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Mindfulness-based Intervention in Police Officers - the POLICE Study

Primary Purpose

Mindfulness, Police, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness-based Intervention
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mindfulness

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Mindfulness

    Control

    Arm Description

    Mindfulness-based Intervention (8 sessions - 2 hours each- 1 session/week)

    Waiting List

    Outcomes

    Primary Outcome Measures

    Change from baseline quality of Life
    A mindfulness intervention increase quality of life (measured by change in Whoqol-Bref scale).
    Change from baseline burnout symptoms
    A mindfulness intervention decrease burnout symptoms (measured by change in MBI-GS scale)

    Secondary Outcome Measures

    Change from baseline stress levels
    A mindfulness intervention decreases stress levels (measured by change in PSQ scale)
    Change from baseline anxiety and depression symptoms
    A mindfulness intervention reduces anxiety and depression symptoms (measured by change in HADS scale)
    Change from baseline Mental health
    A mindfulness intervention increases mental health (measured by change in GHQ-12 scale)
    Change from baseline decentering skills
    A mindfulness intervention increases decentering skills (measured by change in EQ scale)
    Change from baseline resilience
    A mindfulness intervention increases resilience capacity (measured by change in CD-RISC-25 scale)
    Change from baseline spirituality, religiosity, personal beliefs
    A mindfulness intervention increases spirituality, religiosity and personal beliefs (measured by change in WHOQOL-SRPB-BREF scale)
    Change from baseline religiosity
    A mindfulness intervention increases religiosity (measured by change in DUREL scale)
    Change from baseline mindfulness trait
    A mindfulness intervention increases mindfulness trait (measured by change in MAAS scale)
    Change from baseline self-compassion
    A mindfulness intervention increases self-compassion (measured by change in SCS scale)
    Change from baseline Burnout subtypes
    A mindfulness intervention decrease burnout symptoms according to burnout subtypes (measured by change in BCSQ-12 scale)
    Mindfulness mechanisms
    Self-compassion (SCS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
    Mindfulness mechanisms
    Resilience capacity (CD-RISC-25 scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
    Mindfulness mechanisms
    Decentering skills (EQ scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
    Mindfulness mechanisms
    Spirituality (WHOQOL-SRPB-BREF scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
    Mindfulness mechanisms
    Religiosity (DUREL scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
    Mindfulness mechanisms
    Mindfulness trait (MAAS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

    Full Information

    First Posted
    March 21, 2017
    Last Updated
    October 4, 2019
    Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Centro Mente Aberta de Mindfulness
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03114605
    Brief Title
    Mindfulness-based Intervention in Police Officers - the POLICE Study
    Official Title
    imPact Of a mindfuLness-based Intervention on Quality of Life and reduCtion of Burnout Symptoms in policE Officers - the POLICE Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 10, 2016 (Actual)
    Primary Completion Date
    November 1, 2018 (Actual)
    Study Completion Date
    November 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Centro Mente Aberta de Mindfulness

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mindfulness, Police, Quality of Life, Burnout Syndrome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    170 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfulness
    Arm Type
    Experimental
    Arm Description
    Mindfulness-based Intervention (8 sessions - 2 hours each- 1 session/week)
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Waiting List
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness-based Intervention
    Primary Outcome Measure Information:
    Title
    Change from baseline quality of Life
    Description
    A mindfulness intervention increase quality of life (measured by change in Whoqol-Bref scale).
    Time Frame
    8 weeks and 6 months
    Title
    Change from baseline burnout symptoms
    Description
    A mindfulness intervention decrease burnout symptoms (measured by change in MBI-GS scale)
    Time Frame
    8 weeks and 6 months
    Secondary Outcome Measure Information:
    Title
    Change from baseline stress levels
    Description
    A mindfulness intervention decreases stress levels (measured by change in PSQ scale)
    Time Frame
    8 weeks and 6 months
    Title
    Change from baseline anxiety and depression symptoms
    Description
    A mindfulness intervention reduces anxiety and depression symptoms (measured by change in HADS scale)
    Time Frame
    8 weeks and 6 months
    Title
    Change from baseline Mental health
    Description
    A mindfulness intervention increases mental health (measured by change in GHQ-12 scale)
    Time Frame
    8 weeks and 6 months
    Title
    Change from baseline decentering skills
    Description
    A mindfulness intervention increases decentering skills (measured by change in EQ scale)
    Time Frame
    8 weeks and 6 months
    Title
    Change from baseline resilience
    Description
    A mindfulness intervention increases resilience capacity (measured by change in CD-RISC-25 scale)
    Time Frame
    8 weeks and 6 months
    Title
    Change from baseline spirituality, religiosity, personal beliefs
    Description
    A mindfulness intervention increases spirituality, religiosity and personal beliefs (measured by change in WHOQOL-SRPB-BREF scale)
    Time Frame
    8 weeks and 6 months
    Title
    Change from baseline religiosity
    Description
    A mindfulness intervention increases religiosity (measured by change in DUREL scale)
    Time Frame
    8 weeks and 6 months
    Title
    Change from baseline mindfulness trait
    Description
    A mindfulness intervention increases mindfulness trait (measured by change in MAAS scale)
    Time Frame
    8 weeks and 6 months
    Title
    Change from baseline self-compassion
    Description
    A mindfulness intervention increases self-compassion (measured by change in SCS scale)
    Time Frame
    8 weeks and 6 months
    Title
    Change from baseline Burnout subtypes
    Description
    A mindfulness intervention decrease burnout symptoms according to burnout subtypes (measured by change in BCSQ-12 scale)
    Time Frame
    8 weeks and 6 months
    Title
    Mindfulness mechanisms
    Description
    Self-compassion (SCS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
    Time Frame
    6 months
    Title
    Mindfulness mechanisms
    Description
    Resilience capacity (CD-RISC-25 scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
    Time Frame
    6 months
    Title
    Mindfulness mechanisms
    Description
    Decentering skills (EQ scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
    Time Frame
    6 months
    Title
    Mindfulness mechanisms
    Description
    Spirituality (WHOQOL-SRPB-BREF scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
    Time Frame
    6 months
    Title
    Mindfulness mechanisms
    Description
    Religiosity (DUREL scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
    Time Frame
    6 months
    Title
    Mindfulness mechanisms
    Description
    Mindfulness trait (MAAS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neusa Sica da Rocha, MD, PhD
    Organizational Affiliation
    Hospital de Clínicas de Porto Alegre
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marcelo Marcos Piva Demarzo, MD, PhD
    Organizational Affiliation
    UNIFESP - Federal University of Sao Paulo, Brazil
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    33716824
    Citation
    Trombka M, Demarzo M, Campos D, Antonio SB, Cicuto K, Walcher AL, Garcia-Campayo J, Schuman-Olivier Z, Rocha NS. Mindfulness Training Improves Quality of Life and Reduces Depression and Anxiety Symptoms Among Police Officers: Results From the POLICE Study-A Multicenter Randomized Controlled Trial. Front Psychiatry. 2021 Feb 26;12:624876. doi: 10.3389/fpsyt.2021.624876. eCollection 2021.
    Results Reference
    derived
    PubMed Identifier
    29801444
    Citation
    Trombka M, Demarzo M, Bacas DC, Antonio SB, Cicuto K, Salvo V, Claudino FCA, Ribeiro L, Christopher M, Garcia-Campayo J, Rocha NS. Study protocol of a multicenter randomized controlled trial of mindfulness training to reduce burnout and promote quality of life in police officers: the POLICE study. BMC Psychiatry. 2018 May 25;18(1):151. doi: 10.1186/s12888-018-1726-7.
    Results Reference
    derived

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    Mindfulness-based Intervention in Police Officers - the POLICE Study

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