Exercise to Prevent Depression and Anxiety in Older Hispanics
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
- Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview
研究概览
简要总结
The study is a randomized pilot trial of a health promotion intervention in the prevention of anxiety and depression in older Hispanics.
详细描述
Eligible participants will be randomized to either the Happy Older Latinos are Active (HOLA) intervention or a psychoeducation condition. Participants randomized to HOLA will participate in a group exercise, 3 times a week, for 16 weeks. The exercise is a moderate intensity walk at a centrally located park in Miami-Dade county and will last for an hour (10 minute warmup/stretching, 30 minute walk, 5 minute cool down). Groups will consist of 6 participants and be led by a community health worker. During the cool down phase, participants will plan a pleasant event to be done in between sessions. Participants randomized to the psychoeducation component will receive a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received. These discussion groups will last one hour and will consist of 10 participants. A total of 60 participants will be randomized (30 to HOLA, 30 to fotonovela). Assessments will be conducted at baseline, post intervention, 6 months post-intervention, and 12 months post-intervention.
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
- 是
入选标准
- •Hispanic (self-identified);
- •Minor depression as defined by a primary DSM-IV Axis I diagnosis of minor depressive disorder or subthreshold depression defined as a score ≥ 3 on the Patient Health Questionnaire (PHQ-2), OR subthreshold anxiety as defined as a score ≥ 3 on the Generalized Anxiety Disorder-2 scale (GAD-2);
- •Absence of episodes of major depression and anxiety disorders for past 12 months (as determined by the 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 an exercise program by a physician, physician's assistant, or nurse practitioner;
- •Expect to be resident in Miami for the subsequent 12 months.
排除标准
- •Currently residing in a nursing or group home;
- •A terminal physical illness expected to result in the death within one year;
- •A diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by an MMSE score <24;
- •Presence of any axis 1 psychiatric disorder or substance abuse during preceding 12 months;
- •History of psychiatric disorders other than non-psychotic unipolar major depression or anxiety disorder;
- •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);
- •Participants taking cognitive enhancing medication or psychotropic medications (e.g. antidepressants);
- •unable to complete 400 m walk test in less than 15 min;
- •if participant heart rate exceeded 170 beats per minute OR systolic blood pressure exceeds 180 during 400 m walk test;
- •chest or leg pain, dyspnea, dizziness, feeling faint, or other significant symptoms while completing 400 m walk test;
- •(i) acute or severe medical illness that would prevent participants from walking at a moderate pace for 45 minutes, three times a week.
结局指标
主要结局
Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview
时间窗: change from baseline at 16 months
I will be using the Mini International Neuropsychiatric Interview to test whether the HOLA intervention was successful in preventing participants from getting major depressive disorder, generalized anxiety disorder, and social anxiety disorder.
次要结局
- Self-efficacy as measured by the General Self-Efficacy Scale(change from baseline at 16 months)
- Physical functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)(change from baseline at 16 months)
- Change in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).(change from baseline at 16 months)
- Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)(change from baseline at 16 months)
- Sleep quality as measured by the Pittsburgh Sleep Quality Index(change from baseline at 16 months)
- Change in anxiety symptom severity as measured by the Beck Anxiety Inventory (BAI)(change from baseline at 16 months)
研究者
Daniel Enrique Jimenez
Assistant Professor
University of Miami