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

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.

Grant Number: 5IK2RX003527-04
NIH Institute/Center: VA
Principal Investigator: Patricia Bamonti