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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
RECRUITING
Boston
Contact Information
Primary
Patricia Bamonti, PhD
Patricia.Bamonti@va.gov
(774) 826-3718
Backup
Jennifer A Moye, PhD
Jennifer.Moye@va.gov
(774) 826-3721
Time Frame
Start Date: 2021-11-02
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 40
Treatments
Experimental: Step-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.
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov