ID

23069

Beschreibung

<Responsible Party: Christian Schmahl, Prof. Dr. med. Christian Schmahl, Central Institute of Mental Health, Mannheim ClinicalTrials.gov Identifier: NCT02866110 History of Changes Other Study ID Numbers: KFO_IP5 DRKS00009363 ( Registry Identifier: German Clinical Trials Register, DRKS ) Study First Received: July 28, 2016 Last Updated: October 20, 2016 Individual Participant Data Plan to Share IPD: Yes Plan Description: Pseudonymized data will be shared with projects from the BrainTrain-network, http://www.braintrainproject.eu Training of Neural Responding in BPD (IP5n) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02866110

Link

http://www.braintrainproject.eu

Stichworte

Versionen (1)
  1. 21.06.17 21.06.17 -
Hochgeladen am

21. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Neural Responding Training in BPD DRKS00009363 NCT02866110 DRKS00009363

Englisch

Eligibility Neural Responding Training in BPD NCT02866110 DRKS00009363

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Ages Eligible for Study: 18 Years to 45 Years (Adults)
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Sexes Eligible for Study: Female
Beschreibung

Sex

Datentyp

boolean

Current BPD (≥ 5 DSM‐V criteria)
Beschreibung

Borderline Personality Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0006012
Informed consent for study participation
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Beschreibung

Control Group

Datentyp

boolean

Alias
UMLS CUI [1]
C0009932
Psychotropic medication 2 weeks before start (SSRIs excluded)
Beschreibung

Psychotropic medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0033978
Lifetime diagnosis of schizophrenia or bipolar I
Beschreibung

Schizophrenia or bipolar I

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0853193
Substance dependence in the preceding year
Beschreibung

Previous Substance Use Disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0038586
Current substance use
Beschreibung

Substance Use Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
Pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
Epilepsy
Beschreibung

Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
Antecedent cranial or brain injuries
Beschreibung

Brain injuries

Datentyp

boolean

Alias
UMLS CUI [1]
C0270611
Organic brain diseases
Beschreibung

Organic brain diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C1385010
Severe medical or neurological condition
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
BMI<16.5
Beschreibung

BMI

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Metallic non-removable items in or on the body which are not MR compatible,
Beschreibung

Presence of metallic device / implant

Datentyp

boolean

Alias
UMLS CUI [1]
C3693688
Permanent make-up
Beschreibung

Permanent make-up

Datentyp

boolean

Alias
UMLS CUI [1]
C3267045
Claustrophobia, left-handedness
Beschreibung

Claustrophobia, left-handedness

Datentyp

text

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2]
C0234418
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Ähnliche Modelle

Eligibility Neural Responding Training in BPD NCT02866110 DRKS00009363

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Ages Eligible for Study: 18 Years to 45 Years (Adults)
boolean
C0001779 (UMLS CUI [1])
Sex
Item
Sexes Eligible for Study: Female
boolean
Borderline Personality Disorder
Item
Current BPD (≥ 5 DSM‐V criteria)
boolean
C0006012 (UMLS CUI [1])
Informed Consent
Item
Informed consent for study participation
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Psychotropic medication
Item
Psychotropic medication 2 weeks before start (SSRIs excluded)
boolean
C0033978 (UMLS CUI [1])
Schizophrenia or bipolar I
Item
Lifetime diagnosis of schizophrenia or bipolar I
boolean
C0036341 (UMLS CUI [1])
C0853193 (UMLS CUI [2])
Previous Substance Use Disorder
Item
Substance dependence in the preceding year
boolean
C0205156 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
Substance Use Disorder
Item
Current substance use
boolean
C0038586 (UMLS CUI [1])
Pregnancy
Item
Pregnancy
boolean
C0032961 (UMLS CUI [1])
Epilepsy
Item
Epilepsy
boolean
C0014544 (UMLS CUI [1])
Brain injuries
Item
Antecedent cranial or brain injuries
boolean
C0270611 (UMLS CUI [1])
Organic brain diseases
Item
Organic brain diseases
boolean
C1385010 (UMLS CUI [1])
Comorbidity
Item
Severe medical or neurological condition
boolean
C0009488 (UMLS CUI [1])
BMI
Item
BMI<16.5
boolean
C1305855 (UMLS CUI [1])
Presence of metallic device / implant
Item
Metallic non-removable items in or on the body which are not MR compatible,
boolean
C3693688 (UMLS CUI [1])
Permanent make-up
Item
Permanent make-up
boolean
C3267045 (UMLS CUI [1])
Claustrophobia, left-handedness
Item
Claustrophobia, left-handedness
text
C0008909 (UMLS CUI [1])
C0234418 (UMLS CUI [2])
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