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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Pacific University

    Forest Grove, Oregon, 97116

Other trials in United States

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.

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 groups in NCT01299064
Study groupRoleWhat they receive
Buddhist Clergy and LaypersonsNot described

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2011 (estimated)
  2. Study startAug 2010
  3. Primary completionJul 2011
  4. Study completionJul 2014

Resources

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)
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

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.

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