Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04953806
Status:
RECRUITING
Last Update Posted:
2023-08-04
First Post:
2021-06-24
Brief Title:
The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD Emotion Distress and Low Physical Activity
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD Emotion Distress and Low Physical Activity
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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 N6 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 N25 with COPD low physical activity and clinically significant depression andor 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 patients homes would offer a safe option to increasemaintain physical functioning and mental health in Veterans with COPD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None