Status:
COMPLETED
Reducing Anxiety and Stress in Primary Care Patients
Lead Sponsor:
VA Office of Research and Development
Conditions:
Anxiety
Eligibility:
All Genders
18+ years
Phase:
NA
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 reducin...
Detailed Description
Background/Rationale: 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 heal...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Veteran seen in the Syracuse VA Medical Center primary care clinic in the past year
- Screen positive for current (past 2 weeks) clinically significant anxiety symptoms (8 on Generalized Anxiety Disorder-7)
Exclusion
- Inability to communicate in English (as assessed by study staff)
- Report or demonstrate hearing impairment that would preclude telephone screening (as assessed by study staff)
- Inability to demonstrate informed consent
- defined as not being able to comprehend the study description as assessed by study staff and/or not being able to answer the comprehension of consent questions
- have a diagnosis of dementia or severe cognitive impairment (defined by primary care provider or self-report, or having a diagnosis in Problem List)
- screen positive for cognitive impairment (3 or more errors on cognitive screener)
- Have a diagnosis of obsessive-compulsive disorder (OCD) or serious mental illness (SMI) in Problem List
- i.e., psychotic disorders, bipolar disorder
- Have an encounter diagnosis of post-traumatic stress disorder (PTSD) within the past 2 years OR screen positive for PTSD (3 or more on PC-PTSD-5)
- Currently in psychotherapy/counseling for anxiety and/or depression, defined as any of the following within the past 30 days:
- attending specialty mental health sessions \[excluding a single intake session\]
- attending 2 or more Primary Care-Mental Health Integration sessions
- Being hospitalized for mental health treatment
- Report severe depressive symptoms (20 or more on Patient Health Questionnaire-9)
- At imminent risk of suicide
- defined as being identified as imminent risk based on study staff's suicide risk assessment \[verified by the PI\] and in need of intensive treatment
- e.g., hospitalization\] to ensure safety
- Started or had dosage change in psychotropic medication for anxiety or depression in the past 30 days
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03794089
Start Date
April 1 2019
End Date
December 30 2021
Last Update
July 27 2023
Active Locations (1)
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1
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States, 13210-2716