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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG057929 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
| Virginia Commonwealth University | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Program A | Experimental | cognitive behavioral therapy type A plus medications in packaging type A |
|
| Program B | Active Comparator | cognitive behavioral therapy type B plus medications in packaging type B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Program A | Other | Cognitive behavioral therapy type A plus medications prepared in packaging type A. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Hypnotic Discontinuation | 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. | 6 months after treatment ends (which is an average of 8 months from randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | 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. | One week post intervention (which is an average of 9 weeks from randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Digit Symbol Substitution | 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. | One week post intervention (which is an average of 9 weeks from randomization) |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Constance Fung, MD, MSHS | UCLA, VA Greater Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles | Los Angeles | California | 90073 | United States | ||
| University of California, Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42168527 | Derived | Ghadimi S, Erickson AJ, Vaughan M, Mitchell MN, Josephson K, Badr MS, Martin JL, Zeidler M, Alessi C, Fung CH. Sleep aid usage following benzodiazepine receptor agonist tapering and cognitive behavioral therapy for insomnia in middle-aged and older adults. J Clin Sleep Med. 2026 May 21;22(1):80. doi: 10.1007/s44470-026-00089-5. | |
| 39374004 | Derived | Fung CH, Alessi C, Martin JL, Josephson K, Kierlin L, Dzierzewski JM, Moore AA, Badr MS, Zeidler M, Kelly M, Smith JP, Cook IA, Der-Mcleod E, Ghadimi S, Naeem S, Partch L, Guzman A, Grinberg A, Mitchell M. Masked Taper With Behavioral Intervention for Discontinuation of Benzodiazepine Receptor Agonists: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1448-1456. doi: 10.1001/jamainternmed.2024.5020. |
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Compliance at one of the sites is not permitting data sharing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Program A | Cognitive Behavioral Therapy for Insomnia, plus novel cognitive and behavioral exercises addressing placebo mechanisms. Medications were prepared in weekly masked blister packs. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period. |
| FG001 | Program B | Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Program A | Cognitive behavioral therapy type A plus medications in packaging type A Program A: Cognitive behavioral therapy type A plus medications prepared in packaging type A. |
| BG001 | Program B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rates of Hypnotic Discontinuation | 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. | For this outcome, the analysis is performed only on those participants who completed the 6-month follow-up assessment and provided data on medication usage. As a result, there were 87 in program A and 89 in program B who met these criteria. | Posted | Count of Participants | Participants | 6 months after treatment ends (which is an average of 8 months from randomization) |
|
Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Program A | Cognitive behavioral therapy type A plus medications in packaging type A Program A: Cognitive behavioral therapy type A plus medications prepared in packaging type A. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for respiratory viral illness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
The trial was interrupted by the COVID-19 pandemic. Protocol changes were made in response to the COVID-19 pandemic (see protocol).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Constance Fung | University of California, Los Angeles and VA Greater Los Angeles Healthcare System | 818 891-7711 | 39311 | Constance.Fung@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2020 | Oct 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016344 | Medicare Part A |
| ID | Term |
|---|---|
| D006278 | Medicare |
| D008483 | Medical Assistance |
| D011632 | Public Assistance |
| D005380 | Financing, Government |
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| Program B | Other | Cognitive behavioral therapy type B plus medications in packaging type B. |
|
| Insomnia Severity Index |
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. |
| 6 months after treatment ends (which is an average of 8 months from randomization) |
| Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale | 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. | One week post intervention (which is an average of 9 weeks from randomization) |
| Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale | 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. | 6 months after treatment ends (which is an average of 8 months from randomization) |
| Rates of Hypnotic Discontinuation | 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. | One week post intervention (which is an average of 9 weeks from randomization) |
| Hypnotic Dose | The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams). | One week post intervention (which is an average of 9 weeks from randomization) |
| Hypnotic Dose | The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams). | 6 months after treatment ends (which is an average of 8 months from randomization) |
| Digit Symbol Substitution | 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. | 6 months after treatment ends (which is an average of 8 months from randomization) |
| Mini-Mental State Examination | This is a 30-item test of cognitive function. Scores range from 0-30, with higher scores indicating better cognitive function. | One week post intervention (which is an average of 9 weeks from randomization) |
| Mini-Mental State Examination | This is a 30-item test of cognitive function. Scores range from 0-30, with higher scores indicating better cognitive function. | 6 months after treatment ends (which is an average of 8 months from randomization) |
