Positive Emotion Regulation Intervention for Benzodiazepine Receptor Agonist Deprescribing in Older Adults: Anxiety Lowering and Deprescribing Through Emotion Regulation (ALDER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Feasibility of Intervention
研究概览
简要总结
The goal of this clinical trial is to test ALDER (Anxiety Lowering and Deprescribing through Emotion Regulation), an online self-guided positive emotion intervention, in patients over the age of 65 who are candidates for benzodiazepine receptor agonist (BZRA, commonly called benzos, or z-drugs) deprescribing. The main questions it aims to answer are:
- Is ALDER relevant to and satisfactory for older adult BZRA users?
- Does ALDER help to increase positive emotions and decrease anxiety, trouble sleeping, and use of BZRA medications?
Participants will complete the 5-week online self-guided ALDER intervention as well as two survey assessments, one before the intervention and one after.
详细描述
ALDER (Anxiety Lowering and Deprescribing through Emotion Regulation) is a pilot trial of an online positive emotion intervention for adults age 65 and over who are candidates for benzodiazepine receptor agonist (BZRA) deprescribing. The ALDER intervention is 5 weeks long and involves weekly self-guided positive emotion skill lessons and daily skill practice exercises, both housed on the ALDER website.
Up to n=40 patients over the age of 65 will be recruited from Northwestern Medicine Primary Care clinics. To participate, patients must have (1) a BZRA prescription from Northwestern Medicine Primary Care within the past year, (2) at least 1 NM Primary Care visit in the past year, and (3) take a BZRA at least twice a week. Participants will complete survey assessments via REDCap before and after they go through the ALDER intervention. All study activities will take place online.
Feasibility, acceptability, and adoption of the ALDER program will be assessed using enrollment and retention rates, website user data, and measures of relevance and satisfaction in the post-intervention assessment. Patient reported outcomes such as anxiety, sleep and positive affect will be measured both pre- and post-intervention and rate of BZRA usage will be extracted from participant medical records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Age 65 and over.
- •≥1 NM Internal Medicine clinic visit within the past year.
- •BZRA prescribed by NM primary care within the past year.
- •Takes BZRA at least twice a week.
- •Daily access to internet-connected device.
- •Ability to read and speak English.
排除标准
- •Dementia, seizure, or REM sleep disorder diagnosis.
- •In hospice care.
- •No daily internet access.
- •Cannot speak and read English.
结局指标
主要结局
Feasibility of Intervention
时间窗: Measured post-intervention (7-weeks).
Measured by enrollment rate (# consented/# eligible) and retention rate (# of complete post-intervention assessments/# consented).
Acceptability of Intervention
时间窗: Measured post-intervention (7-weeks).
Measured during the post-intervention assessment using the Acceptability of Intervention Measure to evaluate relevance of and satisfaction with the ALDER intervention. Examples of survey items include "ALDER meets my approval" and "I like ALDER." The final score is an average of the scores from 4 items. Maximum score is 5, minimum score is 1. Higher scores indicate greater acceptability.
Adoption of Intervention
时间窗: Measured post-intervention (7-weeks).
Measured via usage metrics from the BrightOutcome intervention platform (e.g., mean number of skills accessed).
次要结局
- Patient Benzodiazepine Receptor Agonist (BZRA) Use(Measured at baseline (pre-intervention) and post-intervention (7-weeks).)
- Patient-reported Sleep Disturbance(Measured at baseline (pre-intervention) and post-intervention (7-weeks).)
- Patient-reported Anxiety(Measured at baseline (pre-intervention) and post-intervention (7-weeks).)
- Patient-reported Stress(Measured at baseline (pre-intervention) and post-intervention (7-weeks).)
- Patient-reported Depression(Measured at baseline (pre-intervention) and post-intervention (7-weeks).)
- Patient-reported Positive Affect(Measured at baseline (pre-intervention) and post-intervention (7-weeks).)
- Patient-reported Meaning and Purpose(Measured at baseline (pre-intervention) and post-intervention (7-weeks).)
研究者
Elizabeth Addington
Associate Professor
Northwestern University