Insomnia Disorder
Conditions
Keywords
Cognitive Behavioral Therapy for Insomnia, Self-Directed Treatment, Telehealth
Brief summary
Insomnia is one of the most common complaints among service-members and Veterans of recent military conflicts. Insomnia has been shown to play a causal role in mental health, hypertension, obesity, and other health conditions, increasing risk for all-cause mortality. Cognitive-Behavioral Therapy for Insomnia (CBTI) produces both short-term and sustained resolution of insomnia with fewer adverse side effects than medications, but access to behavioral sleep medicine expertise within the VA is very limited. This study compares Tele-Self CBTI to Health Education Control for improved insomnia severity among treatment-seeking Veterans with Insomnia. In this study, 200 participants will be randomized with a 50/50 chance to either Tele-Self CBTI or a Health Education Control condition. Eligible participants are Veterans who are: a) prescribed sleep medications; b) diagnosed with insomnia; and/or c) referred for clinic-based CBTI (but not yet treated) for insomnia. Participants will be identified using electronic health records (EHR) and telephone interviews. Participants' sleep will be assessed at three time points, at Baseline, 8 weeks and 6 months after Baseline. The Tele-Self CBTi intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 8 week intervention period. Participants randomized to Tele-Self CBTI will complete 6 weekly readings in addition to having 6 weekly telephone contacts with a study nurse; each call lasting approximately 20 minutes. Patients randomized to Health Education Control (HEC) will receive a health education manual on 6 health topics. They will also complete 6 weekly readings from the HEC manual and receive 6 weekly telephone contacts from a study nurse. All participants will continue to receive usual medical care while participating in the study. Following completion of this 6 month study, participants randomized to HEC and interested in additional help for their sleep will be referred to the Durham VA Behavioral Sleep Medicine Clinic.
Detailed description
Insomnia is one of the most common complaints among service-members and Veterans of recent military conflicts. Insomnia diagnoses increased 19-fold among military service members from 2000 to 2009. Insomnia has been shown to play a causal role in depression, anxiety, suicidality, disability due to a mental health disorder, hypertension, obesity, metabolic syndrome, diabetes, and all-cause mortality, thus serving as an additional risk factor for some of the most common medical conditions seen in patients utilizing the VA healthcare system. Cognitive-Behavioral Therapy for Insomnia (CBTI) produces both short-term and sustained resolution of insomnia with fewer adverse side effects than pharmacotherapy. But access to behavioral sleep medicine expertise within the VA is very limited. Self-management and telehealth are viable options for achieving these goals. This study is a randomized controlled trial comparing Tele-Self CBTI to Health Education Control (HEC) for improved insomnia severity among treatment-seeking Veterans with Insomnia. In this 2-arm trial, 200 participants will be randomized in a 1:1 ratio to Tele-Self CBTI or a Health Education Control condition. Eligible participants are Veterans who are: a) prescribed sleep medications; b) diagnosed with insomnia; or c) referred for clinic-based CBTI (but not yet treated) will be identified using electronic health records (EHR) and telephone interviews. Outcomes include insomnia severity in addition to subjective (sleep diary) and objective (actigraphy) measures of sleep variables, including: sleep onset latency (SOL), wakefulness after sleep onset (WASO), and sleep efficiency (SE). These outcomes will be assessed at 3 time points: baseline, 8 weeks, and 6 months after baseline. Participants in both arms will continue to receive usual medical care. Each assessment period involves: a) 2 weeks of home-based sleep assessment (diary and actigraphy), and b) completion of telephone-based questionnaires. Following completion of each home-based sleep assessment period, a study staff member will contact participants to complete study questionnaires by phone. Study participants will be asked to return actigraphy devices at the end of each assessment period. Tele-Self CBTI is comprised of two treatment components: 1) Self-directed treatment via a treatment manual entitled, Improve your Sleep: A Self-Guided Approach for Veterans with Insomnia and 2) telephone-based nurse support. Participants will complete 6 weekly reading modules from the treatment manual on topics reflecting typical CBTI treatment components: Sleep Restriction; Stimulus Control; Cognitive Therapy; Relaxation; and Sleep Hygiene Education. Tele-Self CBTI will be delivered across 6 weekly telephone contacts of 20 minutes or less through a study nurse who will briefly review treatment manual content with the participant, review sleep diaries, and create and adjust sleep prescriptions as needed. Patients randomized to Health Education Control (HEC) will completed weekly readings and receive 6 weekly phone calls from a study nurse. Consistent with phone contacts in the intervention arm, HEC phone contacts will involve reviewing content in the health education manual and will last approximately 20 minutes; matching as closely as possible call duration with Tele-Self CBTI participants. Sleep-focused content will be prohibited during HEC calls. Participants have 8 weeks to complete the 6 phone calls.
