Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD

NCT04786184 | Completed Results DMC

• 3 other identifiers: AAAT855620-00751R34AT010673
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot study is part of a phased approach to refine, optimize, and test the feasibility of CALM Breathing. Preliminary participant feedback from the Capnography-Assisted Respiratory Therapy (CART) 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.

Conditions

COPD

Keywords

Breathing; Anxiety

Outcome Measures

Primary Outcomes (3)

• Mean Attendance Rate of CALM Breathing Treatment Sessions

  Attendance rate will be measured from the total number of sessions completed out of the 8 total.

  4 weeks

• Drop-Out Rate

  The drop-out rate will be calculated from the total number of participants who drop-out from receiving the CALM Breathing therapy.

  3 months

• CALM Breathing Satisfaction Rating

  The acceptability of the CALM Breathing therapy will be evaluated based on mixed methods data collected from CALM Breathing satisfaction ratings. Participants were asked item 8 of FACIT ("how do rate this treatment overall?"), which was rated from 0 to 4 (0 = "poor" and 4 = "excellent") in which higher scores indicate more satisfaction (better outcome).

  4 weeks

Secondary Outcomes (14)

• Chronic Respiratory Disease Questionnaire (CRQ) Score

  Baseline, 4 weeks, 3 months

• Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score

  4 weeks

• Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Score

  3 months

• Modified Borg Scale Score

  4 weeks

• Modified Borg Scale Score

  3 months

Other Outcomes (1)

• Self-Evaluation of Breathing Questionnaire (SEBQ) Score

  Baseline, 4 weeks, 3 months

Study Arms (2)

CALM Breathing

EXPERIMENTAL

Behavioral: CALM Breathing

Wait-List Control

ACTIVE COMPARATOR

Behavioral: Traditional outpatient PR

Interventions

CALM Breathing BEHAVIORAL

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.

CALM Breathing

Traditional outpatient PR BEHAVIORAL

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.

Wait-List Control

Eligibility Criteria

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

You may qualify if:

• be adult males or females
• 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)
• 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
• 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)
• have dyspnea \[as documented in their medical record or based on self-report; e.g., ≥1 on modified Medical Research Council questionnaire (mMRC) dyspnea; or ≥2 dyspnea score on item: "Over the last 4 weeks, I have had shortness of breath: almost every day = 4, several days a week = 3, a few days a month = 2, only with lung/respiratory infections = 1, not at all = 0; or "yes" response of binary presence of dyspnea-related avoidance of activities: "Have you avoided any activities due to shortness of breath?")\]
• have elevated dyspnea-related anxiety symptoms:
• DMQ-CAT dyspnea anxiety score ≤50; or
• DMQ-CAT activity avoidance ≤50;
• VAS dyspnea anxiety scale score of ≥20, administered with 6-minute walk test;
• ASI-16: item #10, "It scares me when I become short of breath (at least "some");
• require ≤ 24 hours per day of supplemental oxygen
• Mini-Mental State Examination score ≥24
• speak, read, and write English
• 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
• have not received any pulmonary rehabilitation training in the past 12 months.

You may not qualify if:

• are not eligible for pulmonary rehabilitation
• are actively being treated for cancer
• have morbid obesity (Body Mass Index (BMI) \> 40)
• have hypercapnia of ETCO2 \> 50 mmHg at rest
• have a musculoskeletal disorder severe enough to interfere with walking or ability to exercise or have neuromuscular disease
• have had a seizure in the past 3 months
• reside in an acute hospital, sub-acute care, assisted living, or nursing home
• are active smokers
• are pregnant
• 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
• 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?"
• have a diagnosis or medical history of schizophrenia, psychotic disorders, or bipolar disorder as diagnosed by study psychologist
• have alcohol or substance abuse or dependence within the past 6 months as evaluated by study psychologist
• 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
• Take prescribed opioids ≥50 MME (morphine mg equivalents) per day. A dosage threshold of ≥50 MME significantly increases the risk of fatal respiratory depression and necessitates additional precautions. Participants' opioid medication dose will be confirmed by their prescribing physician (e.g., their primary care or pain management doctor).

Sponsors & Collaborators

• Columbia University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

New York University Grossman School of Medicine

New York, New York, 10016, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Norweg A, Oh C, DiMango A, Hofferber B, Spinner M, Stavrolakes K, Pavol M, Lindenauer P, Murphy CG, Simon NM. Mind the Breath: Feasibility of Capnography-Assisted Learned Monitored (CALM) Breathing for Dyspnea Treatment. J Cardiopulm Rehabil Prev. 2025 Mar 1;45(2):118-131. doi: 10.1097/HCR.0000000000000939. Epub 2025 Feb 13.

  PMID: 39976559 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration; Anxiety Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Mental Disorders

Results Point of Contact

• Title: Annamaria Norweg, PhD
• Organization: Columbia University

amn2212@cumc.columbia.edu

212-305-1651

Study Officials

• Anna Norweg, PhD, OTR

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective RCT: In Phase I, participants will be randomized 1:1 to one of two groups: CALM Breathing (N = 25) and Wait-List control (N = 25). In Phase II, both groups will be offered Columbia University's 10-week PR program (care as usual). Access to timely initiation of PR will be facilitated. We will use a hybrid design to evaluate feasibility and acceptability.

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 8, 2021
• Study Start: October 1, 2021
• Primary Completion: July 14, 2023
• Study Completion: November 30, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements
• Access Criteria: Requests may be directed to the PI.

Locations

US (2)