NCT02241070

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

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

June 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

September 7, 2014

Last Update Submit

September 12, 2014

Conditions

Keywords

mindfulness meditationmental health promotionworker

Outcome Measures

Primary Outcomes (1)

  • psychological distress

    Psychological distress was measured by the Chinese Health Questionnaire (CHQ-12), a well-validated instrument

    four months

Secondary Outcomes (3)

  • prolonged fatigue

    Four months

  • job strain

    four months

  • perceived stress

    four months

Study Arms (2)

mindulness-based intervention

EXPERIMENTAL

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.

Behavioral: mindulness-based intervention

waiting-list control

NO INTERVENTION

passive control group

Interventions

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.

mindulness-based intervention

Eligibility Criteria

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

You may qualify if:

  • Healthy employees with psychological distress and job strain
  • Full-time paid workers

You may not qualify if:

  • Age \< 18y or \> 65y
  • Part-time workers
  • The workers are not willing to take part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, 402, Taiwan

Location

Related Publications (1)

  • 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.

Study Officials

  • Feng-Cheng Tang, MD; PhD

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chung Shan Medical University

Study Record Dates

First Submitted

September 7, 2014

First Posted

September 16, 2014

Study Start

June 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations