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Completed

NCT Number: NCT01870154

Effectiveness of an Intervention for Prevention and Treatment of Burnout in Primary Care

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gerencia de Atención Primaria

Madrid, 28003, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No one.

Treatment and study plan

Training

Behavioral

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).

Primary outcomes

  1. Maslach's burnout inventory (MBI)

    Time frame: One year

    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.

Secondary outcomes

  1. Goldberg's General Health Questionnaire (GHQ-28)

    Time frame: One year

    It consists of 28 items, divided into 4 sub-scales. It is used to estimate the prevalence of psychiatric disease in a specific population and discover cases of psychiatric pathologies in non specialized consultations. It is not appropriate for performing clinical diagnosis, but can be employed to evaluate symptomatology using its sub-scales: A (somatic symptoms), B (anxiety/insomnia), C (social dysfunction), and D (severe depression). There are 4 possible answers to each question. The Likert scoring system assigns a value from 0 to 3 to each of the 4 possible answers.

Sponsors and collaborators

Lead sponsor

Gerencia de Atención Primaria, Madrid

Other Gov

Collaborators

  • Fondo de Investigacion Sanitaria

Registry information

Official study title

Effectiveness of an Intervention for Prevention and Treatment of Burnout in Primary Health Care Professionals

Acronym: EDESPROAP

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 5, 2013
Registry last updated
Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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