Clinical trial NCT03114605: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Police
Quality of Life
Burnout Syndrome
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Centro Mente Aberta de Mindfulness
First posted: 2017-04-14
Enrollment: 170
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change from baseline quality of Life
timeFrame: 8 weeks and 6 months
measure: Change from baseline burnout symptoms
timeFrame: 8 weeks and 6 months
Secondary outcomes:
measure: Change from baseline stress levels
timeFrame: 8 weeks and 6 months
measure: Change from baseline anxiety and depression symptoms
timeFrame: 8 weeks and 6 months
measure: Change from baseline Mental health
timeFrame: 8 weeks and 6 months
measure: Change from baseline decentering skills
timeFrame: 8 weeks and 6 months
measure: Change from baseline resilience
timeFrame: 8 weeks and 6 months
measure: Change from baseline spirituality, religiosity, personal beliefs
timeFrame: 8 weeks and 6 months
measure: Change from baseline religiosity
timeFrame: 8 weeks and 6 months
measure: Change from baseline mindfulness trait
timeFrame: 8 weeks and 6 months
measure: Change from baseline self-compassion
timeFrame: 8 weeks and 6 months
measure: Change from baseline Burnout subtypes
timeFrame: 8 weeks and 6 months
measure: Mindfulness mechanisms
timeFrame: 6 months
measure: Mindfulness mechanisms
timeFrame: 6 months
measure: Mindfulness mechanisms
timeFrame: 6 months
measure: Mindfulness mechanisms
timeFrame: 6 months
measure: Mindfulness mechanisms
timeFrame: 6 months
measure: Mindfulness mechanisms
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Neusa Sica da Rocha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIFESP - Federal University of Sao Paulo, Brazil
name: Marcelo Marcos Piva Demarzo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.