ID

30503

Beskrivning

Validating PROMIS Instruments in Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00784199

Länk

https://clinicaltrials.gov/show/NCT00784199

Nyckelord

Versioner (1)
  1. 2018-06-09 2018-06-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00784199

Engelsk

Eligibility Major Depressive Disorder NCT00784199

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
willing and able to give informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
speak, read, and understand english
Beskrivning

Able to speak English Language | Able to read English Language | Comprehension English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0376245
currently in the first 4 months of outpatient treatment at western psychiatric institute and clinic (wpic) for major depressive disorder
Beskrivning

Outpatient treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0002423
participants will be required to have a minimum score of 12 on the 17-item hamilton rating scale for depression
Beskrivning

Hamilton Depression Rating Scale 17 Item Clinical Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
lack of willingness or ability to provide informed consent
Beskrivning

Informed Consent Unwilling | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
dementia or other cognitive impairment that would interfere with questionnaire completion
Beskrivning

Dementia Interferes with Questionnaire Completion | Impaired cognition Interferes with Questionnaire Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0034394
UMLS CUI [1,4]
C0205197
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0034394
UMLS CUI [2,4]
C0205197
lifetime history of any psychotic disorder (e.g., schizophrenia, schizoaffective disorder) or bipolar disorder, as evidenced in the participant's medical records or reported during the structured clinical interview for dsm-iv (scid)
Beskrivning

Psychotic Disorders Lifetime | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime | Bipolar Disorder Lifetime

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C4071830
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C4071830
UMLS CUI [3,1]
C0036337
UMLS CUI [3,2]
C4071830
UMLS CUI [4,1]
C0005586
UMLS CUI [4,2]
C4071830
organic affective syndrome (i.e., mood disorder secondary to a general medical condition or substance-induced mood disorder)
Beskrivning

Organic mood disorder | Mood Disorders Secondary to Medical condition General | Substance-induced mood disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0029232
UMLS CUI [2,1]
C0525045
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C3843040
UMLS CUI [2,4]
C0205246
UMLS CUI [3]
C3267135
current psychiatric inpatient treatment
Beskrivning

Inpatient individual psychiatric therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C2142969
a history of continuous care for 1 year or more in the mental health care system within the prior 5 years (in order to eliminate patients with more chronic presentations)
Beskrivning

Mental health care Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0184643
UMLS CUI [1,2]
C0449238
major medical conditions that influence the central nervous system (e.g., parkinson's disease, stroke, amyotrophic lateral sclerosis [als], multiple sclerosis [ms]), systemic lupus erythematosus [sle], seizure disorders, etc.)
Beskrivning

Medical condition Major Influence Central Nervous System | Parkinson Disease | Cerebrovascular accident | Amyotrophic Lateral Sclerosis | Multiple Sclerosis | Lupus Erythematosus, Systemic | Epilepsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C4054723
UMLS CUI [1,4]
C3714787
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0002736
UMLS CUI [5]
C0026769
UMLS CUI [6]
C0024141
UMLS CUI [7]
C0014544
note: persons with common psychiatric comorbidities (e.g., anxiety disorders) will be included. the presence of psychiatric comorbidities will be documented.
Beskrivning

Inclusion criteria | Comorbidity Psychiatric Common | Anxiety Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205487
UMLS CUI [2,3]
C0205214
UMLS CUI [3]
C0003469
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Similar models

Eligibility Major Depressive Disorder NCT00784199

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
willing and able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Able to speak English Language | Able to read English Language | Comprehension English Language
Item
speak, read, and understand english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0233733 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Outpatient treatment
Item
currently in the first 4 months of outpatient treatment at western psychiatric institute and clinic (wpic) for major depressive disorder
boolean
C0002423 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
participants will be required to have a minimum score of 12 on the 17-item hamilton rating scale for depression
boolean
C3639712 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unwilling | Informed Consent Unable
Item
lack of willingness or ability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Dementia Interferes with Questionnaire Completion | Impaired cognition Interferes with Questionnaire Completion
Item
dementia or other cognitive impairment that would interfere with questionnaire completion
boolean
C0497327 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0034394 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0338656 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0034394 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
Psychotic Disorders Lifetime | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime | Bipolar Disorder Lifetime
Item
lifetime history of any psychotic disorder (e.g., schizophrenia, schizoaffective disorder) or bipolar disorder, as evidenced in the participant's medical records or reported during the structured clinical interview for dsm-iv (scid)
boolean
C0033975 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C0036337 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
C0005586 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
Organic mood disorder | Mood Disorders Secondary to Medical condition General | Substance-induced mood disorder
Item
organic affective syndrome (i.e., mood disorder secondary to a general medical condition or substance-induced mood disorder)
boolean
C0029232 (UMLS CUI [1])
C0525045 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C3843040 (UMLS CUI [2,3])
C0205246 (UMLS CUI [2,4])
C3267135 (UMLS CUI [3])
Inpatient individual psychiatric therapy
Item
current psychiatric inpatient treatment
boolean
C2142969 (UMLS CUI [1])
Mental health care Duration
Item
a history of continuous care for 1 year or more in the mental health care system within the prior 5 years (in order to eliminate patients with more chronic presentations)
boolean
C0184643 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Medical condition Major Influence Central Nervous System | Parkinson Disease | Cerebrovascular accident | Amyotrophic Lateral Sclerosis | Multiple Sclerosis | Lupus Erythematosus, Systemic | Epilepsy
Item
major medical conditions that influence the central nervous system (e.g., parkinson's disease, stroke, amyotrophic lateral sclerosis [als], multiple sclerosis [ms]), systemic lupus erythematosus [sle], seizure disorders, etc.)
boolean
C3843040 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C3714787 (UMLS CUI [1,4])
C0030567 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0002736 (UMLS CUI [4])
C0026769 (UMLS CUI [5])
C0024141 (UMLS CUI [6])
C0014544 (UMLS CUI [7])
Inclusion criteria | Comorbidity Psychiatric Common | Anxiety Disorders
Item
note: persons with common psychiatric comorbidities (e.g., anxiety disorders) will be included. the presence of psychiatric comorbidities will be documented.
boolean
C1512693 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205487 (UMLS CUI [2,2])
C0205214 (UMLS CUI [2,3])
C0003469 (UMLS CUI [3])
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