Efficacy of the Combination of Mindfulness and Buteyko Techniques for the Improvement of Poorly Controlled Asthma.

NCT05593315 | Unknown

• 1 other identifier: IIBSP-MBA-2022-95
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Administration of a combined program for general (Mindfulness) and respiratory (Buteyko technique) relationship in patients with poorly controlled asthma and anxiety/stress to determine if it provides an improvement in current control and future risk of asthma.

Conditions

Asthma; Anxiety; Stress

Keywords

Asthma; Anxiety; Stress; Mindfulness; Buteyko

Outcome Measures

Primary Outcomes (2)

• % patients with changed asthma control

  Changes in asthma symptoms measured with the asthma control test (minimum 5 as worse value; maximum 25, as the best value)

  1 year

• Changes in asthma exacerbation

  Changes in asthma exacerbation measured by number of hospital admissions and medical treatments received

  1 year

Secondary Outcomes (5)

• Anxiety

  1 year

• Functional dyspnea

  1 year

• Pulmonary function

  1 year

• Bronchial inflammation

  1 year

• Therapeutic adherence of patients to inhalers

  1 year

Study Arms (1)

Mindfulness and Buteyko techniques

OTHER

A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards).

Other: Mindfulness and Buteyko techniques

Interventions

Mindfulness and Buteyko techniques OTHER

Joint implementation of a general relaxation program and a respiratory rehabilitation program in patients with poorly controlled asthma.

Mindfulness and Buteyko techniques

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of poorly controlled asthma
• In treatment with a combination of ICS/LABA at medium doses
• Anxiety and/or functional dyspnea
• Attended in the outpatient consultations of the Asthma Unit of the Pneumology and Allergy Service of the Hospital de la Santa Creu i Sant Pau in Barcelona

You may not qualify if:

• Severe asthma exacerbation in the last 30 days
• Severe disabling comorbidity
• Severe psychiatric illness
• Inability to complete questionnaires.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.

Barcelona, 08041, Spain

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Asthma; Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Vicente Plaza Moral, PhD

CONTACT

+34 93 556 56 01; vplaza@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards).

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 25, 2022
• Study Start: March 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

ES (1)