Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trialReport as inadecuate




Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 15:112

First Online: 06 April 2014Received: 13 November 2013Accepted: 12 March 2014DOI: 10.1186-1745-6215-15-112

Cite this article as: Gensichen, J., Hiller, T.S., Breitbart, J. et al. Trials 2014 15: 112. doi:10.1186-1745-6215-15-112

Abstract

BackgroundPanic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness.

Methods-DesignThis is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia 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. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline T0, at follow-up after six months T1, and at follow-up after twelve months T2. The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory BAI. To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs.

Trial registrationCurrent Controlled Trials http:-ISCRTN64669297

KeywordsPanic disorder Agoraphobia Case management Primary health care General practice AbbreviationsBAIBeck Anxiety Inventory

BDSGGerman Federal Data Security Law

CBTcognitive behavioural therapy

CCMcollaborative chronic care models

CRFcase report form

CSSRIClient Sociodemographic and Service Receipt Inventory

EQ-5DEuroQol questionnaire

GPgeneral practitioner

HCAhealth care assistant

ICD-10International Classification of Diseases, version 10

ICERincremental cost-effectiveness ratio, ICH, International Conference on Harmonisation

MIMobility Inventory

OASISOverall Anxiety Severity and Impairment Scale

PACICPatient Assessment of Chronic Illness Care questionnaire

PASPanic and Agoraphobia Scale

PHQPatient Health Questionnaire

PDpanic disorder

PD-AGpanic disorder with or without agoraphobia

QALYsquality adjusted life years.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-112 contains supplementary material, which is available to authorized users.

Jochen Gensichen, Thomas S Hiller contributed equally to this work.

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Author: Jochen Gensichen - Thomas S Hiller - Jörg Breitbart - Tobias Teismann - Christian Brettschneider - Ulrike Schumacher - Ale

Source: https://link.springer.com/







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