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NCT04953806

The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD, Emotion Distress, and Low Physical Activity

Active, Not Recruiting
NAAges 40+InterventionalTreatment
VA Office of Research and Development
~45 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Step-CBT

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measuring change - Late Life Function and Disability Instrument (LLFDI)
Measured over Baseline, Week 8 (mid-point), Week 16 (post-intervention) - measuring change
+1 more outcome measured

Conditions

COPD
Depression
Anxiety

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NCT04953806

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusettsno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Patricia Bamonti, PhD · PRINCIPAL_INVESTIGATOR · VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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%

What this trial measures

  • Measuring change - Late Life Function and Disability Instrument (LLFDI)Baseline, Week 8 (mid-point), Week 16 (post-intervention) - measuring change

    Change in scores on the Late Life Function and Disability Instrument (LLFDI) from baseline to Week 15. The LLFDI is a 32-item measure of self-reported functional impairment and disability. Respondents indicate the degree of difficulty they have performing physical activities without the help of someone or using assistive devices. Scores range from 0 to 100 with higher scores indicating higher levels of functioning. The investigators will only use the Disability component of the LLDFI. The LLDFI is sensitive to change and commonly used as an outcome in geriatric research.

  • Step Count-measuring changeBaseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change

    Change in Step Count. The investigators reference prior MID for estimates of change: Minimally Important Difference = 600-1000 steps. Step count will be measured using two devices: The ActiGraph wGT3X-BT. The ActiGraph wGT3X-BT is research-grade, highly accurate measure of activity, through the use of a special sensor detecting acceleration, position, and timing, to detect steps. The device is worn around the ankle and is unobtrusive. * The FitBit Inspire serves as a tool to track and monitor step counts weekly as part of the intervention and to develop weekly step count goals. Both methods of measuring step count will be reported.