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Table 2 Key variables and measurements

From: 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

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 - - -
  1. T 1 baseline/pretreatment, T 2 post-treatment/10 weeks after randomization, T 3 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