Program A
OtherCognitive behavioral therapy type A plus medications prepared in packaging type A.
NCT Number: NCT03687086
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.
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Notify Me55 year and older
All sexes
Interventional
Not applicable
University of California, Los Angeles, Los Angeles, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High risk for complications in outpatient hypnotic discontinuation program:
Discontinuation of hypnotic not appropriate:
•Study-targeted hypnotic used to treat another clinical condition (e.g., panic disorder)
Poor candidate for cognitive behavioral therapy for insomnia:
Cognitive behavioral therapy type A plus medications prepared in packaging type A.
Cognitive behavioral therapy type B plus medications in packaging type B.
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
The percentage of participants who had stopped taking a benzodiazepine or z-drug at follow-up. This outcome was measured with 7-day self-reported medication logs.
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
Mean score on Insomnia Severity Index. This 7-item scale measures self-reported severity of insomnia symptoms.
Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
Mean score on Insomnia Severity Index. This 7-item scale measures self-reported severity of insomnia symptoms.
Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
These 3-items were used to measure hypnotic expectancies. Items ranged from 0 (strongly disagree/least expectancy) to 10 (strongly agree/most expectancy). The scale score is the average of the 3 items and ranged from 0-10 with higher scores indicating greater hypnotic expectancy. Higher hypnotic expectancies are worse outcomes, lower hypnotic expectancies are better outcomes.
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
These 3-items were used to measure hypnotic expectancies. Items ranged from 0 (strongly disagree/least expectancy) to 10 (strongly agree/most expectancy).The scale score is the average of the 3 items and ranged from 0-10 with higher scores indicating greater hypnotic expectancy. Higher hypnotic expectancies are worse outcomes, lower hypnotic expectancies are better outcomes.
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
The percentage of participants who had stopped taking a benzodiazepine or z-drug one week after the end of treatment . This outcome was measured with 7-day self-reported medication logs.
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams).
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams).
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
This test measures processing speed, working memory, visuospatial processing, and attention. It is sensitive to cognitive impairment and change in cognition. The score is based on the number of symbols that the person correctly substitutes in 90 seconds. Total score can range from 0 to 135, with higher scores indicating better cognitive performance.
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
This test measures processing speed, working memory, visuospatial processing, and attention. It is sensitive to cognitive impairment and change in cognition. The score is based on the number of symbols that the person correctly substitutes in 90 seconds. Total score can range from 0 to 135, with higher scores indicating better cognitive performance.
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
This is a 30-item test of cognitive function. Scores range from 0-30, with higher scores indicating better cognitive function.
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
This is a 30-item test of cognitive function. Scores range from 0-30, with higher scores indicating better cognitive function.
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
Objective measure of cognitive executive functioning. The scores is the number of seconds it takes to complete the test. Lower scores indicate better cognitive functioning.
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
Objective measure of cognitive executive functioning. The scores is the number of seconds it takes to complete the test. Lower scores indicate better cognitive functioning.
Time frame: One week post intervention (which is an average of 9 weeks from randomization)
Objective measure of balance. Participants are timed while they stand on one-leg for up to 60 seconds. Score is the number of seconds able to stand on one-leg. Higher scores indicate better balance.
Time frame: 6 months after treatment ends (which is an average of 8 months from randomization)
Objective measure of balance. Participants are timed while they stand on one-leg for up to 60 seconds. Score is the number of seconds able to stand on one-leg. Higher scores indicate better balance.
University of California, Los Angeles
Other
A Novel Mechanism for Helping Older Adults Discontinue Use of Sleeping Pills
Acronym: SWITCH
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