ID

35699

Description

The Efficacy of a Depression Intervention for Adolescents With Depression and Sleep Disturbances; ODM derived from: https://clinicaltrials.gov/show/NCT02429674

Link

https://clinicaltrials.gov/show/NCT02429674

Keywords

Versions (1)
  1. 3/16/19 3/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT02429674

English

Eligibility Depression NCT02429674

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02429674
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatient participant
Description

Outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
parent or legally authorized representative must provide consent and assent by the participant
Description

Informed Consent Parent | Informed Consent Patient Representative | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
UMLS CUI [3]
C0021430
diagnostic and statistical manual of mental disorders fifth edition (dsm-v) criteria for a depressive disorder
Description

Depressive disorder

Data type

boolean

Alias
UMLS CUI [1]
C0011581
clinical global assessment scale (c-gas) < 65
Description

Clinical Global assessment Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0281858
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0349674
quick inventory of depression symptoms - self report 16 (qids-sr16) over 8 and less than 24.
Description

QIDS-SR

Data type

boolean

Alias
UMLS CUI [1]
C4331197
english speaking
Description

Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
significant sleep complaints
Description

Sleep complaints

Data type

boolean

Alias
UMLS CUI [1,1]
C0037313
UMLS CUI [1,2]
C0277786
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-morbid psychiatric diagnosis of bipolar disorder, psychosis, autism spectrum disorder, intellectual development disorder, conduct disorder or substance abuse disorder
Description

Psychiatric Diagnosis Co-morbid | Bipolar Disorder | Psychotic Disorders | Autism Spectrum Disorders | Intellectual Disability | Conduct Disorder | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0376338
UMLS CUI [1,2]
C1275743
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0033975
UMLS CUI [4]
C1510586
UMLS CUI [5]
C3714756
UMLS CUI [6]
C0149654
UMLS CUI [7]
C0038586
any condition or illness such as uncontrolled seizure disorder, uncontrolled diabetes, or any other conditions that represent as an inappropriate risk to the participant and/or could confound the interpretation of the study
Description

Condition Study Subject Participation Status At risk | Illness Study Subject Participation Status At risk | Condition Interferes with Interpretation Clinical Trial | Illness Interferes with Interpretation Clinical Trial | Epilepsy Uncontrolled | Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0008976
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0459471
UMLS CUI [4,4]
C0008976
UMLS CUI [5,1]
C0014544
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0421258
currently in active evidence-based psychotherapy for the same condition
Description

Psychotherapy Evidence based Condition Same

Data type

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C1740791
UMLS CUI [1,3]
C0348080
UMLS CUI [1,4]
C0445247
currently taking medication for a psychiatric diagnosis that is not a stable dose.
Description

Pharmaceutical Preparations Dose Unstable Psychiatric Diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443343
UMLS CUI [1,4]
C0376338
currently considered at risk for suicide in the opinion of the study doctor, has made a suicide attempt in the past 4 months, or is currently reporting active suicidal ideation.
Description

At risk for suicide | Suicide attempt | Feeling suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C0038663
UMLS CUI [3]
C0424000
history of alcohol or other substance abuse as defined by dsm-v within the last 6 months.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep
Description

Sleep Apnea Syndromes | Restless Legs Syndrome | Periodic limb movement sleep disorder

Data type

boolean

Alias
UMLS CUI [1]
C0037315
UMLS CUI [2]
C0035258
UMLS CUI [3]
C1561887
sleep treatment that might confound the interpretation of sleep outcomes.
Description

Sleep treatment Interferes with Sleep Outcome

Data type

boolean

Alias
UMLS CUI [1,1]
C0871378
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0037313
UMLS CUI [1,4]
C1274040
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Similar models

Eligibility Depression NCT02429674

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02429674
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients
Item
outpatient participant
boolean
C0029921 (UMLS CUI [1])
Informed Consent Parent | Informed Consent Patient Representative | Informed Consent
Item
parent or legally authorized representative must provide consent and assent by the participant
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
Depressive disorder
Item
diagnostic and statistical manual of mental disorders fifth edition (dsm-v) criteria for a depressive disorder
boolean
C0011581 (UMLS CUI [1])
Clinical Global assessment Scale
Item
clinical global assessment scale (c-gas) < 65
boolean
C0281858 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0349674 (UMLS CUI [1,3])
QIDS-SR
Item
quick inventory of depression symptoms - self report 16 (qids-sr16) over 8 and less than 24.
boolean
C4331197 (UMLS CUI [1])
Able to speak English Language
Item
english speaking
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Sleep complaints
Item
significant sleep complaints
boolean
C0037313 (UMLS CUI [1,1])
C0277786 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Psychiatric Diagnosis Co-morbid | Bipolar Disorder | Psychotic Disorders | Autism Spectrum Disorders | Intellectual Disability | Conduct Disorder | Substance Use Disorders
Item
co-morbid psychiatric diagnosis of bipolar disorder, psychosis, autism spectrum disorder, intellectual development disorder, conduct disorder or substance abuse disorder
boolean
C0376338 (UMLS CUI [1,1])
C1275743 (UMLS CUI [1,2])
C0005586 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C1510586 (UMLS CUI [4])
C3714756 (UMLS CUI [5])
C0149654 (UMLS CUI [6])
C0038586 (UMLS CUI [7])
Condition Study Subject Participation Status At risk | Illness Study Subject Participation Status At risk | Condition Interferes with Interpretation Clinical Trial | Illness Interferes with Interpretation Clinical Trial | Epilepsy Uncontrolled | Diabetic - poor control
Item
any condition or illness such as uncontrolled seizure disorder, uncontrolled diabetes, or any other conditions that represent as an inappropriate risk to the participant and/or could confound the interpretation of the study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0008976 (UMLS CUI [3,4])
C0221423 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0008976 (UMLS CUI [4,4])
C0014544 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0421258 (UMLS CUI [6])
Psychotherapy Evidence based Condition Same
Item
currently in active evidence-based psychotherapy for the same condition
boolean
C0033968 (UMLS CUI [1,1])
C1740791 (UMLS CUI [1,2])
C0348080 (UMLS CUI [1,3])
C0445247 (UMLS CUI [1,4])
Pharmaceutical Preparations Dose Unstable Psychiatric Diagnosis
Item
currently taking medication for a psychiatric diagnosis that is not a stable dose.
boolean
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0376338 (UMLS CUI [1,4])
At risk for suicide | Suicide attempt | Feeling suicidal
Item
currently considered at risk for suicide in the opinion of the study doctor, has made a suicide attempt in the past 4 months, or is currently reporting active suicidal ideation.
boolean
C0563664 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
C0424000 (UMLS CUI [3])
Substance Use Disorders
Item
history of alcohol or other substance abuse as defined by dsm-v within the last 6 months.
boolean
C0038586 (UMLS CUI [1])
Sleep Apnea Syndromes | Restless Legs Syndrome | Periodic limb movement sleep disorder
Item
evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep
boolean
C0037315 (UMLS CUI [1])
C0035258 (UMLS CUI [2])
C1561887 (UMLS CUI [3])
Sleep treatment Interferes with Sleep Outcome
Item
sleep treatment that might confound the interpretation of sleep outcomes.
boolean
C0871378 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
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