New program aims to help veterans with COPD breathe easier and feel better
NCT ID NCT04953806
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an 8-week program called Step-CBT that combines physical activity goals with cognitive behavioral therapy for veterans with COPD who also have depression or anxiety. The program is delivered via video calls to make it accessible. Researchers want to see if it is acceptable and feasible, and whether it improves daily function and mood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Step-CBT (a combined physical activity and cognitive behavioral therapy program)
- What this could lead to
- If successful, this could offer a practical, home-based program to help veterans with COPD feel better physically and emotionally.
- What could go wrong
- This is a small early-stage study with only 45 participants, so results may not apply to all veterans. The program requires weekly video sessions, which may not suit everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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45 people
The number who actually took part.
- Started
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Nov 2021
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Any gender-identified, greater than or equal to 40 years of age * Clinical diagnosis of COPD defined as the presence of emphysema on a CT scan and one piece of clinical evidence of COPD (defined as a ratio of FEV1 to forced vital capacity \< 0.70, \> 10 pack-year cigarette smoking history, overall assessment of COPD in their problem list or in Pulmonary/Primary Care notes, or on bronchodilators (specifically antimuscarinics such as Tiotropium or Ipratropium). If there is no evidence of emphysema, or no CT on scan in their medical chart, three pieces of clinical evidence of COPD will suffice for a clinical diagnosis of COPD. * Ability to communicate * Able to participate in in-person study appointment at the VA * English speaking * Competent to provide informed consent * Emotional distress. Clinically significant depression and/or anxiety defined as PHQ-8 \> 10 and/or Beck Anxiety Inventory \> 13 * Wireless Internet connection and Bluetooth capability * Participants with \> 90% accuracy of device Fitbit to manual step counts * Agreeable to audio record study session * Agreeable to wearing an ActiGraphy device and Fitbit and downloading the Fitbit app * Email user for VVC visits links * Either owns a smartphone or iPad compatible with the Fitbit app and enabled with Bluetooth or agreeable to using a study-issued iPad with Wi-Fi and Bluetooth capabilities * Medical clearance from healthcare provider to participate in a physical activity program Exclusion Criteria: * COPD exacerbation in the previous 1 month * Inability to ambulate * Regular use of a rollator, walker, or wheelchair for ambulation * Inability to complete questionnaires * Inability to collect at least 4 valid days of 7-day baseline step count data * Positive screening on the Mini-Cog defined as \< 3 indicating possible cognitive impairment or dementia or major neurocognitive disorder diagnosis in electronic medical chart or refusal to complete the assessment * Currently enrolled in another interventional study targeting exercise, physical activity, or mental health * Average baseline step counts of greater than or equal to 10,000 steps per week * Suicide flag in chart * Oxygen saturation after 6-Minute Walk Test documented to be \<85%
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817, United States
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