| Trail Making Test A and B | 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. | One week post intervention (which is an average of 9 weeks from randomization) |
| Trail Making Test A and B | 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. | 6 months after treatment ends (which is an average of 8 months from randomization) |
| One-leg Balance Test | 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. | One week post intervention (which is an average of 9 weeks from randomization) |
| One-leg Balance Test | 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. | 6 months after treatment ends (which is an average of 8 months from randomization) |
| Los Angeles |
| California |
| 90095 |
| United States |
| 37526436 | Derived | 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. J Am Geriatr Soc. 2023 Dec;71(12):3924-3927. doi: 10.1111/jgs.18528. Epub 2023 Aug 1. No abstract available. |
| Death |
|
| Incomplete assessment |
|
Cognitive behavioral therapy type B plus medications in packaging type B
Program B: Cognitive behavioral therapy type B plus medications in packaging type B.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Insomnia Severity Index | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Program B | Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period. |
|
|
|
| Secondary | Insomnia Severity Index | 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. | Posted | Mean | Standard Error | score on a scale | One week post intervention (which is an average of 9 weeks from randomization) |
|
|
|
|
| Secondary | Insomnia Severity Index | 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. | Posted | Mean | Standard Error | score on a scale | 6 months after treatment ends (which is an average of 8 months from randomization) |
|
|
|
|
| Secondary | Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale | 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. | Posted | Mean | Standard Error | score on a scale | One week post intervention (which is an average of 9 weeks from randomization) |
|
|
|
|
| Secondary | Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale | 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. | Posted | Mean | Standard Error | score on a scale | 6 months after treatment ends (which is an average of 8 months from randomization) |
|
|
|
|
| Secondary | Rates of Hypnotic Discontinuation | 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. | For this outcome, the analysis is performed only on those participants who completed the post-intervention assessment and provided data on medication usage. As a result, there were 86 in program A and 92 in program B who met these criteria. | Posted | Count of Participants | Participants | One week post intervention (which is an average of 9 weeks from randomization) |
|
|
|
|
| Secondary | Hypnotic Dose | The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams). | Posted | Mean | Standard Error | diazepam-equivalent milligrams | One week post intervention (which is an average of 9 weeks from randomization) |
|
|
|
|
| Secondary | Hypnotic Dose | The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams). | Posted | Mean | Standard Error | diazepam-equivalent milligrams | 6 months after treatment ends (which is an average of 8 months from randomization) |
|
|
|
|
| Other Pre-specified | Digit Symbol Substitution | 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. | Not Posted | One week post intervention (which is an average of 9 weeks from randomization) | Participants |
| Other Pre-specified | Digit Symbol Substitution | 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. | Not Posted | 6 months after treatment ends (which is an average of 8 months from randomization) | Participants |
| Other Pre-specified | Mini-Mental State Examination | This is a 30-item test of cognitive function. Scores range from 0-30, with higher scores indicating better cognitive function. | Not Posted | One week post intervention (which is an average of 9 weeks from randomization) | Participants |
| Other Pre-specified | Mini-Mental State Examination | This is a 30-item test of cognitive function. Scores range from 0-30, with higher scores indicating better cognitive function. | Not Posted | 6 months after treatment ends (which is an average of 8 months from randomization) | Participants |
| Other Pre-specified | Trail Making Test A and B | 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. | Not Posted | One week post intervention (which is an average of 9 weeks from randomization) | Participants |
| Other Pre-specified | Trail Making Test A and B | 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. | Not Posted | 6 months after treatment ends (which is an average of 8 months from randomization) | Participants |
| Other Pre-specified | One-leg Balance Test | 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. | Not Posted | One week post intervention (which is an average of 9 weeks from randomization) | Participants |
| Other Pre-specified | One-leg Balance Test | 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. | Not Posted | 6 months after treatment ends (which is an average of 8 months from randomization) | Participants |
| 1 |
| 92 |
| 4 |
| 92 |
| 5 |
| 92 |
| EG001 | Program B | Cognitive behavioral therapy type B plus medications in packaging type B Program B: Cognitive behavioral therapy type B plus medications in packaging type B. | 0 | 96 | 0 | 96 | 6 | 96 |
| Death from COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gout attack requiring ED visit | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| COVID-19 requiring ED visit | Infections and infestations | Non-systematic Assessment |
|
| Hallucinations | Psychiatric disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Knee pain with torn meniscus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Parasomnia prior to receiving study medication | Nervous system disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D001523 |
| Mental Disorders |
| D005381 |
| Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D007878 | Legislation as Topic |
| D012926 | Social Control, Formal |