About this trial
The overall goal of this application is to assess feasibility and impact of a remotely delivered guided meditation practice called Yoga Nidra, for reducing or stopping use of Benzodiazepine Receptor Agonists (BZRAs) for insomnia and anxiety in a population of older adults recruited from within the Birmingham VA medical system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
over 65 years of age
Use of benzodiazepine receptor agonist medication at least 3 nights per week for a minimum of three months and wish to decrease their use
Ability to speak, read, and understand English
Ability to sit or lie comfortably for 30 minutes at a time
Disqualifiers
current use of sleep or anxiety medication other than benzodiazepine receptor agonists
severe depression as indicated by a score above 20 on the patient health questionnaire
presence of other comorbidities that may impact sleep i.e. restless leg syndrome, narcolepsy, or others)
regular mind/body practice within 6 months
Trial design
Parallel
Treatments tested in this trial
Yoga Nidra
Other interventionRecordings were created to allow participants access to a variety of Yoga Nidra practices. Participants will be instructed to complete a 30-minute Yoga Nidra 3-5 times per week, at any time of day or night (including before bed and/or during bouts of sleeplessness). This duration and frequency is informed by previous studies. Related to intentionally decreasing BZRA use, the recording requests each practitioner to set a resolve/personal goal at the start of each practice, and they are asked to repeat it again at the end. In our study, participants will be asked to develop a short and simple resolve in their own words, related to reducing BZRA use, improving sleep and decreasing anxiety, and they will be asked to recite it at each practice.
Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education
Other interventionParticipants will be instructed to access excerpts from standardized and trusted materials through our online platform for 30 minutes, 3-5 times per week.
Treatment groups
Trial outcomes
Primary outcomes
Demand
Number of inquiries
Recruitment Success
Whether 30 participants will enroll and complete the 6-week study
Implementation practicality
Whether the interventions can be successfully administered remotely in this population
Acceptability
Comfort and tolerability ratings on a 0-100 scale
Secondary outcomes
Use of Benzodiazepine Receptor Agonist medications
Frequency and amount used during the study
Cessation of Benzodiazepine Receptor Agonist medication
Number of participants not taking Benzodiazepine medication by the end of the trial
Baseline Urine Benzodiazepine Receptor Agonist Concentration
Concentration of Benzodiazepine metabolites in urine
Close-out Urine Benzodiazepine Receptor Agonist Concentration
Concentration of Benzodiazepine metabolites in urine
Other outcomes
Insomnia Severity Index
Validated measure of insomnia severity
Insomnia Severity Index
Validated measure of insomnia severity
Insomnia Severity Index
Validated measure of insomnia severity
Insomnia Severity Index
Validated measure of insomnia severity
Locations
Sponsors and contacts
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National University of Natural Medicine
Lead sponsor
US Department of Veterans Affairs
Collaborator
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