Back to resultsEfficacy of the Combination of Mindfulness and Buteyko Techniques for the Improvement of Poorly Controlled Asthma.
Primary Purpose
Asthma, Anxiety, Stress
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness and Buteyko techniques
Sponsored by
About this trial
This is an interventional other trial for Asthma focused on measuring Asthma, Anxiety, Stress, Mindfulness, Buteyko
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Severe asthma exacerbation in the last 30 days
- Severe disabling comorbidity
- Severe psychiatric illness
- Inability to complete questionnaires.
Sites / Locations
- Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.Recruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mindfulness and Buteyko techniques
Arm Description
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).
Outcomes
Primary Outcome Measures
% 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)
Changes in asthma exacerbation
Changes in asthma exacerbation measured by number of hospital admissions and medical treatments received
Secondary Outcome Measures
Anxiety
Improvement of the anxiety level measured with the test hospital anxiety and depression scale (minimum 0 as the best value, maximum 42 as the worst value)
Functional dyspnea
Changes in functional dyspnea measured with the test Nijmegen (minimum 0 as the worst value, maximum 64 as the worst value)
Pulmonary function
Changes in pulmonary function with spirometry (Forced Expiratory Volume in 1 Second and forced vital capacity)
Bronchial inflammation
Changes in bronchial inflammation with FENO
Therapeutic adherence of patients to inhalers
Changes in therapeutic adherence of patients to inhalers with the "Inhaler Adhesion Test"
Full Information
NCT ID
NCT05593315
First Posted
October 10, 2022
Last Updated
March 15, 2023
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT05593315
Brief Title
Efficacy of the Combination of Mindfulness and Buteyko Techniques for the Improvement of Poorly Controlled Asthma.
Official Title
Efficacy of the Combination of General Relaxation (Mindfulness) and Respiratory (Buteyko) Techniques for the Improvement of Poorly Controlled Asthma. The MBA Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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). Patients will be visited 4 times (at inclusion, one month, 6 months and 12 months after the double intervention), where data on asthmatic morbidity, pulmonary function (spirometry), bronchial inflammation (FENO) will be collected and some questionnaires will be administered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Anxiety, Stress
Keywords
Asthma, Anxiety, Stress, Mindfulness, Buteyko
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness and Buteyko techniques
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Mindfulness and Buteyko techniques
Intervention Description
Joint implementation of a general relaxation program and a respiratory rehabilitation program in patients with poorly controlled asthma.
Primary Outcome Measure Information:
Title
% patients with changed asthma control
Description
Changes in asthma symptoms measured with the asthma control test (minimum 5 as worse value; maximum 25, as the best value)
Time Frame
1 year
Title
Changes in asthma exacerbation
Description
Changes in asthma exacerbation measured by number of hospital admissions and medical treatments received
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Anxiety
Description
Improvement of the anxiety level measured with the test hospital anxiety and depression scale (minimum 0 as the best value, maximum 42 as the worst value)
Time Frame
1 year
Title
Functional dyspnea
Description
Changes in functional dyspnea measured with the test Nijmegen (minimum 0 as the worst value, maximum 64 as the worst value)
Time Frame
1 year
Title
Pulmonary function
Description
Changes in pulmonary function with spirometry (Forced Expiratory Volume in 1 Second and forced vital capacity)
Time Frame
1 year
Title
Bronchial inflammation
Description
Changes in bronchial inflammation with FENO
Time Frame
1 year
Title
Therapeutic adherence of patients to inhalers
Description
Changes in therapeutic adherence of patients to inhalers with the "Inhaler Adhesion Test"
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Severe asthma exacerbation in the last 30 days
Severe disabling comorbidity
Severe psychiatric illness
Inability to complete questionnaires.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vicente Plaza Moral, PhD
Phone
+34 93 556 56 01
Ext
5971
Email
vplaza@santpau.cat
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Plaza, MD
Phone
+34-935565972
Email
vplaza@santpau.cat
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The plan to share IPD is undecided
Citations:
PubMed Identifier
16772035
Citation
Partridge MR, van der Molen T, Myrseth SE, Busse WW. Attitudes and actions of asthma patients on regular maintenance therapy: the INSPIRE study. BMC Pulm Med. 2006 Jun 13;6:13. doi: 10.1186/1471-2466-6-13.
Results Reference
result
PubMed Identifier
22726416
Citation
Olaguibel JM, Quirce S, Julia B, Fernandez C, Fortuna AM, Molina J, Plaza V; MAGIC Study Group. Measurement of asthma control according to Global Initiative for Asthma guidelines: a comparison with the Asthma Control Questionnaire. Respir Res. 2012 Jun 22;13(1):50. doi: 10.1186/1465-9921-13-50.
Results Reference
result
PubMed Identifier
24921985
Citation
Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014 Jun 12;24:14009. doi: 10.1038/npjpcrm.2014.9.
Results Reference
result
PubMed Identifier
19733042
Citation
Di Marco F, Verga M, Santus P, Giovannelli F, Busatto P, Neri M, Girbino G, Bonini S, Centanni S. Close correlation between anxiety, depression, and asthma control. Respir Med. 2010 Jan;104(1):22-8. doi: 10.1016/j.rmed.2009.08.005. Epub 2009 Sep 4.
Results Reference
result
PubMed Identifier
16085217
Citation
Heaney LG, Conway E, Kelly C, Gamble J. Prevalence of psychiatric morbidity in a difficult asthma population: relationship to asthma outcome. Respir Med. 2005 Sep;99(9):1152-9. doi: 10.1016/j.rmed.2005.02.013. Epub 2005 Mar 23.
Results Reference
result
PubMed Identifier
35123357
Citation
Ji Z, Lopez-de-Andres A, Jimenez-Garcia R, Maestre-Miquel C, Zamorano-Leon JJ, Scarano-Pereira JP, Fuentes-Alonso M, Giron-Matute WI, de Miguel-Diez J. Mental health in patients with asthma: A population-based case-control study. Respir Med. 2022 Mar;193:106758. doi: 10.1016/j.rmed.2022.106758. Epub 2022 Jan 31.
Results Reference
result
PubMed Identifier
20100028
Citation
Wisnivesky JP, Lorenzo J, Feldman JM, Leventhal H, Halm EA. The relationship between perceived stress and morbidity among adult inner-city asthmatics. J Asthma. 2010 Feb;47(1):100-4. doi: 10.3109/02770900903426989.
Results Reference
result
PubMed Identifier
19285771
Citation
Janssens T, Verleden G, De Peuter S, Van Diest I, Van den Bergh O. Inaccurate perception of asthma symptoms: a cognitive-affective framework and implications for asthma treatment. Clin Psychol Rev. 2009 Jun;29(4):317-27. doi: 10.1016/j.cpr.2009.02.006. Epub 2009 Mar 4.
Results Reference
result
PubMed Identifier
15919008
Citation
Martinez-Moragon E, Perpina M, Belloch A, de Diego A. [Prevalence of hyperventilation syndrome in patients treated for asthma in a pulmonology clinic]. Arch Bronconeumol. 2005 May;41(5):267-71. doi: 10.1016/s1579-2129(06)60221-8. Spanish.
Results Reference
result
PubMed Identifier
28137495
Citation
Veidal S, Jeppegaard M, Sverrild A, Backer V, Porsbjerg C. The impact of dysfunctional breathing on the assessment of asthma control. Respir Med. 2017 Feb;123:42-47. doi: 10.1016/j.rmed.2016.12.008. Epub 2016 Dec 18.
Results Reference
result
PubMed Identifier
32056838
Citation
Sedeh FB, Von Bulow A, Backer V, Bodtger U, Petersen US, Vest S, Hull JH, Porsbjerg C. The impact of dysfunctional breathing on the level of asthma control in difficult asthma. Respir Med. 2020 Mar;163:105894. doi: 10.1016/j.rmed.2020.105894. Epub 2020 Feb 8.
Results Reference
result
PubMed Identifier
29248433
Citation
Bruton A, Lee A, Yardley L, Raftery J, Arden-Close E, Kirby S, Zhu S, Thiruvothiyur M, Webley F, Taylor L, Gibson D, Yao G, Stafford-Watson M, Versnel J, Moore M, George S, Little P, Djukanovic R, Price D, Pavord ID, Holgate ST, Thomas M. Physiotherapy breathing retraining for asthma: a randomised controlled trial. Lancet Respir Med. 2018 Jan;6(1):19-28. doi: 10.1016/S2213-2600(17)30474-5. Epub 2017 Dec 14.
Results Reference
result
PubMed Identifier
23101047
Citation
O'Connor E, Patnode CD, Burda BU, Buckley DI, Whitlock EP. Breathing Exercises and/or Retraining Techniques in the Treatment of Asthma: Comparative Effectiveness [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Sep. Report No.: 12-EHC092-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK109355/
Results Reference
result
PubMed Identifier
24085551
Citation
Freitas DA, Holloway EA, Bruno SS, Chaves GS, Fregonezi GA, Mendonca KP. Breathing exercises for adults with asthma. Cochrane Database Syst Rev. 2013 Oct 1;(10):CD001277. doi: 10.1002/14651858.CD001277.pub3.
Results Reference
result
PubMed Identifier
22837543
Citation
Prem V, Sahoo RC, Adhikari P. Comparison of the effects of Buteyko and pranayama breathing techniques on quality of life in patients with asthma - a randomized controlled trial. Clin Rehabil. 2013 Feb;27(2):133-41. doi: 10.1177/0269215512450521. Epub 2012 Jul 26.
Results Reference
result
PubMed Identifier
28322440
Citation
Usmani ZA, Carson KV, Heslop K, Esterman AJ, De Soyza A, Smith BJ. Psychological therapies for the treatment of anxiety disorders in chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017 Mar 21;3(3):CD010673. doi: 10.1002/14651858.CD010673.pub2.
Results Reference
result
PubMed Identifier
22544892
Citation
Pbert L, Madison JM, Druker S, Olendzki N, Magner R, Reed G, Allison J, Carmody J. Effect of mindfulness training on asthma quality of life and lung function: a randomised controlled trial. Thorax. 2012 Sep;67(9):769-76. doi: 10.1136/thoraxjnl-2011-200253. Epub 2012 Apr 27.
Results Reference
result
PubMed Identifier
30286606
Citation
Kraemer KM, McLeish A. Evaluating the role of mindfulness in terms of asthma-related outcomes and depression and anxiety symptoms among individuals with asthma. Psychol Health Med. 2019 Feb;24(2):155-166. doi: 10.1080/13548506.2018.1529326. Epub 2018 Oct 4.
Results Reference
result
PubMed Identifier
28459349
Citation
Shi L, Liang D, Gao Y, Huang J, Nolan C, Mulvaney A, Poole T, Zhang H. Mindfulness and asthma symptoms: A study among college students. J Asthma. 2018 Jan;55(1):101-105. doi: 10.1080/02770903.2017.1306545. Epub 2017 May 1.
Results Reference
result
PubMed Identifier
32475186
Citation
Lopez-Lois B, Gonzalez-Barcala FJ, Facal D. Application of mindfulness techniques in patients with asthma or COPD. J Asthma. 2021 Sep;58(9):1237-1246. doi: 10.1080/02770903.2020.1776729. Epub 2020 Jun 12.
Results Reference
result
PubMed Identifier
31237569
Citation
Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.
Results Reference
result
PubMed Identifier
35859847
Citation
Fazia T, Bubbico F, Nova A, Riggi E, Caimi G, Calgan B, Salvato G, Bruno S, Bottini G, Bernardinelli L. Online Short-Term Mindfulness-Based Intervention During COVID-19 Quarantine in Italy: Effects on Wellbeing, Stress, and Anxiety. Front Psychol. 2022 Jul 4;13:914183. doi: 10.3389/fpsyg.2022.914183. eCollection 2022.
