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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03114605
Other study ID # 60406416.9.1001.5327
Secondary ID 160491
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2016
Est. completion date November 1, 2018

Study information

Verified date March 2017
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility 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 Design


Intervention

Behavioral:
Mindfulness-based Intervention


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre Centro Mente Aberta de Mindfulness

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline quality of Life A mindfulness intervention increase quality of life (measured by change in Whoqol-Bref scale). 8 weeks and 6 months
Primary Change from baseline burnout symptoms A mindfulness intervention decrease burnout symptoms (measured by change in MBI-GS scale) 8 weeks and 6 months
Secondary Change from baseline stress levels A mindfulness intervention decreases stress levels (measured by change in PSQ scale) 8 weeks and 6 months
Secondary Change from baseline anxiety and depression symptoms A mindfulness intervention reduces anxiety and depression symptoms (measured by change in HADS scale) 8 weeks and 6 months
Secondary Change from baseline Mental health A mindfulness intervention increases mental health (measured by change in GHQ-12 scale) 8 weeks and 6 months
Secondary Change from baseline decentering skills A mindfulness intervention increases decentering skills (measured by change in EQ scale) 8 weeks and 6 months
Secondary Change from baseline resilience A mindfulness intervention increases resilience capacity (measured by change in CD-RISC-25 scale) 8 weeks and 6 months
Secondary Change from baseline spirituality, religiosity, personal beliefs A mindfulness intervention increases spirituality, religiosity and personal beliefs (measured by change in WHOQOL-SRPB-BREF scale) 8 weeks and 6 months
Secondary Change from baseline religiosity A mindfulness intervention increases religiosity (measured by change in DUREL scale) 8 weeks and 6 months
Secondary Change from baseline mindfulness trait A mindfulness intervention increases mindfulness trait (measured by change in MAAS scale) 8 weeks and 6 months
Secondary Change from baseline self-compassion A mindfulness intervention increases self-compassion (measured by change in SCS scale) 8 weeks and 6 months
Secondary Change from baseline Burnout subtypes A mindfulness intervention decrease burnout symptoms according to burnout subtypes (measured by change in BCSQ-12 scale) 8 weeks and 6 months
Secondary Mindfulness mechanisms Self-compassion (SCS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers 6 months
Secondary Mindfulness mechanisms Resilience capacity (CD-RISC-25 scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers 6 months
Secondary Mindfulness mechanisms Decentering skills (EQ scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers 6 months
Secondary Mindfulness mechanisms Spirituality (WHOQOL-SRPB-BREF scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers 6 months
Secondary Mindfulness mechanisms Religiosity (DUREL scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers 6 months
Secondary Mindfulness mechanisms Mindfulness trait (MAAS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers 6 months
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