NCT01870154

Brief Summary

Background: Burnout syndrome is an important health problem that affects many professionals and must be addressed globally, with both organizational measures and personal interventions. Burnout of health professionals can be prevented in order to avoid personal, familial, and social consequences, as well as repercussions for patients. Methods/Design: This work describes a protocol for a controlled, pragmatic, randomized clinical trial in 2 parallel groups: intervention and control. All health professionals from 7 health care centers (HCCs) will form the intervention group, and all health professionals from 7 different HCCs will form the control group. The intervention group will receive 16 hours of training at their work place. The Maslach's burnout inventory (MBI), burnout physician Questionnaire (CDPM) or burnout nurse Questionnaire (CDPE), and the 28-item Goldberg's General Health Questionnaire (GHQ-28), validated for our setting, will be used as measurement tools. Change in the average scores from the MBI emotional exhaustion scale will be compared between the intervention and control groups, measured as intention-to-treat, and the intervention will be considered effective if a minimum increase of 20% is achieved. Discussion: Due to the deleterious consequences of burnout syndrome for people suffering from it and for the organization where they work, it is necessary to evaluate the effectiveness of certain interventions for its prevention. Organizational measures are important for preventing burnout syndrome, but so is providing professionals with coping strategies, as this group intervention intends to do.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

June 2, 2013

Last Update Submit

June 4, 2013

Conditions

Keywords

Burnout syndromeJob stressorsPrimary Health CareHealth professional

Outcome Measures

Primary Outcomes (1)

  • Maslach's burnout inventory (MBI)

    Worker classification regarding burnout syndrome will be performed according to the MBI, which includes 22 items to evaluate emotional exhaustion (EE), depersonalization (DP), and personal fulfillment (PF), with scores ranging from 0 to 6 on the Likert scale. We consider a high degree of burnout in the case of EE ≥ 27 points, DP ≥ 10, and PF \<33. Moderate burnout will be considered in the case of 26\<EE\<19 points, 6\<DP\<9 points, and 34\<PF\<39 points. Low levels will be considered for EE≤18 points, DP≤5 points, and PF≥40 points.

    One year

Secondary Outcomes (1)

  • Goldberg's General Health Questionnaire (GHQ-28)

    One year

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention consists of 16 hours of training, to be held at the subject's health center. The workshop involves mixed learning, comprising 4 sessions, each 2 hours long, in addition to personal work previous to and after each session of reading relevant bibliography and performing exercises, self-evaluation, and case studies (8 hours of individual work).

Behavioral: Training

Control group

ACTIVE COMPARATOR

Usual care

Behavioral: Training

Interventions

TrainingBEHAVIORAL

The objective of the intervention is learning from the work experience of professionals attending the workshop to know and recognize the risk and process of the burnout syndrome and the characteristics specific to the health setting, as well as promoting prevention lines by transmitting strategies to manage and control the elements and consequences of the syndrome process (physical, psychological, and social).

Control groupIntervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All health professionals (family physicians, pediatricians, and nurses) who are part of the health care centers at the moment of the trial.

You may not qualify if:

  • No one.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerencia de Atención Primaria

Madrid, Madrid, 28003, Spain

Location

Related Publications (1)

  • Gomez-Gascon T, Martin-Fernandez J, Galvez-Herrer M, Tapias-Merino E, Beamud-Lagos M, Mingote-Adan JC; Grupo EDESPROAP-Madrid. Effectiveness of an intervention for prevention and treatment of burnout in primary health care professionals. BMC Fam Pract. 2013 Nov 17;14:173. doi: 10.1186/1471-2296-14-173.

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Tomás Gómez-Gascón, MD

    Gerencia de Atención Primaria, Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2013

First Posted

June 5, 2013

Study Start

March 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations