Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Miriam Ruesch, Almut Wiebke Helmes, Juergen Bengel

Published in: Trials | Issue 1/2015

Login to get access

Abstract

Background

One in three people with a chronic somatic disease suffer from a comorbid mental disorder. Most common comorbidities are depressive, anxiety and adjustment disorders. These lead to an increase in morbidity and mortality, and a deterioration of quality of life and healthcare costs. Treatment of mental disorders is of great importance, but the waiting time for outpatient individual psychotherapy can be up to six months in Germany. Group therapy has comparable treatment effects and is considerably more economic than individual therapy; however, it is still almost unused in the outpatient care system. The introduction of a stepped care approach, such as attending a group program before individual therapy, could improve this issue. For this purpose we developed a group program (STEpS), and its efficacy will be evaluated in this study.

Methods/Design

A randomized controlled trial will be conducted to evaluate the efficacy of a cognitive behavioral therapy (CBT) group program for patients with somatic diseases and depressive or adjustment disorders, compared to a wait-list control group. A total of 128 adults with any chronic somatic disease and comorbid depression or adjustment disorder will be recruited in our outpatient clinic, and will be randomly assigned to participate in the group program immediately after contacting the clinic (intervention group) or after a waiting period of four months (wait-list control group). Primary outcomes will be self-reported depressive and anxiety symptoms. Secondary outcomes will be self-reported psychological distress, changes in experience and behavior, health-related quality of life, state of self-esteem and subjective need for therapy. Assessments will take place at baseline, 10 weeks (post-treatment) and 18 weeks (follow-up) after randomization. Additionally, treatment acceptance and psychotherapeutic process will be assessed after each session.

Discussion

This study investigates whether the CBT group program is an effective treatment to reduce depressive and anxiety symptoms and psychological distress in these patients. If the group program is effective, it could be implemented as a treatment option prior to individual outpatient therapy. These results will contribute to improving outpatient care for mental disorders in patients with somatic diseases.

