Glucocorticoid Receptor (GR) antagonism as disease-modifying treatment for MDD with childhood trauma: protocol of the RESET-medication randomized controlled trial

Table 2 Overview of RESET-medication measurements per study time-point

Construct	Instrument	Method	Screening	T0	T1	T2	T3	T4
Depression symptom severity	IDS-SR	SR	X	X	X	X	X	X
Childhood trauma	CTQ-SF	SR	X
MDD diagnosis	MINI-S	Int		X	X	X	X	X
Suicidality	C-SSRS	Int		^b	^b	^b	^b	^b
Anxiety symptoms	BAI	SR		X	X	X	X	X
Disability	WHODAS-II	SR		X	X	X	X	X
Sleep duration	ISI	SR		X	X	X	X	X
Perceived stress	PSS	SR		X	X	X	X	X
Stressful life events	LTE	SR		X		X	X	X
Social support	SSL	SR		X	X	X	X	X
Medication adherence-TAU	MARS-5	SR		X	X	X	X	X
Medication adherence-RCT	Pill count	Int			X
Adverse side effects	SC	SR			X^c
Demographics	SC	Int		X
Past/current smoking	SC	SR		X
Physical activity	IPAQ	SR		X
Alcohol use	AUDIT	SR		X
Drug use	SC	SR		X
PTSD symptoms	MINI-S	Int		X
Current/previous TAU	SC	Int		X				X
Resilience	CD-RISC2	SR		X
CT characteristics	MACE	SR		X
Coping style	COPE-16	SR		X
Personality traits	NEO-FFI	SR		X
Contraindications mifepristone	SC	Int	X	X
Pregnancy test	Urine	BM		X
Cortisol	Hair Saliva	BM BM		X X	X	X X
Inflammation, epigenetics, mifepristone plasma levels	Blood	BM		X	X	X
fMRI sub-study^a: Stress-related biological measures	Structural MRI, resting-state fMRI task-based fMRI; Saliva Heart-rate	BM BM BM BM BM		X X X X X		X X X X X
fMRI sub-study: Subjective stress measures	PANAS STAI-S VAS DARS	SR SR SR SR		X X X X		X X X X

T0 Baseline, T1 1 week after start study medication, T2 6 weeks after start study medication, T3 12 weeks after start study medication, T4 6 months after start study medication, TAU treatment as usual, SR Self-Report, Int Interview by researcher, BM Biological measure, IDS-SR Inventory of depressive symptomatology-self rated, MINI-S Mini International Neuropsychiatric Interview-Simplified, CTQ-SF Childhood Trauma Questionnaire – Short Form, C-SSRS Columbia-Suicide Severity Rating Scale, BAI Beck Anxiety Inventory, WHODAS-II WHO Disability Schedule-II, ISI Insomnia Severity Scale, PSS Perceived Stress Scale, LTE List of Threatening Experiences, SSL Social Support List, MARS-5 Medication Adherence Report Scale, SC self-composed questionnaire, IPAQ International Physical Activity Questionnaire, AUDIT Alcohol Use Disorders Identification Test, CD-RISC2 2-item Connor-Davidson Resilience Scale, MACE Maltreatment and Abuse Chronology of Exposure questionnaire, COPE-16 Coping Orientation to Problems Experienced, NEO-FFI NEO Five-Factor Inventory, fMRI functional Magnetic Resonance Imaging
^aonly in fMRI sub-group
^bonly assessed if patient shows risk regarding suicidality
^crepeated 2 weeks after T1

ISSN: 1471-244X