Ignite Creation Date:
2024-05-06 @ 12:34 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03794089
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2019-01-02
Brief Title:
Reducing Anxiety and Stress in Primary Care Patients
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Reducing Anxiety and Stress in Primary Care Patients Pilot RCT of a Brief Intervention CDA 15-262
Status:
COMPLETED
Status Verified Date:
2023-07
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:
Anxiety is common among primary care patients but is undertreated The purpose of this study is to evaluate whether a brief anxiety treatment designed for VA primary care is more effective at reducing anxiety symptoms in Veterans compared to usual care The investigators will also examine whether Veterans like the brief treatment and whether the treatment can be feasibly delivered in primary care Forty-eight adult Veteran primary care patients from the Syracuse VAMC who are experiencing anxiety symptoms will be recruited and randomly assigned to receive the brief anxiety treatment or usual care The brief treatment consists of up to six 30-minute sessions with a cognitive-behavioral skills focus The investigators will compare anxiety symptom severity between the two groups at baseline and at post-assessment 16 weeks later
Detailed Description:
BackgroundRationale Many Veteran primary care patients experience impairing symptoms of anxiety but rates of treatment are low Primary Care-Mental Health Integration PC-MHI in which mental health clinicians provide brief treatment in the primary care setting can bridge the gap between demand for and availability of anxiety treatment However brief anxiety interventions suitable for use in the PC-MHI setting are needed Developing an effective brief PC-MHI intervention for anxiety would address a gap in VA treatment options and facilitate high quality healthcare that improves treatment engagement clinical outcomes and patient experience To ensure maximum reach this intervention should accommodate a variety of subthreshold and diagnostic anxiety presentations as well as comorbid depression
Objectives The overall goal of this research program is to develop refine and evaluate a brief anxiety intervention that will be acceptable to Veterans and feasible for PC-MHI providers The primary aim of the current study is to conduct a pilot randomized controlled trial to evaluate feasibility acceptability potential implementation barriers and facilitators and effectiveness of the intervention compared to usual care
Methods This will be a pilot hybrid type I effectiveness-implementation randomized controlled trial N 35 The primary goal is to evaluate feasibility acceptability and effectiveness of the intervention in reducing anxiety symptom severity compared to usual care The secondary goal is to collect preliminary data on implementation barriers and facilitators that may affect future real-world uptake
Objectives The overall goal of this research program is to develop refine and evaluate a brief anxiety intervention that will be acceptable to Veterans and feasible for PC-MHI providers The primary aim of the current study is to conduct a pilot randomized controlled trial to evaluate feasibility acceptability potential implementation barriers and facilitators and effectiveness of the intervention compared to usual care
Methods This will be a pilot hybrid type I effectiveness-implementation randomized controlled trial N 35 The primary goal is to evaluate feasibility acceptability and effectiveness of the intervention in reducing anxiety symptom severity compared to usual care The secondary goal is to collect preliminary data on implementation barriers and facilitators that may affect future real-world uptake
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