TY - JOUR

T1 - Efficacy of a minimal home-based psychoeducative intervention versus usual care for managing anxiety and dyspnoea in patients with severe chronic obstructive pulmonary disease

T2 - a randomised controlled trial protocol

AU - Bove, Dorthe Gaby

AU - Overgaard, Dorthe

AU - Lomborg, Kirsten

AU - Lindhardt, Bjarne Ørskov

AU - Midtgaard, Julie

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PY - 2015

Y1 - 2015

N2 - INTRODUCTION: 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 AND ANALYSIS: 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).ETHICS AND DISSEMINATION: 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.TRIAL REGISTRATION NUMBER: NCT02366390.

AB - INTRODUCTION: 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 AND ANALYSIS: 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).ETHICS AND DISSEMINATION: 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.TRIAL REGISTRATION NUMBER: NCT02366390.

KW - Adaptation, Psychological

KW - Anxiety

KW - Breathing Exercises

KW - Cognitive Therapy

KW - Dyspnea

KW - Exercise Therapy

KW - Home Care Services

KW - House Calls

KW - Humans

KW - Patient Education as Topic

KW - Psychiatric Status Rating Scales

KW - Pulmonary Disease, Chronic Obstructive

KW - Research Design

KW - Telephone

U2 - 10.1136/bmjopen-2015-008031

DO - 10.1136/bmjopen-2015-008031

M3 - Journal article

C2 - 26152326

VL - 5

SP - 1

EP - 12

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 7

M1 - e008031

ER -