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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2026
  • participants needed
    48
  • sponsor
    VA Office of Research and Development
Updated on 19 November 2021
anxiety
behavior therapy
depressed mood

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 limited-efficacy 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 limited-efficacy 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 and limited-efficacy 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 intervention 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 enhanced usual care (UC; n = 16) matched for social interaction enrolled through 2:1 randomization for feasibility and limited-efficacy 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). The investigators will measure within-group change in Step-CBT (n=32) and wait-list control (WLC) (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.

Details
Condition Chronic Obstructive Lung Disease, depressed mood, miserable, Generalized Anxiety Disorder (GAD), chronic obstructive pulmonary disease, Depression (Major/Severe), Depression (Treatment-Resistant), depressive disorder, Depressed, COPD (Chronic Obstructive Pulmonary Disease), Anxiety Disorders (Pediatric), Generalized Anxiety Disorder (GAD - Pediatric), COPD, ANXIETY NEUROSIS, Reactive Airway Disease, depressive disorders, Depression, Depression (Adolescent), Anxiety, chronic obstructive pulmonary disease (copd), Anxiety Disorders, Endogenous depression, Anxiety Symptoms, anxious, anxiety disorder, Depression (Pediatric), Depression (Adult and Geriatric)
Treatment Step-CBT
Clinical Study IdentifierNCT04953806
SponsorVA Office of Research and Development
Last Modified on19 November 2021

Eligibility

Yes No Not Sure

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 based on results of the TAPA
Ability to communicate
Able to participate in in-session study appointment at the VA
Agreeable to audio record study session
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
Consent to audio recording of the study session
Wireless Internet connection
Participants with > 90% accuracy of devices to manual step counts

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
Not 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note