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NCT Number: NCT06353919

Remote Yoga Nidra for Deprescribing BZRAs

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga Nidra

Other

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

Other

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

Primary outcomes

  1. Demand

    Time frame: Up to one year

    Number of inquiries

  2. Recruitment Success

    Time frame: Up to one year

    Whether 30 participants will enroll and complete the 6-week study

  3. Implementation practicality

    Time frame: Up to one year

    Whether the interventions can be successfully administered remotely in this population

  4. Acceptability

    Time frame: 6 weeks

    Comfort and tolerability ratings on a 0-100 scale

  5. Retention

    Time frame: 6 weeks

    Attrition Rate

  6. Adherence to Protocol

    Time frame: 6 weeks

    Percentage of participants who adhered to each intervention

Secondary outcomes

  1. Use of Benzodiazepine Receptor Agonist medications

    Time frame: 6 weeks

    Frequency and amount used during the study

  2. Cessation of Benzodiazepine Receptor Agonist medication

    Time frame: 6 weeks

    Number of participants not taking Benzodiazepine medication by the end of the trial

  3. Baseline Urine Benzodiazepine Receptor Agonist Concentration

    Time frame: Baseline

    Concentration of Benzodiazepine metabolites in urine

  4. Close-out Urine Benzodiazepine Receptor Agonist Concentration

    Time frame: Week 6

    Concentration of Benzodiazepine metabolites in urine

Other outcomes

  1. Insomnia Severity Index

    Time frame: Baseline

    Validated measure of insomnia severity

  2. Insomnia Severity Index

    Time frame: Week 6

    Validated measure of insomnia severity

  3. Insomnia Severity Index

    Time frame: Month 1

    Validated measure of insomnia severity

  4. Insomnia Severity Index

    Time frame: Month 3

    Validated measure of insomnia severity

  5. Patient reported outcomes measurement information system 29

    Time frame: Baseline

    Self reported assessment of sleep quality, pain, and anxiety

  6. Patient reported outcomes measurement information system 29

    Time frame: Week 6

    Self reported assessment of sleep quality, pain, and anxiety

  7. Generalized Anxiety Disorder 7 Questionnaire

    Time frame: Baseline

    Average GAD7 score

  8. Generalized Anxiety Disorder 7 Questionnaire

    Time frame: Week 6

    Average GAD7 score

Study contacts

Contact information is provided by the study sponsor or research team.

Anders Gundersen, MS

CONTACT

[email protected]

503-451-0481

Erica Sharpe, PhD

CONTACT

[email protected]

518-681-2580

Sponsors and collaborators

Lead sponsor

National University of Natural Medicine

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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