ID

41024

Beschreibung

Automatic Self Transcending Meditation (ASTM) Versus Heart Rate Variability (HRV) Biofeedback in Patients With Late Life Depression (LLD): a Longitudinal Pilot Feasibility Study; ODM derived from: https://clinicaltrials.gov/show/NCT01908673

Link

https://clinicaltrials.gov/show/NCT01908673

Stichworte

Versionen (1)
  1. 14.06.20 14.06.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

14. Juni 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Late Life Depression NCT01908673

Englisch

Eligibility Late Life Depression NCT01908673

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. of either gender, age 66-80 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. have an axis 1 diagnosis of major depressive disorder (dsm iv code 296.2x or 296.3x) (comorbid anxiety and dysthymic disorder will be acceptable).
Beschreibung

Axis I diagnosis Major Depressive Disorder | Co-morbid condition Anxiety | Co-morbid condition Dysthymic Disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C1269683
UMLS CUI [2,1]
C1275743
UMLS CUI [2,2]
C0003467
UMLS CUI [3,1]
C1275743
UMLS CUI [3,2]
C0013415
3. hamd-24 score of >20.
Beschreibung

HAMD-24

Datentyp

boolean

Alias
UMLS CUI [1]
C4330187
4. low risk of suicide as elicited by clinical interview.
Beschreibung

Low suicide risk

Datentyp

boolean

Alias
UMLS CUI [1]
C1271076
5. being able to sit for 30-45 minutes, without physical pain
Beschreibung

Able to sit Duration Without Pain

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0560880
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C0030193
6. of general good physical health with no severe cardiovascular disease in the past 12 months (myocardial infarction, stroke or tia).
Beschreibung

General health good | Absence Cardiovascular Disease Severe | Myocardial Infarction Absent | Cerebrovascular accident Absent | Transient Ischemic Attack Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0007222
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0027051
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0038454
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0007787
UMLS CUI [5,2]
C0332197
7. no past history of neurological disease or seizures.
Beschreibung

Nervous system disorder Absent | Seizures Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C0332197
8. sufficient hearing to comprehend verbal instructions without the need to lip read.
Beschreibung

Hearing Sufficient | Verbal Comprehension Instructions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018767
UMLS CUI [1,2]
C0205410
UMLS CUI [2,1]
C0871570
UMLS CUI [2,2]
C1442085
9. able to attend regular outpatient follow-up appointments.
Beschreibung

Compliance Follow-up in outpatient clinic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0589125
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. incapable of giving informed consent to study participation.
Beschreibung

Informed Consent incapable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1550518
2. participating in other similar studies.
Beschreibung

Study Subject Participation Status | Clinical Trial Similar

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C2348205
3. other significant axis i diagnosis (including ptsd, ocd, panic disorder, bipolar affective disorder, substance dependence, dementia)
Beschreibung

Axis I diagnosis Other | Post-Traumatic Stress Disorder | Obsessive-Compulsive Disorder | Panic Disorder | Bipolar Disorder | Substance Dependence | Dementia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0038436
UMLS CUI [3]
C0028768
UMLS CUI [4]
C0030319
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0038580
UMLS CUI [7]
C0497327
4. psychotic episodes within the past 12 months.
Beschreibung

Psychotic episodes

Datentyp

boolean

Alias
UMLS CUI [1]
C0338614
5. recent (within the past 6 months) head trauma that required emergency care
Beschreibung

Craniocerebral Trauma Requirement Emergency Care

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018674
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1527398
6. currently on an antidepressant from the classes of tricyclic antidepressants, monoamine oxidase (mao) inhibitors, or serotonin noradrenaline reuptake inhibitors (snri) such as venlafaxine, desvenlafaxine or duloxetine.
Beschreibung

Antidepressive Agents | Tricyclic Antidepressive Agents | Monoamine Oxidase Inhibitors | Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) | venlafaxine | Desvenlafaxine | duloxetine

Datentyp

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0003290
UMLS CUI [3]
C0026457
UMLS CUI [4]
C1579361
UMLS CUI [5]
C0078569
UMLS CUI [6]
C1880288
UMLS CUI [7]
C0245561
7. currently practicing any type of formal meditation, mindfulness or breathing techniques.
Beschreibung

Meditation Therapy | Mindfulness Relaxation | Breathing control (regime/therapy)

Datentyp

boolean

Alias
UMLS CUI [1]
C0814263
UMLS CUI [2]
C2985553
UMLS CUI [3]
C0454508
8. mini mental score exam (mmse) ≤18
Beschreibung

