ID

15809

Beschrijving

Oxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02191423

Link

https://clinicaltrials.gov/show/NCT02191423

Trefwoorden

Versies (1)
  1. 14-06-16 14-06-16 -
Geüploaded op

14 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Postpartum Depression NCT02191423

Engels

Eligibility Postpartum Depression NCT02191423

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
women of all ages who are 3 to 8 months post-partum.
Beschrijving

Age | Postpartum Women

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032804
women who have completed a minimum of 12 years of education.
Beschrijving

Gender | Education Period | Minimum Complete

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0013621
UMLS CUI [2,2]
C1948053
UMLS CUI [3,1]
C1524031
UMLS CUI [3,2]
C0205197
women who are willing and able to provide informed consent for their participation and after the study has been explained. infant participation will be allowed after consent has been obtained from mothers.
Beschrijving

Gender | Informed Consent | Infant participation

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0021270
UMLS CUI [3,2]
C0679823
current dsm-iv-tr diagnosis of ppd disorder as confirmed by scid (administered as part of the study of protocol number ppd1, proposed to the helsinki committee on june 2014).
Beschrijving

Depression, Postpartum

Datatype

boolean

Alias
UMLS CUI [1]
C0221074
symptoms: bdi total score >9, epds total score >10
Beschrijving

Symptoms | Beck depression inventory | Edinburgh postnatal depression scale

Datatype

boolean

Alias
UMLS CUI [1]
C1457887
UMLS CUI [2]
C0451022
UMLS CUI [3]
C0451144
treatment with antidepressants will be allowed provided that patients have been on the medication for at least 4 weeks prior to entry into the pre-treatment assessment phase of the study.
Beschrijving

Antidepressant therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1096649
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
unwilling or unable, in the opinion of the investigator, to comply with study instructions.
Beschrijving

Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
pregnant women.
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).
Beschrijving

Disease Clinical Significance | Malignant Neoplasms | Diabetes mellitus poor control | Heart Diseases Ischemic | Cardiomyopathies | Lung diseases Serious | Kidney Diseases | Liver Dysfunction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0860161
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0475224
UMLS CUI [5]
C0878544
UMLS CUI [6,1]
C0024115
UMLS CUI [6,2]
C0205404
UMLS CUI [7]
C0022658
UMLS CUI [8]
C0086565
women with significant risk of committing suicide or harming others in the opinion of the psychiatrist.
Beschrijving

Gender | At risk for suicide | At risk of harming others

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0563664
UMLS CUI [3]
C1271966
women with a current dsm-iv-tr substance or alcohol abuse. however, patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
Beschrijving

Gender | Substance Use Disorders | Recreational substance use | Cannabinoids | Cigarette smoker

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0038586
UMLS CUI [3]
C2748205
UMLS CUI [4]
C0006864
UMLS CUI [5]
C0337667
women who suffers from depression due to physical condition.
Beschrijving

Gender | Depressive disorder Due to Physical Condition

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C3714565
women who suffers from severe major depression (madras>30)
Beschrijving

Gender | Severe major depression | Montgomery-Asberg Depression Rating Scale Questionnaire

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3472470
UMLS CUI [3]
C4054475
women who suffers from chronic depression (over 6 months)
Beschrijving

Gender | Chronic depression

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0581391
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Similar models

Eligibility Postpartum Depression NCT02191423

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Postpartum Women
Item
women of all ages who are 3 to 8 months post-partum.
boolean
C0001779 (UMLS CUI [1])
C0032804 (UMLS CUI [2])
Gender | Education Period | Minimum Complete
Item
women who have completed a minimum of 12 years of education.
boolean
C0079399 (UMLS CUI [1])
C0013621 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C1524031 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Gender | Informed Consent | Infant participation
Item
women who are willing and able to provide informed consent for their participation and after the study has been explained. infant participation will be allowed after consent has been obtained from mothers.
boolean
C0079399 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0021270 (UMLS CUI [3,1])
C0679823 (UMLS CUI [3,2])
Depression, Postpartum
Item
current dsm-iv-tr diagnosis of ppd disorder as confirmed by scid (administered as part of the study of protocol number ppd1, proposed to the helsinki committee on june 2014).
boolean
C0221074 (UMLS CUI [1])
Symptoms | Beck depression inventory | Edinburgh postnatal depression scale
Item
symptoms: bdi total score >9, epds total score >10
boolean
C1457887 (UMLS CUI [1])
C0451022 (UMLS CUI [2])
C0451144 (UMLS CUI [3])
Antidepressant therapy
Item
treatment with antidepressants will be allowed provided that patients have been on the medication for at least 4 weeks prior to entry into the pre-treatment assessment phase of the study.
boolean
C1096649 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Compliance behavior Limited
Item
unwilling or unable, in the opinion of the investigator, to comply with study instructions.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Pregnancy
Item
pregnant women.
boolean
C0032961 (UMLS CUI [1])
Disease Clinical Significance | Malignant Neoplasms | Diabetes mellitus poor control | Heart Diseases Ischemic | Cardiomyopathies | Lung diseases Serious | Kidney Diseases | Liver Dysfunction
Item
clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C0860161 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0475224 (UMLS CUI [4,2])
C0878544 (UMLS CUI [5])
C0024115 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0022658 (UMLS CUI [7])
C0086565 (UMLS CUI [8])
Gender | At risk for suicide | At risk of harming others
Item
women with significant risk of committing suicide or harming others in the opinion of the psychiatrist.
boolean
C0079399 (UMLS CUI [1])
C0563664 (UMLS CUI [2])
C1271966 (UMLS CUI [3])
Gender | Substance Use Disorders | Recreational substance use | Cannabinoids | Cigarette smoker
Item
women with a current dsm-iv-tr substance or alcohol abuse. however, patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
boolean
C0079399 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C2748205 (UMLS CUI [3])
C0006864 (UMLS CUI [4])
C0337667 (UMLS CUI [5])
Gender | Depressive disorder Due to Physical Condition
Item
women who suffers from depression due to physical condition.
boolean
C0079399 (UMLS CUI [1])
C0011581 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C3714565 (UMLS CUI [2,3])
Gender | Severe major depression | Montgomery-Asberg Depression Rating Scale Questionnaire
Item
women who suffers from severe major depression (madras>30)
boolean
C0079399 (UMLS CUI [1])
C3472470 (UMLS CUI [2])
C4054475 (UMLS CUI [3])
Gender | Chronic depression
Item
women who suffers from chronic depression (over 6 months)
boolean
C0079399 (UMLS CUI [1])
C0581391 (UMLS CUI [2])
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