Clinical trial NCT02241070: The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion
Official title: The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion: Results of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: mindfulness meditation
mental health promotion
worker
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: Changhua Christian Hospital
First posted: 2014-09-16
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: psychological distress
timeFrame: four months
Secondary outcomes:
measure: prolonged fatigue
timeFrame: Four months
measure: job strain
timeFrame: four months
measure: perceived stress
timeFrame: four months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Changhua Christian Hospital
name: Feng-Cheng Tang, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang SL, Li RH, Huang FY, Tang FC. The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion: Results of a Randomized Controlled Trial. PLoS One. 2015 Sep 14;10(9):e0138089. doi: 10.1371/journal.pone.0138089. eCollection 2015.