- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03510117
Mindfulness-toimenpiteiden luominen ja optimointi kliinisen arvioinnin tehostamiseksi ja normalisoimiseksi (COMMENCE)
Mindfulness-toimenpiteiden luominen ja optimointi kliinisen arvioinnin tehostamiseksi ja normalisoimiseksi (ALOITUS)
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Tutkijat käyttävät Patient Reported Outcomes Measurement Information System (PROMIS®) -menetelmiä rakentaakseen parempia itseraportoivia mindfulnessiin liittyviä mittareita. He käyttävät myös PROMIS-pohjaisia PROsetta Stone® -instrumenttien yhdistämismenetelmiä tasatakseen pisteet ja luodakseen risteyksiä uusien mindfulness-mittausten ja olemassa olevien välillä. Tutkimusryhmällä on laaja kokemus potilaiden raportoimien tulosten (PRO) kehittämisestä PROMISin ja siihen liittyvien PRO-kehityshankkeiden kautta, mukaan lukien mielen ja kehon mittaukset (Chicago ja Pittsburgh), PROsetta Stone -linkitysmenetelmät (Chicago) ja mindfulness-tutkimus (Pittsburgh ja Chicago).
PROMIS-metodologiat sisältävät systemaattisen ja iteratiivisen lähestymistavan henkilökeskeiseen mittaukseen ja ovat kultainen standardi. PROMIS-menetelmiä noudattaen äskettäin luoduista mindfulness-mittauksista tiedottavat: 1) olemassa oleva kirjallisuus ja 2) sidosryhmät, kuten mindfulness-tutkijat, buddhalaiset ja MBI-opettajat sekä uudet ja kokeneet meditoijat. COMMENCE-analyysit heijastavat myös PROMISia, joka tuottaa ytimekkäitä, tarkkoja, kliinisesti merkityksellisiä mittareita, joita voidaan antaa tietokoneistettuina adaptiivisina testeinä (CAT) tai kiinteäpituisina lyhyinä lomakkeina. PROsetta Stone -menetelmät mahdollistavat risteyksen uusien mindfulness-mittausten ja vanhojen, samanlaisia rakenteita arvioivien instrumenttien välillä. Kaikella tällä on suuri vaikutus mindfulness-tutkimukseen lisäämällä mittaustarkkuutta ja vertailtavuutta tutkimusten välillä ja välillä: menneisyydessä, nykyisyydessä ja tulevaisuudessa. Hankkeessa käsitellään myös vastaussiirtohaastetta. Uusia mindfulness-toimenpiteitä ja ylikulkutien yhdistämistä tuotetaan seuraavien kolmen ERITYISEN TAVOITTEEN kautta:
ERITYISTAVOITE I. Uusien mindfulness-kohdepankkien kehittäminen. Toimintaan kuuluu: 1) mindfulness-mittauskirjallisuuden katsaus; 2) online-kysely mindfulness-tutkijoille kohdepankkien kehittämisen toimialueiden ja mittausnäkökohtien tunnistamiseksi; 3) fokusryhmät uusien ja kokeneiden meditoijien kanssa ja yksilölliset haastattelut mindfulness-meditaatioharjoittajien, mukaan lukien buddhalaisten opettajien, kanssa käsitteiden, kuten vastausmuutoksen, kehittämiseksi; 4) nimikkeen tarkennus; 6) käännettävyyden arviointi; ja 7) kognitiiviset haastattelut kohteen selkeyden arvioimiseksi.
ERITYISTAVOITE II. Uusien Mindfulness-kohdepankkien kalibrointi ja pisteiden yhdistäminen vanhojen mittareiden kanssa. Kalibrointitoimintaan kuuluu: 1) uusien mindfulness-kohdepankkien testaaminen laajassa online-yleisväestöotteessa (n=4200) ja mindfulness-opettajien ja -opiskelijoiden otoksessa (n=500); 2) ulottuvuuksien ja muiden oletusten arviointi ennen Item Response Theory (IRT) -analyysiä; 3) IRT-analyysit; ja 4) CAT:ien ja kiinteäpituisten lyhyiden lomakkeiden luominen. Uusien mindfulness-pankkien rinnalla hallinnoidaan myös joukko vanhoja toimenpiteitä. PROsetta Stone -menetelmien avulla tutkijat testaavat mindfulness-pankkeja ja vanhoja mittareita uudessa suuressa online-otoksessa (n=3000) linkittääkseen mittauksia yhteiseen mittausmittariin ja luodakseen ylikulkupisteytystaulukoita tulkinnan helpottamiseksi.