Results Reference
result
PubMed Identifier
35874414
Citation
Devillers-Reolon L, Mascret N, Sleimen-Malkoun R. Online Mindfulness Intervention, Mental Health and Attentional Abilities: A Randomized Controlled Trial in University Students During COVID-19 Lockdown. Front Psychol. 2022 Jul 7;13:889807. doi: 10.3389/fpsyg.2022.889807. eCollection 2022.
Results Reference
result
PubMed Identifier
18097865
Citation
Vega JM, Badia X, Badiola C, Lopez-Vina A, Olaguibel JM, Picado C, Sastre J, Dal-Re R; Covalair Investigator Group. Validation of the Spanish version of the Asthma Control Test (ACT). J Asthma. 2007 Dec;44(10):867-72. doi: 10.1080/02770900701752615.
Results Reference
result
PubMed Identifier
6880820
Citation
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Results Reference
result
PubMed Identifier
4009520
Citation
van Dixhoorn J, Duivenvoorden HJ. Efficacy of Nijmegen Questionnaire in recognition of the hyperventilation syndrome. J Psychosom Res. 1985;29(2):199-206. doi: 10.1016/0022-3999(85)90042-x.
Results Reference
result
PubMed Identifier
12885982
Citation
Cooper S, Oborne J, Newton S, Harrison V, Thompson Coon J, Lewis S, Tattersfield A. Effect of two breathing exercises (Buteyko and pranayama) in asthma: a randomised controlled trial. Thorax. 2003 Aug;58(8):674-9. doi: 10.1136/thorax.58.8.674.
Results Reference
result
PubMed Identifier
16517572
Citation
Slader CA, Reddel HK, Spencer LM, Belousova EG, Armour CL, Bosnic-Anticevich SZ, Thien FC, Jenkins CR. Double blind randomised controlled trial of two different breathing techniques in the management of asthma. Thorax. 2006 Aug;61(8):651-6. doi: 10.1136/thx.2005.054767. Epub 2006 Mar 3.
Results Reference
result
PubMed Identifier
17386196
Citation
Fortuna AM, Feixas T, Casan P. [Measurement of fraction of exhaled nitric oxide with the portable NIOX-MINO monitor in healthy adults]. Arch Bronconeumol. 2007 Mar;43(3):176-9. doi: 10.1016/s1579-2129(07)60044-5. Spanish.
Results Reference
result
PubMed Identifier
3396198
Citation
Report on skin test standardization. The Committee on Skin Test Standardization of The Netherlands Society of Allergology. Clin Allergy. 1988 May;18(3):305-10.
Results Reference
result
PubMed Identifier
10489826
Citation
Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x.
Results Reference
result
PubMed Identifier
7788083
Citation
Sanjuas C, Alonso J, Sanchis J, Casan P, Broquetas JM, Ferrie PJ, Juniper EF, Anto JM. [The quality-of-life questionnaire with asthma patients: the Spanish version of the Asthma Quality of Life Questionnaire]. Arch Bronconeumol. 1995 May;31(5):219-26. doi: 10.1016/s0300-2896(15)30927-3. Spanish.
Results Reference
result
PubMed Identifier
26230150
Citation
Plaza V, Fernandez-Rodriguez C, Melero C, Cosio BG, Entrenas LM, de Llano LP, Gutierrez-Pereyra F, Tarragona E, Palomino R, Lopez-Vina A; TAI Study Group. Validation of the 'Test of the Adherence to Inhalers' (TAI) for Asthma and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):142-52. doi: 10.1089/jamp.2015.1212. Epub 2015 Jul 31.
Results Reference
result
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Efficacy of the Combination of Mindfulness and Buteyko Techniques for the Improvement of Poorly Controlled Asthma.
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