The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion

Mental Health Wellness 1 Clinical Trial

Official title:

The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion: Results of a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241070
• Other study ID #: CCH 110606
• Status: Completed
• Phase: N/A
• First received: September 7, 2014
• Last updated: September 12, 2014
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2014
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aims of the study are to determine the effectiveness of Mindfulness-Based Interventionas a workplace health promotion program on psychological distress, prolonged fatigue, job strain (job control and job demand), and perceived stress and to explore the influences of personal characteristics (including gender, age, education, and occupation) on the outcomes of the intervention with time.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

Behavioral:
• mindulness-based intervention
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.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychological distress	Psychological distress was measured by the Chinese Health Questionnaire (CHQ-12), a well-validated instrument	four months	No
Secondary	prolonged fatigue	Prolonged fatigue was measured by The Checklist Individual Strength questionnaire (CIS), which confirmed discriminant validity and convergent validity.	Four months	No
Secondary	job strain	The Job Content Questionnaire (JCQ) was used to assess job control and job demands (job strain).	four months	No
Secondary	perceived stress	The 10-item Perceived Stress Scale (PSS-10) was adopted to measure a global level of perceived stress.	four months	No