Pilot of a Brief Cognitive Behavioral Therapy Intervention to Enhance Benzodiazepine Deprescribing in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Feasibility: Retention
研究概览
简要总结
The goal of this clinical trial is to conduct a single-arm pilot trial of a brief cognitive-behavioral therapy-enhanced benzodiazepine deprescribing intervention in 20 older adults (aged ≥55 years) prescribed chronic benzodiazepines by their primary care clinicians.
详细描述
Nearly 10% of Americans aged 55 years and older fill benzodiazepine (BZD) prescriptions annually. Chronic use of BZD place older adults at an increased risk of falls, cognitive impairment, functional decline, preventable hospitalizations, and mortality.
Research study investigators will conduct a single-arm pilot trial of the intervention in 20 adults aged 55 and older currently taking chronic BZDs. The aim is to evaluate feasibility/acceptability of the refined deprescribing intervention using mixed methods. At intervention end, research study investigators will conduct surveys and qualitative interviews with participants to obtain feedback on participant experience and intervention components (e.g., acceptability, usefulness, relevance, satisfaction) as well as views on future format options. Using these data and the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, research study investigators will further refine the intervention in preparation for larger scale testing and implementation.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescribed chronic benzodiazepines by their primary care clinicians at a Beth Israel Deaconess Medical Center (BIDMC) Primary Care Clinic.
排除标准
- •Primary Care Practitioner (PCP) opt out
- •Severe anxiety or depression symptoms
研究组 & 干预措施
Benzodiazepine Medication Taper with Cognitive Behavioral Therapy
Brief Cognitive Behavioral Therapy to Enhance Benzodiazepine Deprescribing
干预措施: Benzodiazepine Medication Taper with Cognitive Behavioral Therapy (Other)
结局指标
主要结局
Feasibility: Retention
时间窗: Immediately after 10 weeks of participation
Recruitment, retention (\<10% dropout)
Feasibility: Intervention adherence
时间窗: Immediately after 10 weeks of participation
Intervention adherence (\>75% in at least 2 of 3 sessions)
Acceptability: Open-ended qualitative interview
时间窗: Immediately after 10 weeks of participation
Usefulness in supporting tapering process, use of specific skills and mindfulness techniques, clarity/length of sessions, helpfulness, plans to continue, suggestions for improvements, alternative session formats using open-ended qualitative interview.
Change in Benzodiazepine Use
时间窗: From enrollment to end of intervention at 10 weeks.
Patient-reported benzodiazepine medication doses with change measured by % change from baseline dose.
Change in Sleep Disturbance Scores
时间窗: From enrollment to end of intervention at 10 weeks.
PROMIS Sleep Short Form 8b survey.
Change in Anxiety Scores
时间窗: From enrollment to end of intervention at 10 weeks.
PROMIS Anxiety Short Form 8a Survey.
次要结局
- Behavior: Self-efficacy measured by 7-point Likert scale questions(Week 0 and Immediately after 10 weeks of participation)
- Behavior: Intentions on tapering measured by a 15-point validated scale(Week 0 and Immediately after 10 weeks of participation)
- Behavior: Attitudes on benzodiazepine use measured by 7-point Likert scale(Week 0 and Immediately after 10 weeks of participation)
- Behavior: Knowledge on benzodiazepine risk/benefits measured by true/false questions(Week 0 and Immediately after 10 weeks of participation)
- Behavior: Norms of using benzodiazapine medications measured by 7-point Likert Scale(Week 0 and Immediately after 10 weeks of participation)
- Sustainability of Intervention Effect measured by electronic health record review(Up to 6 months post intervention)
研究者
Gloria Y. Yeh
Associate Professor of Medicine
Beth Israel Deaconess Medical Center