Augmenting Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- BRZA dose change
研究概览
简要总结
The main purpose of this 12-week study is to see if a new combination of treatments can help older adults reduce benzodiazepine or related medication use. The treatment combination consists of 1) medical provider visits to gradually reduce the medication dose over 12 weeks, 2) acupuncture treatments, and 3) private yoga classes. Participants will be offered weekly visits for 12 weeks to receive combined treatments. Participants will be provided surveys before, during, and after the study to learn about their experience of the treatments. At the end of the study, participants will be invited to participate in a focus group to learn about their experience in the study.
详细描述
This study consists of a single-arm clinical study among 30 older adults taking benzodiazepine receptor antagonists (BRZA) to assess the feasibility of protocol-driven BRZA deprescribing augmented with combined acupuncture and yoga. Adults 65 years or older that are taking BRZA will be recruited. Deprescribing will be provided at weekly visits with a psychiatric nurse practitioner at the Osher Center for Integrative Health at Vanderbilt University Medical Center. Participants will receive acupuncture and yoga from a staff acupuncturist and yoga instruction from a yoga instructor at the Osher Center. Feasibility of study enrollment will occur through the study enrollment period. Feasibility of study treatments will be evaluated during and after study treatment delivery. Feasibility of study outcome assessments will occur at baseline, 4, 8, and 12 weeks. Throughout the research process, investigators will engage a Stakeholder Advisory Panel consisting of patients and clinicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years and older
- •Taking benzodiazepines or related medications (i.e. zolpidem, zopiclone, eszopiclone, zaleplon) at least 4 times in the last month
- •English speaking
- •Ability to understand study procedures and to comply with them for the length of the study
排除标准
- •Cognitive impairment
- •Drinking more than 3 alcoholic beverages per day
- •Substance abuse disorder
- •Uncontrolled psychiatric disorder, such as major depression or psychosis
- •Inability or unwillingness of individual or legal guardian.representative to give written informed consent.
结局指标
主要结局
BRZA dose change
时间窗: Baseline to 12 weeks
Dose of BRZA for patients will be measured at baseline, 4, 8, and 12 weeks
次要结局
- Insomnia(Baseline to12 weeks)
- Proportion of participants whom the investigators collect primary and secondary outcomes.(Baseline to 12 weeks)
- Anxiety(Baseline to 12 weeks)
研究者
Gurjeet Birdee
Director, Osher Center for Integrative Health Department of Physical Medicine and Rehabilitation
Vanderbilt University Medical Center