Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT04953806

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

Led by VA Office of Research and Development · Updated on 2025-06-24

40

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic Obstructive Pulmonary Disease (COPD) is prevalent and debilitating chronic disease in Veterans. COPD is highly co-morbid with depression and anxiety conferring greater morbidity and mortality risk. Physical activity is a modifiable behavior that can improve COPD outcomes. However, to date, interventions targeting physical activity have not addressed the high comorbidity between COPD and depression and/or anxiety symptoms ("emotional distress") despite emotional distress predicting poorer response to physical activity interventions. This CDA-2 proposal will develop and test the acceptability and feasibility of an integrative physical activity and mental health intervention for Veterans with COPD, emotional distress, and low physical activity. The intervention will be delivered via VA Video Connect enabling access to care among Veterans with substantial barriers to hospital-based outpatient care.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Any gender, 40 years of age or older
  • Clinical diagnosis of COPD confirmed by emphysema on CT scan with one additional clinical evidence or three clinical evidences if no CT scan
  • Ability to communicate and participate in in-person study appointment at the VA
  • English speaking and competent to provide informed consent
  • Clinically significant depression and/or anxiety defined as PHQ-8 > 10 and/or Beck Anxiety Inventory > 13
  • Access to wireless internet and Bluetooth capability
  • Fitbit device step counts with > 90% accuracy compared to manual counts
  • Agreeable to audio recording of study sessions
  • Willing to wear ActiGraphy and Fitbit devices and download the Fitbit app
  • Email user for VA Video Connect visit links
  • Owns or willing to use a study-issued smartphone or iPad compatible with the Fitbit app and Bluetooth
  • Medical clearance from healthcare provider to participate in physical activity program
Not Eligible

You will not qualify if you...

  • COPD exacerbation within the previous 1 month
  • Inability to walk
  • Regular use of rollator, walker, or wheelchair for walking
  • Unable to complete questionnaires
  • Unable to collect at least 4 valid days of 7-day baseline step count data
  • Positive Mini-Cog screening indicating possible cognitive impairment or dementia, or major neurocognitive disorder diagnosis, or refusal to complete the assessment
  • Currently enrolled in another interventional study targeting exercise, physical activity, or mental health
  • Average baseline step count of 10,000 steps per week or more
  • Suicide risk flagged in medical chart
  • Oxygen saturation less than 85% after 6-Minute Walk Test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Boston, Massachusetts, United States, 02130-4817

Actively Recruiting

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Research Team

P

Patricia Bamonti, PhD

CONTACT

J

Jennifer A Moye, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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