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
About this trial
This is an interventional prevention trial for Mindfulness
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
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
NCT ID
NCT03114605
First Posted
March 21, 2017
Last Updated
October 4, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Centro Mente Aberta de Mindfulness
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
Learn more about this trial
Mindfulness-based Intervention in Police Officers - the POLICE Study
We'll reach out to this number within 24 hrs