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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005140

Enrollment

Registered

2013-08-27

Start date

2013-09-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F43.2 F32.0 F32.1 F33.0 F33.1 F34.1

Interventions

Group 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 consist

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 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), 213–223. Zielke, M. & Kopf-Mehnert, C. (1978). Veränderungsfragebogen des Erlebens und Verhaltens: VEV. Weinheim: Beltz Test.	—

Measure

Time frame

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 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), 213–223. Zielke, M. & Kopf-Mehnert, C. (1978). Veränderungsfragebogen des Erlebens und Verhaltens: VEV. Weinheim: Beltz Test.

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Secondary

Measure	Time frame
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 2000. Zeitschrift für Klinische Psychologie und Psychotherapie, 39 (2), 71–79.	—

Measure

Time frame

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 2000. Zeitschrift für Klinische Psychologie und Psychotherapie, 39 (2), 71–79.

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Countries

Germany

Contacts

Public ContactMiriam Rüsch

ruesch@psychologie.uni-freiburg.de0761-203-9439

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 17, 2026