NCT03114605

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

October 7, 2019

Status Verified

March 1, 2017

Enrollment Period

2.1 years

First QC Date

March 21, 2017

Last Update Submit

October 4, 2019

Conditions

MindfulnessPoliceQuality of LifeBurnout Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

  • Change from baseline burnout symptoms

    A mindfulness intervention decrease burnout symptoms (measured by change in MBI-GS scale)

    8 weeks and 6 months

Secondary Outcomes (16)

  • Change from baseline stress levels

    8 weeks and 6 months

  • Change from baseline anxiety and depression symptoms

    8 weeks and 6 months

  • Change from baseline Mental health

    8 weeks and 6 months

  • Change from baseline decentering skills

    8 weeks and 6 months

  • Change from baseline resilience

    8 weeks and 6 months

  • +11 more secondary outcomes

Study Arms (2)

Mindfulness

EXPERIMENTAL

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

Behavioral: Mindfulness-based Intervention

Control

NO INTERVENTION

Waiting List

Interventions

Mindfulness-based InterventionBEHAVIORAL
Mindfulness

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active Police Officers
  • Availability to attend 8 sessions
  • Willingness to voluntarily participation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 33716824DERIVED

  • 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.

    PMID: 29801444DERIVED

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

April 14, 2017

Study Start

October 10, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

October 7, 2019

Record last verified: 2017-03