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临床试验/NCT07386951
NCT07386951招募中不适用

Heart Rate Variability Biofeedback in Distress Regulation and Burnout Prevention Among Security Forces

Egas Moniz - Cooperativa de Ensino Superior, CRL1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Change in Psychological Distress (Kessler Psychological Distress Scale - K10)

研究概览

简要总结

This exploratory study evaluates the effectiveness of a 12-session Heart Rate Variability Biofeedback (HRV-BFB) protocol in reducing distress and burnout while promoting psychological well-being among Portuguese National Republican Guard (GNR) professionals. Exposed to high occupational stress from unpredictable risks, shift work, and limited resources, these individuals face elevated vulnerability to chronic stress outcomes. The intervention leverages real-time HRV feedback to enhance autonomic regulation, breathing techniques, and emotional self-regulation.

详细描述

Security forces like the GNR play a critical role in public safety but endure chronic stress from violence exposure, rapid decisions, shift rotations, and institutional resource shortages, heightening risks of distress, burnout, and impaired well-being. Distress arises when perceived threats exceed coping resources, leading to persistent negative emotions and health disruptions. Burnout manifests as exhaustion, mental distancing, and reduced efficacy from unmanaged chronic stress, with organizational impacts including absenteeism and eroded public trust. Psychological well-being encompasses multidimensional aspects like autonomy, relationships, and purpose beyond mere absence of illness. Traditional interventions face barriers such as stigma and access issues in rural GNR contexts, necessitating flexible, self-administered tools.

Intervention: HRV-BFB Protocol HRV-BFB trains participants to consciously modulate physiological responses via real-time monitoring of heart rate variability (HRV), reflecting sympathetic-parasympathetic balance. Low HRV links to mental health risks, while training targets resonance frequency breathing (~6 breaths/min or 0.1 Hz) to boost HRV amplitude, cardiac coherence, and baroreflex strength. Delivered autonomously via app post-initial guidance, the 12-session protocol requires no daily clinician oversight, enhancing accessibility for dispersed GNR personnel. Evidence shows HRV-BFB reduces stress, anxiety, depression, and burnout while fostering well-being in high-stress groups like emergency workers.

Study Objectives This exploratory trial tests whether HRV-BFB significantly lowers distress (multidimensional: physical, cognitive, emotional, behavioral), burnout levels, and boosts psychological well-being in GNR professionals. It aims to inform scalable interventions tailored to Portuguese police realities, addressing gaps in institutional support.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Due to the nature of the intervention, participants and investigators are aware of who receive HRV biofeedback training or not.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Operational military personnel of the Guarda Nacional Republicana (GNR) performing security, patrol, criminal investigation, or road safety duties
  • Any military rank or professional category within operational roles
  • Age between 18 and 55 years, inclusive
  • Both males and females
  • Capable of providing informed consent in Portuguese language

排除标准

  • Extended sick leave or medical absence
  • Currently involved in serious disciplinary proceedings
  • Use, modification, or initiation of psychotropic medication (including antidepressants, anti-anxiety medications, antipsychotics, mood stabilizers) within the past 6 months

研究组 & 干预措施

HRV Biofeedback Training

Experimental

Participants receive 12 individual sessions of heart rate variability biofeedback (HRV-BFB) over 4 weeks (one 12-minute session every 2 days). Training is delivered using a chest-worn ECG sensor (eSense Pulse) connected to a mobile application that provides real-time visual feedback.

干预措施: Heart Rate Variability Biofeedback (HRV-BFB) Training (Behavioral)

Control: No Intervention

No Intervention

Participants receive no active intervention during the 4-week study intervention period and continue their usual duties and routines. They complete the same assessment schedule as the experimental group at baseline, 4 weeks, and 10 weeks. After completion of the final follow-up assessment, they are offered the opportunity to receive the HRV biofeedback training protocol.

结局指标

主要结局

Change in Psychological Distress (Kessler Psychological Distress Scale - K10)

时间窗: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 10)

The Kessler Psychological Distress Scale (K-10) is a 10-item self-report measure assessing psychological distress over the past 30 days. Items measure anxiety and depressive symptoms on a 5-point Likert scale (1=never to 5=always). Total score range: 10-50 (higher scores indicate greater distress). Portuguese validation: α=0.91. Primary outcome is change from baseline to post-intervention (week 4) and follow-up (week 10).

Change in Occupational Burnout (Burnout Assessment Tool - BAT-12)

时间窗: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 10)

The Burnout Assessment Tool Short Form (BAT-12) is a 12-item self-report measure of occupational burnout across 4 dimensions: exhaustion (3 items), mental distance (3 items), cognitive impairment (3 items), emotional impairment (3 items). 5-point Likert scale (1=never to 5=always). Total score range: 12-60. Portuguese validation: α=0.85. Primary outcome is change from baseline to post-intervention and follow-up.

Change in Psychological Well-Being (WHO-5 Well-Being Index)

时间窗: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 10)

The WHO-5 Well-Being Index is a 5-item self-report measure of psychological well-being over the past 2 weeks. Items assess positive mood, vitality, sleep, daily functioning, and life satisfaction on a 0-5 scale. Total score range: 0-25 (higher=higher well-being). Primary outcome is change from baseline to post-intervention and follow-up.

次要结局

  • SDNN (Standard Deviation of NN Intervals) - Heart Rate Variability(Baseline (Week 0), after each of 12 training sessions)
  • RMSSD (Root Mean Square of Successive Differences) - Parasympathetic Activity(Baseline (Week 0), after each of 12 training sessions)
  • Stress Index - Autonomic Balance Indicator(Baseline (Week 0), after each of 12 training sessions)

研究者

发起方
Egas Moniz - Cooperativa de Ensino Superior, CRL
申办方类型
Other
责任方
Sponsor

研究点 (1)

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