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Table 2 Data Collection at Screening, Baseline and Follow-up Evaluation

From: The establishment of the objective diagnostic markers and personalized medical intervention in patients with major depressive disorder: rationale and protocol

Domain Measure Participant Method Assessment time Administrator
Informed consent Informed consent All participants Interview Screening Investigator
Eligibility Inclusion/Exclusion All participants Interview Screening Investigator
Psychiatric diagnoses MINI All participants Interview Screening Investigator
Demographic, medical history, family history of psychiatric disease and MDD course Self-designed questionnaire All participantsa Self-report Baseline Investigator
Life events in the past year, adverse childhood experience, social support, coping style, personality trait LES, CTQ, SSQ, SCSQ,EPQ All participants Interview Baseline Investigator
Treatment process, concurrent treatment, stress events, mood disorder episodes and adverse events Self-designed questionnaire 600-MDD patients subgroup Self-report Every follow-up Investigator
Anxiety symptom HAMA 600-MDD patients subgroup Interview Every follow-up Investigator
Depressive symptom severity HRSD17 600-MDD patients subgroup Interview Baseline and every follow-up Investigator
Depressive symptom improvement CGIS 600-MDD patients subgroup Interview Every follow-up Investigator
Cognitive function CPT-IP, AVFSS, CTTI and II, BACS, BVNT-R, HVLT-R, SCWT 600-MDD patients and 300-Health controls subgroup Interview Baseline, week 8 and 48b Investigator and computerized touch screen platformc
  1. Abbreviations: MINI Mini-International Neuropsychiatric Interview, LES Life Events Scale, CTQ Childhood Trauma Questionnaire, SSQ Social Support Questionnaire, SCSQ Simplified Coping Style Questionnaire, EPQ Eysenck Personality Questionnaire, HAMA Hamilton Anxiety Scale, HRSD17 17-Item Hamilton Rating Scale for Depression, CGIS Clinical Global impression Scale, CPT-IP Continuous Performance Test-Identical Pairs, AVFSS Animal Verbal Fluency Scale, CTTIand II = Color Trial Test I and II, BACS the Brief Assessment of Cognition in Schizophrenia, BVNT-R Brief Visual Memory Test-Revised, HVLT-R Hopkins Verbal Learning Test-Revised, SCWT Stroop Color Word Test
  2. a Except “MDD course” for 1200 MDD patients only, other data of this domain would be collected for all participants
  3. b For 300-Healthy controls subgroup, cognitive function data would only be collected at baseline
  4. c Except for the data of CPT-IP collected using a standardized computerized touch screen platform, other data of this domain would be collected by the trained investigator