ID

15587

Beskrivning

Mindfulness-based Stress Reduction for Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02340754

Länk

https://clinicaltrials.gov/show/NCT02340754

Nyckelord

Versioner (1)
  1. 2016-06-03 2016-06-03 -
Uppladdad den

3 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02340754

Engelsk

Eligibility Multiple Sclerosis NCT02340754

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women 18 years of age or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
definite relapsing remitting, secondary progressive, or primary progressive ms by revised mcdonald criteria;
Beskrivning

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive

Datatyp

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0751965
UMLS CUI [3]
C0751964
expanded disability severity scale ≤ 8 at baseline;
Beskrivning

Kurtzke multiple sclerosis rating scale

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
stable on ms disease modifying, anxiolytic, or antidepressant medications for three months prior to baseline visit;
Beskrivning

Multiple Sclerosis | Biological Response Modifier Therapy | Anti-Anxiety Agents | Antidepressive Agents | Stable status

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0005527
UMLS CUI [3]
C0040616
UMLS CUI [4]
C0003289
UMLS CUI [5]
C0205360
mild to moderate stress defined by a score of ≥ 10 on the perceived stress scale at screening;
Beskrivning

stress severity rating mild | stress severity rating moderate | Perceived stress scale

Datatyp

boolean

Alias
UMLS CUI [1]
C2020721
UMLS CUI [2]
C2020723
UMLS CUI [3]
C0582653
ability to read and write in english;
Beskrivning

English Language Able to read Able to write

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0376245
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0584993
willingness to provide informed consent and comply with study activities, including weekly mbsr sessions and daily practice or weekly education control classes.
Beskrivning

Informed Consent | Compliance behavior Study Protocol | stress reduction techniques

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C2348563
UMLS CUI [3]
C0884454
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
mbsr or cognitive behavioral therapy training within the last 5 years;
Beskrivning

stress reduction techniques | Cognitive Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0884454
UMLS CUI [2]
C0009244
current regular meditation or yoga practice (weekly or more often);
Beskrivning

Participation in meditation Regular | Participation in yoga Regular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1821915
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0454430
UMLS CUI [2,2]
C0205272
ms exacerbation within 30 days of baseline visit;
Beskrivning

Exacerbation of multiple sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0581392
mini-mental status examination (mmse) score of ≤ 26 at screening visit;
Beskrivning

Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
active suicidal ideation (beck depression inventory) at screening visit;
Beskrivning

Feeling suicidal

Datatyp

boolean

Alias
UMLS CUI [1]
C0424000
reported or medically recorded diagnoses of current serious psychological disorders other than depression and anxiety;
Beskrivning

psychological disease | Depressive disorder | Anxiety

Datatyp

boolean

Alias
UMLS CUI [1]
C1658764
UMLS CUI [2]
C0011581
UMLS CUI [3]
C0003467
other current life-threatening or severely disabling physical disorders;
Beskrivning

Disease is life-threatening if untreated | Physical illness Severely disabling

Datatyp

boolean

Alias
UMLS CUI [1]
C3553594
UMLS CUI [2,1]
C0683323
UMLS CUI [2,2]
C4035398
positive pregnancy urine test at baseline and women planning pregnancy during the study period (contraception not required);
Beskrivning

Urine pregnancy test positive | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0430059
UMLS CUI [2]
C0032992
cancer, other than basal or squamous skin cancers; or
Beskrivning

Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Multiple Sclerosis NCT02340754

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive
Item
definite relapsing remitting, secondary progressive, or primary progressive ms by revised mcdonald criteria;
boolean
C0751967 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0751964 (UMLS CUI [3])
Kurtzke multiple sclerosis rating scale
Item
expanded disability severity scale ≤ 8 at baseline;
boolean
C0451246 (UMLS CUI [1])
Multiple Sclerosis | Biological Response Modifier Therapy | Anti-Anxiety Agents | Antidepressive Agents | Stable status
Item
stable on ms disease modifying, anxiolytic, or antidepressant medications for three months prior to baseline visit;
boolean
C0026769 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
C0040616 (UMLS CUI [3])
C0003289 (UMLS CUI [4])
C0205360 (UMLS CUI [5])
stress severity rating mild | stress severity rating moderate | Perceived stress scale
Item
mild to moderate stress defined by a score of ≥ 10 on the perceived stress scale at screening;
boolean
C2020721 (UMLS CUI [1])
C2020723 (UMLS CUI [2])
C0582653 (UMLS CUI [3])
English Language Able to read Able to write
Item
ability to read and write in english;
boolean
C0376245 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0584993 (UMLS CUI [1,3])
Informed Consent | Compliance behavior Study Protocol | stress reduction techniques
Item
willingness to provide informed consent and comply with study activities, including weekly mbsr sessions and daily practice or weekly education control classes.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0884454 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
stress reduction techniques | Cognitive Therapy
Item
mbsr or cognitive behavioral therapy training within the last 5 years;
boolean
C0884454 (UMLS CUI [1])
C0009244 (UMLS CUI [2])
Participation in meditation Regular | Participation in yoga Regular
Item
current regular meditation or yoga practice (weekly or more often);
boolean
C1821915 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0454430 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
Exacerbation of multiple sclerosis
Item
ms exacerbation within 30 days of baseline visit;
boolean
C0581392 (UMLS CUI [1])
Mini-mental state examination
Item
mini-mental status examination (mmse) score of ≤ 26 at screening visit;
boolean
C0451306 (UMLS CUI [1])
Feeling suicidal
Item
active suicidal ideation (beck depression inventory) at screening visit;
boolean
C0424000 (UMLS CUI [1])
psychological disease | Depressive disorder | Anxiety
Item
reported or medically recorded diagnoses of current serious psychological disorders other than depression and anxiety;
boolean
C1658764 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
C0003467 (UMLS CUI [3])
Disease is life-threatening if untreated | Physical illness Severely disabling
Item
other current life-threatening or severely disabling physical disorders;
boolean
C3553594 (UMLS CUI [1])
C0683323 (UMLS CUI [2,1])
C4035398 (UMLS CUI [2,2])
Urine pregnancy test positive | Pregnancy, Planned
Item
positive pregnancy urine test at baseline and women planning pregnancy during the study period (contraception not required);
boolean
C0430059 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
cancer, other than basal or squamous skin cancers; or
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
Informed Consent Unable
Item
inability or unwillingness of individual or legal guardian/representative to give written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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