Trial registration

German Clinical Trials Register DRKS00005140 (27 August 2013).
Literature
1.
Lange C. Daten und Fakten: Ergebnisse der Studie “Gesundheit in Deutschland aktuell 2010”. Berlin: Robert-Koch-Institut; 2012.
2.
Busse R. Tackling chronic disease in Europe: strategies, interventions and challenges. Copenhagen: World Health Organization on behalf of the European Observatory on Health Systems and Policies; 2010.
3.
World Health Organization. The European health report 2012: charting the way to well-being. Copenhagen: World Health Organization; 2013.
4.
Härter M, Baumeister H, Reuter K, Jacobi F, Höfler M, Bengel J, et al. Increased 12-month prevalence rates of mental disorders in patients with chronic somatic diseases. Psychother Psychosom. 2007;76:354–60.CrossRefPubMed
5.
Bengel J, Hubert S. Anpassungsstörung und Akute Belastungsreaktion. Göttingen: Hogrefe; 2010.
6.
Bengel J, Hecht H, Frommberger U. Anpassungsstörungen. In: Berger M, editor. Psychische Erkrankungen: Klinik und Therapie. 5th ed. München: Urban & Fischer, Elsevier; 2015. p. 517–24.
7.
Casey P, Dowrick C, Wilkinson G. Adjustment disorders: fault line in the psychiatric glossary. Brit J Psychiat. 2001;179:479–81.CrossRefPubMed
8.
Mehnert A, Koch U. Prevalence of acute and post-traumatic stress disorder and comorbid mental disorders in breast cancer patients during primary cancer care: a prospective study. Psychooncology. 2007;16:181–8.CrossRefPubMed
9.
Strain J. Adjustment disorder: a multisite study of its utilization and interventions in the consultation-liaison psychiatry setting. Gen Hosp Psychiat. 1998;20:139–49.CrossRef
10.
Maercker A, Einsle F, Kollner V. Adjustment disorders as stress response syndromes: a new diagnostic concept and its exploration in a medical sample. Psychopathology. 2007;40:135–46.CrossRefPubMed
11.
Baumeister H, Härter M. Auswirkungen komorbider psychischer Störungen bei chronischen körperlichen Erkrankungen. Z Med Psychol. 2005;14:175–89.
12.
13.
McCarthy K, McGee HM, O’Boyle CA. Outpatient clinic waiting times and non-attendance as indicators of quality. Psychol Health Med. 2000;5:287–93.CrossRef
14.
Loumidis KS, Shropshire JM. Effects of waiting time on appointment attendance with clinical psychologists and length of treatment. Irish J Psychol Med. 1997;14:49–54.CrossRef
15.
Hicks C, Hickman G. The impact of waiting-list times on client attendance for relationship counselling. Brit J Guid Couns. 1994;22:175–82.CrossRef
16.
Hoyer J, Helbig S, Wittchen H. Experiences with psychotherapy for depression in routine care: a naturalistic patient survey in Germany. Clin Psychol Psychot. 2006;13:414–21.CrossRef
17.
May RJ. Effects of waiting for clinical services on attrition, problem resolution, satisfaction, attitudes toward psychotherapy, and treatment outcome: a review of the literature. Prof Psychol Res Pr. 1991;22:209–14.CrossRef
18.
Whiteford HA, Harris MG, McKeon G, Baxter A, Pennell C, Barendregt JJ, et al. Estimating remission from untreated major depression: a systematic review and meta-analysis. Psychol Med. 2013;43:1569–85.CrossRefPubMed
19.
Lepine JP. Epidemiology, burden, and disability in depression and anxiety. J Clin Psychiat. 2001;62 Suppl 13:4–10. discussion 11–2.
20.
Bower P, Gilbody S. Stepped care in psychological therapies: access, effectiveness and efficiency: narrative literature review. Brit J Psychiat. 2005;186:11–7.CrossRefPubMed
21.
Broten LA, Naugle AE, Kalata AH, Gaynor ST. Depression and a stepped care model. In: Draper C, O’Donohue WT, editors. Stepped care and e-health. New York, NY: Springer; 2011. p. 17–43.CrossRef
22.
Vos T, Corry J, Haby MM, Carter R, Andrews G. Cost-effectiveness of cognitive-behavioural therapy and drug interventions for major depression. Aust N Z J Psychiatry. 2005;39:683–92.PubMed
23.
Tucker M, Oei TPS. Is group more cost effective than individual cognitive behaviour therapy? The evidence is not solid yet. Behav Cogn Psychoth. 2007;35:77.CrossRef
24.
