Mindfulness for Burnout Prevention in Primary Care Providers

NCT ID: NCT02897284

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-12-31

Brief Summary

Burnout Syndrome is one of the major challenges for health systems worldwide. This study strives to evaluate the feasibility and effectiveness of an 8- versus 2-week mindfulness-based self-care program on burnout symptoms and psychological and biological variables.

Detailed Description

The development of stepped-care interventions allows for the development of new strategies within mindfulness-based approaches, classically described as a weekly two-hour commitment which lasts eight weeks. Such approaches might reach larger and stratified groups, more suitable for usage in Brazilian health-system context. For such evaluations, the investigators will use a 3-arms randomized clinical trial design, with Sociodemographic and Labor variables, such as age, sex, number of offspring, adherence to the program, adherence to the mindfulness practices, Burnout Clinical Subtype Questionnaire -(BCSQ-36), Maslach Burnout Inventory (MBI-GS), Mindfulness Attention Awareness Scale (MAAS), Freiburg Mindfulness Inventory adapted for Brazil (FMI-Br-13), Five-Facet Mindfulness Questionnaire (FFMQ-Br). DNA methylation will be measured by Methylase-reaction, and BDNF (brain-derived neurotrophic factor) will be quantified by ELISA-sandwich. The primary outcome will be the effectiveness of such programs on different clinical subtypes of Burnout symptoms (frenetic, under challenged and worn-out). The secondary outcome will be mindfulness levels, and adherence to the program and to the mindfulness practice, and on inflammation and epigenetic variables.

Conditions

Burnout, Professional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Mindfulness 8 weeks

Mindfulness-based intervention with 8 weekly sessions

Group Type: EXPERIMENTAL

Mindfulness 8 weeks

Intervention Type: BEHAVIORAL

8 sessions of mindfulness

Mindfulness 2 weeks

Mindfulness-based intervention with 2 weekly sessions

Group Type: ACTIVE_COMPARATOR

Mindfulness 2 weeks

Intervention Type: BEHAVIORAL

2 sessions of mindfulness

Control

waiting list

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness 8 weeks

8 sessions of mindfulness

Intervention Type: BEHAVIORAL

Mindfulness 2 weeks

2 sessions of mindfulness

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Active Primary Care Providers

Exclusion Criteria

• Acute disease (physical or mental)
• Schizophrenia or other psychotic symptoms
• Concomitant use of medication causing attentional, cognitive or concentration impairments
• Having practiced mindfulness or other contemplative techniques in the previous 12 months of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Centro Mente Aberta de Mindfulness

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Marcos Piva Demarzo

Professor at Preventive Medicine Dept. - Unifesp

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelo MP Demarzo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mente Aberta - Brazilian Center for Mindfulness and Health Promotion

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Other Identifiers

CMAMindfulness

Identifier Type: -

Identifier Source: org_study_id