- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465809
Mental Health Resources and Employability in Healthcare
Mental Health Resources for Employability of Health-care Workers
Study Overview
Status
Intervention / Treatment
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 emotional self-regulation, measured by the Self-Regulation Questionnaire (SRQ) at baseline. This tailored approach ensured that participants received the intervention most suited to their current psychological needs.
Study Arms and Interventions:
- Mindfulness Training Program: Participants with lower baseline self-regulation scores underwent a 10-week mindfulness-based intervention. This program focused on emotional stabilization, stress management, and cognitive processing using meditative techniques, relaxation, and reflective writing.
- Coaching Training Program: Participants with optimal/higher baseline self-regulation scores participated in a 10-week professional coaching program. 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 0), Post-intervention (Week 10), and a Follow-up assessment (Week 16). The primary focus was the change in employability scores, with secondary measures tracking anxiety, perceived stress, and general well-being.
Qualitative Component: To provide a deeper understanding of the intervention's impact, a qualitative component was included. Semi-structured interviews were conducted with a subset of participants after the program completion. These interviews explored subjective experiences and perceived changes in professional life, and the data were subsequently processed using thematic analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Slovakia
-
Bratislava, Slovakia, Slovakia, 821 05
- Comenius University Bratislava, Faculty of Social and Economic Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18+
- Employed as healthcare worker
- Willing to participate in 10-week intervention
- Signed informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness Training Program
Participants with lower baseline emotional self-regulation receive a structured 10-week mindfulness-based intervention aimed at improving emotional regulation and stress management.
|
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.
|
|
Experimental: Coaching Training Program
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in overall employability score
Time Frame: Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mental Health Indicators: Change in Self-Regulation
Time Frame: Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)
|
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.
|
Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)
|
|
Change in Mental Health Indicators: Change in Perceived Employability
Time Frame: Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)
|
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).
|
Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)
|
|
Change in Mental Health Indicators: Change in Psychological Well-Being
Time Frame: Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)
|
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.
|
Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)
|
|
Change in Mental Health Indicators: Change in Anxiety Symptoms
Time Frame: Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)
|
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)
|
Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)
|
|
Change in Mental Health Indicators: Change in Perceived Stress
Time Frame: Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)
|
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)
|
Baseline (Pre-test), 10 weeks (Post-test), and 16 weeks (Follow-up)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09I03-03-V04-00257
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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