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Reducing Anxiety and Stress in Primary Care Patients

August 13, 2019

Overview

 

This study examines if brief anxiety treatment for veterans is more effective at providing relief than usual care. The brief treatment will include a cognitive-behavioral skills focus and up to six 30-minute sessions. They will compare the anxiety symptoms at baseline and 16 weeks after the assessment.

 

Study Information

 

This is an internventionalized, randomized, single-blind, parallel assignment with a primary purpose of treatment. There are an estimated 48 participants. The study began on April 1, 2019 and is still recruiting participants. It is expected to be completed by June 30, 2020.

 

Inclusion Criteria

 

To be eligible for this study, participants are required:

  • To be ages 18 years or older
  • A 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 Criteria

 

Those ineligible for this study include:

  • 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 show informed consent
    • defined as not being able to comprehend the study description as assessed by study staff and/or not being able to understand the 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

 

Location

 

You may participate in this study at Syracuse VA Medical Center in Syracuse, New York, United States, 13210. If you have any questions or concerns please contact Robyn L. Shepardson, PhD at 315-425-4400 ext. 53956 or at Robyn.Shapardson@va.gov.

 

Sponsors/Collaborators

 

This clinical trial is sponsored by the VA Office of Research and Development at Syracuse VA Medical Center in Syracuse, NY. The Principal Investigator for this study is Robyn L. Shepardson, PhD.

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