title: Efficacy of a minimal home-based psychoeducative intervention versus usual care for managing anxiety and dyspnoea in patients with severe chronic obstructive pulmonary disease: a randomised controlled trial protocol.
abstract: BACKGROUND
  In its final stages, chronic obstructive pulmonary disease is a severely disabling condition that is characterised by dyspnoea, which causes substantial anxiety. Anxiety is associated with an impaired quality of life and increased hospital admissions. Untreated comorbid anxiety can have devastating consequences for both patients and their relatives. Non-pharmacological interventions, including cognitive-behavioural therapy, have been effective in managing anxiety and dyspnoea in patients with chronic obstructive pulmonary disease. However, the majority of existing interventions have tested the efficacy of relatively intensive comprehensive programmes and primarily targeted patients who have moderate pulmonary disease. We present the rationale and design for a trial that focused on addressing the challenges experienced by severe pulmonary disease populations. The trial investigates the efficacy of a minimal home-based psychoeducative intervention versus usual care for patients with severe chronic obstructive pulmonary disease.
  
  
  METHODS
  The trial is a randomised controlled trial with a 4-week and 3-month follow-up. 66 patients with severe chronic obstructive pulmonary disease and associated anxiety will be randomised 1:1 to either an intervention or control group. The intervention consists of a single psychoeducative session in the patient's home in combination with a telephone booster session. The intervention is based on a manual, with a theoretical foundation in cognitive-behavioural therapy and psychoeducation. The primary outcome is patient-reported anxiety as assessed by the Hospital and Anxiety and Depression Scale (HADS).
  
  
  BACKGROUND
  This trial complies with the latest Declaration of Helsinki, and The Ethics Committee of the Capital Region of Denmark (number H-1-2013-092) was queried for ethical approval. Trial results will be disseminated in peer-reviewed publications and presented at scientific conferences.
  
  
  BACKGROUND
  NCT02366390.
authors.affiliation: Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, Nordsjælland, Hillerød, Denmark.
authors.forename: Dorthe Gaby
authors.initials: DG
authors.lastname: Bove
authors.affiliation: Research Unit, Copenhagen University Hospital, Nordsjælland and Metropolitan, Department of Nursing, Copenhagen, Denmark.
authors.forename: Dorthe
authors.initials: D
authors.lastname: Overgaard
authors.affiliation: Faculty of Health Sciences, Department of Clinical Medicine and Department of Public Health, Section for Nursing, Aarhus University, Palle Juul-Jensens Boulevard, Aarhus, Denmark.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Lomborg
authors.affiliation: Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Hvidovre, Denmark.
authors.forename: Bjarne Ørskov
authors.initials: BØ
authors.lastname: Lindhardt
authors.affiliation: Institute of Public Health, University of Copenhagen and Senior Researcher, The University Hospital Centre for Health Research, Copenhagen University Hospital, Rigshospitalet, København, Denmark.
authors.forename: Julie
authors.initials: J
authors.lastname: Midtgaard
mesh_terms: D000223:Adaptation, Psychological; D001007:Anxiety / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D001945:Breathing Exercises; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D004417:Dyspnea / Q000523:psychology / Q000628:therapy*; D005081:Exercise Therapy; D006699:Home Care Services; D006792:House Calls; D006801:Humans; D010353:Patient Education as Topic; D011569:Psychiatric Status Rating Scales; D029424:Pulmonary Disease, Chronic Obstructive / Q000523:psychology* / Q000534:rehabilitation; D012107:Research Design; D013689:Telephone
keywords: PALLIATIVE CARE; REHABILITATION MEDICINE