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

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Affective Disorder | Study protocol

eHealth-supported case management for patients with panic disorder or depression in primary care: Study protocol for a cRCT (PREMA)

Authors: Karoline Lukaschek, Karola Mergenthal, Dirk Heider, Alexander Hanke, Kathrein Munski, Anne Moschner, Michelle Emig, Marjan van den Akker, Antonia Zapf, Karl Wegscheider, Hans-Helmut König, Jochen Gensichen, for the PREMA-study group

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

Panic disorder (PD), frequently occurring with agoraphobia (AG), and depression are common mental disorders in primary care and associated with considerable individual and societal costs. Early detection and effective treatment of depression and PD/AG are of major importance. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety and depressive symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study aims at evaluating the effects and cost-effectiveness of a primary care team-based intervention using behavioural therapy elements and case management supported by eHealth components in patients with PD/AG or depression compared to treatment as usual.

Methods/design

This is a two-arm cluster-randomized, controlled trial (cRCT). General practices represent the units of randomisation. General practitioners recruit adult patients with depression and PD ± AG according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. Practice teams and patients are supported by eHealth components. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after 6 months (T1), and at follow-up after 12 months (T2). The primary outcome is the mental health status of patients as measured by the Mental Health Index (MHI-5). Effect sizes of 0.2 standard deviation (SD) are regarded as relevant. Assuming a drop-out rate of 20% of practices and patients each, we aim at recruiting 1844 patients in 148 primary care practices. This corresponds to 12.5 patients on average per primary care practice. Secondary outcomes include depression and anxiety-related clinical parameters and health-economic costs.

Discussion

If the intervention is more effective than treatment as usual, the three-component (cognitive behaviour therapy, case-management, eHealth) primary care-based intervention for patients suffering from PD/AG or depression could be a valuable low-threshold option that benefits patients and primary care practice teams.

Trial registration

German clinical trials register, DRKS00016622. Registered on February 22nd, 2019.
Appendix
Available only for authorised users
Literature
1.
Goodwin RD, Faravelli C, Rosi S, Cosci F, Truglia E, de Graaf R, Wittchen HU. The epidemiology of panic disorder and agoraphobia in Europe. Eur Neuropsychopharmacol. 2005;15(4):435–43.PubMedCrossRef
2.
Wittchen HU, Reed V, Kessler RC. The relationship of agoraphobia and panic in a community sample of adolescents and young adults. Arch Gen Psychiatry. 1998;55(11):1017–24.PubMedCrossRef
3.
Jacobi F, Hofler M, Siegert J, Mack S, Gerschler A, Scholl L, Busch MA, Hapke U, Maske U, Seiffert I, et al. Twelve-month prevalence, comorbidity and correlates of mental disorders in Germany: the Mental Health Module of the German Health Interview and Examination Survey for Adults (DEGS1-MH). Int J Methods Psychiatr Res. 2014;23(3):304–19.PubMedCrossRefPubMedCentral
4.
Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jonsson B, Olesen J, Allgulander C, Alonso J, Faravelli C, et al. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011;21(9):655–79.PubMedCrossRef
5.
Gustavsson A, Svensson M, Jacobi F, Allgulander C, Alonso J, Beghi E, Dodel R, Ekman M, Faravelli C, Fratiglioni L, et al. Cost of disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011;21(10):718–79.PubMedCrossRef
6.
Alonso J, Angermeyer MC, Bernert S, Bruffaerts R, Brugha TS, Bryson H, de Girolamo G, Graaf R, Demyttenaere K, Gasquet I, et al. 12-Month comorbidity patterns and associated factors in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand Suppl. 2004;420:28–37.
7.
Katon W, Schulberg H. Epidemiology of depression in primary care. Gen Hosp Psychiatry. 1992;14(4):237–47.PubMedCrossRef
8.
Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007;146(5):317–25.PubMedCrossRef
9.
Schneider F, Härter M, Schorr S. S3-Leitlinie/Nationale VersorgungsLeitlinie Unipolare Depression. Berlin Heidelberg: Springer-Verlag; 2017.
10.
11.
Bandelow B, Wiltink J, Alpers GW, Benecke C, Deckert J, Eckhardt-Henn A, Ehrig C, Engel K, Falkai P, Geiser F. Deutsche S3-Leitlinie Behandlung von Angststörungen; 2014.
12.
Melchior H, Schulz H, Härter M, Walker J, Ganninger M. Faktencheck Gesundheit–Regionale Unterschiede in der Diagnostik und Behandlung von Depressionen. Bertelsmann Stiftung: Gütersloh; 2014.
13.
14.
15.
Carey M, Noble N, Mansfield E, Waller A, Henskens F, Sanson-Fisher R. The role of eHealth in optimizing preventive care in the primary care setting. J Med Internet Res. 2015;17(5):e126.PubMedPubMedCentralCrossRef
16.
Furukawa TA, Watanabe N, Churchill R. Combined psychotherapy plus antidepressants for panic disorder with or without agoraphobia. Cochrane Database Syst Rev. 2007;1:CD004364.
17.
Mitte K. A meta-analysis of the efficacy of psycho- and pharmacotherapy in panic disorder with and without agoraphobia. J Affect Disord. 2005;88(1):27–45.PubMedCrossRef
18.
Craske M. Cognitive-behavioral therapy. New York: APA Books; 2010.
19.
Sanchez-Meca J, Rosa-Alcazar AI, Marin-Martinez F, Gomez-Conesa A. Psychological treatment of panic disorder with or without agoraphobia: a meta-analysis. Clin Psychol Rev. 2010;30(1):37–50.PubMedCrossRef
20.
Cuijpers P, Schuurmans J. Self-help interventions for anxiety disorders: an overview. Curr Psychiatry Rep. 2007;9(4):284–90.PubMedCrossRef
21.
Seekles W, van Straten A, Beekman A, van Marwijk H, Cuijpers P. Effectiveness of guided self-help for depression and anxiety disorders in primary care: a pragmatic randomized controlled trial. Psychiatry Res. 2011;187(1–2):113–20.PubMedCrossRef
22.
Van't Hof E, Cuijpers P, Stein DJ. Self-help and Internet-guided interventions in depression and anxiety disorders: a systematic review of meta-analyses. CNS Spectr. 2009;14(2 Suppl 3):34–40.CrossRef
23.
Morgan AJ, Jorm AF. Self-help interventions for depressive disorders and depressive symptoms: a systematic review. Ann General Psychiatry. 2008;7:13.CrossRef
24.
Seekles W, Cuijpers P, Kok R, Beekman A, van Marwijk H, van Straten A. Psychological treatment of anxiety in primary care: a meta-analysis. Psychol Med. 2013;43(2):351–61.PubMedCrossRef
25.
Hoifodt RS, Strom C, Kolstrup N, Eisemann M, Waterloo K. Effectiveness of cognitive behavioural therapy in primary health care: a review. Fam Pract. 2011;28(5):489–504.PubMedCrossRef
26.
Archer J, Bower P, Gilbody S, Lovell K, Richards D, Gask L, Dickens C, Coventry P. Collaborative care for depression and anxiety problems. Cochrane Database Syst Rev. 2012;10:CD006525.PubMed
27.
Gensichen J, Beyer M, Muth C, Gerlach FM, Von Korff M, Ormel J. Case management to improve major depression in primary health care: a systematic review. Psychol Med. 2006;36(1):7–14.PubMedCrossRef
28.
Gensichen J, Hiller TS, Breitbart J, Brettschneider C, Teismann T, Schumacher U, Lukaschek K, Schelle M, Schneider N, Sommer M, et al. Panic disorder in primary care. Dtsch Arztebl Int. 2019;116(10):159–66.PubMed
29.
Gensichen J, Von Korff M, Rutter CM, Seelig MD, Ludman EJ, Lin EH, Ciechanowski P, Young BA, Wagner EH, Katon WJ. Physician support for diabetes patients and clinical outcomes. BMC Public Health. 2009;9:367.PubMedPubMedCentralCrossRef
30.
Bundespsychotherapeutenkammer: Ein Jahr nach der Reform der Psychotherapie-Richtlinie. Wartezeiten 2018. 2018.
31.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, Medical Research Council G. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.PubMedPubMedCentralCrossRef
32.
Bundesärztekammer: (Muster-)KursbuchPsychosomatische Grundversorgungmit integriertem Fortbildungscurriculum Patientenzentrierte Kommunikation; 2018.
33.
Chan AW, Tetzlaff JM, Altman DG, Dickersin K, Moher D. SPIRIT 2013: new guidance for content of clinical trial protocols. Lancet. 2013;381(9861):91–2.PubMedCrossRef
34.
35.
Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004;81(1):61–6.PubMedCrossRef
36.
Campbell-Sills L, Norman SB, Craske MG, Sullivan G, Lang AJ, Chavira DA, Bystritsky A, Sherbourne C, Roy-Byrne P, Stein MB. Validation of a brief measure of anxiety-related severity and impairment: the Overall Anxiety Severity and Impairment Scale (OASIS). J Affect Disord. 2009;112(1–3):92–101.PubMedCrossRef
37.
Norman SB, Campbell-Sills L, Hitchcock CA, Sullivan S, Rochlin A, Wilkins KC, Stein MB. Psychometrics of a brief measure of anxiety to detect severity and impairment: the Overall Anxiety Severity and Impairment Scale (OASIS). J Psychiatr Res. 2011;45(2):262–8.PubMedCrossRef
38.
Hiller TS, Freytag A, Breitbart J, Teismann T, Schone E, Blank W, Schelle M, Vollmar HC, Margraf J, Gensichen J, et al. The Jena Anxiety Monitoring List (JAMoL) - a tool for the evidence-based treatment of panic disorder with or without agoraphobia in primary care. Z Evid Fortbild Qual Gesundhwes. 2018;131-132:28–37.PubMedCrossRef
39.
Gensichen J, Peitz M, Torge M, Mosig-Frey J, Wendt-Hermainski H, Rosemann T, Gerlach FM, Lowe B. The “Depression Monitoring list” (DeMoL) with integrated PHQ-D-Rationale and design of a tool for the case management for depression in primary care. Z Arztl Fortbild Qualitatssich. 2006;100(5):375–82.PubMed
40.
Berwick DM, Murphy JM, Goldman PA, Ware JE Jr, Barsky AJ, Weinstein MC. Performance of a five-item mental health screening test. Med Care. 1991;29(2):169–76.PubMedCrossRef
41.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473–83.PubMedCrossRef
42.
Means-Christensen AJ, Arnau RC, Tonidandel AM, Bramson R, Meagher MW. An efficient method of identifying major depression and panic disorder in primary care. J Behav Med. 2005;28(6):565–72.PubMedCrossRef
43.
Lowe B, Grafe K, Zipfel S, Spitzer RL, Herrmann-Lingen C, Witte S, Herzog W. Detecting panic disorder in medical and psychosomatic outpatients: comparative validation of the Hospital Anxiety and Depression Scale, the Patient Health Questionnaire, a screening question, and physicians’ diagnosis. J Psychosom Res. 2003;55(6):515–9.PubMedCrossRef
44.
Bandelow B. Panik- und Agoraphobie-Skala (PAS). Göttingen: Hogrefe; 1997.
45.
Chambless DL, Caputo GC, Jasin SE, Gracely EJ, Williams C. The Mobility Inventory for Agoraphobia. Behav Res Ther. 1985;23(1):35–44.PubMedCrossRef
46.
Rosemann T, Korner T, Wensing M, Schneider A, Szecsenyi J. Evaluation and cultural adaptation of a German version of the AIMS2-SF questionnaire (German AIMS2-SF). Rheumatology (Oxford). 2005;44(9):1190–5.CrossRef
47.
Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24(1):67–74.PubMedCrossRef
48.
Liu CF, Hedrick SC, Chaney EF, Heagerty P, Felker B, Hasenberg N, Fihn S, Katon W. Cost-effectiveness of collaborative care for depression in a primary care veteran population. Psychiatr Serv. 2003;54(5):698–704.PubMedCrossRef
49.
Katon W, Russo J, Sherbourne C, Stein MB, Craske M, Fan MY, Roy-Byrne P. Incremental cost-effectiveness of a collaborative care intervention for panic disorder. Psychol Med. 2006;36(3):353–63.PubMedCrossRef
50.
51.
van Walraven C, Austin PC, Jennings A, Quan H, Forster AJ. A modification of the Elixhauser comorbidity measures into a point system for hospital death using administrative data. Med Care. 2009;47(6):626–33.PubMedCrossRef
52.
53.
Linnan L, Steckler A. Process evaluation for public health interventions and research. An overview. In: Allan B, Steckler LL, editors. Process evaluation for public health interventions and research. San Francisco: Jossey-Bass; 2002;1–23.
54.
Gensichen J, von Korff M, Peitz M, Muth C, Beyer M, Guthlin C, Torge M, Petersen JJ, Rosemann T, Konig J, et al. Case management for depression by health care assistants in small primary care practices: a cluster randomized trial. Ann Intern Med. 2009;151(6):369–78.PubMedCrossRef
Metadata
Title
eHealth-supported case management for patients with panic disorder or depression in primary care: Study protocol for a cRCT (PREMA)
Authors
Karoline Lukaschek
Karola Mergenthal
Dirk Heider
Alexander Hanke
Kathrein Munski
Anne Moschner
Michelle Emig
Marjan van den Akker
Antonia Zapf
Karl Wegscheider
Hans-Helmut König
Jochen Gensichen
for the PREMA-study group
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3751-3

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Effects of combining functional exercises with exercise training on daily physical activities and functionality in patients with COPD: a protocol for a randomized clinical trial

Study protocol

A central nervous system-focused treatment approach for people with frozen shoulder: protocol for a randomized clinical trial

Research

Using an incentive spirometer reduces pulmonary complications in patients with traumatic rib fractures: a randomized controlled trial

Study protocol

Eye movement desensitization and reprocessing (EMDR) therapy for posttraumatic stress disorder in adults with serious mental illness within forensic and rehabilitation services: a study protocol for a randomized controlled trial

Study protocol

Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training

Study protocol

Online Social anxiety Cognitive therapy for Adolescents (OSCA): protocol for a randomised controlled trial