Efficacy of a Mindfulness-Based Intervention Versus Relaxation in Primary Care Burnout Providers.

NCT02387528 | Completed

• 1 other identifier: CEP639061
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Burnout Syndrome

Keywords

MIndfulness; Primary Health Care

Outcome Measures

Primary Outcomes (1)

• A mindfulness intervention decreases burnout symptoms

  Measured by MBI-GS.

  up to 2 months

Secondary Outcomes (4)

• 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

Study Arms (3)

1- Mindfulness Intervention

EXPERIMENTAL

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

Behavioral: 1- Mindfulness Intervention

2- Relaxation Intervention

PLACEBO COMPARATOR

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.

Behavioral: 2- Relaxation Intervention

3- Wait List Control Group

OTHER

The wait list passive control group did not receive any intervention while the study was been enrolling.

Other: 3- Wait List Control Group

Interventions

1- Mindfulness Intervention BEHAVIORAL

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.

Also known as: Mindfulness Based Stress Reduction

1- Mindfulness Intervention

2- Relaxation Intervention BEHAVIORAL

Eight meetings where the participants will practice relaxation techniques.

Also known as: Relaxation

2- Relaxation Intervention

3- Wait List Control Group OTHER

No intervention

Also known as: Wait List

3- Wait List Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers over 18 years old who consent to be randomized to one of two groups, and
• have available time to join the research

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Marcelo Marcos Piva Demarzo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Mindfulness-Based Stress Reduction; Waiting Lists

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Daniela Sopezki, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 13, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 9, 2018
• Last Updated: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)