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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04953806
• Other study ID #: D3527-W
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: November 1, 2026

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Patricia Bamonti, PhD
• Phone: (774) 826-3718
• Email: Patricia.Bamonti[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

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

Related Conditions & MeSH terms

• Anxiety
• COPD
• Depression

Intervention

Behavioral:
• Step-CBT
Participants will complete Step-CBT, an integrative 10-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.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. We 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 15 - measuring change
Primary	Step Count-measuring change	Change in Step Count. We reference prior MID for estimates of change: Minimally Important Difference = 600-1000 steps. Step count will be measured with the StepWatch Activity Monitor (SAM). The SAM is FDA-approved and 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 unobtrusive. The FitBit Inspire serves as a tool to track step count goals.	Baseline, Week 6, Week 15- measuring change
Secondary	Patient Health Questionniare-9- measuring change	Change in scores on the Patient Health Questionnaire-9 (PHQ-9) from baseline to Week 15. 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.	Baseline, Week 15- measuring change
Secondary	Beck Anxiety Inventory- measuring change	Change in scores on the Beck Anxiety Inventory (BAI) from baseline to Week 15. 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.	Baseline, Week 15- measuring change
Secondary	Exercise Capacity	The six-minute walk test is an assessment of functional capacity, and is the distance walked in 6 minutes. The minimum clinically important difference (MCID) for COPD is 26 m.	Baseline, Week 15-measuring change