CO-PRINCIPAL Investigators:
Timothy Anderson, MD, MAS (University of Pittsburgh)
Gloria Yeh, MD, MPH (Beth Israel Deaconess Medical Center)
Project title:
Pilot of a Brief Cognitive Behavioral Therapy Intervention to Enhance Benzodiazepine Deprescribing in Older Adults
Literature Gap: Benzodiazepines have been identified as potentially inappropriate medications due to their association with increased health risks especially in older adults. It is important to create successful models for patient-centered describing to prevent severe withdrawal symptoms or mental health crises. One frequently identified psychological predictor for successful benzodiazepine discontinuation is self-efficacy.
Primary Study Aims: There are two study aims. The first aim is to refine, based on stakeholder feedback, a novel, brief telehealth intervention consisting of psychologist-led third-wave cognitive behavioral therapy sessions focused on reducing fears and improving self-efficacy related to deprescribing integrated within a pharmacist-led benzodiazepine tapering program. The second aim is to evaluate the feasibility and acceptability of the refined deprescribing intervention using mixed methods.
Study Design: Single-arm pilot trial of the refined brief cognitive behavioral therapy-assisted deprescribing intervention in 20 older adults prescribed chronic benzodiazepines. By collecting quantitative data during the trial and qualitative interviews of participants at the end of the intervention, we will further refine the intervention in preparation for larger scale testing and implementation.
PRINCIPAL Investigator:
Elizabeth L. Addington, PhD – Northwestern University Feinberg School of Medicine
Project Title:
Positive emotion regulation intervention for benzodiazepine receptor agonist deprescribing in older adults: Anxiety Lowering and Deprescribing through Emotion Regulation (ALDER)
Literature Gap: Positive psychological interventions have demonstrated efficacy for improving well-being and health behaviors, including treatment adherence. However, they have not been tailored for older adults or integrated into clinical care as a non-pharmacologic, integrative health approach to managing symptoms such as anxiety and supporting BZRA deprescribing.
Primary Study Aims: Aim 1: Tailor ALDER for implementation as an adjunct to primary care BZRA deprescribing for older adults, using key informant interviews with older adults who are identified as candidates for BRZA deprescribing and with clinicians who provide primary care for older adults prescribed BZRAs. Aim 2: Evaluate feasibility, acceptability, and adoption of ALDER among older adults who are candidates for BZRA deprescribing. Aim 3: Design a type 2 hybrid implementation-effectiveness trial based on stakeholder feedback, including follow-up interviews with patients who participated in the Aim 2 trial, as well as their clinicians.
Study Design: Stakeholder-engaged tailoring and feasibility pilot test of ALDER, a web-based positive emotion regulation intervention to support BRZA deprescribing in adults age 65+.
PRINCIPAL Investigator:
Gurjeet Birdee, MD MPH- Vanderbilt University Medical Center
PROJECT TITLE:
Augmenting Benzodiazepine Receptor Agonist Deprescribing with Yoga and Acupuncture Among Older Adults
Literature Gap: Benzodiazepine receptor agonists (BRZA) are associated with unacceptable health risks for older adults. Barriers to deprescribing BRZA medications include rebound symptoms of insomnia and anxiety. Integrative therapies such as yoga and acupuncture are commonly used to treat insomnia and anxiety, however, it is unclear if these therapies will be helpful while deprescribing BRZAs.
Primary Study Aims: Aim 1) Assess feasibility to enroll older adults taking BRZAs into study. Aim 2) Evaluated the fidelity, adherence, and acceptability of 12-week BRZA deprescribing augmented with acupuncture and yoga treatments. Aim 3) Assess the feasibility of outcome assessments at baseline, 4, 8, and 12 weeks for BRZA dose and symptoms of anxiety and insomnia.
Study Design: Single arm clinical study among 30 older adults taking BRZA to assess the feasibility of protocol-driven BRZA deprescribing augmented with combined acupuncture and yoga.
PRINCIPAL Investigator:
Ryan Bradley, ND, MPH
PROJECT TITLE:
Remotely-delivered Yoga Nidra for Decreasing Use of Benzodiazepine Drugs for Insomnia and Anxiety in Older Adults
Literature Gap: Benzodiazepine receptor-agonists (BZRA) are widely used to treat insomnia and anxiety. However, these medications have well-documented and serious side effects, including risk of addiction, falls, motor vehicle accidents, and respiratory failure resulting in death. Older adults are especially vulnerable to these risks. Thus, there is a need for research on non-pharmacologic approaches to treating insomnia and anxiety, such that reliance on BZRAs can decrease. While Cognitive Behavioral Therapy (CBT) for Insomnia has been shown to assist with treating insomnia and reducing use of BZRAs, use is limited by low durability, high remission rates, limited access, latency of response, and high cost. Several studies suggest yoga and meditation are promising as safe, effective treatments for insomnia and anxiety. Thus, we propose a 6-week investigation of Yoga Nidra (an easily accessible and safe guided meditation technique, practiced while lying down) as a candidate non-pharmacologic intervention for reducing BZRA use by older adults for insomnia comorbid with anxiety.
Primary Study Aims: The aims of the current research are to: 1. Evaluate feasibility, acceptability, and protocol adherence via recruitment and retention data, participant ratings of comfort and tolerability, and adherence tracking using practice logs and digital tracking of the intervention (30-min 3-5’s/week for 6 weeks); 2. Measure changes in BZRA use over 6 weeks of Yoga Nidra via online self-report BZRA use logs, and urine analysis over 6 weeks; and 3. Evaluate self-report and objective changes in insomnia and anxiety over 6 weeks of Yoga Nidra using self-report surveys (Insomnia Severity Index and Generalized Anxiety Disorder) and objective measures (respiration rate via the Spire® tag).
Study Design: The research approach will consist of a randomized clinical trial comparing Yoga Nidra + Basic education on sleep hygiene & anxiety vs. Intensive education on sleep hygiene and anxiety for 6-weeks, with all interventions delivered remotely to 30 older adults taking BZRAs prescribed for insomnia and anxiety. Participants will be recruited using online screening plus evaluation by a sleep psychiatrist, who will also monitor participants for safety throughout the study. Outcome measures after 6-weeks will determine feasibility, preliminary safety and changes in BZRA use throughout the intervention.