ERITYISTAVOITE III. Uusien Mindfulnessin lyhyiden muotojen validointi käynnissä olevilla Mindfulness-kursseilla. Arvioidakseen erilaisia validiteettimuotoja (esim. konstruktio, kriteeri), reagointikykyä ajan myötä tapahtuviin muutoksiin ja minimaalisten tärkeiden erojen arviointia tutkijat antavat uusia mindfulnessin lyhyitä muotoja ja perintömittauksia 250 mindfulness-opiskelijalle lähtötilanteessa, 8 viikon ja 16 viikkoa useilla käynnissä olevilla 8-viikkoisilla Mindfulness-Based Stress Reduction (MBSR) -kursseilla ja vastaavilla MBI-ohjelmilla Pittsburghin ja Chicagon toimipisteissä sekä Academic Consortium for Integrative Medicine and Health -konsortiossa ja BraveNet Practice -järjestössä. Perustettu tutkimusverkosto. Perinteisten mittareiden lisäksi osa otosta suorittaa meditaation hengitystietoisuuden pisteytyksen, joka on keskittyneen huomion kokemuksellinen mitta.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Pennsylvania
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Pittsburgh, Pennsylvania, Yhdysvallat, 15232
- University of Pittsburgh
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Sisällyttämiskriteerit:
- Ikää tulee olla vähintään 18 vuotta
- Pitää osata puhua ja ymmärtää englantia
- Sinun on oltava ilmoittautunut usean viikon mittaiseen, ryhmäpohjaiseen, ohjaajan johtamaan, live- (henkilökohtaisesti tai verkossa) mindfulness-pohjaiseen ohjelmaan, joka ei ole vielä alkanut (eli ennen istuntoa 1)
Poissulkemiskriteerit:
- Ei voida antaa suostumusta
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Muut: Tarkkaavaisuus
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Tarkkaavaisuus
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Mindfulness-kyselylomake
Aikaikkuna: PÄIVÄ 0
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Mindfulness-kyselylomake
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: David E Victorson, PhD, Northwestern University
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
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- 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.
- Creswell 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.
- Ferrarelli F, Smith R, Dentico D, Riedner BA, Zennig C, Benca RM, Lutz A, Davidson RJ, Tononi G. Experienced mindfulness meditators exhibit higher parietal-occipital EEG gamma activity during NREM sleep. PLoS One. 2013 Aug 28;8(8):e73417. doi: 10.1371/journal.pone.0073417. eCollection 2013.
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- Grossman P. Defining mindfulness by how poorly I think I pay attention during everyday awareness and other intractable problems for psychology's (re)invention of mindfulness: comment on Brown et al. (2011). Psychol Assess. 2011 Dec;23(4):1034-40; discussion 1041-6. doi: 10.1037/a0022713.
- Walach H, Buchheld N, Buttenmuller V, Kleinknecht N, Schmidt S. Measuring mindfulness - the Freiburg Mindfulness Inventory (FMI). Personality and Individual Differences. 2006;40(8):1543-1555
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- Davidson RJ. Empirical explorations of mindfulness: conceptual and methodological conundrums. Emotion. 2010 Feb;10(1):8-11. doi: 10.1037/a0018480.
- Morone NE, Rollman BL, Moore CG, Li Q, Weiner DK. A mind-body program for older adults with chronic low back pain: results of a pilot study. Pain Med. 2009 Nov;10(8):1395-407. doi: 10.1111/j.1526-4637.2009.00746.x.
- Cherkin DC, Sherman KJ, Turner JA. Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy for Chronic Low Back Pain--Reply. JAMA. 2016 Aug 9;316(6):663-4. doi: 10.1001/jama.2016.7951. No abstract available.
- Park T, Reilly-Spong M, Gross CR. Mindfulness: a systematic review of instruments to measure an emergent patient-reported outcome (PRO). Qual Life Res. 2013 Dec;22(10):2639-59. doi: 10.1007/s11136-013-0395-8. Epub 2013 Mar 29.
- Pilkonis PA, Yu L, Dodds NE, Johnston KL, Lawrence SM, Daley DC. Validation of the alcohol use item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS). Drug Alcohol Depend. 2016 Apr 1;161:316-22. doi: 10.1016/j.drugalcdep.2016.02.014. Epub 2016 Feb 17.
- Sung VW, Griffith JW, Rogers RG, Raker CA, Clark MA. Item bank development, calibration and validation for patient-reported outcomes in female urinary incontinence. Qual Life Res. 2016 Jul;25(7):1645-54. doi: 10.1007/s11136-015-1222-1. Epub 2016 Jan 6.
- Dampier C, Jaeger B, Gross HE, Barry V, Edwards L, Lui Y, DeWalt DA, Reeve BB. Responsiveness of PROMIS(R) Pediatric Measures to Hospitalizations for Sickle Pain and Subsequent Recovery. Pediatr Blood Cancer. 2016 Jun;63(6):1038-45. doi: 10.1002/pbc.25931. Epub 2016 Feb 8.
- Howell CR, Gross HE, Reeve BB, DeWalt DA, Huang IC. Known-groups validity of the Patient-Reported Outcomes Measurement Information System (PROMIS((R))) in adolescents and young adults with special healthcare needs. Qual Life Res. 2016 Jul;25(7):1815-23. doi: 10.1007/s11136-016-1237-2. Epub 2016 Feb 12.
- Greco CM, Yu L, Johnston KL, Dodds NE, Morone NE, Glick RM, Schneider MJ, Klem ML, McFarland CE, Lawrence S, Colditz J, Maihoefer CC, Jonas WB, Ryan ND, Pilkonis PA. Measuring nonspecific factors in treatment: item banks that assess the healthcare experience and attitudes from the patient's perspective. Qual Life Res. 2016 Jul;25(7):1625-34. doi: 10.1007/s11136-015-1178-1. Epub 2015 Nov 12.
- Victorson D, Tulsky DS, Kisala PA, Kalpakjian CZ, Weiland B, Choi SW. Measuring resilience after spinal cord injury: Development, validation and psychometric characteristics of the SCI-QOL Resilience item bank and short form. J Spinal Cord Med. 2015 May;38(3):366-76. doi: 10.1179/2045772315Y.0000000016.
- Victorson DE, Choi S, Judson MA, Cella D. Development and testing of item response theory-based item banks and short forms for eye, skin and lung problems in sarcoidosis. Qual Life Res. 2014 May;23(4):1301-13. doi: 10.1007/s11136-013-0567-6. Epub 2013 Nov 9.
- Victorson D, Beaumont JL, Mahadevan R, Grimone A, Burns V, Murry W, Gutierrez S, Schuette S, Brady C, Ring M. Acupuncture-Related Quality of Life Changes Using PROMIS Computer Adaptive Tests in a Pragmatic Trial with Oncology and General Integrative Medicine Patients: The Role of Baseline Acupuncture Expectations. J Altern Complement Med. 2016 Oct;22(10):778-787. doi: 10.1089/acm.2015.0121. Epub 2016 Jul 28.
- Schalet BD, Rothrock NE, Hays RD, Kazis LE, Cook KF, Rutsohn JP, Cella D. Linking Physical and Mental Health Summary Scores from the Veterans RAND 12-Item Health Survey (VR-12) to the PROMIS((R)) Global Health Scale. J Gen Intern Med. 2015 Oct;30(10):1524-30. doi: 10.1007/s11606-015-3453-9. Epub 2015 Jul 16.
- Schalet BD, Revicki DA, Cook KF, Krishnan E, Fries JF, Cella D. Establishing a Common Metric for Physical Function: Linking the HAQ-DI and SF-36 PF Subscale to PROMIS((R)) Physical Function. J Gen Intern Med. 2015 Oct;30(10):1517-23. doi: 10.1007/s11606-015-3360-0.
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- Pilkonis PA, Yu L, Colditz J, Dodds N, Johnston KL, Maihoefer C, Stover AM, Daley DC, McCarty D. Item banks for alcohol use from the Patient-Reported Outcomes Measurement Information System (PROMIS): use, consequences, and expectancies. Drug Alcohol Depend. 2013 Jun 1;130(1-3):167-77. doi: 10.1016/j.drugalcdep.2012.11.002. Epub 2012 Dec 1.
- Pilkonis PA, Yu L, Dodds NE, Johnston KL, Maihoefer CC, Lawrence SM. Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study. J Psychiatr Res. 2014 Sep;56:112-9. doi: 10.1016/j.jpsychires.2014.05.010. Epub 2014 May 29.
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- Hankin VV, D.; Polster, R. . Maximizing Acceptance and Enrollment in MBSR Randomized Controlled Trials with Older Men Diagnosed with Cancer. . Poster presented to the 8th Annual International Scientific Conference of Mindfulness in Medicine, Health Care, and Society. Worcester, MA. 2010
- Victorson D, Du H, Hankin V, et al. MINDFULNESS BASED STRESS REDUCTION DECREASES FEAR OF PROGRESSION OVER TIME FOR MEN WITH PROSTATE CANCER ON ACTIVE SURVEILLANCE: RESULTS FROM A RANDOMIZED CLINICAL TRIAL. The Journal of Urology. 2012;187(4S):384
- Victorson D, Maletich, C, Gutierrez, B, Schuette, S, Morgan, T, Kutikov, A, Kundu, S, Eggener, S, Brendler, C. Description of a New National Cancer Institute Funded Randomized Controlled Trial
- Victorson DK, M.; Maletich, C.; Lawton, R.C.; Hankin Kaufman, V.; Borrero, M.; Languido, L.; Lewett, K.; Pancoe, H.; Berkowitz, C. . A Systematic Review and Meta-Analysis of Mindfulness-Based Randomized Controlled Trials Relevant to Lifestyle Medicine. . American Journal of Lifestyle Medicine. 2015;9(3):185-211
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- Branstrom R, Kvillemo P, Brandberg Y, Moskowitz JT. Self-report mindfulness as a mediator of psychological well-being in a stress reduction intervention for cancer patients--a randomized study. Ann Behav Med. 2010 May;39(2):151-61. doi: 10.1007/s12160-010-9168-6.
- Branstrom R, Duncan LG, Moskowitz JT. The association between dispositional mindfulness, psychological well-being, and perceived health in a Swedish population-based sample. Br J Health Psychol. 2011 May;16(Pt 2):300-16. doi: 10.1348/135910710X501683. Epub 2011 Mar 8.
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- Ong JC, Shapiro SL, Manber R. Combining mindfulness meditation with cognitive-behavior therapy for insomnia: a treatment-development study. Behav Ther. 2008 Jun;39(2):171-82. doi: 10.1016/j.beth.2007.07.002. Epub 2007 Nov 14.
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- Perez L, Huang J, Jansky L, Nowinski C, Victorson D, Peterman A, Cella D. Using focus groups to inform the Neuro-QOL measurement tool: exploring patient-centered, health-related quality of life concepts across neurological conditions. J Neurosci Nurs. 2007 Dec;39(6):342-53. doi: 10.1097/01376517-200712000-00005.
- Lynch EB, Butt Z, Heinemann A, Victorson D, Nowinski CJ, Perez L, Cella D. A qualitative study of quality of life after stroke: the importance of social relationships. J Rehabil Med. 2008 Jul;40(7):518-23. doi: 10.2340/16501977-0203.
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