Clinical trial NCT04953806: The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD, Emotion Distress, and Low Physical Activity
Official title: The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD, Emotion Distress, and Low Physical Activity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Depression
Anxiety
Keywords: COPD
Physical Activity
Depression
Anxiety
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-07-08
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Assess the feasibility of Step-CBT in a proof-of -concept, single-arm trial in Veterans (N=25) with COPD, low physical activity, and clinically significant depression and/or anxiety symptoms.
Primary purpose: TREATMENT

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.

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=25) 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.

Eligibility criteria: Inclusion Criteria:

* 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-session 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-II \> 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
* Active email user (to complete consent via DocuSign) and VVC visits
* Owns a smartphone or IPad compatible with the Fitbit app
* Medical clearance from healthcare provider to participate in a physical activity program

Exclusion Criteria:

* COPD exacerbation in the previous 1 month
* Inability to ambulate with or without assistance from another person
* Has used a wheelchair in the last two months for everyday life
* 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
* Currently engaged in pulmonary rehabilitation
* Suicide flag in chart

Primary outcomes:
measure: Measuring change - Late Life Function and Disability Instrument (LLFDI)
timeFrame: Baseline, Week 8 (mid-point), Week 16 (post-intervention) - measuring change
measure: Step Count-measuring change
timeFrame: Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change
Secondary outcomes:
measure: Patient Health Questionniare-8- measuring change
timeFrame: Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change
measure: Beck Anxiety Inventory- measuring change
timeFrame: Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change
measure: Exercise Capacity
timeFrame: Baseline, Week 8 (mid-point), Week 16 (post-intervention)- measuring change
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Patricia Bamonti, PhD
role: PRINCIPAL_INVESTIGATOR
References: