NCT03687086

Sleep Without Insomnia or The Use of Chronic Hypnotics

A Novel Mechanism for Helping Older Adults Discontinue Use of Sleeping Pills

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

Sleeping medications, called hypnotics, are often prescribed for insomnia and are 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. In this study, investigators are comparing two programs for discontinuing hypnotic medications-a program that addresses placebo effects associated with hypnotic use and a program that does not address these effects.

Detailed description

Investigators will complete a 5-year randomized trial, recruiting participants from two healthcare systems using a three-step screening process that minimizes time and travel burden to participants. Step 1 (identification of participants): Investigators will identify participants aged \>= 55 years who have current prescriptions for lorazepam, temazepam, alprazolam, and/or zolpidem for \>= 3 months. Investigators will use three sources to identify these patients: medication lists from electronic health records/administrative data, consults to insomnia clinic, and referrals from providers. The research team will mail a recruitment letter (with opt-out card) to patients identified from these sources. Step 2 (phone screening for current or prior insomnia and current hypnotic use); Patients who endorse a history of insomnia symptoms and current hypnotic use will be invited for an in-person screening. Step 3 (in-person screening for remaining eligibility criteria (and baseline assessments): After written consent, the in-person screening visit consists of a comprehensive sleep, mental health, and brief physical health assessment. Individuals who meet study criteria and agree to continue will be randomized to receive either the Program A (N=94) or Program B (N=94). The interventions are approximately 2 months. Following intention-to-treat principles, all randomized participants will complete an assessment immediately after the intervention ends and 6 months after completing treatment. Participants will be compensated monetarily for assessment visits. Investigators will measure hypnotic expectancies, hypnotic discontinuation, and insomnia severity post-treatment and at 6-months follow-up.

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
OTHER	Program A	Cognitive behavioral therapy type A plus medications prepared in packaging type A.
OTHER	Program B	Cognitive behavioral therapy type B plus medications in packaging type B.

Timeline

• Start date: 2018-12-11
• Primary completion: 2023-11-27
• Completion: 2023-11-27
• First posted: 2018-09-27
• Last updated: 2026-04-07
• Results posted: 2024-12-30

Locations

2 sites across 1 country: United States