The Effect of a Remote Mindfulness-Based Stress Reduction Program on the Mental Health of Healthcare Professionals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in Recovery Experience Questionnaire Total Score
研究概览
简要总结
Healthcare professionals may experience high levels of work-related stress and burnout. This study will examine whether an 8-week online Mindfulness-Based Stress Reduction (MBSR) program improves recovery from stress and other mental health outcomes in healthcare professionals who provide direct patient care.
The MBSR group will attend eight weekly online group sessions led by trained instructors. The wait-list group will not receive the program during the initial comparison period but will be offered it after completing the 6-month follow-up.
Participants will complete online questionnaires before the program, immediately after the program, and 3 and 6 months later. The main outcome is change in the participants' ability to recover from stress. The study will also assess burnout, anxiety, depression, psychological well-being, personality traits, and professional quality of life. Hair samples will be collected at specified time points to measure stress-related steroid hormone levels.
详细描述
This is a prospective, two-arm, randomized controlled trial using a wait-list control design. The planned sample size is 158 to 160 healthcare professionals. The sample size allows for approximately 20% attrition and is expected to provide 80% statistical power to detect a medium standardized effect of Cohen d = 0.50 using a two-sided significance level of 0.05.
After providing written informed consent, participants will undergo an eligibility and safety assessment and complete the baseline assessment (T0). Eligible participants will then be randomly assigned in a 1:1 ratio to the MBSR intervention group or the wait-list control group. Randomization will be performed by the principal investigator using a computer-generated random number sequence.
Participants and the principal investigator cannot be blinded to group assignment because participation in the MBSR program is apparent. A second investigator who is not involved in randomization will remain unaware of individual group assignments. The MBSR instructors will not participate in participant screening, randomization, data collection, or data analysis. Statistical analyses will be conducted using coded data by a statistician who will be unaware of the group labels.
The intervention will follow a standardized MBSR program structure and will consist of eight structured online group sessions delivered once weekly by videoconference. Each group is expected to include approximately 16 participants. The sessions will be delivered by instructors who have completed formal training in mindfulness-based cognitive and behavioral approaches. The same program structure, content, duration, and sequence will be used for all intervention groups.
Participants assigned to the wait-list control group will not receive the study intervention during the initial comparison period. They may continue to use any usual psychological or healthcare services available to them. After completing the 6-month assessment (T3), participants in the wait-list group will be offered the online MBSR program. An additional assessment (T4) will be completed by this group immediately after their MBSR program.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Employed at a healthcare institution at a minimum of 0.25 full-time equivalent.
- •Has direct contact with patients.
- •Provides personal healthcare services, including physicians, resident physicians, nurses, paramedics, physiotherapists, lifestyle medicine specialists, and other healthcare professionals.
- •Aged 18 years or older.
- •Able to understand Lithuanian.
- •Has access to the internet and a smart device suitable for participating in the online MBSR program and completing the study questionnaires.
排除标准
- •Currently participating in a structured mindfulness-based program or regularly practicing mindfulness-based meditation.
- •Currently experiencing a mental health condition that may interfere with safe participation in the study, including high suicide risk or suspected psychotic symptoms.
- •Unable, because of a health condition, to reasonably understand and assess their own interests.
- •Younger than 18 years.
- •A student whose participation in the biomedical study is related to their studies.
- •Residing in a social care institution.
- •Serving as active-duty military personnel.
- •Imprisoned or otherwise deprived of liberty.
- •An employee of the Clinic of Psychiatry, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, who is subordinate to a study investigator.
结局指标
主要结局
Change in Recovery Experience Questionnaire Total Score
时间窗: Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention
Recovery from stress will be measured using the 16-item Recovery Experience Questionnaire (REQ). The questionnaire assesses four areas: psychological detachment from work, relaxation, mastery, and control. Each item is rated from 1 (strongly disagree) to 5 (strongly agree). Item scores are summed to produce a total score ranging from 16 to 80. Higher scores indicate a greater ability to recover from stress. Changes in total scores will be compared between the online MBSR and wait-list control groups.
次要结局
- Change in Generalized Anxiety Disorder-7 Total Score(Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention)
- Change in Patient Health Questionnaire-9 Total Score(Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention)
- Change in World Health Organization-5 Well-Being Index Score(Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention)
- Change in Big Five Inventory-2 Domain Scores(Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention)
- Change in Burnout Assessment Tool Short Form Score(Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention)
- Change in Professional Quality of Life Scale Subscale Scores(Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention)
- Change in Hair Steroid Hormone Concentrations(Baseline, 1 month after the intervention, and 6 months after the intervention)
研究者
Kamile Pociute
Junior Assistant, and PhD Student
Vilnius University