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

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This study will develop and test the feasibility and limited-efficacy 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, we will develop and test the feasibility and limited-efficacy 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 intervention based on established interventions: pedometer-based PA intervention and bCBT. In order to develop Step-CBT, we 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 we will integrate this content with existing content included in pedometer-based PA intervention and bCBT. We will provide specific language based on patients' lived experience and mirror the language they use to describe their experience. We will tailor examples, home exercises, and psychoeducation based on the data we collect. We 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 enhanced usual care (UC; n = 16) matched for social interaction enrolled through 2:1 randomization for feasibility and limited-efficacy 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). We will measure within-group change in Step-CBT (n=32) and usual care (n=16) groups from baseline to post- assessment (Week 15). We 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. Pilot data from this CDA-2 will be used inform the design and methodology of a future Merit submission. Advanced education and training is required in four areas: 1) Pulmonary Rehabilitation and COPD; 2) Science of behavior change; Methodology and Statistics; and 4) Career Development. The combination of didactic and experiential training in these areas will serve the PI's long-term goal of becoming an independent clinician-investigator at VA Boston focused on the development of innovative combined physical activity/rehabilitation interventions and mental health interventions, to optimize physical functioning in aging Veterans with chronic disease and physical disability. In the shorter-term, this CDA-2 will provide a feasible, patient-centered intervention that can be incorporated into existing systems of care and supplement hospital- based pulmonary rehabilitation.