Interventions
BEHAVIORALTele-Self CBTI
The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 8 week intervention period. Participants have 8 weeks to complete 6 study-related phone calls
The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 8 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets diagnostic criteria for Insomnia Disorder * Receives care through the Durham VA Health Care System (HCS) catchment area
Exclusion criteria
* Severe Obstructive Sleep Apnea with treatment non-adherence * Unstable co-morbid sleep disorder determined via chart review * e.g., rule out for Narcolepsy, rule out for Shift Work Disorder * Current or prior participation in Cognitive Behavioral Therapy for Insomnia (CBTI) * Excessive daytime sleepiness * Nighttime or rotating shift work within the last year * Psychotic disorder diagnosis * Bipolar disorder diagnosis * Recreational substance use * Current alcohol abuse * Severe depression or suicidality * Dementia diagnosis * Cognitive impairment * Epilepsy diagnosis * Seizure disorder diagnosis * Lack of proficiency in the English language * Hearing impairment that impedes telehealth intervention * Unable to complete study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity | Baseline to 8 weeks | Insomnia Severity Index (ISI): The ISI is recommended as the standard for self-reported insomnia symptoms, and will be used as the primary outcome measure. The ISI is a 7-item questionnaire providing a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale and the total score ranges from 0 (no reported symptoms) to 28 (highest insomnia severity symptoms). The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (sub threshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). In clinical samples, a cut off score of 11 was shown to have the greatest sensitivity and specificity for correctly identifying study participants meeting criteria for insomnia diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Wake After Sleep Onset (WASO) | Baseline to 8 week | Sleep Diary WASO, using the Consensus Sleep Diary (CSD). The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data will then be averaged across each 2-week assessment period to determine SOL, WASO and SE. |
| Subjective Sleep Efficiency (SE) | Baseline to 8 week | Sleep Diary sleep efficiency, calculated from the Consensus Sleep Diary (CSD), which is the percent of the time asleep out of amount of time spent in bed. The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data are averaged across each 2-week assessment period. |
| Subjective Sleep Onset Latency (SOL) | Baseline to 8 week | Sleep Diary sleep onset latency, using the Consensus Sleep Diary (CSD), which is the amount of time asleep in bed divided by the amount of time in bed, averaged across days. The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data will then be averaged across each 2-week assessment period. |
| Objective Total Sleep Time (TST) | Baseline to 8 week | Objective total sleep time using Wrist Actigraphy: The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. The investigators will average data across each two-week assessment period to determine actigraphy-based WASO, Total Sleep Time (TST) and SE. Not all participants completed actigraphy procedures |
| Objective Sleep Efficiency (SE) | Baseline to 8 week | Objective SE using Wrist Actigraphy. The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. SE is the percentage of time spent in bed sleeping, scored total sleep time divided by (interval duration minus total invalid time (sleep/wake)) of the given rest interval multiplied by 100.The investigators will average data across each two-week assessment period. |
| Objective Wake After Sleep Onset | Baseline to 8 week | Objective WASO using Wrist Actigraphy: The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. WASO is the total number of epochs between the start time and the end time of the given sleep interval scored as wake by Actiware software multiplied by the epoch length in minutes. The investigators will average data across each two-week assessment period. Not all participants completed actigraphy procedures |
Countries
United States
Participant flow
Recruitment details
Participants were veterans recruited from the Durham VA Health Care System (HCS) catchment area between 10/4/2019 to 4/26/2022. A data pull from the electronic medical record (EMR), identified veterans who were seeking treatment for insomnia but not yet treated using CBT-I. A chart review of the electronic record was also performed. Potentially eligible patients were then mailed an invitation letter beginning on 9/20/19. They were then contacted, consented and screened over the phone.
