Augmenting Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga Among Older Adults
- Conditions
- AnxietyBenzodiazepineInsomniaDeprescription
- Registration Number
- NCT06197243
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method BRZA dose change Baseline to 12 weeks Dose of BRZA for patients will be measured at baseline, 4, 8, and 12 weeks
- Secondary Outcome Measures
Name Time Method Insomnia Baseline to12 weeks Will use Patient Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Computerized Adaptive Testing to assess difficulties staying and falling asleep. The minimum value is 0 and the maximum value is 100, with higher scores determining worse outcomes.
Proportion of participants whom the investigators collect primary and secondary outcomes. Baseline to 12 weeks Will estimate feasibility of data collection for study measures by calculating proportion of participants whom the investigators collect primary and secondary outcomes.
Anxiety Baseline to 12 weeks Will use Patient Reported Outcomes Measurement Information System(PROMIS) Anxiety Computerized Adaptive Testing. The minimum value is 0 and the maximum value is 100, with higher scores determining worse outcomes.
Trial Locations
- Locations (1)
Osher Center for Integrative Health at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Osher Center for Integrative Health at Vanderbilt🇺🇸Nashville, Tennessee, United States