Reducing Anxiety and Stress in Primary Care Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | April 1, 2019 |
| End Date: | June 30, 2020 |
| Contact: | Robyn L Shepardson, PhD |
| Email: | Robyn.Shepardson@va.gov |
| Phone: | (315) 425-4400 |
Reducing Anxiety and Stress in Primary Care Patients: Pilot RCT of a Brief Intervention (CDA 15-262)
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.
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.
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 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 = 48). 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.
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 = 48). 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.
Inclusion Criteria:
- 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 Criteria:
- 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 errors on cognitive screener)
- Have a diagnosis of obsessive-compulsive disorder (OCD), post-traumatic stress
disorder (PTSD), or serious mental illness (SMI) in Problem List
- i.e., psychotic disorders, bipolar disorder
- screen positive for PTSD (3 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 Primary Care-Mental Health Integration sessions
- Being hospitalized for mental health treatment
- Report severe depressive symptoms (20 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
We found this trial at
1
site
Syracuse, New York 13210
Principal Investigator: Robyn L. Shepardson, PhD
Phone: 315-425-4400
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