An interventional study of Cognitive Behavioral Therapy for Insomnia and Deprescribing in Insomnia, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.
This study's enrollment of 36 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform
Behavioral: Cognitive Behavioral Therapy for Insomnia · Behavioral: Deprescribing
A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies
Also known as: CBT-I
The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes
Also known as: Gradual Dose Reduction, Tapering
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.
Time frame: 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)
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
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)
Time frame: post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
| Milestone | COAST + Deprescribing |
|---|---|
| Started | 36 |
| Completed | 25 |
| Not completed | 11 |
| Milestone | COAST + Deprescribing |
|---|---|
| Started | 25 |
| Completed | 24 |
| Not completed | 1 |
| Milestone | COAST + Deprescribing |
|---|---|
| Started | 24 |
| Completed | 19 |
| Not completed | 5 |
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.
| score on a scale | COAST + Deprescribing |
|---|---|
| Baseline | 14.63 ± 4.04 |
| Post-Treatment | 6.13 ± 4.10 |
| 3-month Follow-Up | 7.17 ± 3.59 |
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)
| % medication dose relative to baseline | COAST + Deprescribing |
|---|---|
| baseline | 100 ± 0 |
| post-treatment | 41.45 ± 43.98 |
| 3-month follow-up | 37.74 ± 54.93 |
Percentage of participants that stopped using sleep medications at post-treatment (T1; week 12) and 3-month follow-up (T2; week 24)
| Participants | COAST + Deprescribing |
|---|---|
| post-treatment | 7 |
| 3-month follow-up | 12 |
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).
| minutes | COAST + Deprescribing |
|---|---|
| baseline | 34.19 ± 27.73 |
| post-treatment | 20.02 ± 14.50 |
| 3-month follow-up | 20.11 ± 16.46 |
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).
| minutes | COAST + Deprescribing |
|---|---|
| baseline | 26.04 ± 31.90 |
| post-treatment | 14.68 ± 14.96 |
| 3-month follow-up | 11.04 ± 14.58 |
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).
| sleep efficiency (%) | COAST + Deprescribing |
|---|---|
| baseline | 87 ± 9 |
| post-treatment | 93 ± 5 |
| 3-month follow-up | 94 ± 5 |
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).
| T-score | COAST + Deprescribing - Baseline | COAST + Deprescribing - Post-Treatment | COAST + Deprescribing - 3-Month Follow-Up |
|---|---|---|---|
| Anxiety | 51.58 ± 8.18 | 48.48 ± 8.51 | 48.39 ± 7.96 |
| Cognitive Function | 45.46 ± 5.94 | 48.46 ± 7.60 | 49.98 ± 4.62 |
| Depression | 50.74 ± 8.77 | 49.08 ± 8.32 | 46.75 ± 6.01 |
| Fatigue | 56.31 ± 7.99 | 50.90 ± 9.17 | 46.93 ± 8.50 |
| Pain Interference/Intensity | 57.74 ± 6.93 | 56.53 ± 7.41 | 53.23 ± 6.38 |
| Physical Function | 42.90 ± 7.30 | 45.40 ± 6.07 | 47.67 ± 6.64 |
| Sleep Disturbance | 58.48 ± 6.11 | 50.10 ± 6.29 | 49.99 ± 5.22 |
| Ability to Participate in Social Roles | 49.07 ± 8.50 | 54.36 ± 8.60 | 57.53 ± 6.63 |
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.
| score 0-1 | COAST + Deprescribing - Baseline | COAST + Deprescribing - Post-Treatment | COAST + Deprescribing - 3-Month Follow-Up |
|---|---|---|---|
| Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr) | 0.29 ± 0.16 | 0.41 ± 0.19 | 0.50 ± 0.15 |
Collected over Baseline through 3-month follow-up assessment (1 year).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COAST + Deprescribing | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Age, Continuous(years) | COAST + Deprescribing |
|---|---|
| Mean | 59.22 ± 13.97 |
| Sex: Female, Male(Participants) | COAST + Deprescribing |
|---|---|
| Female | 3 |
| Male | 33 |
| Race (NIH/OMB)(Participants) | COAST + Deprescribing |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 31 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Marital Status(Participants) | COAST + Deprescribing |
|---|---|
| Married | 23 |
| Divorced | 8 |
| Never Married | 3 |
| Widowed | 1 |
| Unknown | 1 |
| Military Branch(Participants) | COAST + Deprescribing |
|---|---|
| Army | 15 |
| Marine Corps | 8 |
| Navy | 6 |
| Air Force | 5 |
| Coast Guard | 1 |
| Unknown | 1 |
| Combat Exposure(Participants) | COAST + Deprescribing |
|---|---|
| Yes | 21 |
| No | 15 |
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Sleep Initiation and Maintenance Disorders→
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