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

NCT04953806 | Active Not Recruiting

• 1 other identifier: D3527-W
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 acceptability and feasibility 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.

Conditions

COPD; Depression; Anxiety

Keywords

COPD; Physical Activity; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Measuring change - Late Life Function and Disability Instrument (LLFDI)

  Change in scores on the Late Life Function and Disability Instrument (LLFDI) from baseline to Week 15. The LLFDI is a 32-item measure of self-reported functional impairment and disability. Respondents indicate the degree of difficulty they have performing physical activities without the help of someone or using assistive devices. Scores range from 0 to 100 with higher scores indicating higher levels of functioning. The investigators will only use the Disability component of the LLDFI. The LLDFI is sensitive to change and commonly used as an outcome in geriatric research.

  Baseline, Week 8 (mid-point), Week 16 (post-intervention) - measuring change

• Step Count-measuring change

  Change in Step Count. The investigators reference prior MID for estimates of change: Minimally Important Difference = 600-1000 steps. Step count will be measured using two devices: The ActiGraph wGT3X-BT. The ActiGraph wGT3X-BT is research-grade, highly accurate measure of activity, through the use of a special sensor detecting acceleration, position, and timing, to detect steps. The device is worn around the ankle and is unobtrusive. * The FitBit Inspire serves as a tool to track and monitor step counts weekly as part of the intervention and to develop weekly step count goals. Both methods of measuring step count will be reported.

  Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change

Secondary Outcomes (2)

• Patient Health Questionnaire-8- measuring change

  Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change

• Beck Anxiety Inventory- measuring change

  Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change

Study Arms (1)

Step-CBT

EXPERIMENTAL

Participants will complete Step-CBT, an integrative 8-week physical activity and cognitive behavioral therapy (CBT) intervention, delivered by a licensed clinical psychologist. Sessions will take place once per week for 60 minutes using VA Video Connect. Each session will include core components 1) Reviewing physical activity goals, prescribing new step count goal, and problem-solving barriers and 2) The weekly CBT intervention module.

Behavioral: Step-CBT

Interventions

Step-CBT BEHAVIORAL

Participants will complete Step-CBT, an integrative 8-week physical activity and cognitive behavioral therapy (CBT) intervention, delivered by a licensed clinical psychologist. Sessions will take place once per week for 60 minutes using VA Video Connect. Each session will include core components 1) Reviewing physical activity goals, prescribing new step count goal, and problem-solving barriers and 2) The weekly CBT intervention module.

Step-CBT

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Depression; Anxiety Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Patricia Bamonti, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Assess the feasibility of Step-CBT in a proof-of -concept, single-arm trial in Veterans (Enrollment target; N=40) with COPD, low physical activity, and clinically significant depression and/or anxiety symptoms. Targeting 25 completers.

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 8, 2021
• Study Start: November 2, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)