Mental Health Wellness 1NCT01299064
Transcultural Mindfulness Assessment: A Mixed Methods Analysis
An observational study of Mental Health Wellness 1, run by Pacific University at 1 site in United States.
Trial summary
Preliminary evidence attests to the effectiveness of mindfulness-based interventions in reducing symptoms associated with a variety of medical and psychological conditions. However, research progress has been hampered by discrepancies in how mindfulness has been operationalized, assessed, and practiced. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Wellness 1
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jul 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Buddhist clergy and laypersons
Who may be able to join
- Zen, Theravada, or Tibetan clergy
- Zen, Theravada, or Tibetan layperson with meditation experience
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Preliminary evidence attests to the effectiveness of mindfulness-based interventions in reducing symptoms associated with a variety of medical and psychological conditions. However, research progress has been hampered by discrepancies in how mindfulness has been operationalized, assessed, and practiced. Existing contemporary assessments of mindfulness were developed exclusively by Western scientists and have exhibited questionable validity, particularly among diverse cultural groups. Operational definitions of mindfulness are essential for the development of valid measures, which in turn are necessary for investigating the mechanisms of change in mindfulness-based interventions. Therefore, the overall goal of this study is to create a mindfulness measure that is informed by the experience of mindfulness experts - Theravāda, Tibetan, and Zen Buddhist clergy and lay practitioners. To do so, this study will employ the preliminary phases of the sequential exploratory mixed methods for instrument design model. The first phase will involve conducting open-ended interviews with Theravāda, Tibetan, and Zen Buddhist clergy and lay practitioners to ascertain expert information on mindfulness and closely related Buddhist concepts. This qualitative process allows the experts to define the phenomena of interest (i.e., addresses issues of validity). In the second phase, the investigators will use the themes and specific phrases evoked during the qualitative interviews to develop items for a draft closed-ended self-report measure of mindfulness. Following completion of the research outlined in this proposal, the investigators will submit a subsequent proposal to thoroughly evaluate the psychometric properties of our draft mindfulness questionnaire in a variety of different cultures and contexts. This measure can be beneficial in clinical research by helping to elucidate the mechanisms of change in mindfulness-based psychotherapies in the United States and equally so in other cultures such as Thailand, where mindfulness and other Buddhist practices have already been integrated into mainstream mental health treatment. Therefore, our aim is to create a measure that can help improve the assessment and clinical use of mindfulness.
- Conditions
- Mental Health Wellness 1
- Keywords
- mindfulness-based intervention, symptoms reduction, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Buddhist Clergy and Laypersons | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Michael Christopher, PhD, Pacific University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299064
- Sponsor's protocol ID
- 1R15AT005342-01A1
- Other IDs
- 1R15AT005342-01A1
- Status last verified
- Oct 2014
- First submitted
- 17 Feb 2011
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcultural Mindfulness Assessment: A Mixed Methods Analysis
- ClinicalTrials.gov ID
- NCT01299064
- Acronym / sponsor ID
- 1R15AT005342-01A1
- Conditions
- Mental Health Wellness 1
- Keywords
- mindfulness-based intervention, symptoms reduction, mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pacific UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Feb 2011 (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.
Preliminary evidence attests to the effectiveness of mindfulness-based interventions in reducing symptoms associated with a variety of medical and psychological conditions. However, research progress has been hampered by discrepancies in how mindfulness has been operationalized, assessed, and practiced. Existing contemporary assessments of mindfulness were developed exclusively by Western scientists and have exhibited questionable validity, particularly among diverse cultural groups. Operational definitions of mindfulness are essential for the development of valid measures, which in turn are necessary for investigating the mechanisms of change in mindfulness-based interventions. Therefore, the overall goal of this study is to create a mindfulness measure that is informed by the experience of mindfulness experts - Theravāda, Tibetan, and Zen Buddhist clergy and lay practitioners. To do so, this study will employ the preliminary phases of the sequential exploratory mixed methods for instrument design model. The first phase will involve conducting open-ended interviews with Theravāda, Tibetan, and Zen Buddhist clergy and lay practitioners to ascertain expert information on mindfulness and closely related Buddhist concepts. This qualitative process allows the experts to define the phenomena of interest (i.e., addresses issues of validity). In the second phase, the investigators will use the themes and specific phrases evoked during the qualitative interviews to develop items for a draft closed-ended self-report measure of mindfulness. Following completion of the research outlined in this proposal, the investigators will submit a subsequent proposal to thoroughly evaluate the psychometric properties of our draft mindfulness questionnaire in a variety of different cultures and contexts. This measure can be beneficial in clinical research by helping to elucidate the mechanisms of change in mindfulness-based psychotherapies in the United States and equally so in other cultures such as Thailand, where mindfulness and other Buddhist practices have already been integrated into mainstream mental health treatment. Therefore, our aim is to create a measure that can help improve the assessment and clinical use of mindfulness.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Buddhist Clergy and Laypersons | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Buddhist clergy and laypersons
Key inclusion criteria (2 listed)
- Zen, Theravada, or Tibetan clergy
- Zen, Theravada, or Tibetan layperson with meditation experience
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 29 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Wellness 1, run by Pacific University at 1 site in United States.
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 1 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 29 Oct 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 United States. 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.
Where can I read the original study information?
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 29 Oct 2014.