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| ID | Type | Description | Link |
|---|---|---|---|
| 1I21RX003732-01A1 | U.S. NIH Grant/Contract | View source |
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Chronic insomnia is one of the most common health problems among Veterans and significantly impacts their health, function, and quality of life. Sedative-hypnotic medications are the most common treatment despite mixed effectiveness and are associated with numerous risks that can further impact Veteran function. An intervention combining evidence-based interventions for deprescribing sedative-hypnotics and behavioral interventions for insomnia (e.g., Cognitive Behavioral Therapy for Insomnia [CBT-I]) can help to optimize sleep and functional outcomes for Veterans with a desire to reduce or stop using these medications. Furthermore, by delivering these interventions through an easy to use and highly accessible digital platform can provide additional benefits to Veterans, especially those with limited time and access to engage in traditional in-person interventions. The Clinician Operated Assistive Sleep Technology (COAST) is an efficient, scalable, and adaptable platform that can help providers to reach more Veterans and provide evidence-based care that translates to improved health and function.
Aim 1: To assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use to participate in a 12-week combined deprescribing and CBT-I intervention, delivered through the COAST digital platform.
Aim 2: To assess Veteran acceptability and usability of the COAST platform.
Aim 3: To assess change in Veteran sleep, sedative-hypnotic use, and function pre- to post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COAST + Deprescribing | Experimental | CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) Change | Total score (0-28): no insomnia (0-7); sub-threshold (8-14); moderate (15-21); and severe insomnia (22-28). A reduction pre- to post-treatment/follow-up of 8 points (or more) indicate a treatment response and a post-treatment/follow-up score or 7 (or less) indicate remission. | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
| Sedative-Hypnotic Medication Use Change | Change in dose % from baseline (T0; week 0) to post-treatment (T1; week 12) Change in dose % from baseline (T0; week 0) to 3-month follow-up (T2; week 24) | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Sedative-Hypnotic Medication Cessation | Percentage of participants that stopped using sleep medications at post-treatment (T1; week 12) and 3-month follow-up (T2; week 24) | post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
| Sleep Diary - Sleep Onset Latency (SOL) Change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam D. Bramoweth, PhD | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37471122 | Background | Bramoweth AD, Hough CE, McQuillan AD, Spitznogle BL, Thorpe CT, Lickel JJ, Boudreaux-Kelly M, Hamm ME, Germain A. Reduction of Sleep Medications via a Combined Digital Insomnia and Pharmacist-Led Deprescribing Intervention: Protocol for a Feasibility Trial. JMIR Res Protoc. 2023 Jul 20;12:e47636. doi: 10.2196/47636. | |
| 42050101 | Derived | Bramoweth AD, Hough CE, Lickel JJ, Spitznogle BL, McQuillan AD, McCoy JL, Boudreaux-Kelly MY, Hamm ME, Thorpe CT, Germain A. Reducing sleep medication via parallel delivery of clinical pharmacist-led deprescribing and clinician-supervised asynchronous CBT for insomnia: the SEDATIVE trial. J Behav Med. 2026 Apr 29. doi: 10.1007/s10865-026-00671-5. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | COAST + Deprescribing | CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies Deprescribing: The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention |
| |||||||||||||
| Post-Treatment |
| |||||||||||||
| 3-month Follow-Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | COAST + Deprescribing | CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies Deprescribing: The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes |
| 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 | Insomnia Severity Index (ISI) Change | Total score (0-28): no insomnia (0-7); sub-threshold (8-14); moderate (15-21); and severe insomnia (22-28). A reduction pre- to post-treatment/follow-up of 8 points (or more) indicate a treatment response and a post-treatment/follow-up score or 7 (or less) indicate remission. | intent to treat analysis - time frame sample size differs due to drop out | Posted | Mean | Standard Deviation | score on a scale | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
|
Baseline through 3-month follow-up assessment (1 year).
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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 | COAST + Deprescribing | CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies Deprescribing: The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes |
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Drop out during intervention and failure to complete post-treatment and follow-up assessments resulted in smaller number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Bramoweth, PhD (Principal Investigator) | VA Pittsburgh Healthcare System | (412) 360-2806 | adam.bramoweth@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 | Jan 24, 2023 | Feb 18, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2022 | Jan 12, 2024 | ICF_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 |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000069340 | Deprescriptions |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D004358 | Drug Therapy |
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pre-post design
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|
| Deprescribing | Behavioral | The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes |
|
|
The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors: Sleep Onset Latency (SOL) is the subjective estimate of time it takes to fall asleep after going to bed and turning the lights out (or attempting to go to sleep). SOL is measured in minutes (lower values are better). |
| baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
| Sleep Diary - Wake After Sleep Onset (WASO) Change | The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors: Wake After Sleep Onset (WASO) is the subjective estimate of time awake in the middle of the night, after falling asleep and before final rise time/out of bed. WASO is measured in minutes (lower values are better). | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
| Sleep Diary - Sleep Efficiency Change | The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors: Sleep Efficiency (SE) = (total sleep time [TST] / time in bed [TIB]) x 100. SE is measured as a percentage (range 0-100%; higher values are better). | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
| Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Includes constructs of Physical Function, Participation in Social Roles, Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference and Intensity, and Cognitive Function. Constructs are scored individually (4 items, 4-20) except Cognitive Function (2 items, 2-10). T-score: population mean=50 and a standard deviation=10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, Depression, Sleep, Pain, and Fatigue, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function, Cognitive Function, and Social Roles, a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average. When all constructs are scored together, a preference score is calculated, representing health-related quality of life ranging from 0 (as bad as dead) to 1 (perfect or ideal health). | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
| Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr) | The PROMIS-29+2 Profile v2.1 (PROPr) is used to calculate a preference score (PROMIS Preference, PROPr). Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). Scores can be used in comparisons across groups and for cost-utility analyses. The profile includes all items in the PROMIS-29 Profile v2.1 plus two Cognitive Function Abilities items. T-scores from the measure can be used to calculate a preference-based score. | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Military Branch | Count of Participants | Participants |
|
| Combat Exposure | Count of Participants | Participants |
|
|
|
|
| Primary | Sedative-Hypnotic Medication Use Change | Change in dose % from baseline (T0; week 0) to post-treatment (T1; week 12) Change in dose % from baseline (T0; week 0) to 3-month follow-up (T2; week 24) | intent to treat analysis - time frame sample size differs due to drop out | Posted | Mean | Standard Deviation | % medication dose relative to baseline | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
|
|
|
|
| Secondary | Sedative-Hypnotic Medication Cessation | Percentage of participants that stopped using sleep medications at post-treatment (T1; week 12) and 3-month follow-up (T2; week 24) | intent to treat analysis - time frame sample size differs due to drop out | Posted | Count of Participants | Participants | post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
|
|
|
|
| Secondary | Sleep Diary - Sleep Onset Latency (SOL) Change | The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors: Sleep Onset Latency (SOL) is the subjective estimate of time it takes to fall asleep after going to bed and turning the lights out (or attempting to go to sleep). SOL is measured in minutes (lower values are better). | intent to treat analysis - time frame sample size differs due to drop out | Posted | Mean | Standard Deviation | minutes | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
