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

Depression Clinical Trial

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

Status Recruiting

Clinical Trial 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 feasibility and pilot RCT 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.

Clinical Trial Description

This study will develop and test the feasibility and conduct a pilot RCT of a combined physical activity (PA) and cognitive-behavioral therapy intervention (bCBT) for Veterans with COPD, emotional distress (clinically significant depression and anxiety), and low PA level. Prior research has shown that combined PA+CBT interventions produce superior physical and emotional outcomes in heart failure and diabetes patients. Drawing from this body of literature, the research team will develop and test the feasibility of an integrated PA+CBT intervention (Step-CBT) tailored and adapted to COPD patients and delivered via VA Video Connect (VVC). Step-CBT will be an integrated treatment based on established interventions: pedometer-based PA intervention and bCBT. In order to develop Step-CBT, the research team will first conduct mixed-methods interviews with (n=20) Veterans with COPD. Mixed-methods data will identify target behaviors, emotions, and cognitions related to emotional distress and PA, and the research team will integrate this content with existing content included in pedometer-based PA intervention and bCBT. The research team will provide specific language based on patients' lived experience and mirror the language they use to describe their experience. The research team will tailor examples, home exercises, and psychoeducation based on the data collected. The investigators will adapt to delivery over VVC. Step-CBT will then be tested for acceptability with (n=5) Veterans. Acceptability data will be reviewed and submitted to the multidisciplinary expert panel for review and modifications of the treatment protocol will be made based on this process.

Next, Step-CBT will be delivered to Veterans (n=32) compared to usual care (UC; n = 16) matched for enrolled through 2:1 randomization for feasibility testing with a two week run-in period. Step-CBT will target primary outcomes of step count and patient-reported disability (LLDFI Disability Component), and secondary outcomes of emotional distress (PHQ-9 and BAI) and exercise capacity (Six Minute Walk Test-Distance-6MWT). The investigators will measure within-group change in Step-CBT (n=32) and UC (n=16) groups from baseline to post-assessment (Week 15). The research team will also compare between-group differences across outcomes. When available, minimally important differences will be used to guide analyses. This study will leverage advances in telehealth interventions. Step-CBT will be deliverable to Veterans' home bypassing numerous barriers to hospital-based care and increasing access to more Veterans with COPD. ;

Related Conditions & MeSH terms

• Anxiety
• COPD
• Depression

• NCT number: NCT04953806
• Study type: Interventional
• Source: VA Office of Research and Development
• Contact: Patricia Bamonti, PhD
• Phone: (774) 826-3718
• Email: Patricia.Bamonti@va.gov
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2021
• Completion date: November 1, 2026