STEpS stage-by-stage psychotherapy for patients with physical diseases and depressive or adjustement disorders.

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1 Trial Description Title STEpS stage-by-stage psychotherapy for patients with physical diseases and depressive or adjustement disorders. Trial Acronym STEpS URL of the trial [---]* Brief Summary in Lay Language There is increasing demand for psychotherapies for patients with somatic diseases and mental disorders. The waiting time for psychotherapy can be up to several months. This study investigates if a group program can contribute to a better care for patients with somatic diseases and depressive or adjustment disorders. Patients of our outpatient clinic will be randomly assigned to participate in a group program immediately after contacting the clinic or after a waiting period of 4 months. Brief Summary in Scientific Language The randomized-controlled trial investigates if attending a cbt-group program (8 sessions) before an individual therapy is an effective concept for patients with somatic diseases and comorbid depressive or adjustment disorders. Primary outcome of the study is the psychological distress of the patients. Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 285/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg Secondary IDs Universal Trial Number (UTN): U Page 1 of 6

2 Health condition or Problem studied ICD10: F Adjustment disorders ICD10: F Mild depressive episode ICD10: F Moderate depressive episode ICD10: F Recurrent depressive disorder, current episode mild ICD10: F Recurrent depressive disorder, current episode moderate ICD10: F Dysthymia Interventions/Observational Groups Arm 1: Study participants randomized to the intervention group participate in a cbt-group program for patients with somatic diseases and depressive or adjustment disorders. The group program consists of 8 weekly sessions of 100 minutes. The group setting is half-open: entry for new members is possible for every new topic (every other session). Topics of the program are: behavioral activation, cognitive restructuring, coping, self-esteem and meaning. Arm 2: Patients randomized to the waiting control group pass the usual waiting process of our outpatient clinic. After completing the follow-up-assessment they can participate in the goup program, if they wish. Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: [---]* Who is blinded: [---]* Control: Control group receives no treatment Purpose: Treatment Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome Primary outcome is the psychological distress of the patients. Psychological distress will be assessed by self-report questionnaires at three measurement points (before the intervention, after the intervention and 8 weeks after the intervention). Equal measurement intervals will be used for the control group (at the beginning of the study, after 8 weeks, after 16 weeks). Following aspects will be assessed: physical and psychological well-being by the Page 2 of 6

3 german version of the Short Form Health Survey (SF-36; Bullinger & Kirchberger, 1998), current distress by the first part of the german version of the NCCN Distress-Thermometer (Mehnert, Müller, Lehmann & Koch, 2006), anxious and depressive symptoms by the german version of the Hospital Anxiety and Depression Scale (HADS-D; Herrmann-Lingen, Buss & Snaith, 2011), psychological distress by the german version of the Brief Symptom Inventory (BSI; Franke, 2000) and subjective changes in experience and behavior by the german change-questionnaire of experience and behavior (VEV; Zielke & Kopf-Mehnert, 1978). Bullinger, M. & Kirchberger, I. (1998). SF-36, Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe. Franke, G. H. (2000). Brief Symptom Inventory von L. R. Derogatis: BSI. Deutsche Version. Göttingen: Beltz Test. Herrmann-Lingen, C., Buss, U. & Snaith, P. (2011). Hospital anxiety and depression scale : deutsche Version; HADS-D. Bern: Huber. Mehnert, A., Müller, D., Lehmann, C. & Koch, U. (2006). Die deutsche Version des NCCN Distress- Thermometers. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 54 (3), Zielke, M. & Kopf-Mehnert, C. (1978). Veränderungsfragebogen des Erlebens und Verhaltens: VEV. Weinheim: Beltz Test. Secondary Outcome 1. Subjective need for psychotherapy: Assessed by newly developed questions targeting the need for psychotherapy at three measurement points (see above). 2. Acceptance of the treatment: Assessment of drop-out rates and process evaluation of the treatment: Patients evaluate each group session by means of a modified version of the Bern Post Session Report-Patient version (PSTB; Flückiger et al., 2010). The therapist will document treatment attendance and disturbances. After the last group session patients are asked for a comparative evaluation of all sessions. Additionally we will interview 8-10 participants of the intervention group. With these qualitative interviews we aim to find out what is helfpful for the group participants and how the group program could be further improved. Flückiger, C., Regli, D., Zwahlen, D., Hostettler, S. & Caspar, F. (2010). Der Berner Patienten- und Therapeutenstundenbogen Zeitschrift für Klinische Psychologie und Psychotherapie, 39 (2), Countries of recruitment DE Locations of Recruitment Page 3 of 6

4 other Psychotherapieambulanz für psychische Störungen bei körperlichen Erkrankungen, Freiburg im Breisgau Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2013/09/02 Target Sample Size: 50 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: 75 Years Additional Inclusion Criteria Patients are recruited in the outpatient clinic for patients with physical and mental diseases of the University of Freiburg. All patients have physical diseases and a comorbid adjustment disorder, a mild or moderate depressive episode (single or recurrent) or dysthymia (ICD-10: F43.2; F32.0; F32.1; F33.0; F33.1;34.1). Exclusion criteria Not included are patients with comorbid substance abuse (ICD-10: F1), schizophrenia (ICD-10: F2), dementia (ICD-10: F00-F03), mental retardation (ICD-10: F7) bipolar affective disorder (ICD-10: F31), zyklothymia (ICD-10: F34.0) or inadequate knowledge of German. Addresses Primary Sponsor Freiburg Telephone: (Sekretariat) Page 4 of 6

5 Primary Sponsor Freiburg Telephone: (Sekretariat) bengel at psychologie.uni-freiburg.de URL: Contact for Scientific Queries Ms. Dr. Almut Helmes Freiburg im Breisgau Telephone: helmes at psychologie.uni-freiburg.de URL: Contact for Public Queries Ms. Miriam Rüsch Freiburg im Breisgau Telephone: ruesch at psychologie.uni-freiburg.de URL: Sources of Monetary or Material Support Institutional budget, no external funding (budget of sponsor/pi) Page 5 of 6

6 Institutional budget, no external funding (budget of sponsor/pi) Freiburg im Breisgau Telephone: (Sekretariat) bengel at psychologie.uni-freiburg.de URL: Status Recruitment Status: Recruiting complete, follow-up complete Study Closing (LPLV): 2015/07/31 Trial Publications, Results and other documents Abstract <style pdffontname='helvetica-bold' isbold='true'>ruesch, M., Helmes, A. & Bengel, J (2015). 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. Trials, 16:287. doi: /s </style> Paper [---]* * This entry means the parameter is not applicable or has not been set. Page 6 of 6