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Hypnosis for the management of COPD-related anxiety and dyspnoea in pulmonary rehabilitation: rationale and design for a cluster-randomised, active-control trial (HYPNOBPCO_2).

ABSTRACT: Complementary psychological care is recommended for COPD, as it significantly reduces anxiety and boosts the pulmonary rehabilitation efficacy. In a precedent trial (HYPNOBPCO_1, ISRCTN10029862), administering a single hypnosis session was linked to reduced anxiety and improved breathing mechanics in intermediate and advanced COPD patients. However, whether hypnosis could improve self-management of anxiety and dyspnoea in COPD during pulmonary rehabilitation is yet to be investigated. This is the protocol for HYPNOBPCO_2, a 2-arm, cluster-randomised, statistician-blinded superiority monocentre trial (NCT04868357). Its aim is to assess the efficacy of hypnosis as a tool to manage anxiety and dyspnoea during a pulmonary rehabilitation programme (PRP). Clusters of COPD patients eligible for the conventional hospital-based PRP at the Centre Hospitalier de Bligny (CHB) will be randomised and evenly allocated into two parallel arms: "Hypnosis" (treatment) and "Relaxation" (active control). "Hypnosis" will consist of the CHB's conventional 4-week group PRP, supplemented by two educational sessions for teaching self-hypnosis. "Relaxation" will be identical, except standard relaxation exercises will be taught instead. Primary end-point will consist of assessing weekly changes in anxiety throughout the PRP, additional to total anxiety change after treatment completion. Anxiety will be determined by the six-item version of the State-Trait Anxiety Inventory (STAI-6). Secondary outcomes will include change in the 6-min walk test and the COPD assessment test (CAT). Further follow-up outcomes will include CAT and STAI-6 retests, re-hospitalisation rate, action plan use and persistence in self-hypnosis use, throughout the 12 weeks ensuing PRP completion.

SUBMITTER: Anllo H

PROVIDER: S-EPMC8819244 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Hypnosis for the management of COPD-related anxiety and dyspnoea in pulmonary rehabilitation: rationale and design for a cluster-randomised, active-control trial (HYPNOBPCO_2).

Anlló Hernán H Herer Bertrand B Delignières Agathe A Ghergan Adelina A Bocahu Yolaine Y Segundo Isabelle I Moulin Cécile C Larue François F

ERJ open research 20210207 1

Complementary psychological care is recommended for COPD, as it significantly reduces anxiety and boosts the pulmonary rehabilitation efficacy. In a precedent trial (HYPNOBPCO_1, ISRCTN10029862), administering a single hypnosis session was linked to reduced anxiety and improved breathing mechanics in intermediate and advanced COPD patients. However, whether hypnosis could improve self-management of anxiety and dyspnoea in COPD during pulmonary rehabilitation is yet to be investigated. This is th ...[more]

PMID: 35141317

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Project description:BackgroundPulmonary rehabilitation (PR) is a core component of management people with chronic obstructive pulmonary disease (COPD); yet, people with COPD face significant barriers to attending centre-based PR programs. The emergence of new models of PR, remotely delivered directly into people's homes, has the potential to improve rehabilitation access and completion by providing patients with a choice of rehabilitation location (centre or home). However, offering patients a choice of rehabilitation model is not usual practice. We are undertaking a 14-site cluster randomised controlled trial to determine whether offering choice of PR location improves rehabilitation completion rates resulting in reduced all-cause unplanned hospitalisation over 12 months. The aim of this paper is to describe the protocol for the process evaluation of the HomeBase2 trial.MethodsA mixed methods process evaluation, to be undertaken in real time, has been developed in accordance with UK Medical Research Council (MRC) recommendations on process evaluation of complex interventions. This protocol describes the intended use of two theoretical frameworks (RE-AIM framework (Reach; Effectiveness; Adoption; Implementation; Maintenance) and Theoretical Domains Framework (TDF)) to synthesise findings and interpret data from a combination of qualitative (semi-structured interviews) and quantitative (questionnaires, clinical outcome data, intervention fidelity) methodologies. Data will be collected at an intervention, patient and clinician level. Qualitative and quantitative data will be used to derive context-specific potential and actual barriers and facilitators to offering patients choice of rehabilitation location. Acceptability and sustainability of the intervention will be evaluated for future scale-up.DiscussionThe process evaluation described here will appraise the clinical implementation of offering a choice of rehabilitation program location for people with COPD. It will identify and evaluate key factors for future scale-up and sustainability and scale-up of offering choice of pulmonary rehabilitation program model for people.Trial registrationClinicalTrials.gov NCT04217330 Registration date: January 3 2020.

Project description:BackgroundRehabilitation of patients with chronic obstructive pulmonary disease (COPD) is a key treatment in COPD. However, despite the existing evidence and a strong recommendation from lung associations worldwide, 50% of patients with COPD decline to participate in COPD rehabilitation program and 30-50% drop-out before completion. The main reasons are severe symptoms, inflexible accessibility and necessity for transportation. Currently there are no well-established and evident rehabilitation alternatives. Supervised online screen rehabilitation could be a useful approach to increase accessibility and compliance. The aim of this multicenter RCT study is to compare the potential benefits of a 10-week online COPD rehabilitation program (CORe) with conventional outpatient COPD rehabilitation (CCRe).MethodsThis study is a randomized assessor- and statistician blinded superiority multicenter trial with two parallel groups, employing 1:1 allocation to the intervention and the comparison group.On the basis of a sample size calculation, 134 patients with severe or very severe COPD and eligible to conventional hospital based outpatient COPD rehabilitation will be included and randomized from eight different hospitals. The CORe intervention group receives group supervised resistance- and endurance training and patient education, 60 min, three times/week for 10 weeks at home via online-screen. The CCRe comparison group receives group based supervised resistance- and endurance training and patient education, 90 min, two times/week for 10 weeks (two hospitals) or 12 weeks (six hospitals) in groups at the local hospital. The primary outcome is change in the 6-min walking distance after 10/12 weeks; the secondary outcomes are changes in 30 s sit-to-stand chair test, physical activity level, symptoms, anxiety and depression symptoms, disease specific and generic quality of life. Primary endpoint is 10/12 weeks from baseline, while secondary endpoints are 22, 36, 62 weeks from baseline assessments.DiscussionThe study will likely contribute to knowledge regarding COPD tele-rehabilitation and to which extent it is more feasible and thereby more efficient than conventional COPD rehabilitation in patients with severe and very severe COPD.Trial registrationClinicaltrials.gov Identifier: NCT02667171 . Registration data: January 28th 2016.

Dataset Information

Hypnosis for the management of COPD-related anxiety and dyspnoea in pulmonary rehabilitation: rationale and design for a cluster-randomised, active-control trial (HYPNOBPCO_2).

Publications

Hypnosis for the management of COPD-related anxiety and dyspnoea in pulmonary rehabilitation: rationale and design for a cluster-randomised, active-control trial (HYPNOBPCO_2).

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