Augmenting Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga Among Older Adults

Anxiety Clinical Trial

Official title:

Augmenting Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197243
• Other study ID #: 230716
• Secondary ID: R24AG064025
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: December 14, 2024

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Ana Bencomo Estevez
• Phone: (615)5861310
• Email: ana.bencomo.estevez[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 14, 2024
• Est. primary completion date: December 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anxiety
• Benzodiazepine
• Deprescription
• Insomnia

Intervention

Other:
• Acupuncture
Patients will receive acupuncture for 12 weeks.
• Yoga
Patients will receive yoga therapy with one of three yoga instructors. Patients will remain with singular yoga instructor for duration of study. It is anticipated that patients will participate in yoga therapy for 12 weeks at home and in-clinic.
• Deprescribing
Deprescribing of patients' benzodiazepine use will be monitored by psychiatric nurse. Tapering method will be followed for medication deprescription.

Locations

Country	Name	City	State
United States	Osher Center for Integrative Health at Vanderbilt	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BRZA dose change	Dose of BRZA for patients will be measured at baseline, 4, 8, and 12 weeks	Baseline to 12 weeks
Secondary	Insomnia	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.	Baseline to12 weeks
Secondary	Anxiety	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.	Baseline to 12 weeks
Secondary	Proportion of participants whom the investigators collect primary and secondary outcomes.	Will estimate feasibility of data collection for study measures by calculating proportion of participants whom the investigators collect primary and secondary outcomes.	Baseline to 12 weeks