The RELAX Trial: Reducing Limitations From Anxiety in Primary Care
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Health-related quality of life (SF-36 MCS)
研究概览
简要总结
This study will determine the impact of a telephone-based care management program for primary care patients with panic disorder or generalized anxiety disorder.
详细描述
Numerous studies have shown that telephone-based collaborative care programs may be an effective way to monitor the quality of life of individuals with mental health issues such as anxiety disorders. With regular monitoring through telephone conversations, health care providers can gain information from their patients in a convenient forum. This study will determine whether a telephone-based care management program can improve anxiety symptoms, alcohol abuse, employment patterns, use of health care services, and health-related quality of life for individuals with panic disorder or generalized anxiety disorder (GAD).
Participants will be randomly assigned to receive either usual care or a telephone-based collaborative care program for 12 months. Usual care may include one or more of several different treatments such as pharmacotherapy and cognitive behavioral therapy; the treatments will be chosen by participants' physicians. Participants assigned to the telephone-based program will have a choice of what type of treatment they will receive; the choices will include pharmacotherapy, workbook training designed to help participants improve their coping skills, referral to a community mental health specialist, or some combination of these treatments.
Participants receiving usual care will continue their treatment for 12 months. After 12 months, these participants will undergo interviews and complete self-report scales for assessment of their anxiety symptoms, health care use, alcohol use, and quality of life. Their participation in the trial will end after 12 months.
Participants in the telephone intervention group will receive telephone calls 1 to 2 times every month for 12 months. During the calls, participants will be asked about their attitude toward and adherence to their treatment regimen. They will also be asked about recent episodes of anxiety they have experienced and what coping techniques they have used. Monthly follow-up calls will continue for an additional 12 months after the first year of the study; this will help determine the long-term effectiveness of the telephone-based intervention.
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)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of panic disorder or generalized anxiety disorder
- •Score of 7 or higher on the Panic Disorder Severity Scale score OR a score of 14 or higher on the Structured Interview Guide for the Hamilton Anxiety Scale
- •Life expectancy greater than 1 year
- •Have a household telephone and can be contacted by phone for the duration of the study
- •Able to read and write in English
排除标准
- •Presently receiving treatment for a psychiatric disorder from a mental health specialist
- •At risk for suicide
- •History of bipolar disorder
- •Dependence on alcohol or other substances within 6 months prior to study entry
- •Organic anxiety syndromes, including those secondary to medical illness or drugs
- •Unstable medical conditions that would interfere with the study
- •Plan to leave their primary care source during the study or for 1 year after study completion
结局指标
主要结局
Health-related quality of life (SF-36 MCS)
时间窗: Measured at Month 12
次要结局
- Generalized anxiety symptoms(Measured at Month 12)
- PHQ-9(Measured at Month 12)
- Alcohol use(Measured at Month 12)
- Health services utilization(Measured at Month 12)
- Health care costs(Measured at Month 12)
- Panic disorder severity scale (PDSS)(Measured at Month 12)
研究者
Bruce Rollman
Professor of Medicine
University of Pittsburgh