Pre-assignment details
Consented participants completed a 2 week assessment period before being randomized. Participants not completing at least 10 days of sleep diary and/or baseline questionnaires were excluded, even if they provided actigraphy data. 178 completed baseline, enrolled and randomized to either Tele-Self CBTI or Health Education Control (HEC), using a stratified, blocked randomization, by baseline Insomnia Severity Index score (≤20/\>20) and presence/absence of a pre-existing mental health diagnosis.
Participants by arm
| Arm | Count |
|---|---|
| Tele-Self CBTI The Tele-Self CBTI intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 6 week intervention period. | 88 |
| Health Education Control The Health Education Control condition is comprised of two components: 1) weekly reading from a health education manual, and 2) weekly telephone-based nurse support contacts across a 6 week period. At the end of the study, participants in the Health Education arm will be offered assistance for their sleep complaints, as needed, through the Durham Behavioral Sleep Medicine clinic. | 90 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 6 mo Assessment | did not complete assessment | 10 | 11 |
| 8 Week Assessment | Did not complete assessment but remained in study | 6 | 5 |
| 8 Week Assessment | Did not complete due to study error, remained in study | 2 | 0 |
| 8 Week Assessment | Withdrawal by Subject | 6 | 1 |
| Intervention Period | Did not complete at least 3 calls but remained in study | 7 | 1 |
| Intervention Period | Excluded (health) | 1 | 0 |
| Intervention Period | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Tele-Self CBTI | Health Education Control | Total |
|---|---|---|---|
| Age, Continuous Age | 55.1 years STANDARD_DEVIATION 13.2 | 55.1 years STANDARD_DEVIATION 13.3 | 55.1 years STANDARD_DEVIATION 13.2 |
| Baseline ISI >20 n (%) | 17 Participants | 18 Participants | 35 Participants |
| Currently using sleep medications n | 60 Participants | 60 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 81 Participants | 86 Participants | 167 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mental health diagnosis n (%) | 73 Participants | 74 Participants | 147 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 42 Participants | 76 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 47 Participants | 40 Participants | 87 Participants |
| Region of Enrollment United States | 88 Participants | 90 Participants | 178 Participants |
| Sex: Female, Male Female | 26 Participants | 24 Participants | 50 Participants |
| Sex: Female, Male Male | 62 Participants | 66 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 90 |
| other Total, other adverse events | 31 / 88 | 37 / 90 |
| serious Total, serious adverse events | 15 / 88 | 16 / 90 |
Outcome results
Primary
Insomnia Severity
Insomnia Severity Index (ISI): The ISI is recommended as the standard for self-reported insomnia symptoms, and will be used as the primary outcome measure. The ISI is a 7-item questionnaire providing a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale and the total score ranges from 0 (no reported symptoms) to 28 (highest insomnia severity symptoms). The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (sub threshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). In clinical samples, a cut off score of 11 was shown to have the greatest sensitivity and specificity for correctly identifying study participants meeting criteria for insomnia diagnosis.
