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MindfulnessNCT03114605

Mindfulness-based Intervention in Police Officers - the POLICE Study

A study testing Mindfulness-based Intervention in people with Mindfulness and Police, run by Hospital de Clinicas de Porto Alegre.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Mindfulness, Police, Quality of Life
What is being tested?
Mindfulness-based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
No sites listed yet
Study dates
10 Oct 2016to 1 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

About this study

Official title: 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.

Read the 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.

Being tested
Mindfulness-based Intervention
Medical subject headings
Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-based InterventionBehavioural

Study groups in NCT03114605
Study groupRoleWhat they receive
MindfulnessExperimentalMindfulness-based Intervention (8 sessions - 2 hours each- 1 session/week)
Receives: Behavioral: Mindfulness-based Intervention
ControlNo interventionWaiting List

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline quality of Life

    A mindfulness intervention increase quality of life (measured by change in Whoqol-Bref scale).

    Measured: 8 weeks and 6 months

  2. Change from baseline burnout symptoms

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

    Measured: 8 weeks and 6 months

Secondary outcomes (16)

  1. Change from baseline stress levels

    A mindfulness intervention decreases stress levels (measured by change in PSQ scale)

    Measured: 8 weeks and 6 months

  2. Change from baseline anxiety and depression symptoms

    A mindfulness intervention reduces anxiety and depression symptoms (measured by change in HADS scale)

    Measured: 8 weeks and 6 months

  3. Change from baseline Mental health

    A mindfulness intervention increases mental health (measured by change in GHQ-12 scale)

    Measured: 8 weeks and 6 months

  4. Change from baseline decentering skills

    A mindfulness intervention increases decentering skills (measured by change in EQ scale)

    Measured: 8 weeks and 6 months

  5. Change from baseline resilience

    A mindfulness intervention increases resilience capacity (measured by change in CD-RISC-25 scale)

    Measured: 8 weeks and 6 months

  6. Change from baseline spirituality, religiosity, personal beliefs

    A mindfulness intervention increases spirituality, religiosity and personal beliefs (measured by change in WHOQOL-SRPB-BREF scale)

    Measured: 8 weeks and 6 months

  7. Change from baseline religiosity

    A mindfulness intervention increases religiosity (measured by change in DUREL scale)

    Measured: 8 weeks and 6 months

  8. Change from baseline mindfulness trait

    A mindfulness intervention increases mindfulness trait (measured by change in MAAS scale)

    Measured: 8 weeks and 6 months

  9. Change from baseline self-compassion

    A mindfulness intervention increases self-compassion (measured by change in SCS scale)

    Measured: 8 weeks and 6 months

  10. Change from baseline Burnout subtypes

    A mindfulness intervention decrease burnout symptoms according to burnout subtypes (measured by change in BCSQ-12 scale)

    Measured: 8 weeks and 6 months

  11. Mindfulness mechanisms

    Self-compassion (SCS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

    Measured: 6 months

  12. Mindfulness mechanisms

    Resilience capacity (CD-RISC-25 scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

    Measured: 6 months

  13. Mindfulness mechanisms

    Decentering skills (EQ scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

    Measured: 6 months

  14. Mindfulness mechanisms

    Spirituality (WHOQOL-SRPB-BREF scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

    Measured: 6 months

  15. Mindfulness mechanisms

    Religiosity (DUREL scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

    Measured: 6 months

  16. Mindfulness mechanisms

    Mindfulness trait (MAAS scale) will mediate quality of life enhancement and burnout symptoms reduction in police officers

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study start10 Oct 2016
  3. Primary completion1 Nov 2018
  4. Study completion1 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03114605
Sponsor's protocol ID
60406416.9.1001.5327
Other IDs
160491
Status last verified
Mar 2017
First submitted
21 Mar 2017
Last updated
7 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 33716824

  • 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.

    PubMed 29801444

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-based Intervention in people with Mindfulness and Police, run by Hospital de Clinicas de Porto Alegre.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline quality of Life (time frame: 8 weeks and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03114605, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.

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