Insomnia
Conditions
Keywords
Insomnia, Veterans, Hypnotics and Sedatives, Deprescribing, Cognitive Behavioral Therapy for Insomnia, Telemedicine, Mobile Applications
Brief summary
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Insomnia
A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies
BEHAVIORALDeprescribing
The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
pre-post design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A Veteran receiving care at VA Pittsburgh Healthcare System * Active sedative-hypnotic medication use \>14 days/month for \>=3 months * A desire to reduce or stop using sedative-hypnotic medications * Access to a mobile device with internet
Exclusion criteria
* A disorder that would impair participation (e.g., cancer, uncontrolled pain, severe depression) * A disorder that can be exacerbated by changes in sleep (e.g., seizure disorder, bipolar I disorder) * High risk of suicide * An active substance use disorder in past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) Change | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) | 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. |
| Sedative-Hypnotic Medication Use Change | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Diary - Wake After Sleep Onset (WASO) Change | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) | 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). |
| Sleep Diary - Sleep Efficiency Change | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) | 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). |
| Sedative-Hypnotic Medication Cessation | post-treatment (T1; week 12), 3 month follow-up (T2; week 24) | Percentage of participants that stopped using sleep medications at post-treatment (T1; week 12) and 3-month follow-up (T2; week 24) |
| Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr) | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) | 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. |
| Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) | 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). |
| Sleep Diary - Sleep Onset Latency (SOL) Change | baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | COAST + Deprescribing |
|---|---|
| Age, Continuous | 59.22 years STANDARD_DEVIATION 13.97 |
| Combat Exposure No | 15 Participants |
| Combat Exposure Yes | 21 Participants |
| Marital Status Divorced | 8 Participants |
| Marital Status Married | 23 Participants |
| Marital Status Never Married | 3 Participants |
| Marital Status Unknown | 1 Participants |
| Marital Status Widowed | 1 Participants |
| Military Branch Air Force | 5 Participants |
| Military Branch Army | 15 Participants |
| Military Branch Coast Guard | 1 Participants |
| Military Branch Marine Corps | 8 Participants |
| Military Branch Navy | 6 Participants |
| Military Branch Unknown | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
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.
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Population: intent to treat analysis - time frame sample size differs due to drop out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COAST + Deprescribing | Insomnia Severity Index (ISI) Change | Baseline | 14.63 score on a scale | Standard Deviation 4.04 |
| COAST + Deprescribing | Insomnia Severity Index (ISI) Change | Post-Treatment | 6.13 score on a scale | Standard Deviation 4.1 |
| COAST + Deprescribing | Insomnia Severity Index (ISI) Change | 3-month Follow-Up | 7.17 score on a scale | Standard Deviation 3.59 |
Comparison: baseline to post-treatmentp-value: <0.001Mixed Models Analysis
Comparison: baseline to 3-month follow-upp-value: <0.001Mixed Models Analysis
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)
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Population: intent to treat analysis - time frame sample size differs due to drop out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COAST + Deprescribing | Sedative-Hypnotic Medication Use Change | baseline | 100 % medication dose relative to baseline | Standard Deviation 0 |
| COAST + Deprescribing | Sedative-Hypnotic Medication Use Change | post-treatment | 41.45 % medication dose relative to baseline | Standard Deviation 43.98 |
| COAST + Deprescribing | Sedative-Hypnotic Medication Use Change | 3-month follow-up | 37.74 % medication dose relative to baseline | Standard Deviation 54.93 |
Comparison: % change in medication dose from baseline to post-treatmentp-value: 0.004Friedman test
Comparison: % change in medication dose from baseline to 3-month follow-upp-value: 0.005Friedman test
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).
