ID

28901

Beskrivning

Cognitive Behavioral Therapy (CBT) for Adherence and Depression in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01527981

Länk

https://clinicaltrials.gov/show/NCT01527981

Nyckelord

Versioner (1)
  1. 2018-02-13 2018-02-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 februari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depression NCT01527981

Engelsk

Eligibility Depression NCT01527981

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01527981
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 1 diabetes that is poorly controlled (hba1c greater than or equal to 8.0%) despite treatment with insulin.
Beskrivning

Insulin-Dependent Diabetes Mellitus Poorly controlled | Glucohemoglobin measurement | Insulin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0202054
UMLS CUI [3]
C0021641
diagnosis of major depression and/or dysthymia, or current subclinical symptoms of depression in spite of being treated with antidepressants.
Beskrivning

Major Depressive Disorder | Dysthymic Disorder | Symptoms Subclinical Depressive disorder | Antidepressive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0013415
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0205211
UMLS CUI [3,3]
C0011581
UMLS CUI [4]
C0003289
age 18-80.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
if on an antidepressant, stable for two months. oral hypoglycemic medications stable for 2 months, and insulin prescription stable for 2 months (if prescribed).
Beskrivning

Antidepressive Agents Stable | Oral hypoglycemic Stable | Insulin prescribed Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0278329
UMLS CUI [3,3]
C0205360
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
active or untreated major mental illness that would interfere with participation (e.g., untreated psychosis), untreated/unstable bipolar disorder, eating disorder, mental retardation, dementia, or active suicidality.
Beskrivning

Mental disorders Severe untreated | Interference Study Subject Participation Status | Psychotic Disorder untreated | Bipolar Disorder untreated | Bipolar Disorder Unstable | Eating Disorders | Mental Retardation | Dementia | Suicidality

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C2348568
UMLS CUI [3,1]
C0033975
UMLS CUI [3,2]
C0332155
UMLS CUI [4,1]
C0005586
UMLS CUI [4,2]
C0332155
UMLS CUI [5,1]
C0005586
UMLS CUI [5,2]
C0443343
UMLS CUI [6]
C0013473
UMLS CUI [7]
C0025362
UMLS CUI [8]
C0497327
UMLS CUI [9]
C3166387
unable or unwilling to provide informed consent.
Beskrivning

Informed Consent Unable | Informed Consent Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
history of or current cbt for depression.
Beskrivning

Cognitive Therapy Depressive disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009244
UMLS CUI [1,2]
C0011581
currently on dialysis.
Beskrivning

Dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0011946
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Similar models

Eligibility Depression NCT01527981

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01527981
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Poorly controlled | Glucohemoglobin measurement | Insulin
Item
diagnosis of type 1 diabetes that is poorly controlled (hba1c greater than or equal to 8.0%) despite treatment with insulin.
boolean
C0011854 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0202054 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
Major Depressive Disorder | Dysthymic Disorder | Symptoms Subclinical Depressive disorder | Antidepressive Agents
Item
diagnosis of major depression and/or dysthymia, or current subclinical symptoms of depression in spite of being treated with antidepressants.
boolean
C1269683 (UMLS CUI [1])
C0013415 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0205211 (UMLS CUI [3,2])
C0011581 (UMLS CUI [3,3])
C0003289 (UMLS CUI [4])
Age
Item
age 18-80.
boolean
C0001779 (UMLS CUI [1])
Antidepressive Agents Stable | Oral hypoglycemic Stable | Insulin prescribed Stable
Item
if on an antidepressant, stable for two months. oral hypoglycemic medications stable for 2 months, and insulin prescription stable for 2 months (if prescribed).
boolean
C0003289 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0359086 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3,1])
C0278329 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Mental disorders Severe untreated | Interference Study Subject Participation Status | Psychotic Disorder untreated | Bipolar Disorder untreated | Bipolar Disorder Unstable | Eating Disorders | Mental Retardation | Dementia | Suicidality
Item
active or untreated major mental illness that would interfere with participation (e.g., untreated psychosis), untreated/unstable bipolar disorder, eating disorder, mental retardation, dementia, or active suicidality.
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0521102 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0033975 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C0005586 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0005586 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0013473 (UMLS CUI [6])
C0025362 (UMLS CUI [7])
C0497327 (UMLS CUI [8])
C3166387 (UMLS CUI [9])
Informed Consent Unable | Informed Consent Unwilling
Item
unable or unwilling to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Cognitive Therapy Depressive disorder
Item
history of or current cbt for depression.
boolean
C0009244 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
Dialysis
Item
currently on dialysis.
boolean
C0011946 (UMLS CUI [1])
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