Mental Health Wellness 1NCT02241070
The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion
A study testing mindulness-based intervention in people with Mental Health Wellness 1, run by Chung Shan Medical University at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- mindulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy employees with psychological distress and job strain
- Full-time paid workers
Who cannot join
- Age < 18y or > 65y
- Part-time workers
- The workers are not willing to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion: Results of a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Mental Health Wellness 1
- Being tested
- mindulness-based intervention
- Keywords
- mindfulness meditation, mental health promotion, worker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindulness-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: mindulness-based intervention |
| waiting-list control | No intervention | passive control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychological distress
Psychological distress was measured by the Chinese Health Questionnaire (CHQ-12), a well-validated instrument
Measured: four months
Secondary outcomes (3)
prolonged fatigue
Prolonged fatigue was measured by The Checklist Individual Strength questionnaire (CIS), which confirmed discriminant validity and convergent validity.
Measured: Four months
job strain
The Job Content Questionnaire (JCQ) was used to assess job control and job demands (job strain).
Measured: four months
perceived stress
The 10-item Perceived Stress Scale (PSS-10) was adopted to measure a global level of perceived stress.
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Changhua Christian Hospital
- Responsible party
- Principal investigator, GCRC, Chung Shan Medical University
- Investigators
- Feng-Cheng Tang, MD; PhD, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241070
- Sponsor's protocol ID
- CCH 110606
- Status last verified
- Sep 2014
- First submitted
- 7 Sep 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26367270
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion: Results of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02241070
- Acronym / sponsor ID
- CCH 110606
- Conditions
- Mental Health Wellness 1
- Keywords
- mindfulness meditation, mental health promotion, worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- Changhua Christian Hospital
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindulness-based intervention | Experimental | Behavioral: mindulness-based interventionMindulness-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. |
| waiting-list control | No intervention | –passive control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy employees with psychological distress and job strain
- Full-time paid workers
Key exclusion criteria (3 listed)
- Age < 18y or > 65y
- Part-time workers
- The workers are not willing to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindulness-based interventionA 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. | Behavioural | mindulness-based intervention |
Primary outcome
psychological distress
Time frame: four months
Psychological distress was measured by the Chinese Health Questionnaire (CHQ-12), a well-validated instrument
3 secondary outcomes
prolonged fatigue
Time frame: Four months
job strain
Time frame: four months
perceived stress
Time frame: four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
- Derived from this study: PubMed 26367270Huang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng-Cheng Tang, MD; PhD principal investigator
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindulness-based intervention in people with Mental Health Wellness 1, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological distress (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02241070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.