Design and rationale of the REStoring mood after early life trauma with psychotherapy (RESET-psychotherapy) study: a multicenter randomized controlled trial on the efficacy of adjunctive trauma-focused therapy (TFT) versus treatment as usual (TAU) for adult patients with major depressive disorder (MDD) and childhood trauma

Table 1 Overview of RESET-psychotherapy measurements per assessment

Construct	Instrument	Method	Screening	T0	T1	T2	T3
Demographics	Self-composed questionnaire	Int		X
Depression symptom severity ¹	IDS-SR	SR	X	X	X	X	X
Depression diagnosis	MINI-S	Int		X	X	X	X
Childhood trauma	CTQ-SF	SR	X
Subjective stress	PSS	SR		X	X	X	X
Insomnia	ISI	SR		X	X	X	X
Functioning and disability	WHODAS-II	SR		X	X	X	X
Anxiety symptom severity	BAI	SR		X	X	X	X
Suicidality	C-SSRS	Int		*	*	*	*
Alcohol use	AUDIT	SR		X
Drug use	Self-composed questionnaire	SR		X
Physical activity	IPAQ	SR		X
Smoking	Self-composed questionnaire	SR		X
Healthcare use	Self-composed questionnaire	Int					X
Previous/current depression treatment	Self-composed questionnaire	SR		X
Content of TAU ²	Self-composed questionnaire	SR				X
Content of TFT ²	Self-composed questionnaire	SR				X
PTSD/ASD diagnosis	MINI-S	Int		X
Age and context CT exposure	MACE	SR		X
Resilience	CD-RISC2	SR		X
Coping style	COPE-16	SR		X
Personality	NEO-FFI	SR		X
Stressful life events	LTE	SR		X	X	X	X
Social support	SSL	SR		X	X	X	X
Cortisol	Hair	BM		X		X
Questions about hair sample	Self-composed questionnaire	Int		X		X
Epigenetic and inflammatory biomarkers	Blood	BM		X		X
Stress-related brain activity³	Anatomic, resting state and task-based fMRI	BM		X		X

T0 baseline, T1 after 6 weeks, T2 post-treatment, after 12 weeks, T3 6 months after post-treatment, TFT trauma-focused therapy, TAU treatment as usual, PTSD posttraumatic stress disorder, SR self-report, Int interview, BM biological measure,¹ = also assessed in week 2,4,8 and 10 (during treatment), ² = completed by therapists, ³ = only in the fMRI sub-sample, * = only assessed if participant shows risk regarding suicidality, IDS-SR inventory of depressive symptomatology-self rated, MINI-S Mini International Neuropsychiatric Interview-Simplified, CTQ-SF Childhood Trauma Questionnaire – Short Form, PSS Perceived Stress Scale, ISI Insomnia Severity Scale, WHODAS-II WHO Disability Schedule-II, BAI Beck Anxiety Inventory, C-SSRS Columbia-Suicide Severity Rating Scale, AUDIT Alcohol Use Disorders Identification Test, IPAQ International Physical Activity Questionnaire, MACE Maltreatment and Abuse Chronology of Exposure questionnaire, CD-RISC2 2-item Connor-Davidson Resilience Scale, NEO-FFI NEO Five-Factor Inventory, LTE List of Threatening Experiences, SSL Social Support List, fMRI functional Magnetic Resonance Imaging

ISSN: 1471-244X