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Mindfulness-based Intervention in Police Officers - the POLICE Study

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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

Tracking Information
First Submitted Date  ICMJE March 21, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date October 7, 2019
Actual Study Start Date  ICMJE October 10, 2016
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • 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).
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • Change from baseline stress levels [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention decreases stress levels (measured by change in PSQ scale)
  • 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)
  • 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)
  • Change from baseline decentering skills [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increases decentering skills (measured by change in EQ scale)
  • 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)
  • 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)
  • Change from baseline religiosity [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increases religiosity (measured by change in DUREL scale)
  • Change from baseline mindfulness trait [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increases mindfulness trait (measured by change in MAAS scale)
  • Change from baseline self-compassion [ Time Frame: 8 weeks and 6 months ]
    A mindfulness intervention increases self-compassion (measured by change in SCS scale)
  • 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)
  • Mindfulness mechanisms [ Time Frame: 6 months ]
    Self-compassion (SCS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
  • 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
  • Mindfulness mechanisms [ Time Frame: 6 months ]
    Decentering skills (EQ scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
  • Mindfulness mechanisms [ Time Frame: 6 months ]
    Spirituality (WHOQOL-SRPB-BREF scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
  • Mindfulness mechanisms [ Time Frame: 6 months ]
    Religiosity (DUREL scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
  • Mindfulness mechanisms [ Time Frame: 6 months ]
    Mindfulness trait (MAAS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness-based Intervention in Police Officers - the POLICE Study
Official Title  ICMJE imPact Of a mindfuLness-based Intervention on Quality of Life and reduCtion of Burnout Symptoms in policE Officers - the POLICE Study
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Mindfulness
  • Police
  • Quality of Life
  • Burnout Syndrome
Intervention  ICMJE Behavioral: Mindfulness-based Intervention
Study Arms  ICMJE
  • Experimental: Mindfulness
    Mindfulness-based Intervention (8 sessions - 2 hours each- 1 session/week)
    Intervention: Behavioral: Mindfulness-based Intervention
  • No Intervention: Control
    Waiting List
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2019)
170
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2017)
160
Actual Study Completion Date  ICMJE November 1, 2018
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03114605
Other Study ID Numbers  ICMJE 60406416.9.1001.5327
160491 ( Other Identifier: HCPA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Centro Mente Aberta de Mindfulness
Investigators  ICMJE
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
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP