Efficacy of Self-administered Hypnosis for the Complementary Management of Anxiety and Dyspnea During Pulmonary Rehabilitation: A 2-armed Randomized Controlled Trial

Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent and debilitating respiratory condition characterized by chronic airflow limitation, increased respiratory rate, dyspnea and other persistent respiratory symptoms. Growing evidence associates dyspnea to a higher risk of experiencing anxiety, depression and suicidality. In stable COPD, the prevalence of clinical depression ranges between 10% and 42%, and prevalence of anxiety between 10% and 19%. A definitive causal link between these conditions can be hard to establish: symptoms of depression, anxiety and COPD frequently overlap. However, the management of these comorbidities in tandem with COPD is of central importance, as evidence has shown that the alleviation of anxiety symptoms can improve COPD prognosis and increase rehabilitation completion rates. The American Thoracic Society consensus statements on COPD have acknowledged that medical and pharmacological treatments, when used alone, are of limited efficacy for the relief of dyspnea and anxiety in people with advanced COPD. Psychological and complementary management of COPD has been strongly encouraged, and evidence in its favor has been promising so far. Furthermore, because of the interactions between anxiety, depression and chronic dyspnea, it has been proposed that proper assessment and comprehensive management of COPD could constitute a Human Rights matter, and psychological care together with well-informed choice of intervention should be a fundamental complement to standard treatment. The GOLD initiative for COPD acknowledges the benefits from cognitive behavioral therapy and mind-body interventions (mindfulness-based therapy, yoga, relaxation and others) for managing anxiety and depression in patients with COPD. However, despite its numerous advantages (rapid effect, easy and fast implementation, virtually no effort required on behalf of the patient) the efficacy of hypnosis for COPD complementary anxiety management remains scarcely evaluated.

In HYPNOBPCO_1, the investigators found that COPD-related anxiety responded positively to hypnosis (vs sham). The investigators found that a scripted, 15-minute hypnosis session improved anxiety levels, respiratory rate and arterial oxygen saturation. In particular, anxiety as assessed through STAI-6 scores (State-Trait Anxiety Inventory - 6 items), decreased a mean percentage of (Standard Deviation [SD]) -23.8% [18.4] after the hypnosis session (χ2=28, Degrees of Freedom=1, P < 0.0001, Bayes Factor = 1212), equivalent to an 11.2 [9.2] point reduction in STAI-6 score. The difference in anxiety improvement between hypnosis and sham was itself significant (χ2=8, DF=1, P < 0.01, BF = 5.5).

HYPNOBPCO_2 seeks to answer some of the queries that were beyond the scope of its predecessor. The investigators intend to evaluate the efficacy of hypnosis as complementary care during a Pulmonary Rehabilitation Program (PRP). This long-duration protocol will focus on the complementary management and self-management of chronic anxiety in COPD patients through hypnosis. The investigators shall evaluate if the positive effects of hypnosis withstand repeated use, persist when hypnosis is self-administered, and estimate their general impact on psychological and physiological outcomes of COPD patients admitted for a PRP in the PRP conducted by the Centre Hospitalier de Bligny (CHB).

**Baseline Characteristics**

Information other than clinical endpoints of interest is included, to control for confounds and ensure both arms remain comparable: