RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-02
Study Completion:2026-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04953806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any gender-identified, greater than or equal to 40 years of age
  2. * 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.
  3. * Ability to communicate
  4. * Able to participate in in-session study appointment at the VA
  5. * English speaking
  6. * Competent to provide informed consent
  7. * Emotional distress. Clinically significant depression and/or anxiety defined as PHQ-8 \> 10 and/or Beck Anxiety Inventory-II \> 13
  8. * Wireless Internet connection and Bluetooth capability
  9. * Participants with \> 90% accuracy of device Fitbit to manual step counts
  10. * Agreeable to audio record study session
  11. * Agreeable to wearing an ActiGraphy device and Fitbit
  12. * Active email user (to complete consent via DocuSign) and VVC visits
  13. * Owns a smartphone or IPad compatible with the Fitbit app
  14. * Medical clearance from healthcare provider to participate in a physical activity program
  1. * COPD exacerbation in the previous 1 month
  2. * Inability to ambulate with or without assistance from another person
  3. * Has used a wheelchair in the last two months for everyday life
  4. * Inability to complete questionnaires
  5. * Inability to collect at least 8 days of 14-day baseline step count data.
  6. * 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
  7. * Currently engaged in psychotherapy
  8. * Participation in another exercise-related research study at time of screening
  9. * Plans to participate in an exercise-related research study in the next 3 months
  10. * Average baseline step counts of greater than or equal to 10,000 steps per week
  11. * Currently engaged in pulmonary rehabilitation
  12. * Suicide flag in chart

Contacts and Locations

Study Contact

Patricia Bamonti, PhD
CONTACT
(774) 826-3718
Patricia.Bamonti@va.gov
Jennifer A Moye, PhD
CONTACT
(774) 826-3721
Jennifer.Moye@va.gov

Principal Investigator

Patricia Bamonti, PhD
PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Locations (Sites)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Patricia Bamonti, PhD, PRINCIPAL_INVESTIGATOR, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-02
Study Completion Date2026-11-01

Study Record Updates

Study Start Date2021-11-02
Study Completion Date2026-11-01

Terms related to this study

Keywords Provided by Researchers

  • COPD
  • Physical Activity
  • Depression
  • Anxiety

Additional Relevant MeSH Terms

  • COPD
  • Depression
  • Anxiety