- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02241070
The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion
The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion: Results of a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was one component of the Taiwan Workplace Mental Health Promotion Scheme. The study adopted a study design of a randomized controlled trial. Two large-scale manufacturing factories were chosen for this study. All of the factories' 3270 full-time employees were requested to fill in a questionnaire comprising questions regarding mental health and job strain. Of these employees, 2849 individuals were willing to complete the questionnaire. A total of 431 employees (15.13%) were found to be in psychological distress with job strain. The screening procedure was carried out between June and July in 2011. A letter of invitation with an introduction to MBI was sent to these employees. Of these 431 employees, only 144 responded that they would be willing to take part voluntarily in the study. These 144 workers were allocated randomly into the intervention group (Group I, n=72) or the waiting-list control group (Group C, n=72).
All the participants were measured five times with an interval of four weeks between measurements. These measurements were taken at pre-intervention (T1), at mid-intervention (T2), at the completion of intervention (T3), four weeks after intervention (T4), and eight weeks after intervention (T5). The data related with the effectiveness of the intervention were obtained between August and December in 2011.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taichung, Taiwan, 402
- Chung Shan Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy employees with psychological distress and job strain
- Full-time paid workers
Exclusion Criteria:
- Age < 18y or > 65y
- Part-time workers
- The workers are not willing to take part in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mindulness-based intervention
Mindulness-based intervention was eight weeks of mindfulness training with forty-five minutes of homework practice every day during the training course.
A leader and a professional facilitator led the group.
The leader was a long-term mindfulness and vipassana meditation trainer who had practiced both types of meditation for more than two decades and had completed mindfulness trainer education; the professional facilitator was a mindfulness practitioner and a psychiatrist.
The group met weekly for two hours in-session at the workplace.
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A number of mindfulness techniques, including both "formal" and "informal" practices with integration in the context of Mind/Body meditation, were explored in order to cultivate moment-by-moment present awareness with non-judgmental acceptance.
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No Intervention: waiting-list control
passive control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
psychological distress
Time Frame: four months
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Psychological distress was measured by the Chinese Health Questionnaire (CHQ-12), a well-validated instrument
|
four months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prolonged fatigue
Time Frame: Four months
|
Prolonged fatigue was measured by The Checklist Individual Strength questionnaire (CIS), which confirmed discriminant validity and convergent validity.
|
Four months
|
job strain
Time Frame: four months
|
The Job Content Questionnaire (JCQ) was used to assess job control and job demands (job strain).
|
four months
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perceived stress
Time Frame: four months
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The 10-item Perceived Stress Scale (PSS-10) was adopted to measure a global level of perceived stress.
|
four months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Feng-Cheng Tang, MD; PhD, Changhua Christian Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CCH 110606
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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