|
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 |