Mini-mental state examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0451306
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Ähnliche Modelle

Eligibility Late Life Depression NCT01908673

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. of either gender, age 66-80 years.
boolean
C0001779 (UMLS CUI [1])
Axis I diagnosis Major Depressive Disorder | Co-morbid condition Anxiety | Co-morbid condition Dysthymic Disorder
Item
2. have an axis 1 diagnosis of major depressive disorder (dsm iv code 296.2x or 296.3x) (comorbid anxiety and dysthymic disorder will be acceptable).
boolean
C0270287 (UMLS CUI [1,1])
C1269683 (UMLS CUI [1,2])
C1275743 (UMLS CUI [2,1])
C0003467 (UMLS CUI [2,2])
C1275743 (UMLS CUI [3,1])
C0013415 (UMLS CUI [3,2])
HAMD-24
Item
3. hamd-24 score of >20.
boolean
C4330187 (UMLS CUI [1])
Low suicide risk
Item
4. low risk of suicide as elicited by clinical interview.
boolean
C1271076 (UMLS CUI [1])
Able to sit Duration Without Pain
Item
5. being able to sit for 30-45 minutes, without physical pain
boolean
C0560880 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,4])
General health good | Absence Cardiovascular Disease Severe | Myocardial Infarction Absent | Cerebrovascular accident Absent | Transient Ischemic Attack Absent
Item
6. of general good physical health with no severe cardiovascular disease in the past 12 months (myocardial infarction, stroke or tia).
boolean
C1277245 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0007222 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0027051 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0038454 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0007787 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Nervous system disorder Absent | Seizures Absent
Item
7. no past history of neurological disease or seizures.
boolean
C0027765 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hearing Sufficient | Verbal Comprehension Instructions
Item
8. sufficient hearing to comprehend verbal instructions without the need to lip read.
boolean
C0018767 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0871570 (UMLS CUI [2,1])
C1442085 (UMLS CUI [2,2])
Compliance Follow-up in outpatient clinic
Item
9. able to attend regular outpatient follow-up appointments.
boolean
C1321605 (UMLS CUI [1,1])
C0589125 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent incapable
Item
1. incapable of giving informed consent to study participation.
boolean
C0021430 (UMLS CUI [1,1])
C1550518 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial Similar
Item
2. participating in other similar studies.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C2348205 (UMLS CUI [2,2])
Axis I diagnosis Other | Post-Traumatic Stress Disorder | Obsessive-Compulsive Disorder | Panic Disorder | Bipolar Disorder | Substance Dependence | Dementia
Item
3. other significant axis i diagnosis (including ptsd, ocd, panic disorder, bipolar affective disorder, substance dependence, dementia)
boolean
C0270287 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0038436 (UMLS CUI [2])
C0028768 (UMLS CUI [3])
C0030319 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C0038580 (UMLS CUI [6])
C0497327 (UMLS CUI [7])
Psychotic episodes
Item
4. psychotic episodes within the past 12 months.
boolean
C0338614 (UMLS CUI [1])
Craniocerebral Trauma Requirement Emergency Care
Item
5. recent (within the past 6 months) head trauma that required emergency care
boolean
C0018674 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1527398 (UMLS CUI [1,3])
Antidepressive Agents | Tricyclic Antidepressive Agents | Monoamine Oxidase Inhibitors | Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) | venlafaxine | Desvenlafaxine | duloxetine
Item
6. currently on an antidepressant from the classes of tricyclic antidepressants, monoamine oxidase (mao) inhibitors, or serotonin noradrenaline reuptake inhibitors (snri) such as venlafaxine, desvenlafaxine or duloxetine.
boolean
C0003289 (UMLS CUI [1])
C0003290 (UMLS CUI [2])
C0026457 (UMLS CUI [3])
C1579361 (UMLS CUI [4])
C0078569 (UMLS CUI [5])
C1880288 (UMLS CUI [6])
C0245561 (UMLS CUI [7])
Meditation Therapy | Mindfulness Relaxation | Breathing control (regime/therapy)
Item
7. currently practicing any type of formal meditation, mindfulness or breathing techniques.
boolean
C0814263 (UMLS CUI [1])
C2985553 (UMLS CUI [2])
C0454508 (UMLS CUI [3])
Mini-mental state examination
Item
8. mini mental score exam (mmse) ≤18
boolean
C0451306 (UMLS CUI [1])
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