Exposure Therapy for Fear of Falling in Older Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Fear of falling
研究概览
简要总结
This project aims to test the efficacy of an in-home intervention, "Activity, Balance, Learning, and Exposure" (ABLE), which integrates exposure therapy with cognitive restructuring, exercise, and home safety evaluation for older adults with excessive fear of falling. The intervention will be conducted by a licensed physical therapist. A control intervention will be conducted by a health educator. The specific aims of the study are to test the feasibility, acceptability, tolerability, and safety of the ABLE intervention.
详细描述
Approximately 7-14% of older adults living independently in the community, including more than 5% of those who have never experienced a fall, experience moderate to severe fear of falling. Fear of falling leads to decreased physical activity, disability, loss of independence, depression, anxiety, reduced social engagement, and poor quality of life. It is also a major independent risk factor for falls.
Interventions targeting fear of falling, typically delivered in groups and incorporating cognitive restructuring, education, and exercise, have been shown to increase fall-related self-efficacy. Avoidance is resistant to treatment, however, and more than one-third of patients enrolled in these interventions drop out. Factors associated with attrition include high levels of fear and avoidance, indicating that the individuals most in need of such programs are those most likely to withdraw prematurely. These data suggest that avoidance should be targeted in treatment, and that interventions should be designed to reach very fearful individuals who are most likely to drop out of traditional fear of falling programs.
Participation in this study will last up to 8 months. Participants will be randomly assigned to receive either the ABLE intervention or an education control condition. The control condition will consist of in-person education about falls to control for the time and attention provided in the ABLE arm.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years old or older.
- •Severe fear as measured by a brief FES-I score > or =
- •Low to moderate actual risk of falls as set out in Lamb et al. (2008).
- •Distress or functional impairment due to fear of falling.
- •Approval from the patient's primary health care provider.
排除标准
- •Medical condition that would interfere with the safe conduct of the intervention or compromise study participation.
- •Bedbound, wheelchair-dependent, paralyzed in the lower extremities, or requiring the assistance of another person to transfer, walk, or perform intervention exercises within the home.
- •Dementia or cognitive impairment as measured by a score above 10 on the Blessed Orientation Memory Test.
- •Corrected visual acuity < 20/
- •Current participation in psychotherapy or professional rehabilitation services (PT, OT) or in the process of being referred or evaluated for such services. Patients who develop a need for such services during their participation will complete an assessment prior to commencing the outside therapy but will be allowed to continue in the study.
- •Active suicidal ideation
- •Lifetime diagnosis of bipolar I or II disorder or any psychotic disorder.
- •Alcohol or other substance abuse or dependence within six months.
- •Psychosocial factors that would compromise study participation (e.g. homelessness, no telephone).
- •History of osteoporotic fracture.
- •Experiencing 3 or more falls in the past year.
- •Body Mass Index of 17.0 or under.
- •Significant orthostasis, defined as a 20 point or greater difference between seated and standing blood pressure, either systolic or diastolic.
研究组 & 干预措施
Education about falls
In-person education about falls with a health educator.
干预措施: Fall prevention education (Behavioral)
Activity, Balance, Learning, and Exposure
Intervention combining medication review, exercise, home safety evaluation, and exposure therapy.
干预措施: Activity, Balance, Learning, and Exposure (Behavioral)
结局指标
主要结局
Fear of falling
时间窗: 2 months (primary)
Fear of Falling will be measured using the Falls Efficacy Scale - International (FES-I), a version of the most widely used measure of falls self-efficacy. Assessments are performed at baseline, 1 month, 2 months (end of intervention - primary outcome point). We will also collect data at 5 months (3 month follow-up) and 8 months (6 month follow-up).
Activity avoidance
时间窗: 2 months (primary)
Activity avoidance will be assessed using a modified version of the Activity Card Sort, a set of photographs of older adults engaged in various activities that is used in rehabilitation settings. Assessments are performed at baseline, 1 month, 2 months (end of intervention - primary outcome point), 5 months (3 month follow-up), and 8 months (6 month follow-up).
次要结局
- Agoraphobic Avoidance(2 months (primary))
- Post Traumatic Stress Disorder Symptoms(2 months (primary))
- Physical Performance(2 months (primary))
- Physical activity - self-report(2 months (primary))
- Physical activity(2 months)
- Quality of Life(2 months (primary))
- Depressive and Anxiety symptoms(2 months (primary))
- Fear of Falling(2 months (primary))
- Avoidance(2 months (primary))
- Falls(2 months (primary))
研究者
Julie Wetherell
Professor
University of California, San Diego