ID

35657

Beschrijving

Triple Chronotherapy for Perinatal Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02053649

Link

https://clinicaltrials.gov/show/NCT02053649

Trefwoorden

Versies (1)
  1. 14-03-19 14-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Depression NCT02053649

Engels

Eligibility Depression NCT02053649

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02053649
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
pregnant women with a diagnosis of major depressive disorder at 24-28 weeks gestation
Beschrijving

Pregnancy | Major Depressive Disorder | Weeks pregnant Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C1269683
UMLS CUI [3,1]
C1135241
UMLS CUI [3,2]
C1265611
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
active psychosis or suicidality contraindicating outpatient treatment
Beschrijving

Psychotic Disorder | Suicidality | Outpatient Treatment Contraindicated

Datatype

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C3166387
UMLS CUI [3,1]
C0029921
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C1444657
bipolar disorder
Beschrijving

Bipolar Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0005586
seizure disorder
Beschrijving

Epilepsy

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
self report of frequent migraines/headaches precipitated by bright light or sleep deprivation
Beschrijving

Migraine headaches Frequent Due to Light | Migraine headaches Frequent Due to Sleep Deprivation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0332183
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0023693
UMLS CUI [2,1]
C0149931
UMLS CUI [2,2]
C0332183
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0037316
preexisting eye/skin disorders contraindicating light therapy
Beschrijving

Disorder of eye Pre-existing | Dermatologic disorders Pre-existing | Medical contraindication Phototherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015397
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0037274
UMLS CUI [2,2]
C2347662
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0031765
use of photosensitizing medications
Beschrijving

Photosensitizing Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0162713
primary axis i diagnosis other than mdd (comorbid phobia, generalized or social anxiety disorder allowed)
Beschrijving

Axis I diagnosis Primary | Exception Major Depressive Disorder | Phobic anxiety disorder Comorbid allowed | Generalized Anxiety Disorder allowed | Social anxiety disorder allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1269683
UMLS CUI [3,1]
C0349231
UMLS CUI [3,2]
C1275743
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0270549
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C4237417
UMLS CUI [5,2]
C0683607
high risk pregnancy (e.g., conditions requiring mandatory bed rest or complex medical regimens that will interfere with study participation or conditions where poor infant outcomes are anticipated)
Beschrijving

High-Risk Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0242786
starting antidepressants within 4 weeks of enrollment
Beschrijving

Antidepressive Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0003289
current employment as shift worker
Beschrijving

Shift worker

Datatype

boolean

Alias
UMLS CUI [1]
C0425104
current alcohol or drug use disorders
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
women whose infants will not be living in the home or who will have a nighttime caregiver
Beschrijving

Gender | Infants At home Absent | Infants Night time Caregiver

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0021270
UMLS CUI [2,2]
C4534363
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0021270
UMLS CUI [3,2]
C0240526
UMLS CUI [3,3]
C0085537
pittsburgh sleep quality inventory (psqi) < 5 (i.e., those who report no sleep complaints during 3rd trimester of pregnancy and for whom an intervention targeting sleep might not be indicated).
Beschrijving

Pittsburgh Sleep Quality Index score

Datatype

boolean

Alias
UMLS CUI [1]
C4545801
women who do not speak and read english (because the complexity of translating the research instruments is beyond the scope of this project)
Beschrijving

Gender | Lacking Able to speak English Language | Lacking Able to read English Language

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0564215
UMLS CUI [2,3]
C0376245
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0586740
UMLS CUI [3,3]
C0376245
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Similar models

Eligibility Depression NCT02053649

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02053649
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Pregnancy | Major Depressive Disorder | Weeks pregnant Quantity
Item
pregnant women with a diagnosis of major depressive disorder at 24-28 weeks gestation
boolean
C0032961 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C1135241 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Psychotic Disorder | Suicidality | Outpatient Treatment Contraindicated
Item
active psychosis or suicidality contraindicating outpatient treatment
boolean
C0033975 (UMLS CUI [1])
C3166387 (UMLS CUI [2])
C0029921 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1444657 (UMLS CUI [3,3])
Bipolar Disorder
Item
bipolar disorder
boolean
C0005586 (UMLS CUI [1])
Epilepsy
Item
seizure disorder
boolean
C0014544 (UMLS CUI [1])
Migraine headaches Frequent Due to Light | Migraine headaches Frequent Due to Sleep Deprivation
Item
self report of frequent migraines/headaches precipitated by bright light or sleep deprivation
boolean
C0149931 (UMLS CUI [1,1])
C0332183 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0023693 (UMLS CUI [1,4])
C0149931 (UMLS CUI [2,1])
C0332183 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0037316 (UMLS CUI [2,4])
Disorder of eye Pre-existing | Dermatologic disorders Pre-existing | Medical contraindication Phototherapy
Item
preexisting eye/skin disorders contraindicating light therapy
boolean
C0015397 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0037274 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0031765 (UMLS CUI [3,2])
Photosensitizing Agents
Item
use of photosensitizing medications
boolean
C0162713 (UMLS CUI [1])
Axis I diagnosis Primary | Exception Major Depressive Disorder | Phobic anxiety disorder Comorbid allowed | Generalized Anxiety Disorder allowed | Social anxiety disorder allowed
Item
primary axis i diagnosis other than mdd (comorbid phobia, generalized or social anxiety disorder allowed)
boolean
C0270287 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
C0349231 (UMLS CUI [3,1])
C1275743 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0270549 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C4237417 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
High-Risk Pregnancy
Item
high risk pregnancy (e.g., conditions requiring mandatory bed rest or complex medical regimens that will interfere with study participation or conditions where poor infant outcomes are anticipated)
boolean
C0242786 (UMLS CUI [1])
Antidepressive Agents
Item
starting antidepressants within 4 weeks of enrollment
boolean
C0003289 (UMLS CUI [1])
Shift worker
Item
current employment as shift worker
boolean
C0425104 (UMLS CUI [1])
Substance Use Disorders
Item
current alcohol or drug use disorders
boolean
C0038586 (UMLS CUI [1])
Gender | Infants At home Absent | Infants Night time Caregiver
Item
women whose infants will not be living in the home or who will have a nighttime caregiver
boolean
C0079399 (UMLS CUI [1])
C0021270 (UMLS CUI [2,1])
C4534363 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0021270 (UMLS CUI [3,1])
C0240526 (UMLS CUI [3,2])
C0085537 (UMLS CUI [3,3])
Pittsburgh Sleep Quality Index score
Item
pittsburgh sleep quality inventory (psqi) < 5 (i.e., those who report no sleep complaints during 3rd trimester of pregnancy and for whom an intervention targeting sleep might not be indicated).
boolean
C4545801 (UMLS CUI [1])
Gender | Lacking Able to speak English Language | Lacking Able to read English Language
Item
women who do not speak and read english (because the complexity of translating the research instruments is beyond the scope of this project)
boolean
C0079399 (UMLS CUI [1])
C0332268 (UMLS CUI [2,1])
C0564215 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0332268 (UMLS CUI [3,1])
C0586740 (UMLS CUI [3,2])
C0376245 (UMLS CUI [3,3])
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