Integrated physical activity and mental health program for veterans with COPD and emotional distress
The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD, Emotion Distress, and Low Physical Activity
This study is testing a new program that combines physical activity and therapy to help veterans with COPD and emotional distress feel better and move more.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04953806 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and test an integrated intervention called Step-Cognitive Behavioral Therapy (Step-CBT) for veterans suffering from Chronic Obstructive Pulmonary Disease (COPD), emotional distress, and low physical activity. The intervention combines pedometer-based physical activity strategies with brief cognitive behavioral therapy, delivered via VA Video Connect to enhance accessibility for veterans facing barriers to traditional outpatient care. The study will assess the acceptability and feasibility of this intervention through a series of phases, including a cross-sectional study and a proof-of-concept design. Participants will wear an ActiGraphy device to objectively measure physical activity levels over a two-week period.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 40 and older with a clinical diagnosis of COPD and clinically significant depression and/or anxiety.
Not a fit: Patients without a diagnosis of COPD or those who do not experience emotional distress may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve physical activity levels and mental health outcomes for veterans with COPD.
How similar studies have performed: Other studies have shown promise in integrating physical activity with mental health interventions, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * COPD exacerbation in the previous 1 month * Inability to ambulate * Regular use of a rollator, walker, or wheelchair for ambulation * Inability to complete questionnaires * Inability to collect at least 4 valid days of 7-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 enrolled in another interventional study targeting exercise, physical activity, or mental health * Average baseline step counts of greater than or equal to 10,000 steps per week * Suicide flag in chart * Oxygen saturation after 6-Minute Walk Test documented to be \<85%
Where this trial is running
Boston, Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Patricia Bamonti, PhD — VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
- Study coordinator: Patricia Bamonti, PhD
- Email: Patricia.Bamonti@va.gov
- Phone: (774) 826-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.