Calmer Life: A Randomized Controlled Trial of a Participant-Centered Treatment for Anxiety in Low-Income, Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Generalized Anxiety Disorder-7
研究概览
简要总结
The overall goals of the proposed research study are to: (1) examine quantitative outcomes in a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community Care, an information and referral intervention that represents care in a real-world community-service environment, and (2) evaluate implementation feasibility, which includes training community providers; examining program reach, engagement, acceptability, and barriers-facilitators; and preparing practical tools for replicating the program.
详细描述
Cognitive behavioral treatment (CBT) produces positive outcomes for late-life worry/GAD in academic and primary care settings, but minorities are significantly underrepresented in clinical trials, and standard CBT poorly addresses the needs of low-income minority older adults in underserved communities. More attention needs to be given to service delivery of anxiety treatments for underserved older adults. Calmer Life (CL) is a culturally tailored, participant-centered research study that offers a skills-based intervention for late-life anxiety and includes other elements of care to meet the needs of underserved, minority older adults, including the option to integrate religion/spirituality (R/S), flexible delivery modes, and modular treatment format.
Participants will be randomly assigned to CL or Enhanced Community Care(ECC). CL and ECC will be provided by behavioral health clinicians recruited from partner organizations, psychology trainees, and other research staff over 3 months. Assessments will occur at baseline and 3 months.
Participants in the CL condition can choose up to 12 individual skill sessions, and will be recommended to complete a minimum of 6 sessions. If participants desire to incorporate R/S, an R/S assessment occurs during session 2 to help the provider understand the participant's beliefs and practices. R/S can be integrated into any of the skills learned during the intervention (e.g., deep breathing, self-statements, sleep management) or omitted entirely.
Participants in the ECC condition will receive brief biweekly check in calls to provide information about community resources (including mental health), offer emotional support, and assess symptom severity and need for crisis intervention. Emergency procedures will be followed in crisis situations. After 3 months of ECC is completed, participants in the ECC group will be offered the CL intervention.
Outcome measures will be administered for participants in both groups at baseline, 1 month, and 3 months. Participants in ECC will complete measures at 6 months after completion of CL.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 and older
- •Principal or Co-principal diagnosis of GAD or ADNOS
- •Must speak English
- •Must have a health care or social service provider and provide written authorization to research team to communicate with their health-care or social service provider
- •Must live, work, worship, attend community functions, and/or receive health care in target geographic areas
排除标准
- •Active suicidal intent
- •Current psychosis
- •Mania or substance abuse within the last month
- •Cognitive impairment according to a Mini Cog screener score of 3 or lower
结局指标
主要结局
Generalized Anxiety Disorder-7
时间窗: 3 months
Penn State Worry Questionnaire (PSWQ-A)
时间窗: 3 months
Geriatric Anxiety Inventory
时间窗: 3 months
次要结局
- Health services use(3 months)
- Satisfaction with Life Scale(3 months)
- Brief RCOPE(3 months)
- Use of psychotropic medication(3 months)
- Geriatric Depression Scale(3 months)
- Brief Multidimensional Measure of Religiousness and Spirituality(3 months)
- Patient Health Questionnaire-9(3 months)
- Insomnia Severity Index(3 months)
- SF-12 Health Survey(3 months)
- Late-Life Functional Disability Index(3 months)
- Client Satisfaction Questionnaire(3 months)
研究者
Melinda Stanley
Professor
Baylor College of Medicine