Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02387528
Other study ID # CEP639061
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date October 9, 2018

Study information

Verified date March 2019
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
1- Mindfulness Intervention
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.
2- Relaxation Intervention
Eight meetings where the participants will practice relaxation techniques.
Other:
3- Wait List Control Group
No intervention

Locations

Country Name City State
Brazil Marcelo Marcos Piva Demarzo São Paulo SP

Sponsors (2)

Lead Sponsor Collaborator
Federal University of São Paulo Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04728126 - Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
Completed NCT02540317 - Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial N/A
Completed NCT03668080 - Burnout Syndrome Among Medical Residents
Recruiting NCT03313609 - Investigating Burnout in Intensive Care in Middle Incoming Turkey N/A
Completed NCT03114605 - Mindfulness-based Intervention in Police Officers - the POLICE Study N/A
Completed NCT03360136 - Open Clinical Trial of CBT-based Multiprofessional Rehabilitation for Exhaustion Disorder N/A
Completed NCT03839030 - Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa). N/A
Completed NCT01870154 - Effectiveness of an Intervention for Prevention and Treatment of Burnout in Primary Care N/A
Completed NCT01575743 - Effects of Aerobic Exercise on Occupational Burnout N/A
Recruiting NCT03969771 - A Mindfulness Based Intervention as a Key Component of Successful Workplace Functioning and Personal Well-being N/A
Completed NCT03629457 - Efficacy of a Mindfulness Program to Reduce Stress and Burnout in Professionals of Medicine and Nursing (MINDUUDD) N/A
Terminated NCT03535493 - The Effect of ACT and Float REST on Burnout Syndrome. N/A
Completed NCT03489720 - Evaluation of a Daily Brief Exercise Intervention on Resident Physician Personal Resiliency and Burnout N/A
Completed NCT03141190 - Mindful Mental Training for Surgeons to Enhance Resilience and Performance Under Stress N/A
Completed NCT02950363 - Physician Mental Health Study for Medical Trainees N/A
Completed NCT03645798 - The Effects of "Three Good Things" Positive Psychotherapy on Nurses' Burnout N/A
Completed NCT04250012 - Web-based ACT to Support Parents With Children With Chronic and Developmental Conditions N/A
Completed NCT05750160 - Music Therapy on Neutrophyl Lymphocytes Ratio, Interleukin 6 and Interleukin 10 Levels of Burnout Syndrome N/A
Completed NCT03141229 - Health, Integration, Concentration: Mindfulness in Schools N/A
Completed NCT03073772 - Rehabilitation for Improved Cognition N/A