- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03114605
Mindfulness-based Intervention in Police Officers - the POLICE Study
imPact Of a mindfuLness-based Intervention on Quality of Life and reduCtion of Burnout Symptoms in policE Officers - the POLICE Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness
Mindfulness-based Intervention (8 sessions - 2 hours each- 1 session/week)
|
|
|
No Intervention: Control
Waiting List
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
8 weeks and 6 months
|
|
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)
|
8 weeks and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline stress levels
Time Frame: 8 weeks and 6 months
|
A mindfulness intervention decreases stress levels (measured by change in PSQ scale)
|
8 weeks and 6 months
|
|
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)
|
8 weeks and 6 months
|
|
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)
|
8 weeks and 6 months
|
|
Change from baseline decentering skills
Time Frame: 8 weeks and 6 months
|
A mindfulness intervention increases decentering skills (measured by change in EQ scale)
|
8 weeks and 6 months
|
|
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)
|
8 weeks and 6 months
|
|
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)
|
8 weeks and 6 months
|
|
Change from baseline religiosity
Time Frame: 8 weeks and 6 months
|
A mindfulness intervention increases religiosity (measured by change in DUREL scale)
|
8 weeks and 6 months
|
|
Change from baseline mindfulness trait
Time Frame: 8 weeks and 6 months
|
A mindfulness intervention increases mindfulness trait (measured by change in MAAS scale)
|
8 weeks and 6 months
|
|
Change from baseline self-compassion
Time Frame: 8 weeks and 6 months
|
A mindfulness intervention increases self-compassion (measured by change in SCS scale)
|
8 weeks and 6 months
|
|
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)
|
8 weeks and 6 months
|
|
Mindfulness mechanisms
Time Frame: 6 months
|
Self-compassion (SCS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
|
6 months
|
|
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
|
6 months
|
|
Mindfulness mechanisms
Time Frame: 6 months
|
Decentering skills (EQ scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
|
6 months
|
|
Mindfulness mechanisms
Time Frame: 6 months
|
Spirituality (WHOQOL-SRPB-BREF scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
|
6 months
|
|
Mindfulness mechanisms
Time Frame: 6 months
|
Religiosity (DUREL scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
|
6 months
|
|
Mindfulness mechanisms
Time Frame: 6 months
|
Mindfulness trait (MAAS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- 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 and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60406416.9.1001.5327
- 160491 (Other Identifier: HCPA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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