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Burnout, ProfessionalNCT07465809

Mental Health Resources and Employability in Healthcare

A study testing Coaching-Based Self-Regulation Training and Mindfulness training program in people with Burnout, Professional and Mental Health, run by Comenius University at 1 site in Slovakia.

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

This interventional study evaluates the effectiveness of two 8-week self-regulation training programs (coaching-based and mindfulness-based) designed to enhance mental health and employability resources among healthcare workers (HCWs). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Coaching-Based Self-Regulation Training and Mindfulness training program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteSlovakia
Study dates
20 Oct 2025to 20 Feb 2026
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18+
  • Employed as healthcare worker
  • Willing to participate in 8-week intervention
  • Signed informed consent

Who cannot join

  • Current participation in another structured psychological intervention
  • Self-reported mental health concerns that the participant feels may prevent safe or full participation in the training program

Trial locations and contacts

1 site in 1 country.

Slovakia1 site

  • Comenius University Bratislava, Faculty of Social and Economic Sciences

    Bratislava, Slovakia, 821 05

Other trials in Slovakia

About this study

Official title: Mental Health Resources for Employability of Health-care Workers

This interventional study evaluates the effectiveness of two 8-week self-regulation training programs (coaching-based and mindfulness-based) designed to enhance mental health and employability resources among healthcare workers (HCWs). Participants are allocated into two intervention arms based on their baseline level of anxiety (GAD-7). The study applies a non-randomized controlled pre-test/post-test design. The primary outcome is change in employability. Secondary outcomes include mental health indicators, such as perceived stress, anxiety, psychological well-being, and self-regulation. Baseline assessment was conducted in Week 1, the post-test in Week 10, and a follow-up assessment in Week 17. Additionally, qualitative feedback was collected to explore participants' subjective experiences with the interventions.

Read the detailed description

This interventional study employed a non-randomized, parallel-group, pre-test/post-test design to examine the impact of two different behavioral interventions on healthcare workers' (HCWs) psychological resources and employability.

Participant Allocation: Participants were allocated into two study arms based on their initial level of anxiety, measured by the Generalized Anxiety Disorder scale (GAD-7) at baseline. This tailored approach ensured that participants received the intervention most suited to their current psychological needs.

Study Arms and Interventions:

  1. Mindfulness Training Program: Participants with higher baseline anxiety symptoms (GAD-7 > 5) underwent an 8-week mindfulness-based intervention (Weeks 2 to 9). This program focused on emotional stabilization, stress management, and cognitive processing using meditative techniques, relaxation, and reflective writing.
  2. Coaching Training Program: Participants with lower baseline anxiety levels (GAD-7 ≤ 5) participated in an 8-week professional coaching program (Weeks 2 to 9). This intervention focused on identifying core challenges, leveraging personal strengths, and setting actionable career goals to enhance professional growth and employability.

Data Collection and Methodology: Quantitative data were collected at three time points: Baseline (Week 1, N = 124), Post-intervention (Week 10, N = 79), and Follow-up assessment (Week 17, N = 44). The primary focus was the change in employability scores, with secondary measures tracking anxiety, perceived stress, psychological well-being, and self-regulation.

Qualitative Component: To provide a deeper understanding of the intervention's impact, qualitative feedback was collected from participants after program completion to explore subjective experiences and perceived changes in professional life.

Being tested
Coaching-Based Self-Regulation Training, Mindfulness training program
Keywords
Self-regulation, Mindfulness, Coaching, Health-care workers, Employability
Medical subject headings
Burnout, Professional, Psychological Well-Being, Emotional Regulation, Occupational Stress, Self-Control

What participants receive

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

  • Coaching-Based Self-Regulation TrainingBehavioural

    The coaching program is a eight-week intervention based on a meta-analysis of employability training programs. It helps participants identify core professional challenges and personal strengths. Participants work on setting specific goals, creating action plans, and following up on execution. The primary aim is to empower healthcare workers to take actions that reduce stress and improve mental health to support better long-term employability.

  • Mindfulness training programBehavioural

    The mindfulness program is a eight-week intervention designed for participants with higher baseline anxiety. It focuses on developing skills such as stress management, emotion regulation, and cognitive processing. The program utilizes a combination of meditative mindfulness, relaxation techniques, guided imagery, and reflective writing. The aim is to achieve an optimal level of self-regulation to reduce anxious or depressive thoughts and promote employability.

Study groups in NCT07465809
Study groupRoleWhat they receive
Mindfulness Training ProgramExperimentalParticipants with higher baseline anxiety symptoms (GAD-7 > 5) receive a structured 8-week mindfulness-based intervention administered during Weeks 2 to 9. The program focuses on emotional stabilization, stress management, and cognitive processing using meditative techniques, relaxation, guided imagery, and reflective writing. The aim is to reduce anxiety and promote psychological well-being and employability.
Receives: Behavioral: Mindfulness training program
Coaching Training ProgramExperimentalParticipants with lower baseline anxiety levels (GAD-7 ≤ 5) participate in a structured 8-week coaching-based self-regulation training administered during Weeks 2 to 9. The program focuses on goal setting, identifying personal strengths, reflecting on one's career, and learning from role models. The primary aim is to empower healthcare workers to take actions that reduce stress and improve mental health to support better long-term employability.
Receives: Behavioral: Coaching-Based Self-Regulation Training

What is being measured

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

  1. Change in overall employability score and dimensions

    Employability was assessed using the Dispositional Measure of Employability (Employability Scale) across its dimensions. Note: The Resilience dimension (E4) was excluded from final statistical analyses due to low internal consistency (α = .52)

    Measured: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)

Secondary outcomes (5)

  1. Change in Mental Health Indicators: Change in Self-Regulation

    Self-regulation will be assessed using the Short Self-Regulation Questionnaire. The instrument contains 20 items rated on a 5-point Likert scale, with total average scores ranging from 1 to 5. Higher scores indicate better self-regulation.

    Measured: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)

  2. Change in Mental Health Indicators: Change in Perceived Employability

    Perceived employability will be measured using the Perceived Employability Scale (3-item version). Items are rated on a 5-point Likert scale, with total average scores ranging from 1 to 5. Higher scores indicate higher perceived employability (better outcome).

    Measured: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)

  3. Change in Mental Health Indicators: Change in Psychological Well-Being

    Psychological well-being will be assessed using the World Health Organization Five Well-Being Index. The scale includes 5 items rated from 0 to 5. The total score is multiplied by four, resulting in a total score of 0 to 100. Higher scores indicate greater psychological well-being (better outcome) and lower scores indicate depression.

    Measured: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)

  4. Change in Mental Health Indicators: Change in Anxiety Symptoms

    Anxiety symptoms will be measured using the Generalized Anxiety Disorder 7-Item Scale. The scale consists of 7 items rated from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity (worse outcome)

    Measured: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)

  5. Change in Mental Health Indicators: Change in Perceived Stress

    Perceived stress will be assessed using the Perceived Stress Scale - 4 Item Version. The scale includes 4 items rated from 0 to 4, yielding total scores ranging from 0 to 16. Higher scores indicate greater perceived stress (worse outcome)

    Measured: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)

Timeline

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

  1. First posted12 Mar 2026
  2. Study start20 Oct 2025
  3. Primary completion11 Feb 2026
  4. Study completion20 Feb 2026

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
Non-randomised
Intervention model
Parallel groups
Model description
Model Description
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07465809
Sponsor's protocol ID
09I03-03-V04-00257
Status last verified
Oct 2026
First submitted
25 Feb 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cohen, S. (1988). Perceived stress in a probability sample of the United States. In S. Spacapan & S. Oskamp (Eds.), The social psychology of health (pp. 31-67). Sage Publications, Inc. Fugate, M., & Kinicki, A. J. (2008). A dispositional approach to employability: Development of a measure and test of implications for employee reactions to organizational change. Journal of Occupational and Organizational Psychology, 81(3), 503-527. https://doi.org/10.1348/096317907X241579 Jakešová, J., Gavora, P., Kalenda, J., & Vávrová, S. (2016). Czech validation of the self-regulation and self-efficacy questionnaires for learning. Procedia - Social and Behavioral Sciences, 217, 313-321. Spitzer, R. L., Kroenke, K., Williams, J. B. W., & Löwe, B. (2006). A brief measure for assessing generalized anxiety disorder. Archives of Internal Medicine, 166(10), 1092. https://doi.org/10.1001/archinte.166.10.1092 Topp CW, Østergaard SD, Søndergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-176. Wittekind, A., Raeder, S., & Grote, G. (2010). A longitudinal study of determinants of perceived employability. Journal of Organizational Behavior, 31(4), 566-586. https://doi.org/10.1002/job.646

Questions about this trial

What is this clinical trial studying?

A study testing Coaching-Based Self-Regulation Training and Mindfulness training program in people with Burnout, Professional and Mental Health, run by Comenius University at 1 site in Slovakia.

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 4 inclusion and 2 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 16 Oct 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 Slovakia. 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?

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 in overall employability score and dimensions (time frame: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)). 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 NCT07465809, which also lists 1 linked publication.

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 16 Oct 2026.

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