An interventional study of Coaching-Based Self-Regulation Training and Mindfulness training program in Burnout, Professional, Mental Health and Emotional Regulation, sponsored by Comenius University. Completed at 1 site in Slovakia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Comenius University · Not applicable, Interventional, and Prevention
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.
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:
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.
216 studies on the registry are indexed under Burnout, Professional; 33 are open to participants now.
This study's enrollment of 79 is close to the median of 80 across 161 interventional studies indexed under Burnout, Professional.
Browse Burnout, Professional studies →Comenius University is the lead sponsor of 42 studies on the registry; 11 are open to participants now.
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The criteria were revised on the registry on Oct 16, 2026. See what changed
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Behavioral: Mindfulness training program
Participants 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.
Behavioral: Coaching-Based Self-Regulation Training
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.
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.
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)
Time frame: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)
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.
Time frame: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)
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).
Time frame: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)
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.
Time frame: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)
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)
Time frame: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)
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)
Time frame: Baseline (Week 1), Post-intervention (Week 10), and Follow-up (Week 17)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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