Health Promotion in the Prevention of Anxiety and Depression: the Happy Older Latinos Are Active (HOLA Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Incidence of generalized anxiety disorder
研究概览
简要总结
The purpose of this study is to look at the best ways to prevent anxiety and depression in older Latino adults who are at risk for developing anxiety and depression. Participants will be randomized to either a health promotion intervention or a healthy lifestyles education program.
详细描述
Given the prevalence and morbidity of depression in later life, the inadequacies of current treatment approaches for averting years living with disability, the inequities in access to the mental health care delivery system, and the workforce shortages to meet the mental health needs of older Latinos, development and testing of innovative strategies to prevent depression and anxiety are of great public health significance and have the potential to change practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Latino (self-identified);
- •Subthreshold depression defined as a score ≥ 5 on the Patient Health Questionnaire (PHQ-9), OR subthreshold anxiety as defined as a score ≥ 5 on the GAD-7;
- •Do not meet criteria for current MDD or GAD as indicated by the Mini International Neuropsychiatric Inventory (MINI);
- •Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator;
- •Medical clearance for participation in a health promotion intervention by a physician, physician's assistant, or nurse practitioner;
- •Not taking steroidal or anti-inflammatory medication (including NSAIDs) within 2 weeks of treatment randomization;
- •Expect to be resident in Miami for the subsequent 2 years.
排除标准
- •Have met criteria for major depressive disorder or generalized anxiety disorder within the past 12 months;
- •Have met criteria for alcohol or other substance abuse disorders within the past 12 months;
- •Are currently receiving antidepressant medication or participating in other mental health treatment;
- •Have a lifetime history of bipolar disorder or other psychotic disorder including major depression with psychotic features;
- •Have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam (MMSE) score <24;
- •Are current tobacco smokers since smoking influences systemic inflammation;
- •Have contraindications to physical activity outlined in the American College of Sports Medicine standards;
- •Have high suicide risk, i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire;
- •Are unable to complete 10 m walk test;
- •Currently residing in a nursing or group home;
- •Have a terminal physical illness expected to result in the death within one year;
- •Any evidence of current infection; and
- •Have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention (further defined in the protocol).
研究组 & 干预措施
HOLA: A Culturally-Tailored Health Promotion Intervention
16 week, multicomponent, health promotion intervention
干预措施: HOLA Component 1 (Behavioral)
HOLA: A Culturally-Tailored Health Promotion Intervention
16 week, multicomponent, health promotion intervention
干预措施: HOLA Component 2 (Behavioral)
HOLA: A Culturally-Tailored Health Promotion Intervention
16 week, multicomponent, health promotion intervention
干预措施: HOLA Component 3 (Behavioral)
HOLA: A Culturally-Tailored Health Promotion Intervention
16 week, multicomponent, health promotion intervention
干预措施: HOLA Component 4 (Behavioral)
Healthy lifestyles education program
Educational material on mental health, physical activity, and information on community resources
干预措施: Healthy lifestyles education program (Behavioral)
结局指标
主要结局
Incidence of generalized anxiety disorder
时间窗: 2 years
As measured by the Structured Clinical Interview for the Diagnostic and Statistical Manual 5th edition (SCID-5), a structured clinical interview used for diagnosis.
Recurrence of major depression disorder
时间窗: 2 years
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Change in risk factors for major depressive disorder (MDD)
时间窗: Baseline, 16 weeks, 6, 12, 18, and 24 months
As measured by the Beck Depression Inventory that has a range of scores from 0-63 with scores of 0-9 being minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.
Change in risk factors for generalized anxiety disorder (GAD)
时间窗: Baseline, 16 weeks, 6, 12, 18, and 24 months
As measured by the Beck Anxiety Inventory that has a range of scores from 0-63 with scores 0-21 low anxiety, 22-35 moderate anxiety, and 36+ potentially concerning levels
Incidence of major depression disorder
时间窗: 2 years
As measured by the SCID-5, a structured clinical interview used for diagnosis.
Recurrence of generalized anxiety disorder
时间窗: 2 years
As measured by the SCID-5, a structured clinical interview used for diagnosis.
次要结局
- Change in anti-inflammatory markers(Baseline, 16 weeks, 12, and 24 months)
- Change in pro-inflammatory markers(Baseline, 16 weeks, 12, and 24 months)
- Change in physical functioning as measured by the physical performance battery(Baseline, 16 weeks, 6, 12, 18, and 24 months)
- Change in quality of life(Baseline, 16 weeks, 6, 12, 18, and 24 months)
研究者
Daniel Enrique Jimenez
Assistant Professor
University of Miami