Burlingame GM, Fuhriman A, Mosier J. The differential effectiveness of group psychotherapy: a meta-analytic perspective. Group Dyn Theor Res Pract. 2003;7:3–12.CrossRef
25.
McRoberts C, Burlingame GM, Hoag MJ. Comparative efficacy of individual and group psychotherapy: a meta-analytic perspective. Group Dyn Theor Res Pract. 1998;2:101–17.CrossRef
26.
Cuijpers P, van Straten A, Warmerdam L. Are individual and group treatments equally effective in the treatment of depression in adults?: a meta-analysis. Eur J Psychiat. 2008;22:38–51.CrossRef
27.
Sherman AC, Mosier J, Leszcz M, Burlingame GM, Ulman KH, Cleary T, et al. Group interventions for patients with cancer and HIV disease: part I: effects on psychosocial and functional outcomes at different phases of illness. Int J Group Psychother. 2004;54:29–82.CrossRefPubMed
28.
Heckman TG, Sikkema KJ, Hansen N, Kochman A, Heh V, Neufeld S. A randomized clinical trial of a coping improvement group intervention for HIV-infected older adults. J Behav Med. 2011;34:102–11.CrossRefPubMed
29.
Hambridge JA, Turner A, Baker AL. BraveHeart begins: pilot results of group cognitive behaviour therapy for depression and anxiety in cardiac patients. Aust N Z J Psychiatry. 2009;43:1171–7.CrossRefPubMed
30.
Schuster N, Rüddel H, Keck M, Schwarting A. Evaluation einer gruppenpsychotherapeutischen Behandlung bei komorbiden psychischen Störungen in der kardiologischen und orthopädischen Rehabilitation. In: Arbeitskreis Klinische Psychologie in der Rehabilitation BDP, editor. Psychische Störungen in der somatischen Rehabilitation. Bonn: Deutscher Psychologen Verlag; 2009. p. 26–33.
31.
Schulz H. Psychotherapeutische Versorgung. Berlin: Robert-Koch-Institut; 2008.
32.
Taylor NT, Burlingame GM, Kristensen KB, Fuhriman A, Johansen J, Dahl D. A survey of mental health care provider’s and managed care organization attitudes toward, familiarity with, and use of group interventions. Int J Group Psychother. 2001;51:243–63.CrossRefPubMed
33.
Peterson AL, Halstead TS. Group cognitive behavior therapy for depression in a community setting: a clinical replication series. Behav Ther. 1998;29:3–18.CrossRef
34.
35.
Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390.CrossRefPubMedPubMedCentral
36.
Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. Psychiat Ann. 2002;32:1–7.
37.
Maurer K, Hörrmann F, Trendler G, Schmidt M, Häfner H. Früherkennung des Psychoserisikos mit dem Early Recognition Inventory (ERIraos): Beschreibung des Verfahrens und erste Ergebnisse zur Reliabilität und Validität der Checkliste. Nervenheilkunde. 2006;25:11–6.
38.
Sass H, Wittchen H, Zaudig M, Houben I. Diagnostisches und statistisches Manual psychischer Störungen - Textrevision: DSM-IV-TR. Göttingen: Hogrefe; 2003.
39.
Wittchen H, Zaudig M, Fydrich T. SKID-I, Strukturiertes klinisches Interview für DSM-IV, Achse I. Göttingen: Hogrefe; 1997.
40.
Jacobson E, Wirth K. Entspannung als Therapie: Progressive Relaxation in Theorie und Praxis. Stuttgart: Klett-Cotta; 2006.
41.
Herrmann-Lingen C, Buss U, Snaith P. HADS-D: Hospital Anxiety and Depression Scale. Deutsche Version. Bern: Huber; 2011.
42.
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale: an updated literature review. J Psychosom Res. 2002;52:69–77.CrossRefPubMed
43.
Franke GH. BSI: Brief Symptom Inventory von L. R. Derogatis. Deutsche Version. Göttingen: Beltz Test; 2000.
44.
Geisheim C, Hahlweg K, Fiegenbaum W, Frank M, Schröder B, von Witzleben I. Das Brief Symptom Inventory (BSI) als Instrument zur Qualitätssicherung in der Psychotherapie. Diagnostica. 2002;48:28–36.CrossRef
45.
Mehnert A, Müller D, Lehmann C, Koch U. Die deutsche Version des NCCN Distress-Thermometers. Z Psychiatr Psych Ps. 2006;54:213–23.
46.
Gessler S, Low J, Daniells E, Williams R, Brough V, Tookman A, et al. Screening for distress in cancer patients: is the distress thermometer a valid measure in the UK and does it measure change over time? A prospective validation study. Psychooncology. 2008;17:538–47.CrossRefPubMed
47.
Thalén-Lindström A, Larsson G, Hellbom M, Glimelius B, Johansson B. Validation of the Distress Thermometer in a Swedish population of oncology patients; accuracy of changes during six months. Eur J Oncol Nurs. 2013;17:625–31.CrossRefPubMed
48.
Veith A, Willutzki U. Eine Revision des Veränderungsfragebogens des Erlebens und Verhaltens (VEV). Berlin: Vortrag auf dem Kongress für Klinische Psychologie und Psychotherapie der Deutschen Gesellschaft für Verhaltenstherapie; 2000.
49.
Zielke M, Kopf-Mehnert C. Veränderungsfragebogen des Erlebens und Verhaltens (VEV). Weinheim: Beltz; 1978.
50.
Bullinger M, Kirchberger I. SF-36: Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe; 1998.
51.
Ware JE, Kosinski M, Keller SD. A 12-item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–33.CrossRefPubMed
52.
Rudolph A, Schütz A, Schröder-Abé M. Validation of a 15-item German version of the State Self-Esteem Scale. Berlin: XXIX International Congress of Psychology; 2008.
53.
Flückiger C, Regli D, Zwahlen D, Hostettler S, Caspar F. Der Berner Patienten- und Therapeutenstundenbogen 2000. Z Kl Psych Psychoth. 2010;39:71–9.CrossRef
54.
Klauer T, Filipp S. Trierer Skalen der Krankheitsbewältigung (TSK): Handanweisung. Göttingen: Hogrefe; 1993.
55.
Dörner U, Muthny FA. Testgüte-Vergleich von zwei Instrumenten zur Krankheitsverarbeitung in der kardiologischen Rehabilitation – Trierer Skalen zur Krankheitsbewältigung (TSK) und Freiburger Fragebogen zur Krankheitsverarbeitung (FKV). Z Med Psychol. 2008;17:125–32.
56.
Cohen J. Statistical power analysis for the behavioral sciences. Hillsdale: L Erlbaum Associates; 1988.
57.
Faul F, Erdfelder E, Lang A, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39:175–91.CrossRefPubMed
58.
Hair JF, Black WC, Babin BJ, Anderson RE. Multivariate data analysis: a global perspective. Upper Saddle River, NJ: Pearson; 2010.
59.
Cho A, Leonhart R. Lösungsansätze für das Problem fehlender Werte: Mechanismen erkennen und adäquat behandeln. Rehabilitation. 2011;52:273–9.
60.
Hautzinger M. Akute Depression. Göttingen: Hogrefe; 2010.
61.
Hammer M. SBT: Stressbewältigungstraining für psychisch kranke Menschen: Ein Handbuch zur Moderation von Gruppen. Bonn: Psychiatrie-Verlag; 2010.
62.
Fuchs R, Goehner W, Seelig H. Long-term effects of a psychological group intervention on physical exercise and health: the MoVo Concept. J Phys Act Health. 2011;8:794–803.CrossRefPubMed
63.
Ellis A. Die rational-emotive Therapie: Das innere Selbstgespräch bei seelischen Problemen und seine Veränderung. München: Pfeiffer; 1993.
64.
Hautzinger M. Kognitive Verhaltenstherapie bei Depressionen. Weinheim: Beltz, 2013.
65.
66.
Potreck-Rose F, Jacob G. Selbstzuwendung, Selbstakzeptanz, Selbstvertrauen: Psychotherapeutische Interventionen zum Aufbau von Selbstwertgefühl. Stuttgart: Klett-Cotta; 2014.
Metadata
Title
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
Authors
Miriam Ruesch
Almut Wiebke Helmes
Juergen Bengel
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0801-3

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Study protocol

Integrating smoking cessation and alcohol use treatment in homeless populations: study protocol for a randomized controlled trial

Study protocol

Extended brief intervention to address alcohol misuse in people with mild to moderate intellectual disabilities living in the community (EBI-ID): study protocol for a randomised controlled trial

Study protocol

Minocycline as an adjunct for treatment-resistant depressive symptoms: study protocol for a pilot randomised controlled trial

Study protocol

The effects of a protein enriched diet with lean red meat combined with a multi-modal exercise program on muscle and cognitive health and function in older adults: study protocol for a randomised controlled trial

Research

Effectiveness of three oral hygiene regimens on oral malodor reduction: a randomized clinical trial

Study protocol

The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial