MindfulnessCOMMENCENCT03510117
Creating and Optimizing Mindfulness Measures to Enhance and Normalize Clinical Evaluation
A study testing Mindfulness in people with Mindfulness, run by Northwestern University at 1 site in United States.
Trial summary
While MBI trials have reached a greater level of rigor (e.g., random assignment, matching on time, attention, teacher characteristics, non-specific factors) a significant gap still remains in mindfulness research: the lack of a comprehensive and standardized self-report measurement system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,152 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 26 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age
- Must be able to speak and understand English
- Must be enrolled in an multi-week, group-based, instructor-led, live (in-person or online) mindfulness-based program that has not yet started (i.e., before session 1)
Who cannot join
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Creating and Optimizing Mindfulness Measures to Enhance and Normalize Clinical Evaluation (COMMENCE)
While MBI trials have reached a greater level of rigor (e.g., random assignment, matching on time, attention, teacher characteristics, non-specific factors) a significant gap still remains in mindfulness research: the lack of a comprehensive and standardized self-report measurement system. A precise, carefully constructed set of assessment tools based on a common measurement system are needed; where scores can be psychometrically linked to current "legacy" measures to better understand the existing body of mindfulness research. In this study, Creating and Optimizing Mindfulness Measures to Enhance and Normalize Clinical Evaluation (COMMENCE), the investigators will use Patient Reported Outcomes Measurement Information System (PROMIS) methodologies to construct improved self-report mindfulness-related measures. They will also use PROMIS-based PROsetta Stone linking methods to equate scores and create cross-walks between new mindfulness measures and existing ones.
Read the detailed description
The investigators will use Patient Reported Outcomes Measurement Information System (PROMIS®) methodologies to construct improved self-report mindfulness-related measures. They will also use PROMIS-based PROsetta Stone® instrument linking methods to equate scores and create cross-walks between new mindfulness measures and existing ones. The research team has extensive experience in patient reported outcomes (PRO) development through PROMIS and related PRO development initiatives, including mind-body measures (Chicago and Pittsburgh), PROsetta Stone linking methodologies (Chicago), and mindfulness research (Pittsburgh and Chicago).
PROMIS methodologies involve a systematic and iterative approach to person-centered measurement and are the gold standard. Following PROMIS methods, newly created mindfulness measures will be informed by: 1) the existing literature, and 2) stakeholders such as mindfulness researchers, Buddhist and MBI teachers, and new and experienced meditators. COMMENCE analyses will also reflect PROMIS, producing concise, precise, clinically relevant measures that can be administered as Computerized Adaptive Tests (CATs) or fixed-length short forms. PROsetta Stone methods will enable a crosswalk between the new mindfulness measures and legacy instruments that assess similar constructs. All of this will have a major impact on mindfulness research through increasing measurement precision and comparability across and between studies: past, present, and future. The project will also address the response shift challenge. New mindfulness measures and crosswalk linking will be produced through the following three SPECIFIC AIMS:
SPECIFIC AIM I. Development of New Mindfulness Item Banks. Activities include: 1) a review of the mindfulness measurement literature; 2) an online survey of mindfulness researchers to identify domains and measurement considerations for item bank development; 3) focus groups with new and experienced meditators, and individual interviews with mindfulness meditation practitioners, including Buddhist teachers, to elaborate on concepts such as response shift; 4) item refinement; 6) translatability review; and 7) cognitive interviews to assess item clarity.
SPECIFIC AIM II. Calibration of New Mindfulness Item Banks and Score Linking with Legacy Measures. Calibration activities will include: 1) testing new mindfulness item banks in a large online general population sample (n=4200) and a sample of mindfulness teachers and students (n=500); 2) evaluation of dimensionality and other assumptions prior to Item Response Theory (IRT) analysis; 3) IRT analyses; and 4) creation of CATs and fixed length short forms. A battery of legacy measures will also be administrated alongside new mindfulness banks. Using PROsetta Stone procedures, the investigators will test mindfulness banks and legacy measures in a new large online sample (n=3000) to link measures on a common measurement metric and create cross-walk scoring tables to facilitate interpretation.
SPECIFIC AIM III. Validation of New Mindfulness Short Forms in Ongoing Mindfulness Courses. To evaluate different forms of validity (e.g., construct, criterion), responsiveness to change over time, and estimation of minimally important differences, the investigators will administer new mindfulness short forms and legacy measures to 250 mindfulness students at baseline, 8-weeks, and 16 weeks in multiple, on-going 8-week Mindfulness-Based Stress Reduction (MBSR) courses and similar MBI programs at Pittsburgh and Chicago sites, as well as at member sites from the Academic Consortium for Integrative Medicine and Health and the BraveNet Practice-Based Research Network. In addition to legacy measures, a subset of the sample will complete the meditation breath awareness score, an experiential measure of focused attention.
- Conditions
- Mindfulness
- Being tested
- Mindfulness
- Keywords
- Mindfulness, Patient reported outcomes measures, PROMIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Mindfulness
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Other | Mindfulness Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness Questionnaire
Mindfulness Questionnaire
Measured: DAY 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Jul 2017
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (135)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To evaluate different forms of validity (e.g., construct, criterion), responsiveness to change over time, and estimation of minimally important differences, we will administer new mindfulness short forms, legacy measures, and an experiential measure of focused attention to \~250 mindfulness students at baseline, 8-weeks, and 16 weeks in multiple, on-going 8-week Mindfulness-Based Stress Reduction (MBSR) courses and similar MBI programs at Pittsburgh and Chicago sites, as well as at member sites from the Academic Consortium for Integrative Medicine and Health and the BraveNet Practice-Based Research Network.
- Masking
- None (open label)
- Enrolment
- 8,152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Pittsburgh, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, David Victorson, Northwestern University
- Investigators
- David E Victorson, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510117
- Sponsor's protocol ID
- STU00205373
- Other IDs
- 1R01AT009539-01
- Acronym
- COMMENCE
- Status last verified
- Jun 2023
- First submitted
- 16 Apr 2018
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chuang tsu: Basic writings. B. Watson, Trans. ed. New York: Columbia University Press; 1964
Kabat-Zinn J. Full catastrophe living : using the wisdom of your body and mind to face stress, pain, and illness. Revised and updated edition. ed. New York: Bantam Books trade paperback; 2013
Teasdale JD, Segal Z, Williams JM. How does cognitive therapy prevent depressive relapse and why should attentional control (mindfulness) training help? Behav Res Ther. 1995 Jan;33(1):25-39. doi: 10.1016/0005-7967(94)e0011-7.
PubMed 7872934Linehan MM. Dialectical behavior therapy for borderline personality disorder. Theory and method. Bull Menninger Clin. 1987 May;51(3):261-76. No abstract available.
PubMed 3580661Hayes SC, Wilson KG. Acceptance and commitment therapy: Altering the verbal support for experiential avoidance. Behav Anal. 1994 Fall;17(2):289-303. doi: 10.1007/BF03392677.
PubMed 22478193Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5-31. doi: 10.1080/16506073.2015.1098724. Epub 2016 Jan 28.
PubMed 26818413Morone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, Glynn NW, Weiner DK. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):329-37. doi: 10.1001/jamainternmed.2015.8033.
PubMed 26903081Grossman P, Zwahlen D, Halter JP, Passweg JR, Steiner C, Kiss A. A mindfulness-based program for improving quality of life among hematopoietic stem cell transplantation survivors: feasibility and preliminary findings. Support Care Cancer. 2015 Apr;23(4):1105-12. doi: 10.1007/s00520-014-2452-4. Epub 2014 Oct 10.
PubMed 25297466Victorson D, Hankin V, Burns J, Weiland R, Maletich C, Sufrin N, Schuette S, Gutierrez B, Brendler C. Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial. Psychooncology. 2017 Aug;26(8):1155-1163. doi: 10.1002/pon.4135. Epub 2016 May 3.
PubMed 27145355Slowikowski C, Mioduszewski O, MacLean H, Poulin P, Smith AM, Walker LAS. Mindfulness, mood and quality of life in multiple sclerosis. Mult Scler J. 2016;22:47-47
Eisendrath SJ, Gillung E, Delucchi KL, Segal ZV, Nelson JC, McInnes LA, Mathalon DH, Feldman MD. A Randomized Controlled Trial of Mindfulness-Based Cognitive Therapy for Treatment-Resistant Depression. Psychother Psychosom. 2016;85(2):99-110. doi: 10.1159/000442260. Epub 2016 Jan 26.
PubMed 26808973Maxwell L, Duff E. Mindfulness: An Effective Prescription for Depression and Anxiety. Jnp-J Nurse Pract. 2016;12(6):403-409
Brown KW, Weinstein N, Creswell JD. Trait mindfulness modulates neuroendocrine and affective responses to social evaluative threat. Psychoneuroendocrinology. 2012 Dec;37(12):2037-41. doi: 10.1016/j.psyneuen.2012.04.003. Epub 2012 May 22.
PubMed 22626868Creswell JD, Pacilio LE, Lindsay EK, Brown KW. Brief mindfulness meditation training alters psychological and neuroendocrine responses to social evaluative stress. Psychoneuroendocrinology. 2014 Jun;44:1-12. doi: 10.1016/j.psyneuen.2014.02.007. Epub 2014 Feb 23.
PubMed 24767614Creswell JD, Irwin MR, Burklund LJ, Lieberman MD, Arevalo JM, Ma J, Breen EC, Cole SW. Mindfulness-Based Stress Reduction training reduces loneliness and pro-inflammatory gene expression in older adults: a small randomized controlled trial. Brain Behav Immun. 2012 Oct;26(7):1095-101. doi: 10.1016/j.bbi.2012.07.006. Epub 2012 Jul 20.
PubMed 22820409
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating and Optimizing Mindfulness Measures to Enhance and Normalize Clinical Evaluation (COMMENCE)
- ClinicalTrials.gov ID
- NCT03510117
- Acronym / sponsor ID
- COMMENCE / STU00205373
- Conditions
- Mindfulness
- Keywords
- Mindfulness, Patient reported outcomes measures, PROMIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,152 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Pittsburgh, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 27 Apr 2018 (actual)
- 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.
While MBI trials have reached a greater level of rigor (e.g., random assignment, matching on time, attention, teacher characteristics, non-specific factors) a significant gap still remains in mindfulness research: the lack of a comprehensive and standardized self-report measurement system. A precise, carefully constructed set of assessment tools based on a common measurement system are needed; where scores can be psychometrically linked to current "legacy" measures to better understand the existing body of mindfulness research. In this study, Creating and Optimizing Mindfulness Measures to Enhance and Normalize Clinical Evaluation (COMMENCE), the investigators will use Patient Reported Outcomes Measurement Information System (PROMIS) methodologies to construct improved self-report mindfulness-related measures. They will also use PROMIS-based PROsetta Stone linking methods to equate scores and create cross-walks between new mindfulness measures and existing ones.
Detailed description
The investigators will use Patient Reported Outcomes Measurement Information System (PROMIS®) methodologies to construct improved self-report mindfulness-related measures. They will also use PROMIS-based PROsetta Stone® instrument linking methods to equate scores and create cross-walks between new mindfulness measures and existing ones. The research team has extensive experience in patient reported outcomes (PRO) development through PROMIS and related PRO development initiatives, including mind-body measures (Chicago and Pittsburgh), PROsetta Stone linking methodologies (Chicago), and mindfulness research (Pittsburgh and Chicago).
PROMIS methodologies involve a systematic and iterative approach to person-centered measurement and are the gold standard. Following PROMIS methods, newly created mindfulness measures will be informed by: 1) the existing literature, and 2) stakeholders such as mindfulness researchers, Buddhist and MBI teachers, and new and experienced meditators. COMMENCE analyses will also reflect PROMIS, producing concise, precise, clinically relevant measures that can be administered as Computerized Adaptive Tests (CATs) or fixed-length short forms. PROsetta Stone methods will enable a crosswalk between the new mindfulness measures and legacy instruments that assess similar constructs. All of this will have a major impact on mindfulness research through increasing measurement precision and comparability across and between studies: past, present, and future. The project will also address the response shift challenge. New mindfulness measures and crosswalk linking will be produced through the following three SPECIFIC AIMS:
SPECIFIC AIM I. Development of New Mindfulness Item Banks. Activities include: 1) a review of the mindfulness measurement literature; 2) an online survey of mindfulness researchers to identify domains and measurement considerations for item bank development; 3) focus groups with new and experienced meditators, and individual interviews with mindfulness meditation practitioners, including Buddhist teachers, to elaborate on concepts such as response shift; 4) item refinement; 6) translatability review; and 7) cognitive interviews to assess item clarity.
SPECIFIC AIM II. Calibration of New Mindfulness Item Banks and Score Linking with Legacy Measures. Calibration activities will include: 1) testing new mindfulness item banks in a large online general population sample (n=4200) and a sample of mindfulness teachers and students (n=500); 2) evaluation of dimensionality and other assumptions prior to Item Response Theory (IRT) analysis; 3) IRT analyses; and 4) creation of CATs and fixed length short forms. A battery of legacy measures will also be administrated alongside new mindfulness banks. Using PROsetta Stone procedures, the investigators will test mindfulness banks and legacy measures in a new large online sample (n=3000) to link measures on a common measurement metric and create cross-walk scoring tables to facilitate interpretation.
SPECIFIC AIM III. Validation of New Mindfulness Short Forms in Ongoing Mindfulness Courses. To evaluate different forms of validity (e.g., construct, criterion), responsiveness to change over time, and estimation of minimally important differences, the investigators will administer new mindfulness short forms and legacy measures to 250 mindfulness students at baseline, 8-weeks, and 16 weeks in multiple, on-going 8-week Mindfulness-Based Stress Reduction (MBSR) courses and similar MBI programs at Pittsburgh and Chicago sites, as well as at member sites from the Academic Consortium for Integrative Medicine and Health and the BraveNet Practice-Based Research Network. In addition to legacy measures, a subset of the sample will complete the meditation breath awareness score, an experiential measure of focused attention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To evaluate different forms of validity (e.g., construct, criterion), responsiveness to change over time, and estimation of minimally important differences, we will administer new mindfulness short forms, legacy measures, and an experiential measure of focused attention to ~250 mindfulness students at baseline, 8-weeks, and 16 weeks in multiple, on-going 8-week Mindfulness-Based Stress Reduction (MBSR) courses and similar MBI programs at Pittsburgh and Chicago sites, as well as at member sites from the Academic Consortium for Integrative Medicine and Health and the BraveNet Practice-Based Research Network.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Other | Behavioral: MindfulnessMindfulness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be at least 18 years of age
- Must be able to speak and understand English
- Must be enrolled in an multi-week, group-based, instructor-led, live (in-person or online) mindfulness-based program that has not yet started (i.e., before session 1)
Key exclusion criteria (1 listed)
- Unable to provide consent
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 |
|---|---|---|
| MindfulnessMindfulness | Behavioural | Mindfulness |
Primary outcome
Mindfulness Questionnaire
Time frame: DAY 0
Mindfulness Questionnaire
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 13 Jun 2023.
- BackgroundChuang tsu: Basic writings. B. Watson, Trans. ed. New York: Columbia University Press; 1964
- BackgroundKabat-Zinn J. Full catastrophe living : using the wisdom of your body and mind to face stress, pain, and illness. Revised and updated edition. ed. New York: Bantam Books trade paperback; 2013
- Background: PubMed 7872934Teasdale JD, Segal Z, Williams JM. How does cognitive therapy prevent depressive relapse and why should attentional control (mindfulness) training help? Behav Res Ther. 1995 Jan;33(1):25-39. doi: 10.1016/0005-7967(94)e0011-7.
- Background: PubMed 3580661Linehan MM. Dialectical behavior therapy for borderline personality disorder. Theory and method. Bull Menninger Clin. 1987 May;51(3):261-76. No abstract available.
- Background: PubMed 22478193Hayes SC, Wilson KG. Acceptance and commitment therapy: Altering the verbal support for experiential avoidance. Behav Anal. 1994 Fall;17(2):289-303. doi: 10.1007/BF03392677.
- Background: PubMed 26818413Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5-31. doi: 10.1080/16506073.2015.1098724. Epub 2016 Jan 28.
- Background: PubMed 26903081Morone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, Glynn NW, Weiner DK. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):329-37. doi: 10.1001/jamainternmed.2015.8033.
- Background: PubMed 25297466Grossman P, Zwahlen D, Halter JP, Passweg JR, Steiner C, Kiss A. A mindfulness-based program for improving quality of life among hematopoietic stem cell transplantation survivors: feasibility and preliminary findings. Support Care Cancer. 2015 Apr;23(4):1105-12. doi: 10.1007/s00520-014-2452-4. Epub 2014 Oct 10.
- Background: PubMed 27145355Victorson D, Hankin V, Burns J, Weiland R, Maletich C, Sufrin N, Schuette S, Gutierrez B, Brendler C. Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial. Psychooncology. 2017 Aug;26(8):1155-1163. doi: 10.1002/pon.4135. Epub 2016 May 3.
- BackgroundSlowikowski C, Mioduszewski O, MacLean H, Poulin P, Smith AM, Walker LAS. Mindfulness, mood and quality of life in multiple sclerosis. Mult Scler J. 2016;22:47-47
- Background: PubMed 26808973Eisendrath SJ, Gillung E, Delucchi KL, Segal ZV, Nelson JC, McInnes LA, Mathalon DH, Feldman MD. A Randomized Controlled Trial of Mindfulness-Based Cognitive Therapy for Treatment-Resistant Depression. Psychother Psychosom. 2016;85(2):99-110. doi: 10.1159/000442260. Epub 2016 Jan 26.
- BackgroundMaxwell L, Duff E. Mindfulness: An Effective Prescription for Depression and Anxiety. Jnp-J Nurse Pract. 2016;12(6):403-409
- Individual participant dataSharing planned: No
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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.
David E Victorson, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Mindfulness, run by Northwestern 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 3 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 13 Jun 2023. 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.
What does the primary outcome measure?
Mindfulness Questionnaire (time frame: DAY 0). 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 NCT03510117, which also lists 135 linked publications.
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 13 Jun 2023.