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Population: intent to treat analysis - time frame sample size differs due to drop out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COAST + Deprescribing | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Anxiety | 51.58 T-score | Standard Deviation 8.18 |
| COAST + Deprescribing | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Cognitive Function | 45.46 T-score | Standard Deviation 5.94 |
| COAST + Deprescribing | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Depression | 50.74 T-score | Standard Deviation 8.77 |
| COAST + Deprescribing | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Fatigue | 56.31 T-score | Standard Deviation 7.99 |
| COAST + Deprescribing | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Pain Interference/Intensity | 57.74 T-score | Standard Deviation 6.93 |
| COAST + Deprescribing | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Physical Function | 42.90 T-score | Standard Deviation 7.3 |
| COAST + Deprescribing | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Sleep Disturbance | 58.48 T-score | Standard Deviation 6.11 |
| COAST + Deprescribing | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Ability to Participate in Social Roles | 49.07 T-score | Standard Deviation 8.5 |
| COAST + Deprescribing - Post-Treatment | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Depression | 49.08 T-score | Standard Deviation 8.32 |
| COAST + Deprescribing - Post-Treatment | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Sleep Disturbance | 50.10 T-score | Standard Deviation 6.29 |
| COAST + Deprescribing - Post-Treatment | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Fatigue | 50.90 T-score | Standard Deviation 9.17 |
| COAST + Deprescribing - Post-Treatment | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Pain Interference/Intensity | 56.53 T-score | Standard Deviation 7.41 |
| COAST + Deprescribing - Post-Treatment | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Physical Function | 45.40 T-score | Standard Deviation 6.07 |
| COAST + Deprescribing - Post-Treatment | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Anxiety | 48.48 T-score | Standard Deviation 8.51 |
| COAST + Deprescribing - Post-Treatment | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Cognitive Function | 48.46 T-score | Standard Deviation 7.6 |
| COAST + Deprescribing - Post-Treatment | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Ability to Participate in Social Roles | 54.36 T-score | Standard Deviation 8.6 |
| COAST + Deprescribing - 3-Month Follow-Up | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Depression | 46.75 T-score | Standard Deviation 6.01 |
| COAST + Deprescribing - 3-Month Follow-Up | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Cognitive Function | 49.98 T-score | Standard Deviation 4.62 |
| COAST + Deprescribing - 3-Month Follow-Up | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Anxiety | 48.39 T-score | Standard Deviation 7.96 |
| COAST + Deprescribing - 3-Month Follow-Up | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Fatigue | 46.93 T-score | Standard Deviation 8.5 |
| COAST + Deprescribing - 3-Month Follow-Up | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Sleep Disturbance | 49.99 T-score | Standard Deviation 5.22 |
| COAST + Deprescribing - 3-Month Follow-Up | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Physical Function | 47.67 T-score | Standard Deviation 6.64 |
| COAST + Deprescribing - 3-Month Follow-Up | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Pain Interference/Intensity | 53.23 T-score | Standard Deviation 6.38 |
| COAST + Deprescribing - 3-Month Follow-Up | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change | Ability to Participate in Social Roles | 57.53 T-score | Standard Deviation 6.63 |
Comparison: 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.p-value: <0.001Mixed Models Analysis
Comparison: 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.p-value: <0.001Mixed Models Analysis
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.
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Population: intent to treat analysis - time frame sample size differs due to drop out
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COAST + Deprescribing | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr) | 0.29 score 0-1 | Standard Deviation 0.16 |
| COAST + Deprescribing - Post-Treatment | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr) | 0.41 score 0-1 | Standard Deviation 0.19 |
| COAST + Deprescribing - 3-Month Follow-Up | Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr) | 0.50 score 0-1 | Standard Deviation 0.15 |
p-value: 0.22Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
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)
Time frame: post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Population: intent to treat analysis - time frame sample size differs due to drop out
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| COAST + Deprescribing | Sedative-Hypnotic Medication Cessation | post-treatment | 7 Participants |
| COAST + Deprescribing | Sedative-Hypnotic Medication Cessation | 3-month follow-up | 12 Participants |
Comparison: baseline to post-treatmentp-value: 0.052Cochran's Q test
Comparison: baseline to 3-month follow-upp-value: <0.001Cochran's Q test
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).
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Population: intent to treat analysis - time frame sample size differs due to drop out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COAST + Deprescribing | Sleep Diary - Sleep Efficiency Change | baseline | 87 sleep efficiency (%) | Standard Deviation 9 |
| COAST + Deprescribing | Sleep Diary - Sleep Efficiency Change | post-treatment | 93 sleep efficiency (%) | Standard Deviation 5 |
| COAST + Deprescribing | Sleep Diary - Sleep Efficiency Change | 3-month follow-up | 94 sleep efficiency (%) | Standard Deviation 5 |
Comparison: baseline to post-treatmentp-value: <0.001Mixed Models Analysis
Comparison: baseline to 3-month follow-upp-value: <0.001Mixed Models Analysis
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).
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Population: intent to treat analysis - time frame sample size differs due to drop out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COAST + Deprescribing | Sleep Diary - Sleep Onset Latency (SOL) Change | baseline | 34.19 minutes | Standard Deviation 27.73 |
| COAST + Deprescribing | Sleep Diary - Sleep Onset Latency (SOL) Change | post-treatment | 20.02 minutes | Standard Deviation 14.5 |
| COAST + Deprescribing | Sleep Diary - Sleep Onset Latency (SOL) Change | 3-month follow-up | 20.11 minutes | Standard Deviation 16.46 |
Comparison: baseline to post-treatmentp-value: <0.001Mixed Models Analysis
Comparison: baseline to 3-month follow-upp-value: <0.001Mixed Models Analysis
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).
Time frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Population: intent to treat analysis - time frame sample size differs due to drop out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COAST + Deprescribing | Sleep Diary - Wake After Sleep Onset (WASO) Change | post-treatment | 14.68 minutes | Standard Deviation 14.96 |
| COAST + Deprescribing | Sleep Diary - Wake After Sleep Onset (WASO) Change | baseline | 26.04 minutes | Standard Deviation 31.9 |
| COAST + Deprescribing | Sleep Diary - Wake After Sleep Onset (WASO) Change | 3-month follow-up | 11.04 minutes | Standard Deviation 14.58 |
Comparison: baseline to post-treatmentp-value: 0.101Mixed Models Analysis
Comparison: baseline to 3-month follow-upp-value: <0.001Mixed Models Analysis