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临床试验/NCT02391363
NCT02391363已完成不适用

Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2014年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
247
试验地点
2
主要终点
Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months

研究概览

简要总结

The purpose of this research study is to see how helpful two different interventions offered through the Calmer Life program are in reducing worry and improving mood. The investigators also want to understand how a program like Calmer Life can be offered in underserved communities.

详细描述

Background: Recurrent, excessive, uncontrollable worry about multiple topics is common in older adults, but it is not well studied. This significant worry can negatively affect thinking, and it is associated with poorer sleep, more depression, and worse general health. Despite its prevalence, researchers have not studied significant worry enough, particularly in low-income racial and ethnic minority populations. We know these groups are unlikely to have adequate mental health care. We also know that older adults and minorities prefer treatments for worry that do not require medication, and that these kinds of treatments can be effective. Additional tests of treatments that do not involve drugs are needed in low-income racial and ethnic minority populations. Such person-centered research could expand access to appropriate care.

Objectives: The study team plans to compare two approaches, one called Calmer Life (CL) and another called Enhanced Community Care (ECC). CL helps individuals by providing worry-reduction skills and resource counseling for basic needs in a flexible, culturally supportive manner. ECC relies on standard information and resource counseling. The study will answer three questions. First, compared to ECC, is CL more effective at relieving significant worry? Second, which one is more effective at reducing anxiety and depression and improving sleep, ability to do daily activities, and use of medical services? Third, are improvements still present three months after treatment concludes?

Methods: In agreement with our community partners and governed by a council of community leaders, consumers, and providers from low-income minority communities, we will conduct the study. This community-academic partnership, created four years ago, introduced CL to the community. Case managers and community health workers from partner organizations were trained to implement CL. They taught worry-reduction skills and helped participants increase their use of community resources. Content was flexible so that participants could choose which skills to learn and whether or not to include religion or spirituality. They also could learn skills at home, by telephone, or in the community. In a new, larger comparison study, we will enroll 120 women and 30 men who are 50 years of age or older with significant worry. Most (80 percent) will be African American, and 70 percent will have income below poverty. Participants will be assigned by chance to CL or ECC and treated for six months. Brief assessments at enrollment and at six and nine months will rely on participants' reports. Differences will be measured statistically.

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

入选标准

  • PSWQ greater than 22

排除标准

  • PHQ score less than 20
  • Active suicidal intent
  • Active psychosis or bipolar disorder
  • Substance abuse
  • Cognitive impairment

研究组 & 干预措施

Enhanced Community Care

Active Comparator

Enhanced information and referral services for mental health and basic needs

干预措施: Information and referral (Behavioral)

Calmer Life

Experimental

Cognitive behavior treatment for anxiety

干预措施: Cognitive behavior treatment (Behavioral)

结局指标

主要结局

Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months

时间窗: Baseline, 9 months

Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.

Generalized Anxiety Disorder-7 (GAD-7) at 6 Months

时间窗: Baseline, 6 months

Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.

Generalized Anxiety Disorder-7 (GAD-7) at 9 Months

时间窗: Baseline, 9 months

Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.

Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months

时间窗: Baseline, 6 months

Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.

次要结局

  • Insomnia Severity Index (ISI) at 9 Months(Baseline, 9 months)
  • Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months(Baseline, 6 months)
  • Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months(Baseline, 6 months)
  • Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months(Baseline, 9 months)
  • Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS)(Baseline, 9 months)
  • Hospital Admissions at 6 Months(Baseline, 6 months)
  • Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months(Baseline, 9 months)
  • Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months(Baseline, 9 months)
  • Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months(Baseline, 6 months)
  • Geriatric Depression Scale Short Form (GDS) at 9 Months(Baseline, 9 months)
  • Insomnia Severity Index (ISI) at 6 Months(Baseline, 6 months)
  • Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months(Baseline, 6 months)
  • Hospital Admissions at 9 Months(Baseline, 9 months)
  • Social Service or Resource Use at 6 Months(Baseline, 6 months)
  • Geriatric Depression Scale Short Form (GDS) at 6 Months(Baseline, 6 months)
  • Health Service Use at 6 Months(Baseline, 6 months)
  • Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months(Baseline, 6 months)
  • Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation(Baseline, 9 months)
  • Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months(Baseline, 9 months)
  • PTSD Checklist-5 (PCL-5) Total at 6 Months(Baseline, 6 months)
  • PTSD Checklist-5 (PCL-5) Total at 9 Months(Baseline, 9 months)
  • Health Service Use at 9 Months(Baseline, 9 months)
  • Social Service or Resource Use at 9 Months(Baseline, 9 months)
  • Psychological Service Use at 6 Months(Baseline, 6 months)
  • Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months(Baseline, 6 months)
  • Psychological Service Use at 9 Months(Baseline, 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melinda Stanley

Professor and Head, Division of Psychology

Baylor College of Medicine

研究点 (2)

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