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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Inclusion-Exclusion Criteria for BA Treatment

290 Shared Subjects

N/A
Clinical Assessments
Enrollment
10/26/2017
ieba01
07/11/2023
View Change History
01
Definition
Submission Template
Query Element Name Data Type Size Required Description Value Range Notes Aliases
subjectkey GUID Required The NDAR Global Unique Identifier (GUID) for research subject NDAR* guid
src_subject_id String 20 Required Subject ID how it's defined in lab/project subjid
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
interview_age Integer Required Age in months at the time of the interview/test/sampling/imaging. 0::1440 Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
Query eligibility Integer Required Did subject meet assessment requirements for inclusion in the study? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query inclusion_1 Integer Required Did the subject provide a written signed informed consent form/forms (IRB/IEC specific) prior to the initiation of any protocol required procedures and is willing to be video and/or audio recorded during clinical structured interviews and weekly therapy sessions? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query inclusion_2 Integer Required Is the subject a male or female between the ages of 18-50 inclusive and are treatment seeking? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query inclusion_3 Integer Required Does the subject have an overall score of 20 or higher on the SHAPS? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query inclusion_4 Integer Required Does the subject have a urine drug test negative for the presence of illicit substances (cocaine, opioids, amphetamines, PCP, Methadone, THC, etc.)? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query inclusion_5 Integer Required Does the subject have a Clinician's Global Impression Scale severity (CGI-S) score of 3 or higher? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query exclusion_1 Integer Required Does the subject have a NAART IQ Score of < 90? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query exclusion_2 Integer Required Is the subject unable to read, blind, or deaf? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query exclusion_3 Integer Required Has the subject had prior treatment with behavioral activation therapy for depression or mindfulness-based treatments (those with exposure to other forms of psychotherapy will be eligible)? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query pu_suicd6mo Integer Required Suicide attempts during past 6 months? 0;1; 888 0=No; 1=Yes; 888 = Not assessed - patient was ineligible exclusion_4
Query exclusion_5 Integer Required Does the subject have current suicidal ideation with intent/plan (answered yes to either items 4 and/or 5 on the C-SSRS) 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query exclusion_6 Integer Required Does the subject meet current or lifetime criteria for bipolar disorder I or II (with or without current mania)? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query exclusion_7 Integer Required Does the subject meet criteria for any current or lifetime psychotic disorder as defined by the SCID-5? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query exclusion_8 Integer Required Does the subject meet criteria for drug or alcohol abuse/dependence as defined by the SCID-5? OR Subject reports use of a substance of abuse in the past week or has lifetime history of moderate or severe substance use disorder per SCID-5? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query exclusion_9 Integer Required Does the subject meet any current or lifetime feeding and/or eating disorders as defined by the SCID-5? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query exclusion_10 Integer Required Is the subject currently taking any psychiatric medications; has taken a medication within the past 4 weeks (8 weeks for fluoxetine), or is currently in psychotherapy? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query exclusion_11 Integer Required Does the subject have any contraindications for MRI imaging such as metal in the body (confirmed at the MRI visit on the MRI screening checklist)? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible exclusion_4
Query exclusion_12 Integer Required If female, is the subject currently pregnant? (to be confirmed by urine pregnancy screen right before the MRI scan). 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query mri_elig Integer Required Did the subject complete the pre-treatment fMRI within 4 weeks of initial assessment? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible
Query eligible_randomization Integer Required Is participant eligible to be randomized? 0;1 1 = Yes ; 0 = No eligible_study
Query inclusion002 Integer Recommended Is the subject a male or female between the age of 35-75 inclusive? 0::1 1 = Yes ; 0 = No inclusion_002
Query inclusion003 Integer Recommended If female of child bearing potential, is she negative for pregnancy? (to be confirmed by urine pregnancy screen right before the BIAC MRI scan) 0::1 1 = Yes ; 0 = No inclusion_003
Query inclusion004 Integer Recommended Does the subject have no ambulatory or uncorrected sensory deficits? 0::1 1 = Yes ; 0 = No inclusion_004
Query inclusion005 Integer Recommended Does the subject have a NAART verbal IQ Score of 88 or higher? 0::1 1 = Yes ; 0 = No inclusion_005
Query inclusion_6 Integer Recommended If in the Major Depressive Disorder (MDD) group, does the subject have current MDD or PDD assessed by SCID-5 interview? 0::1 1 = Yes ; 0 = No
Query inclusion_7 Integer Recommended If in the Control group, does the subject have no current and/or lifetime history of any psychiatric condition as assessed by SCID-5 interview? 0::1 1 = Yes ; 0 = No
Query inclusion_8 Integer Recommended Does the subject have no MRI contraindications (e.g. metal in the body) 0::1 1 = Yes ; 0 = No
Query exclusion001 Integer Recommended Does the subject meet criteria for drug or alcohol abuse/dependence as defined by the SCID-5? OR Subject has lifetime history of moderate or severe substance use disorder with the exception of lifetime moderate alcohol use, as per SCID-5 interview? 0::1 1 = Yes ; 0 = No exclusion_001
Query exclusion002 Integer Recommended Does the subject meet any current or lifetime psychotic, mania or eating disorders as assessed by the SCID-5 interview? 0::1 1 = Yes ; 0 = No exclusion_002
Query exclusion003 Integer Recommended Does the subject have disorders with impact on brain characteristics (e.g. epilepsy, Parkinson's disease) or history of stroke? 0::1 1 = Yes ; 0 = No exclusion_003
Query exclusion005 Integer Recommended Has the subject use antidepressants or other psychotropics other than sleep aids, anti-anxiety and ADHD medications currently or within the past 4 weeks (8 weeks for fluoxetine)? 0::1 1 = Yes ; 0 = No exclusion_005
Query exclusion006 Integer Recommended Does the subject indicated mild cognitive impairement or dementia? To meet screening criteria, participants must meet all of the following: Score of 23 or higher on the Montreal Cognitive Assessment (MOCA); perform abovel -1.5 standard deviations on the following measures: HVLT delayed recall, Trail Making B, and Animal Naming based normative values ? 0::1 1 = Yes ; 0 = No exclusion_006
Query exclusion_5rev Integer Recommended If subject used antidepressants or other psychotropics other than sleep aids, anti-anxiety and ADHD medications currently or within the past 4 weeks (8 weeks for fluoxetine), Is the subject on a stable dose of a psychiatric medication (especially antidepressant, antipsychotic and/or mood stabilizer) for at least 4 weeks with no intent of changing the medication and/or dose during the 3 in-person visits? 0::1 1 = Yes ; 0 = No
comments_misc String 4,000 Recommended Miscellaneous comments on study, interview, methodology relevant to this form data
inc_03 Integer Recommended Does the subject have a high school degree or equivalent? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible inclusion_03
inc_07 Integer Recommended Can the subject read and speak English? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible inclusion_04
exc_03 Integer Recommended Does the subject have an overall score of 14 or higher on the Beck Depression Inventory? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible inclusion_05
exc_05 Integer Recommended Has the subject ever suffered a head or brain injury? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible inclusion_06
exc_06 Integer Recommended Does the subject have any current psychiatric illness? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible inclusion_07
exc_07 Integer Recommended Does the subject have any current or previous neurological illness? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible inclusion_08
exc_09 Integer Recommended Does the subject suffer from frequent or severe headaches? 0;1; 888 1 = Yes ; 0 = No ; 888 = Not assessed - patient was ineligible inclusion_09
excl_1_hypomania Integer Recommended Does the participant meet criteria for current hypomania? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_3_bipolar1 Integer Recommended Does the participant meet the diagnostic criteria for Bipolar I disorder? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_4_alcohol Integer Recommended Does the participant meet the diagnostic criteria for SCID5 for current alcohol or substance use disorder (moderate and high severity) or meet past history of severe alcohol use disorder? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_6_english Integer Recommended Is the participant a non-English speaker? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_8_hospital Integer Recommended Does the participant have current uncontrolled anorexia or other condition requiring hospitalization? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_10_illness Integer Recommended Does the participant have a current serious medical illness, including current severe migraine headaches? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_11_medication Integer Recommended Has the participant started/changed psychotropic medications in the prior 4 weeks or have plans to change medication during the study? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_12_brain Integer Recommended Does the participant have a history of seizure except those therapeutically induced by electroconvulsive therapy (ECT) (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain injury, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by TMS (pacemaker, medication pump, implanted brain stimulator)? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_13_neuro Integer Recommended Does the participant have conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson''s or Huntington''s disease, multiple sclerosis? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_14_seizuremed Integer Recommended Is the participant on medications that reduce seizure threshold (e.g. stimulants, Wellbutrin, Clozaril, Provigil)? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_15_study Integer Recommended Has the participant used investigational drugs or devices within 4 weeks of screening? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_16_implants Integer Recommended Does the participant have cochlear implants? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_19_prison Integer Recommended Is the participant a prisoner or in police custody at the time of screening, or does the participant have a pending court case jeopardizing the participation in the study? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_21_cbt Integer Recommended Has the participant had Cognitive Behavioral Therapy (CBT) in the past 4 weeks or plans to start therapy during the study? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
excl_22_weight Integer Recommended Does the participant weigh over 300 pounds (could not fit in an MRI scanner)? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
incl_1_age Integer Recommended Is the person between the ages of 18-55? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
incl_2_ders Integer Recommended Does the participant have a Difficulties with Emotion Regulation Scale (DERS) total score of greater than or equal to 90? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
incl_3_stabletx Integer Recommended Has the participant been in the same type of psychotherapy (including none) for the the last 4 weeks/1mo (except for current Cognitive Behavioral Therapy (CBT)) and is willing to stay on the same regimen throughout the study? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
incl_4_erq Integer Recommended Does the participant have a low self-reported cognitive restructuring (Emotion Regulation Questionnaire (ERQ) restructuring subscale average score less than 4.7)? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
incl_5_disorder Integer Recommended Does the participant meet criteria for at least one mood (including Bipolar II w/o current hypomania), anxiety, stressor, OCD, Impulse Control, ADHD, or eating DSM-5 disorder (except exclusionary diagnoses such as severe anorexia)? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
incl_6_stablemed Integer Recommended Has the participant made a verbal agreement to not start any or maintain dose of prescribed psychotropic medication (if any) constant throughout the study? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible
incl_7_naive Integer Recommended Is the participant naive to repetitive transcranial magnetic stimulation (rTMS)? 0;1;888 0 = No; 1 = Yes; 888 = Not assessed - patient was ineligible excl_20_tms
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

At the top of this page you can also:

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