ID

36349

Description

The Neurobiology of Approach Avoidance Training in Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02330744

Link

https://clinicaltrials.gov/show/NCT02330744

Keywords

  1. 5/5/19 5/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 5, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT02330744

Eligibility Major Depressive Disorder NCT02330744

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ages 18-55
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
principal psychiatric diagnosis of major depressive disorder
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
patient health questionnaire - 9 item score ≥ 10
Description

Patient Health Questionnaire - 9 Item

Data type

boolean

Alias
UMLS CUI [1]
C4083201
ability to read and speak english sufficiently to complete study procedures
Description

Able to read English Language | Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of psychosis, mania, or substance dependence
Description

Psychotic Disorders | Mania | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0338831
UMLS CUI [3]
C0038580
current severe medical disorder that requires inpatient treatment or frequent medical follow ups including but not limited to: unstable hypertension, unstable angina, unstable diabetes mellitus, unstable cardiac arrhythmias, transient ischemic attacks, sever coronary artery disease, sever peripheral vascular disease, severe hepato-gastro-intestinal disease, severe infectious disease (e.g. hiv), recurrent severe headache or migraine, fainting spells, seizures, and history of traumatic brain injury with loss of consciousness > 30 minutes
Description

Disease Severe | Hypertensive disease Unstable | Angina, Unstable | Unstable diabetes mellitus | Cardiac Arrhythmia Unstable | Transient Ischemic Attack | Coronary Artery Disease Severe | Peripheral Vascular Disease Severe | Liver disease Severe | Gastrointestinal Disease Severe | Communicable Disease Severe | HIV Infection | Severe headache Recurrent | Migraine Disorders Severe Recurrent | Syncope | Seizures | Traumatic Brain Injury | Unconscious State Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0342302
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0443343
UMLS CUI [6]
C0007787
UMLS CUI [7,1]
C1956346
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0085096
UMLS CUI [8,2]
C0205082
UMLS CUI [9,1]
C0023895
UMLS CUI [9,2]
C0205082
UMLS CUI [10,1]
C0017178
UMLS CUI [10,2]
C0205082
UMLS CUI [11,1]
C0009450
UMLS CUI [11,2]
C0205082
UMLS CUI [12]
C0019693
UMLS CUI [13,1]
C2957106
UMLS CUI [13,2]
C2945760
UMLS CUI [14,1]
C0149931
UMLS CUI [14,2]
C0205082
UMLS CUI [14,3]
C2945760
UMLS CUI [15]
C0039070
UMLS CUI [16]
C0036572
UMLS CUI [17]
C0876926
UMLS CUI [18,1]
C0041657
UMLS CUI [18,2]
C0449238
current use of the following medications: antidepressants, benxodiazepines, antipsychotics, mood stabilizers, or other drugs that can acutely affect the hemodynamic response (methylphenidate and acetazolamide)
Description

Antidepressive Agents | Benzodiazepines | Antipsychotic Agents | Mood Stabilizers | Pharmaceutical Preparations Affecting Hemodynamics | Methylphenidate | Acetazolamide

Data type

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0005064
UMLS CUI [3]
C0040615
UMLS CUI [4]
C4020582
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0019010
UMLS CUI [6]
C0025810
UMLS CUI [7]
C0000981
caffeine intake > 10 cups/day or recent significant changes in consumption
Description

Caffeine intake cups/day | Change Caffeine consumption

Data type

boolean

Alias
UMLS CUI [1,1]
C4062719
UMLS CUI [1,2]
C0560654
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0948365
mri exclusions, including claustrophobia, cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (tens unit), persons who have ever been a metal worker/welder, history of eye surgery/eyes washed out because of metal, women who are or may be pregnant (determined by a positive pregnancy test), women using an intrauterine device, vision problems uncorrectable with lenses, inability to lie still on one's back for 60 minutes; prior neurosurgery; older tattoos with metal dyes; unwillingness to remove nose, ear, tongue or face rings.
Description

MRI Exclusion | Claustrophobia | Artificial cardiac pacemaker | Metal foreign body in eye region | Metal splinters in skin | Metallic foreign body Human body | Shrapnel Human body | Clip Aortic | Aneurysm clip | Prosthesis | Bypass surgery Clip | Coronary artery clip | Hearing Aid | Prosthetic replacement of heart valve | Shunt ventricular | Shunt spinal | Electrode | Metal plates | Pins metallic | Screw | Wire | Neurostimulator | Tens unit electrodes | Metal worker | Welder | Ophthalmologic Surgical Procedures | Pregnancy | Pregnancy test positive | Intrauterine Device | Abnormal vision | Contact Lenses Unsuccessful | Lacking Able to lie down Quiet Duration | Neurosurgical Procedures | Tattoo dye Metallic | Removal of nose ring Unwilling | Ear ring Removal Unwilling | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C2828389
UMLS CUI [2]
C0008909
UMLS CUI [3]
C0030163
UMLS CUI [4]
C0562528
UMLS CUI [5]
C2229035
UMLS CUI [6,1]
C1720389
UMLS CUI [6,2]
C1318419
UMLS CUI [7,1]
C0522670
UMLS CUI [7,2]
C1318419
UMLS CUI [8,1]
C0175722
UMLS CUI [8,2]
C0003483
UMLS CUI [9]
C0179977
UMLS CUI [10]
C0175649
UMLS CUI [11,1]
C1536078
UMLS CUI [11,2]
C0175722
UMLS CUI [12]
C4510021
UMLS CUI [13]
C0018768
UMLS CUI [14]
C0190163
UMLS CUI [15,1]
C0542331
UMLS CUI [15,2]
C0018827
UMLS CUI [16,1]
C0542331
UMLS CUI [16,2]
C0521329
UMLS CUI [17]
C0013812
UMLS CUI [18]
C0013866
UMLS CUI [19,1]
C0175718
UMLS CUI [19,2]
C2986473
UMLS CUI [20]
C0301559
UMLS CUI [21]
C4522306
UMLS CUI [22]
C0582124
UMLS CUI [23]
C1967354
UMLS CUI [24]
C0402937
UMLS CUI [25]
C0336106
UMLS CUI [26]
C0038901
UMLS CUI [27]
C0032961
UMLS CUI [28]
C0240802
UMLS CUI [29]
C0021900
UMLS CUI [30]
C3665386
UMLS CUI [31,1]
C0009836
UMLS CUI [31,2]
C1272705
UMLS CUI [32,1]
C0332268
UMLS CUI [32,2]
C0560841
UMLS CUI [32,3]
C0439654
UMLS CUI [32,4]
C0449238
UMLS CUI [33]
C0524850
UMLS CUI [34,1]
C0303923
UMLS CUI [34,2]
C2986473
UMLS CUI [35,1]
C3686653
UMLS CUI [35,2]
C0558080
UMLS CUI [36,1]
C0563223
UMLS CUI [36,2]
C0015252
UMLS CUI [36,3]
C0558080
UMLS CUI [37]
C3846158
concurrent psychosocial treatment: participants completing ongoing psychosocial treatment will be required to meet a 12-week stability criteria so that symptom changes as a result of other psychosocial treatments are not confounded with changes due to the research.
Description

Psychosocial care | Stability criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1]
C2958078
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C1550543
inability to complete the initial assessment battery or behavioral training sessions.
Description

Assessment initial Completion Unable | Behavior Training Completion Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0150637
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0004927
UMLS CUI [2,2]
C0220931
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C1299582
clinical conditions assessed by the interviewer that necessitate more imminent clinical care (e.g., active suicidal ideation). these criteria are in place so participants with these other, more several symptoms can be referred for appropriate mental health services.
Description

Feeling suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0424000

Similar models

Eligibility Major Depressive Disorder NCT02330744

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
ages 18-55
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
principal psychiatric diagnosis of major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Patient Health Questionnaire - 9 Item
Item
patient health questionnaire - 9 item score ≥ 10
boolean
C4083201 (UMLS CUI [1])
Able to read English Language | Able to speak English Language
Item
ability to read and speak english sufficiently to complete study procedures
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Psychotic Disorders | Mania | Substance Dependence
Item
history of psychosis, mania, or substance dependence
boolean
C0033975 (UMLS CUI [1])
C0338831 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
Disease Severe | Hypertensive disease Unstable | Angina, Unstable | Unstable diabetes mellitus | Cardiac Arrhythmia Unstable | Transient Ischemic Attack | Coronary Artery Disease Severe | Peripheral Vascular Disease Severe | Liver disease Severe | Gastrointestinal Disease Severe | Communicable Disease Severe | HIV Infection | Severe headache Recurrent | Migraine Disorders Severe Recurrent | Syncope | Seizures | Traumatic Brain Injury | Unconscious State Duration
Item
current severe medical disorder that requires inpatient treatment or frequent medical follow ups including but not limited to: unstable hypertension, unstable angina, unstable diabetes mellitus, unstable cardiac arrhythmias, transient ischemic attacks, sever coronary artery disease, sever peripheral vascular disease, severe hepato-gastro-intestinal disease, severe infectious disease (e.g. hiv), recurrent severe headache or migraine, fainting spells, seizures, and history of traumatic brain injury with loss of consciousness > 30 minutes
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0342302 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0007787 (UMLS CUI [6])
C1956346 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0085096 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0023895 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0017178 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0009450 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C0019693 (UMLS CUI [12])
C2957106 (UMLS CUI [13,1])
C2945760 (UMLS CUI [13,2])
C0149931 (UMLS CUI [14,1])
C0205082 (UMLS CUI [14,2])
C2945760 (UMLS CUI [14,3])
C0039070 (UMLS CUI [15])
C0036572 (UMLS CUI [16])
C0876926 (UMLS CUI [17])
C0041657 (UMLS CUI [18,1])
C0449238 (UMLS CUI [18,2])
Antidepressive Agents | Benzodiazepines | Antipsychotic Agents | Mood Stabilizers | Pharmaceutical Preparations Affecting Hemodynamics | Methylphenidate | Acetazolamide
Item
current use of the following medications: antidepressants, benxodiazepines, antipsychotics, mood stabilizers, or other drugs that can acutely affect the hemodynamic response (methylphenidate and acetazolamide)
boolean
C0003289 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
C0040615 (UMLS CUI [3])
C4020582 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0019010 (UMLS CUI [5,3])
C0025810 (UMLS CUI [6])
C0000981 (UMLS CUI [7])
Caffeine intake cups/day | Change Caffeine consumption
Item
caffeine intake > 10 cups/day or recent significant changes in consumption
boolean
C4062719 (UMLS CUI [1,1])
C0560654 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C0948365 (UMLS CUI [2,2])
MRI Exclusion | Claustrophobia | Artificial cardiac pacemaker | Metal foreign body in eye region | Metal splinters in skin | Metallic foreign body Human body | Shrapnel Human body | Clip Aortic | Aneurysm clip | Prosthesis | Bypass surgery Clip | Coronary artery clip | Hearing Aid | Prosthetic replacement of heart valve | Shunt ventricular | Shunt spinal | Electrode | Metal plates | Pins metallic | Screw | Wire | Neurostimulator | Tens unit electrodes | Metal worker | Welder | Ophthalmologic Surgical Procedures | Pregnancy | Pregnancy test positive | Intrauterine Device | Abnormal vision | Contact Lenses Unsuccessful | Lacking Able to lie down Quiet Duration | Neurosurgical Procedures | Tattoo dye Metallic | Removal of nose ring Unwilling | Ear ring Removal Unwilling | Other Coding
Item
mri exclusions, including claustrophobia, cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (tens unit), persons who have ever been a metal worker/welder, history of eye surgery/eyes washed out because of metal, women who are or may be pregnant (determined by a positive pregnancy test), women using an intrauterine device, vision problems uncorrectable with lenses, inability to lie still on one's back for 60 minutes; prior neurosurgery; older tattoos with metal dyes; unwillingness to remove nose, ear, tongue or face rings.
boolean
C0024485 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2])
C0030163 (UMLS CUI [3])
C0562528 (UMLS CUI [4])
C2229035 (UMLS CUI [5])
C1720389 (UMLS CUI [6,1])
C1318419 (UMLS CUI [6,2])
C0522670 (UMLS CUI [7,1])
C1318419 (UMLS CUI [7,2])
C0175722 (UMLS CUI [8,1])
C0003483 (UMLS CUI [8,2])
C0179977 (UMLS CUI [9])
C0175649 (UMLS CUI [10])
C1536078 (UMLS CUI [11,1])
C0175722 (UMLS CUI [11,2])
C4510021 (UMLS CUI [12])
C0018768 (UMLS CUI [13])
C0190163 (UMLS CUI [14])
C0542331 (UMLS CUI [15,1])
C0018827 (UMLS CUI [15,2])
C0542331 (UMLS CUI [16,1])
C0521329 (UMLS CUI [16,2])
C0013812 (UMLS CUI [17])
C0013866 (UMLS CUI [18])
C0175718 (UMLS CUI [19,1])
C2986473 (UMLS CUI [19,2])
C0301559 (UMLS CUI [20])
C4522306 (UMLS CUI [21])
C0582124 (UMLS CUI [22])
C1967354 (UMLS CUI [23])
C0402937 (UMLS CUI [24])
C0336106 (UMLS CUI [25])
C0038901 (UMLS CUI [26])
C0032961 (UMLS CUI [27])
C0240802 (UMLS CUI [28])
C0021900 (UMLS CUI [29])
C3665386 (UMLS CUI [30])
C0009836 (UMLS CUI [31,1])
C1272705 (UMLS CUI [31,2])
C0332268 (UMLS CUI [32,1])
C0560841 (UMLS CUI [32,2])
C0439654 (UMLS CUI [32,3])
C0449238 (UMLS CUI [32,4])
C0524850 (UMLS CUI [33])
C0303923 (UMLS CUI [34,1])
C2986473 (UMLS CUI [34,2])
C3686653 (UMLS CUI [35,1])
C0558080 (UMLS CUI [35,2])
C0563223 (UMLS CUI [36,1])
C0015252 (UMLS CUI [36,2])
C0558080 (UMLS CUI [36,3])
C3846158 (UMLS CUI [37])
Psychosocial care | Stability criteria Fulfill
Item
concurrent psychosocial treatment: participants completing ongoing psychosocial treatment will be required to meet a 12-week stability criteria so that symptom changes as a result of other psychosocial treatments are not confounded with changes due to the research.
boolean
C2958078 (UMLS CUI [1])
C0205360 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Assessment initial Completion Unable | Behavior Training Completion Unable
Item
inability to complete the initial assessment battery or behavioral training sessions.
boolean
C0150637 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0004927 (UMLS CUI [2,1])
C0220931 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
Feeling suicidal
Item
clinical conditions assessed by the interviewer that necessitate more imminent clinical care (e.g., active suicidal ideation). these criteria are in place so participants with these other, more several symptoms can be referred for appropriate mental health services.
boolean
C0424000 (UMLS CUI [1])

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