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.
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. Questionnaire data will be collected electronically at baseline (T0), immediately after the initial intervention period (T1), 3 months after the intervention (T2), and 6 months after the intervention (T3). Each questionnaire assessment is expected to take approximately 25 to 35 minutes. Hair samples will be collected before MBSR, 1 month after MBSR, and 6 months after MBSR. Concentration of cortisol in hair will be examined as objective indicators related to stress. The primary outcome is change in the total score of the Recovery Experience Questionnaire. Secondary outcomes include symptoms of anxiety, depression, and burnout; psychological well-being; professional quality of life; and personality traits. Associations between mental health outcomes and demographic, occupational, lifestyle, health-related, and significant life-event variables will also be explored. Descriptive statistics will be used to summarize the study data, and the internal consistency of the questionnaires will be assessed. Baseline comparability between the two groups will be evaluated using statistical tests appropriate to the type and distribution of each variable. Changes in primary and secondary outcomes will be analyzed using mixed-effects models for repeated measurements. The main measure of intervention effectiveness will be the group-by-time interaction. Effect sizes and 95% confidence intervals will be reported. Correlation and regression models will be used for additional exploratory analyses. Before enrollment, participants will be assessed for mental health conditions that could interfere with safe participation, including high suicide risk and suspected psychotic symptoms. Participants experiencing emotional deterioration during the study will be advised to contact the principal investigator and appropriate healthcare or emergency services. Participation may be discontinued when needed to protect the participant's health and well-being.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
74
A standardized 8-week online Mindfulness-Based Stress Reduction (MBSR) program consisting of eight structured group sessions delivered once weekly by videoconference. The program will be delivered by instructors who have completed formal training in mindfulness-based cognitive and behavioral approaches. The intervention includes mindfulness practice, attention regulation, self-observation, psychoeducation, and reflection on personal well-being.
Vilnius University
Vilnius, Vilnius County, Lithuania
Change in Recovery Experience Questionnaire Total Score
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.
Time frame: Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention
Change in Generalized Anxiety Disorder-7 Total Score
Anxiety symptoms will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Each item is rated from 0 to 3, producing a total score from 0 to 21. Higher scores indicate greater anxiety symptom severity. Changes in total scores will be compared between the online MBSR and wait-list control groups.
Time frame: Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention
Change in Patient Health Questionnaire-9 Total Score
Depressive symptoms will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Each item is rated from 0 to 3, producing a total score from 0 to 27. Higher scores indicate greater depressive symptom severity. Changes in total scores will be compared between the online MBSR and wait-list control groups.
Time frame: 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
Psychological well-being will be measured using the 5-item World Health Organization Well-Being Index (WHO-5). Each item is rated from 0 to 5, producing a raw total score from 0 to 25. Higher scores indicate better psychological well-being. Changes in total scores will be compared between the online MBSR and wait-list control groups.
Time frame: Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention
Change in Big Five Inventory-2 Domain Scores
Personality traits will be measured using the 60-item Big Five Inventory-2 (BFI-2). The instrument assesses extraversion, agreeableness, conscientiousness, negative emotionality, and open-mindedness. Items are rated on a 5-point scale. A mean score will be calculated for each personality domain, with higher scores indicating a greater expression of the corresponding trait.
Time frame: Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention
Change in Burnout Assessment Tool Short Form Score
Burnout symptoms will be measured using the 12-item short form of the Burnout Assessment Tool (BAT-12). Items are rated on a 5-point frequency scale ranging from never to always. Higher scores indicate greater burnout symptom severity. Changes in scores will be compared between the online MBSR and wait-list control groups.
Time frame: Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention
Change in Professional Quality of Life Scale Subscale Scores
Professional quality of life will be measured using the 30-item Professional Quality of Life Scale (ProQOL). The instrument includes three subscales: compassion satisfaction, burnout, and secondary traumatic stress. Each subscale score ranges from 10 to 50. Higher scores indicate a greater level of the construct measured by the corresponding subscale.
Time frame: Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention
Change in Hair Steroid Hormone Concentrations
Hair samples will be used to measure concentration of cortisol as objective indicators related to stress. Changes in the concentration of each hormone will be evaluated over time and compared between the online MBSR and wait-list control groups.
Time frame: Baseline, 1 month after the intervention, and 6 months after the intervention
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