ID

39890

Description

Treatment for Depression Among HIV-Infected Youth; ODM derived from: https://clinicaltrials.gov/show/NCT01049789

Link

https://clinicaltrials.gov/show/NCT01049789

Keywords

Versions (1)
  1. 2/29/20 2/29/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 29, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility HIV NCT01049789

English

Eligibility HIV NCT01049789

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility HIV NCT01049789
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adolescents and young adults ages 16 years and 0 days to 24 years and 364 days at time of enrollment;
Description

Adolescent | Young Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0205653
UMLS CUI [2]
C0238598
UMLS CUI [3]
C0001779
engaged in care at the participating amtu;
Description

Employee Care Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0599987
UMLS CUI [1,2]
C1947933
UMLS CUI [1,3]
C0008976
documented hiv infection by medical record review or verbal verification from referring professional and aware of their hiv status;
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
primary diagnosis of non-psychotic depression, either mdd, depression nos, or dysthymia, as defined by dsm-iv criteria and as documented prior to study screening by treating licensed mental health clinician;
Description

Depressive disorder Except Psychotic depression | Major Depressive Disorder | Depression NOS | Dysthymic Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0743072
UMLS CUI [2]
C1269683
UMLS CUI [3]
C0011581
UMLS CUI [4]
C0013415
current depressive symptoms warranting intervention as determined by treating licensed mental health clinician with a score of ≥ 7 on the qids-c; note: youth already receiving treatment for depression with qids-c scores ≥ 7 are eligible but those with scores < 7, indicating who minimal ongoing depressive symptoms, are not eligible.
Description

Depressive Symptoms | Intervention Determined by Psychiatrist | QIDS-C

Data type

boolean

Alias
UMLS CUI [1]
C0086132
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0521095
UMLS CUI [2,3]
C0033872
UMLS CUI [3]
C4331196
ability to understand written and spoken english; and
Description

Comprehension English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
ability and willingness to provide informed consent or assent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or self-reported by participant to have a history of any psychotic disorder (including depression with psychotic features) and/or bipolar i or ii disorder;
Description

Psychotic Disorders | Depression, psychotic | Bipolar I disorder | Bipolar II disorder

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0743072
UMLS CUI [3]
C0853193
UMLS CUI [4]
C0236788
alcohol or substance dependence based on dsm-iv criteria within the past six months as determined by treating licensed mental health clinician. any cases that are uncertain require protocol team approval;
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
pregnant or breast-feeding females;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known or self-reported by participant (or parent if available) to have a first degree relative(s) with bipolar i disorder;
Description

First Degree Relative Bipolar I disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C1517194
UMLS CUI [1,2]
C0853193
depression and/or suicidal ideation requiring more intensive treatment than the study provides or at immediate risk of being a danger to themselves or others as determined by treating licensed mental health clinician;
Description

Depressive disorder | Feeling suicidal | At risk Self-harm | Risk of violence or harm to others

Data type

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0424000
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0424366
UMLS CUI [4]
C0549013
cognitive limitations, emotional instability or medical illness as determined by treating licensed mental health clinician and/or study coordinator; and
Description

Impaired cognition | Mood swings | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0338656
UMLS CUI [2]
C0085633
UMLS CUI [3]
C0004936
for phase ii only, previous participation in phase i.
Description

Study Subject Participation Status | Trial Phase Participation Previous

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1710475
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0205156
for participants at comb sites only, ongoing cbt for treatment of depressive symptoms at time of study enrollment (e.g., teaching cognitive restructuring using role-play, identification of cognitive distortions, automatic thoughts, dysfunctional attitudes); and note: youth who received cbt in the past may be considered for enrollment. any cases that are uncertain require protocol team approval.
Description

Cognitive Therapy Depressive Symptoms | Role playing therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009244
UMLS CUI [1,2]
C0086132
UMLS CUI [2]
C0035822
for participants at comb sites only, continuing antidepressant management by a site clinician who is not trained in comb.
Description

Antidepressant therapy Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility HIV NCT01049789

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility HIV NCT01049789
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adolescent | Young Adult | Age
Item
adolescents and young adults ages 16 years and 0 days to 24 years and 364 days at time of enrollment;
boolean
C0205653 (UMLS CUI [1])
C0238598 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Employee Care Clinical Trial
Item
engaged in care at the participating amtu;
boolean
C0599987 (UMLS CUI [1,1])
C1947933 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
HIV Infection
Item
documented hiv infection by medical record review or verbal verification from referring professional and aware of their hiv status;
boolean
C0019693 (UMLS CUI [1])
Depressive disorder Except Psychotic depression | Major Depressive Disorder | Depression NOS | Dysthymic Disorder
Item
primary diagnosis of non-psychotic depression, either mdd, depression nos, or dysthymia, as defined by dsm-iv criteria and as documented prior to study screening by treating licensed mental health clinician;
boolean
C0011581 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0743072 (UMLS CUI [1,3])
C1269683 (UMLS CUI [2])
C0011581 (UMLS CUI [3])
C0013415 (UMLS CUI [4])
Depressive Symptoms | Intervention Determined by Psychiatrist | QIDS-C
Item
current depressive symptoms warranting intervention as determined by treating licensed mental health clinician with a score of ≥ 7 on the qids-c; note: youth already receiving treatment for depression with qids-c scores ≥ 7 are eligible but those with scores < 7, indicating who minimal ongoing depressive symptoms, are not eligible.
boolean
C0086132 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C0521095 (UMLS CUI [2,2])
C0033872 (UMLS CUI [2,3])
C4331196 (UMLS CUI [3])
Comprehension English Language
Item
ability to understand written and spoken english; and
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Informed Consent
Item
ability and willingness to provide informed consent or assent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Psychotic Disorders | Depression, psychotic | Bipolar I disorder | Bipolar II disorder
Item
known or self-reported by participant to have a history of any psychotic disorder (including depression with psychotic features) and/or bipolar i or ii disorder;
boolean
C0033975 (UMLS CUI [1])
C0743072 (UMLS CUI [2])
C0853193 (UMLS CUI [3])
C0236788 (UMLS CUI [4])
Substance Dependence
Item
alcohol or substance dependence based on dsm-iv criteria within the past six months as determined by treating licensed mental health clinician. any cases that are uncertain require protocol team approval;
boolean
C0038580 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding females;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
First Degree Relative Bipolar I disorder
Item
known or self-reported by participant (or parent if available) to have a first degree relative(s) with bipolar i disorder;
boolean
C1517194 (UMLS CUI [1,1])
C0853193 (UMLS CUI [1,2])
Depressive disorder | Feeling suicidal | At risk Self-harm | Risk of violence or harm to others
Item
depression and/or suicidal ideation requiring more intensive treatment than the study provides or at immediate risk of being a danger to themselves or others as determined by treating licensed mental health clinician;
boolean
C0011581 (UMLS CUI [1])
C0424000 (UMLS CUI [2])
C1444641 (UMLS CUI [3,1])
C0424366 (UMLS CUI [3,2])
C0549013 (UMLS CUI [4])
Impaired cognition | Mood swings | Mental disorders
Item
cognitive limitations, emotional instability or medical illness as determined by treating licensed mental health clinician and/or study coordinator; and
boolean
C0338656 (UMLS CUI [1])
C0085633 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Study Subject Participation Status | Trial Phase Participation Previous
Item
for phase ii only, previous participation in phase i.
boolean
C2348568 (UMLS CUI [1])
C1710475 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
Cognitive Therapy Depressive Symptoms | Role playing therapy
Item
for participants at comb sites only, ongoing cbt for treatment of depressive symptoms at time of study enrollment (e.g., teaching cognitive restructuring using role-play, identification of cognitive distortions, automatic thoughts, dysfunctional attitudes); and note: youth who received cbt in the past may be considered for enrollment. any cases that are uncertain require protocol team approval.
boolean
C0009244 (UMLS CUI [1,1])
C0086132 (UMLS CUI [1,2])
C0035822 (UMLS CUI [2])
Antidepressant therapy Other
Item
for participants at comb sites only, continuing antidepressant management by a site clinician who is not trained in comb.
boolean
C1096649 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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