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)

Complementary psychological care is recommended for COPD, as it significantly reduces anxiety and boosts the pulmonary rehabilitation efficacy. In a precedent trial (HYPNORPCO_1,1SRCTN10029862), 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 Hospitaller 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 (STAY-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 STAT-6 retests, re-hospitalisation rate, action plan use and persistence in self-hypnosis use, throughout the 12 weeks ensuing PRP completion.