The Positive and Negative Scale (PANAS) to evaluate
      affection, Five Facet Mindfulness Questionnaire (FFMQ) to measure mindfulness dimensions; the
      Experience Scale to measure decentering and rumination (ES), and the Self-Compassion Scale
      (SCS) to measure compassion.
    

Intervention name(s): 1- Mindfulness Intervention; 2- Relaxation Intervention; 3- Wait List Control Group
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): An intervention program integrating elements of Mindfulness Breathworks Institute Mindfulness based approaches for Pain and illness (MBPI), (Burch , 2009) and Mindfulness Based Stress Reduction (MBSR), (Kabat Zinn, 2003), and Mindfulness based Cognitive Therapy (MBCT) shall be used. All programs are highly structured, lasting eight weeks, with a weekly meeting about two hours , and working with four main techniques during these meetings : mindfulness in breathing, body scan, walking meditation and mindfulness yoga. In order to facilitate the home practice of meditation by participants during and after the intervention protocol, all will receive a CD containing guided meditation sessions, covering the above techniques.; Eight meetings where the participants will practice relaxation techniques.; No intervention
Other intervention name(s): Mindfulness Based Stress Reduction; Relaxation; Wait List
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MIndfulness; Primary Health Care