Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD
Study Details
Study Description
Brief Summary
This study is part of a phased approach to refine, optimize, and test the feasibility of CALM Breathing. Preliminary participant feedback from our CART (Capnography-Assisted Respiratory Therapy) study was applied to adapt and design CALM Breathing (including its dose, schedule, delivery, and home program). This pilot builds on initial lessons learned and identifies intervention areas still needing greater development to assure the success of a future large trial, targeting a subpopulation at risk, that is, those with COPD and anxiety sensitivity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this pilot study is to establish success benchmarks of CALM Breathing and to test feasibility of:
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recruiting a target group of adults with COPD and concurrent anxiety, including building a partnership with the Columbia University Pulmonary department; ensuring adequacy of recruitment and study referral procedures;
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ASI-16 anxiety sensitivity cut-point for eligibility;
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randomizing participants to CALM Breathing and Wait-List;
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assessment procedures; confirming our estimates of time needed to administer assessments; evaluating participant ratings of assessment burden; and testing that target timelines and blinding are achievable;
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facilitating timely PR intake assessment initiation (to limit wait);
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implementing manualized CALM Breathing, including adequacy of dose (timing, frequency, and session duration), fidelity procedures, and transportation funds; attention will be given to additional considerations and tailoring needs of patients with significant anxiety sensitivity and/or anxiety disorders;
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implementing home-based breathing exercise component (e.g., new RR device fidelity checks and new distribution of therapist-guided audio exercises using an MP3 player to improve adherence rate)
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retaining participants at 3-month follow-up post-PR, including ensuring adequacy of retention strategies.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CALM Breathing
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Behavioral: CALM Breathing
CALM Breathing is a mind-body breathing therapy that links CO2 changes to dyspnea and anxiety symptoms and targets breathing efficiency and self-efficacy in COPD. CALM Breathing: Individual interoception- based breathing therapy with capnography (non- exercise training) Home Program: Monitored home- based breathing exercises; RR biofeedback; goal setting; exercise logging. Coaching: Motivational interviewing. Personnel: PT, EP, occupational therapist, or nurse. Frequency: 1-hour sessions, twice per week for 4 weeks. Exercises: • 10 core breathing exercises with ETCO2 biofeedback in recovery postures at rest and with body movement (gentle stretches and brief low-moderate intensity physical activity). • Breathing biofeedback (ETCO2, RR, airflow pattern). Education: Education on anxiety; COPD Patient Guide.
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| Active Comparator: Wait-List Control
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Behavioral: Traditional outpatient PR
After referral to Columbia's outpatient pulmonary rehabilitation (PR) program, participants randomized to the Wait-List control group will be put on a PR wait list (usual care). In Phase II, all participants will receive PR of 1-hour sessions, twice per week for 10 weeks. Traditional outpatient PR: Group exercise training (ET) combined with pursed lips breathing (PLB) training; 1:2 therapist to patient ratio. Home Program: Unmonitored walking exercise 1-2 days/week; no biofeedback monitoring. Coaching: Traditional monitoring and verbal cueing. Personnel: PT or EP. Frequency:
1-hour sessions, twice per week for 10 weeks. Exercises: • ET of muscles of ambulation with exercise equipment, such as on a treadmill or cycle ergometer (30-min), plus 15-min strengthening and posture exercises; O2 supplementation as needed. No breathing biofeedback. • PLB instruction only during exercise training. Education: Verbal and written information.
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Outcome Measures
Primary Outcome Measures
- Feasibility Index [3 months]
CALM Breathing treatment session attendance rate greater than or equal to 70% (where 100% = all 8 sessions attended).
- Acceptability Index [3 months]
The acceptability of CALM Breathing will be evaluated based on mixed methods data collected from satisfaction ratings
Secondary Outcome Measures
- Chronic Respiratory Disease Questionnaire Score [3 months]
disease-specific health-related quality of life questionnaire.
- DMQ-CAT Score [3 months]
recently developed dyspnea patient-reported outcome measure for adults with COPD
- Modified Borg scale Score [3 months]
most commonly used to assess symptoms of breathlessness
- GAD-7 Score [3 months]
screening tool and symptom severity measure for the four most common anxiety disorders
- Perceived Stress Scale Score [3 months]
a classic stress assessment instrument
- 6 mile Walking Distance Score [3 months]
sub-maximal exercise test used to assess aerobic capacity and endurance.
- Physical Activity Scale for the Elderly (PASE) [3 months]
investigate specifically older people with an age-specific physical activity questionnaire, filling what was an important need in epidemiological research at that time
- COPD Assessment Test (CAT) [3 months]
Quantifies impact of COPD symptoms on patients' overall health.
- Patient-Reported Outcomes Measurement Information System (PROMIS-24). [3 months]
5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes (PROs) relevant across common medical conditions
- End-tidal CO2 [3 months]
the partial pressure of CO2 at the end of an exhaled breath
- Respiratory Rate (RR) [3 months]
Breaths per minute
- Percent of predicted forced expiratory volume in 1 second (FEV1 % predicted) [3 months]
- Forced vital capacity (FVC) [3 months]
is the total amount of air exhaled during the FEV test.
- Ratio of FEV1/FVC [3 months]
Ratio of FEV1/FVC based on American Thoracic Society (ATS) guidelines
- Pulmonary Rehabilitation Engagement [3 months]
Uptake; treatment initiation; attrition; and patient activation using the Patient Activation Measure
Eligibility Criteria
Criteria
Inclusion Criteria:
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be adult males or females
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have a diagnosis of COPD as defined by FEV1/FVC of < 0.70 on spirometry testing or as shown on a chest computed tomography (CT)
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receive standard care of pharmacotherapy with bronchodilators (e.g. long-acting beta-agonists, LABAs, or long-acting muscarinic antagonists, or LAMAs) as prescribed by their physician
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are in stable medical condition as determined by pulmonary rehabilitation physician (i.e., not in need of acute higher level of care such as hospitalization)
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have dyspnea [as documented in their medical record or based on self-report; e.g., ≥1 on modified Medical Research Council questionnaire (mMRC) dyspnea; or ≥2 dyspnea score on item: "Over the last 4 weeks, I have had shortness of breath: almost every day = 4, several days a week = 3, a few days a month = 2, only with lung/respiratory infections = 1, not at all = 0; or "yes" response of binary presence of dyspnea-related avoidance of activities: "Have you avoided any activities due to shortness of breath?")]
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have elevated dyspnea-related anxiety symptoms:
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DMQ-CAT dyspnea anxiety score ≤50; or
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DMQ-CAT activity avoidance ≤50;
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VAS dyspnea anxiety scale score of ≥20, administered with 6-minute walk test;
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ASI-16: item #10, "It scares me when I become short of breath (at least "some");
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require ≤8 hours per day of supplemental oxygen
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can maintain oxygen saturation (SaO2) ≥ 90% on room air at rest
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Mini Mental State Examination score ≥24
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speak, read and write English
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are stably medicated for at least 4 weeks prior to study entry with long-acting anti-anxiety medication (e.g., selective serotonin reuptake inhibitors, SSRIs, and serotonin norepinephrine reuptake inhibitors, SNRIs), benzodiazepines, or cannabis if prescribed, with no plans to change psychotropic medication dose
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have not received any pulmonary rehabilitation training in the past 12 months.
Exclusion Criteria:
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are not eligible for pulmonary rehabilitation
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are actively being treated for cancer
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have morbid obesity (Body Mass Index (BMI) > 40)
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have hypercapnia of ETCO2 > 50 mmHg at rest
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have a musculoskeletal disorder severe enough to interfere with walking or ability to exercise or have neuromuscular disease
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have had a seizure in the past 3 months
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reside in an acute hospital, sub-acute care, assisted living, or nursing home
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are active smokers
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are pregnant
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have any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening, which in the opinion of the investigator may put the patient at risk or interfere with study assessments
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have low literacy as indicated by scores of 4 or 5 ("often" and "always") on the Single Item Literacy Screener (SILS) that asks, "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?"
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have a diagnosis or medical history of schizophrenia, psychotic disorders, or bipolar disorder as diagnosed by study psychologist
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have alcohol or substance abuse or dependence within the past 6 months as evaluated by study psychologist
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have serious suicidal risk (suicidal ideation or suicidal behaviors within the past year) as defined by a score of >1 on psychologist interview-administered Clinician Suicide Assessment Checklist, which is a Modified Columbia-Suicide Severity Rating Scale-CSSRS
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have been using opioids (e.g., morphine) in the past 4 weeks.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York University Grossman School of Medicine | New York | New York | United States | 10016 |
| 2 | Columbia University Vagelos College of Physicians and Surgeons | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
- National Center for Complementary and Integrative Health (NCCIH)
Investigators
- Principal Investigator: Anna Norweg, PhD, OTR, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-AAAT8556
- 20-00751
- R34AT010673