RecruitingNot ApplicableNCT04953806

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

Sponsor

VA Office of Research and Development

Enrollment

40 participants

Start Date

Nov 2, 2021

Study Type

INTERVENTIONAL

Conditions

Depression Anxiety COPD

Summary

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.

Eligibility

Min Age: 40 Years

Inclusion Criteria14

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 Criteria10

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%

Interventions

BEHAVIORALStep-CBT

Participants will complete Step-CBT, an integrative 8-week physical activity and cognitive behavioral therapy (CBT) intervention, delivered by a licensed clinical psychologist. Sessions will take place once per week for 60 minutes using VA Video Connect. Each session will include core components 1) Reviewing physical activity goals, prescribing new step count goal, and problem-solving barriers and 2) The weekly CBT intervention module.