ID

15587

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02340754

Stichworte

Versionen (1)
  1. 03.06.16 03.06.16 -
Hochgeladen am

3. Juni 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Multiple Sclerosis NCT02340754

Englisch

Eligibility Multiple Sclerosis NCT02340754

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

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

Datentyp

boolean

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

Kurtzke multiple sclerosis rating scale

Datentyp

boolean

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

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

Datentyp

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;
Beschreibung

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

Datentyp

boolean

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

English Language Able to read Able to write

Datentyp

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.
Beschreibung

Informed Consent | Compliance behavior Study Protocol | stress reduction techniques

Datentyp

boolean

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

Exclusion Criteria

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

stress reduction techniques | Cognitive Therapy

Datentyp

boolean

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

Participation in meditation Regular | Participation in yoga Regular

Datentyp

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;
Beschreibung

Exacerbation of multiple sclerosis

Datentyp

boolean

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

Mini-mental state examination

Datentyp

boolean

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

Feeling suicidal

Datentyp

boolean

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

psychological disease | Depressive disorder | Anxiety

Datentyp

boolean

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

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

Datentyp

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);
Beschreibung

Urine pregnancy test positive | Pregnancy, Planned

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Multiple Sclerosis NCT02340754

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video