Occupational Stress or Workplace StressNCT07745634
Online Mindfulness-Based Stress Reduction for the Mental Health of Healthcare Professionals
A study testing Online Mindfulness-Based Stress Reduction Program in people with Occupational Stress or Workplace Stress and Burnout, Professionals, run by Vilnius University at 1 site in Lithuania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occupational Stress or Workplace Stress, Burnout, Professionals, Mental Health
- What is being tested?
- Online Mindfulness-Based Stress Reduction Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteLithuania
- Study dates
- 16 Apr 2026to 14 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Remote Mindfulness-Based Stress Reduction Program on the Mental Health of Healthcare Professionals
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 3-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.
Read the detailed description
This is a prospective, two-arm, partially 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). Participants will be asked whether they have a preference for the MBSR intervention group or the wait-list control group. Those expressing a preference will be allocated to their preferred group, whereas participants without a preference will be randomly assigned in a 1:1 ratio to the MBSR intervention or 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 3-month assessment (T2), participants in the wait-list group will be offered the online MBSR program. An additional assessment (T3) 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). At T3, the assessment will evaluate the longer-term effects of MBSR in the initial intervention group and outcomes following MBSR participation in the original wait-list control group. Each questionnaire assessment is expected to take approximately 25 to 35 minutes. Hair samples will be collected before MBSR, after MBSR, 3 months, and 6 months after initial 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.
- Being tested
- Online Mindfulness-Based Stress Reduction Program
- Keywords
- Mindfulness, Online, Healthcare Professionals, Recovery From Stress, Burnout, Hair Cortisol, Mental Health
- Medical subject headings
- Occupational Stress, Burnout, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mindfulness-Based Stress Reduction ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online MBSR Group | Experimental | Participants assigned to this arm will receive a standardized 8-week online Mindfulness-Based Stress Reduction (MBSR) program. The program will consist of eight structured group sessions delivered once weekly by videoconference. Each group will be led by instructors who have completed formal MBSR training. Receives: Behavioral: Online Mindfulness-Based Stress Reduction Program |
| Wait-List Control Group | No intervention | Participants assigned to this arm will not receive the MBSR program during the initial 6-month comparison period and may continue using their usual healthcare or psychological support services. After completing the follow-up assessment, participants will be offered the same 8-week online MBSR program. An additional assessment will be completed immediately after the program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month after the intervention, and 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start16 Apr 2026
- Primary completion14 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational Stress or Workplace StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamile Pociute, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745634
- Sponsor's protocol ID
- 2026/3-1741-1186
- Status last verified
- Nov 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the approved study protocol does not permit the transfer of participant-level data to third parties. Only aggregate, statistically processed results that do not permit the identification of individual participants will be disseminated.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Remote Mindfulness-Based Stress Reduction Program on the Mental Health of Healthcare Professionals
- ClinicalTrials.gov ID
- NCT07745634
- Acronym / sponsor ID
- 2026/3-1741-1186
- Keywords
- Mindfulness, Online, Healthcare Professionals, Recovery From Stress, Burnout, Hair Cortisol, Mental Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 3-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.
Detailed description
This is a prospective, two-arm, partially 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). Participants will be asked whether they have a preference for the MBSR intervention group or the wait-list control group. Those expressing a preference will be allocated to their preferred group, whereas participants without a preference will be randomly assigned in a 1:1 ratio to the MBSR intervention or 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 3-month assessment (T2), participants in the wait-list group will be offered the online MBSR program. An additional assessment (T3) 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). At T3, the assessment will evaluate the longer-term effects of MBSR in the initial intervention group and outcomes following MBSR participation in the original wait-list control group. Each questionnaire assessment is expected to take approximately 25 to 35 minutes. Hair samples will be collected before MBSR, after MBSR, 3 months, and 6 months after initial 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online MBSR Group | Experimental | Behavioral: Online Mindfulness-Based Stress Reduction ProgramParticipants assigned to this arm will receive a standardized 8-week online Mindfulness-Based Stress Reduction (MBSR) program. The program will consist of eight structured group sessions delivered once weekly by videoconference. Each group will be led by instructors who have completed formal MBSR training. |
| Wait-List Control Group | No intervention | –Participants assigned to this arm will not receive the MBSR program during the initial 6-month comparison period and may continue using their usual healthcare or psychological support services. After completing the follow-up assessment, participants will be offered the same 8-week online MBSR program. An additional assessment will be completed immediately after the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Mindfulness-Based Stress Reduction ProgramA 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. | Behavioural | Online MBSR Group |
Primary outcome
Change in Recovery Experience Questionnaire Total Score
Time frame: 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.
7 secondary outcomes
Change in Generalized Anxiety Disorder-7 Total Score
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
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
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
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
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
Time frame: Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention
Change in Hair Steroid Hormone Concentrations
Time frame: Baseline, 1 month after the intervention, and 6 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the approved study protocol does not permit the transfer of participant-level data to third parties. Only aggregate, statistically processed results that do not permit the identification of individual participants will be disseminated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mindfulness-Based Stress Reduction Program in people with Occupational Stress or Workplace Stress and Burnout, Professionals, run by Vilnius University at 1 site in Lithuania.
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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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 in Recovery Experience Questionnaire Total Score (time frame: Baseline, immediately after the 8-week intervention, and 3 and 6 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.