|
|
|
|
| Secondary | Sleep Diary - Wake After Sleep Onset (WASO) Change | The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors: Wake After Sleep Onset (WASO) is the subjective estimate of time awake in the middle of the night, after falling asleep and before final rise time/out of bed. WASO is measured in minutes (lower values are better). | intent to treat analysis - time frame sample size differs due to drop out | Posted | Mean | Standard Deviation | minutes | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
|
|
|
|
| Secondary | Sleep Diary - Sleep Efficiency Change | The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors: Sleep Efficiency (SE) = (total sleep time [TST] / time in bed [TIB]) x 100. SE is measured as a percentage (range 0-100%; higher values are better). | intent to treat analysis - time frame sample size differs due to drop out | Posted | Mean | Standard Deviation | sleep efficiency (%) | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
|
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Includes constructs of Physical Function, Participation in Social Roles, Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference and Intensity, and Cognitive Function. Constructs are scored individually (4 items, 4-20) except Cognitive Function (2 items, 2-10). T-score: population mean=50 and a standard deviation=10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, Depression, Sleep, Pain, and Fatigue, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function, Cognitive Function, and Social Roles, a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average. When all constructs are scored together, a preference score is calculated, representing health-related quality of life ranging from 0 (as bad as dead) to 1 (perfect or ideal health). | intent to treat analysis - time frame sample size differs due to drop out | Posted | Mean | Standard Deviation | T-score | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
|
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr) | The PROMIS-29+2 Profile v2.1 (PROPr) is used to calculate a preference score (PROMIS Preference, PROPr). Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). Scores can be used in comparisons across groups and for cost-utility analyses. The profile includes all items in the PROMIS-29 Profile v2.1 plus two Cognitive Function Abilities items. T-scores from the measure can be used to calculate a preference-based score. | intent to treat analysis - time frame sample size differs due to drop out | Posted | Mean | Standard Deviation | score 0-1 | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
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| D001523 |
| Mental Disorders |
| D013812 |
| Therapeutics |
|
| 3-month follow-up |
|
|
| Friedman test |
| 0.005 |
Bonferroni correction |
| Mean Difference (Net) |
| 62.26 |
| Standard Deviation |
| 54.93 |
| 2-Sided |
| Superiority |
|
Bonferroni correction |
| <0.001 |
| Proportion (%) |
| 60 |
| 2-Sided |
| Superiority |
|
| 3-month follow-up |
|
|
baseline to 3-month follow-up |
| Mixed Models Analysis |
| <0.001 |
| Mean Difference (Net) |
| -17.11 |
| Standard Deviation |
| 22.11 |
| 2-Sided |
3-month follow-up - baseline (negative value indicates reduction of symptoms) |
| Superiority |
effect size (f2) = 0.47 (large >=0.35) |
|
| 3-month follow-up |
|
|
baseline to 3-month follow-up |
| Mixed Models Analysis |
| <0.001 |
| Mean Difference (Net) |
| -10.34 |
| Standard Deviation |
| 18.28 |
| 2-Sided |
3-month follow-up - baseline (negative value indicates reduction of symptoms) |
| Superiority |
effect size (f2) = 0.34 (medium; large >=0.35) |
|
| 3-month follow-up |
|
|
baseline to 3-month follow-up |
| Mixed Models Analysis |
| <0.001 |
| Mean Difference (Net) |
| 6 |
| Standard Deviation |
| 6 |
| 2-Sided |
3-month follow-up - baseline (positive value indicates improvement) |
| Superiority |
effect size (f2) = 0.96 (large >=0.35) |
|
| Depression |
|
| Fatigue |
|
| Pain Interference/Intensity |
|
| Physical Function |
|
| Sleep Disturbance |
|
| Ability to Participate in Social Roles |
|
| Sleep Disturbance - higher scores indicate more sleep disturbance. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. | Mixed Models Analysis | <0.001 | Mean Difference (Net) | -7.82 | Standard Deviation | 5.62 | 2-Sided | 3-month follow-up - baseline (negative value indicates improvement) | Superiority | effect size (f2) = 1.21 (large >=0.35) |
| Mixed Models Analysis |
| <0.001 |
| Mean Difference (Net) |
| 0.20 |
| Standard Deviation |
| 0.12 |
| 2-Sided |
3-month follow-up - baseline (positive value indicates improvement) |
| Superiority |
effect size (f2) = 1.99 (large >=0.35) |