Immediate help through group therapy for patients with somatic diseases and depressive or adjustment disorders in outpatient care: study protocol for a randomized controlled trial

Table 2 Key variables and measurements

Variables	Measurement	T₁	Monitoring	T₂	T₃
Inclusion and exclusion criteria
Psychiatric disorders (Axis-I)	SCID-I	x	-	-	-
Somatic disorders	self-report in telephone screening	x	-	-	-
Primary outcomes
Anxiety and depressive symptoms	HADS-D	x	-	x	x
Secondary outcomes
Psychological distress	BSI	x	-	x	x
Current psychosocial distress	NCCN Distress Thermometer	x	-	x	x
Changes in experience and behavior since baseline	VEV-VW	-	-	x	x
Health-related quality of life	SF-12	x	-	x	x
State of self-esteem	SSES-revised	x	-	x	x
Subjective need for psychotherapy	newly developed questions	x	-	x	x
Process evaluation
Acceptance of treatment	treatment attendance, self-report	-	x	-	-
Therapeutic processes during the group program from patients’ perspectives	BPSR-G 2000	-	x	-	-
Covariates
Demographic variables (sex, age, family status, education, employment, and so forth)	demographic survey	x	-	-	-
Psycho-pharmacotherapy	demographic survey	x	-	-	-
Pretreatment of psychiatric disorders	demographic survey	x	-	-	-
Psychological treatment since baseline	self-report	-	-	x	x
Changes in somatic health and psycho-pharmacotherapy since baseline	self-report	-	-	x	x
Coping with a chronic disease	TSK	x	-	-	-

T₁ baseline/pretreatment, T₂ post-treatment/10 weeks after randomization, T₃ follow-up/18 weeks after randomization, BPSR-G-2000 Bern Post Session Report 2000 modified for groups, BSI Brief Symptom Inventory, HADS-D Hospital Anxiety and Depression Scale, German version, SCID-I Structured Clinical Interview for DSM-IV Axis I Disorders, SF-12 Short Form Health Survey, SSES-revised State Self-Esteem Scale, revised version, TSK Trier Scales of Coping with Disease, VEV-VW revised short form of Change Questionnaire of Experience and Behavior

ISSN: 1745-6215