ID

28884

Description

Pilot Study of a Self-help Intervention for Depression in Patients With a Chronic Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00854984

Link

https://clinicaltrials.gov/show/NCT00854984

Keywords

Versions (1)
  1. 2/10/18 2/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT00854984

English

Eligibility Depression NCT00854984

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00854984
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Coronary heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0010068
be aged 35 or over.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
be attending a participating primary care practice.
Description

Visit Primary Care Physicians' Office participating

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0033137
UMLS CUI [1,3]
C0031834
UMLS CUI [1,4]
C0679823
have a depression severity scale rating indicating moderate to moderately severe depression, such as:prime-md-phq9 of 10-21; hads-d of 8-15;bdi-2 of 23-44
Description

Moderate depression | Severe depression Moderately | Patient Health Questionnaire - 9 Item | Hospital Anxiety and Depression Scale Questionnaire | Beck depression inventory

Data type

boolean

Alias
UMLS CUI [1]
C0588007
UMLS CUI [2,1]
C0588008
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C4083201
UMLS CUI [4]
C3539657
UMLS CUI [5]
C0451022
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to provide informed consent to participate
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
already receiving psychological treatment for their depression
Description

Psychological therapy Depressive disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0841584
UMLS CUI [1,2]
C0011581
have commenced treatment with an ssri within the past 8 weeks
Description

SSRI

Data type

boolean

Alias
UMLS CUI [1]
C0360105
likely to have difficulty communicating by telephone
Description

Difficulty communicating Telephone

Data type

boolean

Alias
UMLS CUI [1,1]
C0566003
UMLS CUI [1,2]
C0039457
likely to have difficulty completing the forms and questionnaires
Description

Forms Completion Difficulty | Questionnaires Completion Difficulty

Data type

boolean

Alias
UMLS CUI [1,1]
C0871508
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0332218
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0332218
have a serious physical disorder
Description

Physical disorder Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0683323
UMLS CUI [1,2]
C0205404
have a serious mental disorder
Description

Mental disorder Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205404
express significant suicidal thoughts (phq9 or bdi-2 question 9 scoring >1)
Description

Feeling suicidal | Patient Health Questionnaire - 9 Item | Beck depression inventory

Data type

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C4083201
UMLS CUI [3]
C0451022
took part in an earlier related focus group
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Depression NCT00854984

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00854984
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Coronary heart disease
Item
have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease.
boolean
C0011860 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
Age
Item
be aged 35 or over.
boolean
C0001779 (UMLS CUI [1])
Visit Primary Care Physicians' Office participating
Item
be attending a participating primary care practice.
boolean
C0545082 (UMLS CUI [1,1])
C0033137 (UMLS CUI [1,2])
C0031834 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,4])
Moderate depression | Severe depression Moderately | Patient Health Questionnaire - 9 Item | Hospital Anxiety and Depression Scale Questionnaire | Beck depression inventory
Item
have a depression severity scale rating indicating moderate to moderately severe depression, such as:prime-md-phq9 of 10-21; hads-d of 8-15;bdi-2 of 23-44
boolean
C0588007 (UMLS CUI [1])
C0588008 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C4083201 (UMLS CUI [3])
C3539657 (UMLS CUI [4])
C0451022 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
unable to provide informed consent to participate
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Psychological therapy Depressive disorder
Item
already receiving psychological treatment for their depression
boolean
C0841584 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
SSRI
Item
have commenced treatment with an ssri within the past 8 weeks
boolean
C0360105 (UMLS CUI [1])
Difficulty communicating Telephone
Item
likely to have difficulty communicating by telephone
boolean
C0566003 (UMLS CUI [1,1])
C0039457 (UMLS CUI [1,2])
Forms Completion Difficulty | Questionnaires Completion Difficulty
Item
likely to have difficulty completing the forms and questionnaires
boolean
C0871508 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Physical disorder Serious
Item
have a serious physical disorder
boolean
C0683323 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Mental disorder Serious
Item
have a serious mental disorder
boolean
C0004936 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Feeling suicidal | Patient Health Questionnaire - 9 Item | Beck depression inventory
Item
express significant suicidal thoughts (phq9 or bdi-2 question 9 scoring >1)
boolean
C0424000 (UMLS CUI [1])
C4083201 (UMLS CUI [2])
C0451022 (UMLS CUI [3])
Study Subject Participation Status
Item
took part in an earlier related focus group
boolean
C2348568 (UMLS CUI [1])
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