The multi-level outcome study of psychoanalysis for chronically depressed patients with early trauma (MODE): rationale and design of an international multicenter randomized controlled trial

Table 3 Study timetable of assessments

Assessments	Screening	Visit 1	Visit 2	Visit 3	Visit 4	Visit 5
Description	Inclusion	Study start	FU 3 months	FU 6 months	FU 9 months	Study end
Days	Day -x	Day 0	Day 91	Day 182	Day 273	Day 365
Window (dates)			± 7	± 7	± 7	± 3
Weeks		0	13	26	39	52
Informed consent signed	X
Eligibility	X
Demographics		X
SCID (CI)	X	(X)^a				X
Psychoanalytic interview	X	(X)^a
MRI scan	X	(X)^a				X
Trust game	X	(X)^a				X
GAF (Cl)		X				X
BDI-II (SR)	X	X	X	X	X	X
DEQ (SR)		X	X	X	X	X
QIDS (Cl, SR)		X	X (only SR)	X (only SR)	X (only SR)	X
SCL-90-R (SR)		X	X	X	X	X
CTQ (SR)	X
IIP (SR)		X	X	X	X	X
Work Ability Index (SR)		X	X	X	X	X
OPD_SF (SR)		X	X	X	X	X
Dream Diary (SR)						X
Patient trauma narratives		X				X
WAI-SRp (SR)		Collected each month from Assessment 1 to 5
Psychotherapy		Throughout study
Adverse Events			X	X	X	X
SAE		Throughout study
Medication		X	X	X	X	X

FU Follow-up, Cl Clinician rated, SR Self-reported, SCID Structured Clinical Interview for DSM, GAF Global Assessment of functioning, BDI-II Beck Depression Inventory-II, DEQ Depressive Experience Questionnaire, QIDS Quick Inventory of Depressive Symptoms (Cl, SR), SCL-90-R Symptom Checklist, CTQ Childhood Trauma Questionnaire, IIP Inventory Interpersonal Problems, WAI Work Ability Index, OPD-SF OPD structure questionnaire, WAI-SRp Working Alliance Inventory, SAE Severe Adverse Event
^aDepending on the availability of the persons concerned, the first MRI examination, the administration of the Trustgame, the SCID interview, and the psychoanalytical interview can take place at the screening visit or visit 1

ISSN: 1471-244X