Reducing Anxiety and Stress in Primary Care Patients: Pilot RCT of a Brief Intervention (CDA 15-262)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Generalized Anxiety Disorder-7 at Post-Assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Baseline assessment, monthly follow-up assessments, and post assessment will be conducted by research assistants who are masked to participant condition
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Generalized Anxiety Disorder-7 at Post-Assessment
时间窗: Baseline & Post-Assessment (at 16 weeks)
The primary outcome of anxiety symptom severity will be measured by the Generalized Anxiety Disorder-7 (GAD-7) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how much they have been bothered by each of 7 anxiety symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score ranging from 0 to 21 indicating severity of anxiety symptoms; higher scores indicate more severe symptoms. The total score is sensitive to change from treatment across the anxiety disorders. The GAD-7 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders.
次要结局
- Patient Health Questionnaire-9 at Post-Assessment(Baseline & Post-Assessment (at 16 weeks))
- Depression Anxiety Stress Scale-21 Anxiety Subscale Change(Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks))
- Depression Anxiety Stress Scale-21 Depression Subscale Change(Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks))
- Depression Anxiety Stress Scale-21 Stress Subscale Change(Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks))
- Overall Anxiety Severity and Impairment Scale Change(Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks))
- Overall Depression Severity and Impairment Scale Change(Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks))