1. Alessi CA, Martin JL, Fiorentino L, Fung CH, Dzierzewski JM, Rodriguez JC, Song Y, Josephson KR, Jouldjian S, Mitchell MN: A Randomized Trial of Cognitive Behavioral Therapy for Insomnia in Older Veterans Using Non-Clinician Sleep Coaches. Journal of the American Geriatrics Society. Sep;64(9):1830-8, 2016.
2. Fung CH, Martin JL, Josephson K, Fiorentino L, Dzierzewski JM, Jouldjian S, Song Y, Rodriguez JC, Mitchell MN, Alessi C. Cognitive expectancies for hypnotic use among older adults with chronic insomnia. Clinical Gerontologist. 41(2):130-135, 2018.
3. Fung CH, Martin JL, Alessi C, Dzierzewski JM, Cook IA, Moore A, Grinberg A, Zeidler M, Kierlin L. Hypnotic discontinuation using a blinded (masked) tapering approach: a case series. Frontiers in Psychiatry. 10:717. doi: 10.3389/fpsyt.2019.0071\
4. Alessi CA, Fung CH, Dzierzewski JM, Fiorentino L, Stepnowsky C, Rodriguez JC, Song Y, Zeidler M, Josephson K, Jouldjian S, Mitchell MN, Martin JL. Randomized controlled trial of an integrated approach to treating insomnia and improving use of positive airway pressure therapy in veterans with comorbid insomnia disorder and obstructive sleep apnea. SLEEP. 44(4):zsaa235, 2021.
5. Fung CH, Martin JL., Liang LJ, Hays RD, Col N, Patterson E, Josephson K, Mitchell MN, Sanchez MC, Aysola R, Song Y, Dzierzewski J, Huang D, Zeidler M, Alessi C. The efficacy of a patient decision aid for improving person-centered decision-making in older adults with obstructive sleep apnea. Journal of Clinical Sleep Medicine. 17(2):121-8, 2021.
6. Ghadimi S, Grinberg A, Mitchell MN, Alessi C, Moore AA, Martin JL, Dzierzewski JM, Kelly M, Badr MS, Guzman A, Smith JP, Zeidler M, Fung CH. Sleep characteristics and use of multiple benzodiazepine receptor agonists in older adults. Journal of the American Geriatrics Society. 71(12):3924-27, 2023.
|
Introduction: Benzodiazepines and benzodiazepine receptor agonists (BZRAs) are not recommended as first-line therapy for insomnia in older adults due to adverse events (e.g., falls). Although guidelines recommend cognitive behavioral therapy for insomnia (CBTI) and BZRA discontinuation, discontinuing BZRAs is challenging. To improve discontinuation success, we developed and tested a novel intervention (grounded in the science of known placebo effects of BZRAs), masked taper plus cognitive behavioral therapy-augmented program (MTcap), which masks the daily BZRA dose during tapering and adds novel cognitive and behavioral exercises targeting placebo effects to CBTI. We hypothesized that MTcap would increase BZRA discontinuation 1 week (PTX) and 6 months post-treatment (6M) compared to standard CBTI plus supervised (unmasked) gradual taper (SGT).
Methods: In a multi-site randomized trial, adults (>= 55 years) who use lorazepam, alprazolam, clonazepam, temazepam, and/or zolpidem at doses <= 8 mg diazepam-equivalent 2+ nights/week for >= 3 months for insomnia were randomized to MTcap versus SGT. Blinded research staff conducted PTX and 6M assessments including one-week medication logs and Insomnia Severity Index (ISI). Effects of MTcap versus SGT on BZRA discontinuation (primary outcome) were modeled with logistic regression. Using two-level mixed-effects models, we predicted additional outcomes (frequency [#days/week taken], dose, ISI) as a function of treatment group, site, treatment-site interaction, and time.
Results: 188 participants (mean age 69.8 years, 34.6% female) were randomized (MTcap n=92, SGT n=96), with PTX and 6M. BZRA discontinuation for MTcap was superior to SGT at both PTX (MTcap=0.884, SGT=0.674; odds ratio [OR] 3.68, 95% CI 1.67, 8.12, p=.001) and 6M (MTcap=0.734, SGT=0.586; OR 1.955, 95% CI 1.03, 3.70, p=.04). Change in BZRA frequency was lower in MTcap than SGT at PTX (-1.31, 95% CI -2.05, -0.57, p<.001), but not 6M. ISI did not differ between these two active treatment groups at PTX or 6M.
Conclusion: Adding a masked taper and novel cognitive and behavioral exercises targeting placebo effects to traditional unmasked tapering plus CBTI results in markedly improved long-term BZRA discontinuation, with similar improvement in symptoms of insomnia.
|