Reducing Anxiety and Stress in Primary Care Patients

Completed · Not applicable

Conditions studied: Anxiety

In brief

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.

Key facts

Study ID

NCT03794089

Run by

VA Office of Research and Development

People needed

35

Starts

2019-04-01

Expected to finish

2021-12-30

Last updated by the study team

2023-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Syracuse VA Medical Center, Syracuse, NY — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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