Clinical trial NCT03794089: Reducing Anxiety and Stress in Primary Care Patients
Official title: Reducing Anxiety and Stress in Primary Care Patients: Pilot RCT of a Brief Intervention (CDA 15-262)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: anxiety
primary health care
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-01-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial with randomization to the intervention condition or control condition
Primary purpose: TREATMENT

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: 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 = 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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Generalized Anxiety Disorder-7 at Post-Assessment
timeFrame: Baseline & Post-Assessment (at 16 weeks)
Secondary outcomes:
measure: Patient Health Questionnaire-9 at Post-Assessment
timeFrame: Baseline & Post-Assessment (at 16 weeks)
measure: Depression Anxiety Stress Scale-21 Anxiety Subscale Change
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
measure: Depression Anxiety Stress Scale-21 Depression Subscale Change
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
measure: Depression Anxiety Stress Scale-21 Stress Subscale Change
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
measure: Overall Anxiety Severity and Impairment Scale Change
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
measure: Overall Depression Severity and Impairment Scale Change
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Other outcomes:
measure: Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment
timeFrame: Baseline & Post-Assessment (at 16 weeks)
measure: Engagement in Treatment
timeFrame: Post-assessment (16 weeks)
measure: Number of Treatment Sessions Completed
timeFrame: Post-assessment (16 weeks)
measure: Treatment Satisfaction
timeFrame: Post-assessment (at 16 weeks)
measure: Treatment Credibility
timeFrame: Post-assessment (16 weeks)
measure: Therapeutic Alliance
timeFrame: Post-assessment (16 weeks)
Locations:
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
Study officials:
affiliation: Syracuse VA Medical Center, Syracuse, NY
name: Robyn L. Shepardson, PhD
role: PRINCIPAL_INVESTIGATOR
References: