Use of hypnotics such as benzodiazepines and benzodiazepine receptor agonists is associated with adverse health outcomes in older adults. Response rates to hypnotic discontinuation programs are often inadequate, and many patients eventually resume use of hypnotics, suggesting that other mechanisms need to be targeted to achieve and sustain high rates of non-use. Current programs focus on the tapering of hypnotics and/or the treatment of insomnia symptoms. These programs employ strategies such as supervised gradual taper, cognitive behavioral therapy targeting hypnotic withdrawal, and/or cognitive behavioral therapy for insomnia. Evidence suggests that another mechanism involving ?placebo? effects may be a viable target for achieving and sustaining higher discontinuation rates. Cognitive expectancies play a key role in producing placebo effects, which are characterized as real improvements in sleep arising from psychosocial aspects of treatment rather than drug effects alone. The long-term goal of this research is to improve the health of older adults who use hypnotics and have insomnia. This project's objectives are to determine whether a new program, entitled Masked Taper plus cognitive behavioral therapy-augmented program (MTcap), which combines novel cognitive exercises and masked tapering (described below), compared to an unmasked supervised gradual taper plus cognitive behavioral therapy for insomnia (SGT+CBTI), reduces expectancies for hypnotics, improves hypnotic discontinuation rates, and improves insomnia symptoms. The central hypothesis is that cognitive expectancies that produce placebo effects are modifiable and that hypnotic discontinuation and insomnia severity improve when cognitive expectancies for hypnotics are diminished. This hypothesis has been formulated on our extensive preliminary data, which includes results from a ?masked? tapering intervention aimed at altering cognitive expectancies that produce placebo effects. Masking is achieved by encapsulating hypnotics so the participant, who has consented to a gradual taper, is unaware of the actual dose in each capsule until the end of the taper, when the tapering schedule is revealed to the participant. The therapist uses masking as a tool to challenge expectancies about hypnotics that may be contributing to chronic use and to augment cognitive behavioral therapy targeting hypnotic withdrawal (e.g., preparing for withdrawal). The central hypothesis will be tested by pursing three specific aims in a 5-year randomized trial conducted among 188 participants recruited from 2 sites: Determine whether MTcap improves 1) expectancies about hypnotics more than SGT+CBTI, 2) hypnotic discontinuation more than SGT+CBTI, and 3) insomnia severity more than SGT+CBTI at follow-up. This innovative approach targets a previously unaddressed mechanism? the placebo effect?that may contribute to chronic hypnotic use. This highly significant research will improve understanding of hypnotic-related placebo effects and ultimately, improve efforts to discontinue hypnotics and other potentially inappropriate medications.
The proposed research is relevant to public health because the study targets a previously unaddressed mechanism (placebo effect) that likely contributes to chronic hypnotic use, which is associated with adverse health outcomes. It will examine the reversibility of hypnotic-related cognitive expectancies and determine whether higher sustained rates of hypnotic discontinuation and improvement in insomnia, which is a prevalent condition that adversely affects the health of older adults, can be achieved with a novel intervention. The project is relevant to the National Institute on Aging's mission statement??to extend the healthy, active years of life??because a program that helps older adults discontinue hypnotics and treats insomnia with cognitive- behavioral therapy has the potential to improve the overall health of older adults.
