Remote Yoga Nidra for Deprescribing BZRAs

Anxiety Clinical Trial

Official title:

Remotely-delivered Yoga Nidra for Decreasing Use of BZRAs for Insomnia and Anxiety in Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06353919
• Other study ID #: NUNM
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: National University of Natural Medicine
• Contact: Erica Sharpe, PhD
• Phone: 518-681-2580
• Email: esharpe[@]nunm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Before 2020, insomnia and anxiety were estimated to affect much of the US adult population at some point in their life (50% and 30% respectively). By summer of 2022, however, daily negative impacts of insomnia and anxiety were reported by 28% and 52% of US adults, respectively. In the absence of intervention, the COVID-19 pandemic will have lasting negative impacts on our society's sleep and mental health, plus contribute to increased mortality due to depression, heart disease and stroke resulting from insomnia and anxiety. Insomnia and anxiety often co-exist and generalized anxiety disorder is the most common co-morbid psychiatric condition diagnosed with insomnia, with 73% of individuals suffering from anxiety later developing insomnia. Although Benzodiazepine Receptor Agonists (BZRAs) provide rapid symptom relief, they carry risks of side effects including addictive potential, greater risk for falls and motor vehicle accidents, and potential respiratory failure resulting in death, especially when combined with other CNS suppressants such as opiates. Furthermore, many medications may require life-long use, and long-term safety and efficacy have not been established, plus cost remains a barrier to access and adherence. As a result, the first-line treatment for insomnia and anxiety is often Cognitive Behavioral Therapy (CBT). However, CBT is difficult to access, expensive, and takes 4-6 weeks before clinical benefit becomes evident. And it is not very effective in eliminating long-term BZRA use [18] or insomnia/anxiety (34% remission rate for individuals with insomnia and comorbid anxiety). Thus, there is need to test accessible, fast-acting therapies, as stand-alone treatments, or precursor therapies in a stepped care model with CBT-I, to decrease BZRAs used for insomnia and anxiety. Mind-body therapies offer one solution as they are purported to increase self-efficacy and self-regulation, potentially helping to facilitate cognitive and behavioral change needed to decrease BZRA use, and to modify sleep and anxious thought patterns. Importantly, for individuals who struggle to fall asleep or stay asleep (often resulting when anxiety exists alongside insomnia) a fast-acting therapy needs to be accessible in the middle of the night. An effective mind-body therapy for comorbid insomnia and anxiety requires specific qualities such as ease of access, ease of adoption, and mechanisms that support sleep such as inducing relaxation. Remotely-delivered interventions for insomnia and anxiety have been in greater demand since healthcare systems became strained by the pandemic. They offer a valuable opportunity for easy access, and there is evidence of effectiveness. Yet there remains room for improvement, and there has been limited research on remotely-delivered mind-body interventions. Yoga Nidra, a remotely-delivered 30-minute guided meditation (practiced by listening to a voice, while lying down with eyes closed) could be an excellent practice to address insomnia as it is relaxing, free, easily accessible, and only requires passive involvement. It naturally produces a hypnogogic state, which occurs during a normal transition to sleep and promotes a state of deep rest (with simultaneous release of physical, mental, and emotional tensions), accompanied by a unique change in awareness, allowing passive self-exploration, resolution, and growth. The practice is described in detail elsewhere, and is scripted, making it easily reproducible for research, clinical, and personal use. Importantly, this practice can be used at any time of day or night (including to help fall asleep) and requires no special physical capabilities or movements. Setting it apart from BZRAs or CBT-I, Yoga Nidra has no limitations for long-term use (such as side effects or cost) and in fact, ongoing practice provides regular opportunities for self-exploration and biopsychosocial benefit. Relevance to Deprescribing in Older Adults: In spring of 2021, 32% of older adults had reported increased sleep disturbances since the start of the pandemic, and amongst those individuals 78% reported "trouble falling or staying asleep". Additionally, with 44% of older adults reporting self-medicating when they could not sleep, especially since COVID-19 began, risks must be considered. Further complicating matters, issues of polypharmacy and cognitive decline, make safe BZRA use more difficult to ensure in older adults. With 20-30% of older adults suffering daily from anxiety and insomnia, Yoga Nidra is a very promising, accessible, passive, low-cost, and rapid-acting intervention to turn to, instead of BZRAs, for help falling asleep, improving sleep quality, and decreasing anxiety. Yoga Nidra could be especially helpful to those with hypnotic-dependent insomnia, as it is traditionally used to break habits and addictions, with reports of practitioners spontaneously quitting smoking or drinking. This phenomenon was also observed in our work and is attributed to deeply tuning in to what is best for oneself. Description of the Population to be Served: This study will focus on adults in the US over age 65, who are using BZRAs for insomnia comorbid with anxiety, have been using them regularly for at least 3 months, and who are interested in decreasing or discontinuing usage.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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
• Must be under the care of a primary care provider

Exclusion Criteria:

• 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
• unavoidable lifestyle disruptions to sleep

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Yoga Nidra
Recordings 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
Participants will be instructed to access excerpts from standardized and trusted materials through our online platform for 30 minutes, 3-5 times per week.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National University of Natural Medicine	US Department of Veterans Affairs

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insomnia Severity Index	Validated measure of insomnia severity	Baseline
Other	Insomnia Severity Index	Validated measure of insomnia severity	Week 6
Other	Insomnia Severity Index	Validated measure of insomnia severity	Month 1
Other	Insomnia Severity Index	Validated measure of insomnia severity	Month 3
Other	Patient reported outcomes measurement information system 29	Self reported assessment of sleep quality, pain, and anxiety	Baseline
Other	Patient reported outcomes measurement information system 29	Self reported assessment of sleep quality, pain, and anxiety	Week 6
Other	Generalized Anxiety Disorder 7 Questionnaire	Average GAD7 score	Baseline
Other	Generalized Anxiety Disorder 7 Questionnaire	Average GAD7 score	Week 6
Primary	Demand	Number of inquiries	Up to one year
Primary	Recruitment Success	Whether 30 participants will enroll and complete the 6-week study	Up to one year
Primary	Implementation practicality	Whether the interventions can be successfully administered remotely in this population	Up to one year
Primary	Acceptability	Comfort and tolerability ratings on a 0-100 scale	6 weeks
Primary	Retention	Attrition Rate	6 weeks
Primary	Adherence to Protocol	Percentage of participants who adhered to each intervention	6 weeks
Secondary	Use of Benzodiazepine Receptor Agonist medications	Frequency and amount used during the study	6 weeks
Secondary	Cessation of Benzodiazepine Receptor Agonist medication	Number of participants not taking Benzodiazepine medication by the end of the trial	6 weeks
Secondary	Baseline Urine Benzodiazepine Receptor Agonist Concentration	Concentration of Benzodiazepine metabolites in urine	Baseline
Secondary	Close-out Urine Benzodiazepine Receptor Agonist Concentration	Concentration of Benzodiazepine metabolites in urine	Week 6