NCT07465809

Brief Summary

This interventional study evaluates the effectiveness of two 10-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 emotional self-regulation. 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, depressive symptoms and self-regulation. A follow-up assessment was conducted six weeks after the post-test. Additionally, qualitative semi-structured interviews were conducted to explore participants' subjective experiences with the interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

February 25, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

Self-regulationMindfulnessCoachingHealth-care workersEmployability

Outcome Measures

Primary Outcomes (1)

  • Change in overall employability score

    Employability was assessed using the Dispositional Measure of Employability (Employability Scale). The scale consists of 25 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Total average scores range from 1 to 5, with higher scores indicating greater employability.

    Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)

Secondary Outcomes (5)

  • Change in Mental Health Indicators: Change in Self-Regulation

    Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)

  • Change in Mental Health Indicators: Change in Perceived Employability

    Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)

  • Change in Mental Health Indicators: Change in Psychological Well-Being

    Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)

  • Change in Mental Health Indicators: Change in Anxiety Symptoms

    Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)

  • Change in Mental Health Indicators: Change in Perceived Stress

    Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)

Study Arms (2)

Mindfulness Training Program

EXPERIMENTAL

Participants with lower baseline emotional self-regulation receive a structured 10-week mindfulness-based intervention aimed at improving emotional regulation and stress management.

Behavioral: Mindfulness training program

Coaching Training Program

EXPERIMENTAL

Participants with optimal baseline emotional self-regulation receive a structured 10-week coaching-based self-regulation training focused on goal setting, resilience, and career development.

Behavioral: Coaching-Based Self-Regulation Training

Interventions

The coaching program is a ten-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.

Coaching Training Program

The mindfulness program is a ten-week intervention designed for participants with lower baseline self-regulation. 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.

Mindfulness Training Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18+
  • Employed as healthcare worker
  • Willing to participate in 10-week intervention
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comenius University Bratislava, Faculty of Social and Economic Sciences

Bratislava, Slovakia, 821 05, Slovakia

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Burnout, ProfessionalPsychological Well-BeingEmotional RegulationOccupational StressSelf-Control

Condition Hierarchy (Ancestors)

Occupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehaviorPersonal SatisfactionSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Masking Description
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 12, 2026

Study Start

October 20, 2025

Primary Completion

February 11, 2026

Study Completion

February 20, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations