COPDNCT04953806
The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD, Emotion Distress, and Low Physical Activity
A study testing Step-CBT in people with COPD and Depression, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Depression, Anxiety
- What is being tested?
- Step-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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%
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
About this study
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.
Read the detailed description
The current study will develop and test Step-Cognitive Behavioral Therapy (CBT) (Step-CBT), an integrated intervention that draws from existing pedometer-based physical activity (PA) interventions and brief CBT to target low PA, emotional distress, and physical disability in Veterans with chronic obstructive pulmonary disease (COPD) delivered via VA Video Connection (VVC). This study has three components: In Aim 1, we will conduct a cross-sectional study with 50 Veterans with COPD, low PA, and clinically significant depression and/or anxiety symptoms. Self-report measures will be collected and provide information on mean level and magnitude of the relations between PA, emotional distress, and physical disability. Participants will wear an ActiGraphy device for 14 days following their in-person session to measure objective PA. Based on these data, we will create Step-CBT, an intervention that integrates, tailors, and adapts a pedometer-based PA intervention and brief CBT (existing transdiagnostic protocol), based on patient interviews and current literature. In Aim 2, we will examine the acceptability of Step-CBT, an 8-session intervention delivered via VVC, in Veterans (N=6) collecting recruitment, enrollment, completion data and measures of physical functioning and emotional distress. We will conduct expert panel review of the manualized intervention protocol and acceptability results. In Aim 3, we will assess the feasibility of Step-CBT in a proof-of -concept study design in Veterans (N=40 enrolled with target of 25 completers) with COPD, low physical activity, and clinically significant depression and/or anxiety symptoms. The current research has great potential to improve physical and psychological functioning in Veterans with COPD through the development of an integrated PA-mental health intervention. Step-CBT delivered to patient's homes, would offer a safe option to increase/maintain physical functioning and mental health in Veterans with COPD.
- Conditions
- COPD, Depression, Anxiety
- Being tested
- Step-CBT
- Keywords
- COPD, Physical Activity, Depression, Anxiety
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Depression, Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step-CBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Step-CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change
Secondary outcomes (2)
Patient Health Questionnaire-8- measuring change
Change in scores on the Patient Health Questionnaire-8 (PHQ-8) from baseline to Week 16. The PHQ-8 is an 8-item measure of depression symptoms severity mapping on to DSM-IV criteria. Higher scores are indicative of more severe depression symptoms. Score range from 0 to 24, with higher scores indicative of greater depression symptom severity. The investigators use estimates of clinically meaningful change in the literature: PHQ-8 (≤9 combined with improvement of 50%).
Meaningful change in the literature is PHQ-9 score (< = 9 combined with improvement of 50%). The PHQ-9 is a 9-item measure of depression symptoms severity mapping on to DSM-IV criteria. Higher scores are indicative of more severe depression symptoms. Score range from 0 to 27, with higher scores indicative of greater depression symptom severity.
Measured: Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change
Beck Anxiety Inventory- measuring change
Change in scores on the Beck Anxiety Inventory (BAI) from baseline to Week 16. Meaningful change in the literature is a 17.5% reduction in BAI scores over time. The BAI is a 21-item screening measure of cognitive and somatic symptoms of anxiety over the past week. Respondents indicate the degree to which they experienced each symptom from 0 (not at all) to 3 (severely), ranging from 0 to 63. Higher scores indicated greater anxiety severity.
Measured: Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start2 Nov 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Patricia Bamonti, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953806
- Sponsor's protocol ID
- D3527-W
- Status last verified
- May 2026
- First submitted
- 24 Jun 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD, Emotion Distress, and Low Physical Activity
- ClinicalTrials.gov ID
- NCT04953806
- Acronym / sponsor ID
- D3527-W
- Conditions
- COPD, Depression, Anxiety
- Keywords
- COPD, Physical Activity, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current study will develop and test Step-Cognitive Behavioral Therapy (CBT) (Step-CBT), an integrated intervention that draws from existing pedometer-based physical activity (PA) interventions and brief CBT to target low PA, emotional distress, and physical disability in Veterans with chronic obstructive pulmonary disease (COPD) delivered via VA Video Connection (VVC). This study has three components: In Aim 1, we will conduct a cross-sectional study with 50 Veterans with COPD, low PA, and clinically significant depression and/or anxiety symptoms. Self-report measures will be collected and provide information on mean level and magnitude of the relations between PA, emotional distress, and physical disability. Participants will wear an ActiGraphy device for 14 days following their in-person session to measure objective PA. Based on these data, we will create Step-CBT, an intervention that integrates, tailors, and adapts a pedometer-based PA intervention and brief CBT (existing transdiagnostic protocol), based on patient interviews and current literature. In Aim 2, we will examine the acceptability of Step-CBT, an 8-session intervention delivered via VVC, in Veterans (N=6) collecting recruitment, enrollment, completion data and measures of physical functioning and emotional distress. We will conduct expert panel review of the manualized intervention protocol and acceptability results. In Aim 3, we will assess the feasibility of Step-CBT in a proof-of -concept study design in Veterans (N=40 enrolled with target of 25 completers) with COPD, low physical activity, and clinically significant depression and/or anxiety symptoms. The current research has great potential to improve physical and psychological functioning in Veterans with COPD through the development of an integrated PA-mental health intervention. Step-CBT delivered to patient's homes, would offer a safe option to increase/maintain physical functioning and mental health in Veterans with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Step-CBT | Experimental | Behavioral: Step-CBTParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step-CBTParticipants 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. | Behavioural | Step-CBT |
Primary outcome
Measuring change - Late Life Function and Disability Instrument (LLFDI)
Time frame: Baseline, Week 8 (mid-point), Week 16 (post-intervention) - measuring change
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.
Step Count-measuring change
Time frame: Baseline, Week 8 (mid-point), Week 16 (post-intervention)- 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.
2 secondary outcomes
Patient Health Questionnaire-8- measuring change
Time frame: Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change
Beck Anxiety Inventory- measuring change
Time frame: Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Bamonti, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step-CBT in people with COPD and Depression, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring change - Late Life Function and Disability Instrument (LLFDI) (time frame: Baseline, Week 8 (mid-point), Week 16 (post-intervention) - measuring change). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.