Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mindfulness-based Intervention in Police Officers - the POLICE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114605
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
Centro Mente Aberta de Mindfulness
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:

The physical, emotional, economic and social damage of stress in the police corporation indicates an urgent call for preventive programs to approach stress reduction, burnout symptoms and promotion of quality of life and well-being.

The aim of the POLICE study is to evaluate the effectiveness of a Mindfulness-based intervention (MBI), compare to a waiting list (WL), in promoting quality of life and mental health in police officers.


Condition or disease Intervention/treatment Phase
Mindfulness Police Quality of Life Burnout Syndrome Behavioral: Mindfulness-based Intervention Not Applicable

Detailed Description:

Police officers are submitted to a high burden of chronic stress. It is no surprise to find that this occupation ranks highest on diseases and accidents rates among all professions. These professionals presents a very high incidence of depression, anxiety disorders, alcohol dependence and suicidal behavior. In addition to mental health suffering, evidence suggests an increase risk of sudden cardiac death, diabetes, obesity and metabolic syndrome.

Mindfulness-based interventions have been tested and incorporated for several clinical and non-clinical conditions for more than three decades, with emphasis on stress reduction, promotion of quality of life, chronic pain, anxiety, depression and eating disorders.

The main hypothesis is that mindfulness training will improve their quality of life and reduce burnout symptoms. The investigators expect that individuals allocated in the MBI group will report, besides showing a better quality of life, mental health and less burnout, lower levels of stress, anxiety and depression symptoms.

With regard to the working mechanism of the MBI, investigators will examine if the changes in mindfulness trait, self-compassion, spirituality, decentering and resilience skills will mediate the main hypothesis.

The study will be conducted in Porto Alegre-RS and São Paulo-SP.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: imPact Of a mindfuLness-based Intervention on Quality of Life and reduCtion of Burnout Symptoms in policE Officers - the POLICE Study
Actual Study Start Date : October 10, 2016
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Arm Intervention/treatment
Experimental: Mindfulness
Mindfulness-based Intervention (8 sessions - 2 hours each- 1 session/week)
Behavioral: Mindfulness-based Intervention
No Intervention: Control
Waiting List



Primary Outcome Measures :
  1. Change from baseline quality of Life [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increase quality of life (measured by change in Whoqol-Bref scale).

  2. Change from baseline burnout symptoms [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention decrease burnout symptoms (measured by change in MBI-GS scale)


Secondary Outcome Measures :
  1. Change from baseline stress levels [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention decreases stress levels (measured by change in PSQ scale)

  2. Change from baseline anxiety and depression symptoms [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention reduces anxiety and depression symptoms (measured by change in HADS scale)

  3. Change from baseline Mental health [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increases mental health (measured by change in GHQ-12 scale)

  4. Change from baseline decentering skills [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increases decentering skills (measured by change in EQ scale)

  5. Change from baseline resilience [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increases resilience capacity (measured by change in CD-RISC-25 scale)

  6. Change from baseline spirituality, religiosity, personal beliefs [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increases spirituality, religiosity and personal beliefs (measured by change in WHOQOL-SRPB-BREF scale)

  7. Change from baseline religiosity [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increases religiosity (measured by change in DUREL scale)

  8. Change from baseline mindfulness trait [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increases mindfulness trait (measured by change in MAAS scale)

  9. Change from baseline self-compassion [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increases self-compassion (measured by change in SCS scale)

  10. Change from baseline Burnout subtypes [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention decrease burnout symptoms according to burnout subtypes (measured by change in BCSQ-12 scale)

  11. Mindfulness mechanisms [ Time Frame: 6 months ]
    Self-compassion (SCS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

  12. Mindfulness mechanisms [ Time Frame: 6 months ]
    Resilience capacity (CD-RISC-25 scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

  13. Mindfulness mechanisms [ Time Frame: 6 months ]
    Decentering skills (EQ scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

  14. Mindfulness mechanisms [ Time Frame: 6 months ]
    Spirituality (WHOQOL-SRPB-BREF scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

  15. Mindfulness mechanisms [ Time Frame: 6 months ]
    Religiosity (DUREL scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

  16. Mindfulness mechanisms [ Time Frame: 6 months ]
    Mindfulness trait (MAAS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Active Police Officers
  • Availability to attend 8 sessions
  • Willingness to voluntarily participation

Exclusion Criteria:

  • Manic or hypomanic episode (current)
  • Psychotic syndrome (current or past)
  • Substance Use Disorder (past 12 months, except tobacco)
  • Risk of suicide
  • Previously completed Mindfulness-Based Intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114605


Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Centro Mente Aberta de Mindfulness
Investigators
Layout table for investigator information
Principal Investigator: Neusa Sica da Rocha, MD, PhD Hospital de Clínicas de Porto Alegre
Principal Investigator: Marcelo Marcos Piva Demarzo, MD, PhD UNIFESP - Federal University of Sao Paulo, Brazil
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03114605    
Other Study ID Numbers: 60406416.9.1001.5327
160491 ( Other Identifier: HCPA )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms