Overview
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.
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.
Eligibility
Inclusion Criteria:
- Any gender-identified, greater than or equal to 40 years of age
- Clinical diagnosis of COPD defined as either the ratio of FEV1 to forced vital capacity < 0.70 or prior documentation of FEV1/FVC ratio of < 0.70 and clinical evidence of COPD (defined as > 10 pack-year cigarette smoking history, dyspnea, or on bronchodilators)
- PA level below recommended national guidelines for older adults or < 150 minutes of PA per week of moderate intensity. This will be measured using the Physical Activity Vital Signs questionnaire (PAVS).
- Ability to communicate
- Able to participate in in-session study appointment at the VA
- English speaking
- Competent to provide informed consent
- Emotional distress. Clinically significant depression and/or anxiety defined as PHQ-9 > 10 and/or Beck Anxiety Inventory-II > 13
- Wireless Internet connection
- 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
- Active email user (to complete consent via DocuSign) and VVC visits
- Owns a smartphone or IPad compatible with the Fitbit app
Exclusion Criteria:
- COPD exacerbation in the previous 1 month
- Prescribed supplemental oxygen for activity
- Chair stand < 16.7 seconds on SPPB
- Inability to ambulate with or without assistance
- Use of assistive device for walking such as cane or walker
- Inability to complete questionnaires
- Inability to collect at least 8 days of 14-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 engaged in psychotherapy
- Participation in another exercise-related research study at time of screening
- Plans to participate in an exercise-related research study in the next 3 months
- Average baseline step counts of greater than or equal to 10,000 steps per week
- Suicide flag in chart