Time frame: Baseline to 8 weeks
Population: This is an intention to treat analysis. All subjects who completed baseline were included in analysis. Estimated means were calculated from a linear mixed model and used for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-Self CBTI | Insomnia Severity | Baseline | 16.1 ISI score | Standard Error 0.2 |
| Tele-Self CBTI | Insomnia Severity | 8 Weeks | 10.4 ISI score | Standard Error 0.5 |
| Health Education Control | Insomnia Severity | Baseline | 16.1 ISI score | Standard Error 0.2 |
| Health Education Control | Insomnia Severity | 8 Weeks | 14.1 ISI score | Standard Error 0.5 |
Comparison: Analyses were conducted according to the intention-to-treat principle. All available data, including observations from participants who dropped out of the study, were used for primary and secondary analyses. Our modeling estimation approach was conducted with full-likelihood methods, providing unbiased treatment effect estimates under a missing-data framework known as missing at random (MAR).p-value: <0.0195% CI: [-5, -2.4]Mixed Models Analysis
Secondary
Objective Sleep Efficiency (SE)
Objective SE using Wrist Actigraphy. The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. SE is the percentage of time spent in bed sleeping, scored total sleep time divided by (interval duration minus total invalid time (sleep/wake)) of the given rest interval multiplied by 100.The investigators will average data across each two-week assessment period.
Time frame: Baseline to 8 week
Population: To be included in actigraphy analyses, actigraphy data must have overlapped with sleep diary data (same dates) for a minimum of 7 nights. Estimated means were used. This is an intention to treat analysis. All subjects who completed baseline were included in analysis. Estimated means were calculated from a linear mixed model and used for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-Self CBTI | Objective Sleep Efficiency (SE) | Baseline | 86.3 percentage of time in bed where asleep | Standard Error 0.4 |
| Tele-Self CBTI | Objective Sleep Efficiency (SE) | 8 week | 87.0 percentage of time in bed where asleep | Standard Error 0.6 |
| Health Education Control | Objective Sleep Efficiency (SE) | Baseline | 86.3 percentage of time in bed where asleep | Standard Error 0.4 |
| Health Education Control | Objective Sleep Efficiency (SE) | 8 week | 85.4 percentage of time in bed where asleep | Standard Error 0.5 |
p-value: <0.0595% CI: [0.2, 2.9]Mixed Models Analysis
Secondary
Objective Total Sleep Time (TST)
Objective total sleep time using Wrist Actigraphy: The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. The investigators will average data across each two-week assessment period to determine actigraphy-based WASO, Total Sleep Time (TST) and SE. Not all participants completed actigraphy procedures
Time frame: Baseline to 8 week
Population: To be included in actigraphy analyses, actigraphy data must have overlapped with sleep diary data (same dates) for a minimum of 7 nights. Estimated means were used. This is an intention to treat analysis. All subjects who completed baseline were included in analysis. Estimated means were calculated from a linear mixed model and used for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-Self CBTI | Objective Total Sleep Time (TST) | Baseline | 5.9 minutes | Standard Error 0.1 |
| Tele-Self CBTI | Objective Total Sleep Time (TST) | 8 week | 6.2 minutes | Standard Error 0.2 |
| Health Education Control | Objective Total Sleep Time (TST) | Baseline | 5.9 minutes | Standard Error 0.1 |
| Health Education Control | Objective Total Sleep Time (TST) | 8 week | 6.2 minutes | Standard Error 0.2 |
p-value: >0.0595% CI: [-0.4, 0.5]Mixed Models Analysis
Secondary
Objective Wake After Sleep Onset
Objective WASO using Wrist Actigraphy: The investigators will use Actiwatch (Respironics, Inc.) wristwatch style actigraphs for collecting objective sleep data. Actiwatches contain a calibrated accelerometer that samples, digitizes, and stores movement activity. When interfaced with a computer, a scoring algorithm provides estimates of various sleep parameters. WASO is the total number of epochs between the start time and the end time of the given sleep interval scored as wake by Actiware software multiplied by the epoch length in minutes. The investigators will average data across each two-week assessment period. Not all participants completed actigraphy procedures
Time frame: Baseline to 8 week
Population: To be included in actigraphy analyses, actigraphy data must have overlapped with sleep diary data (same dates) for a minimum of 7 nights. Estimated means were used. All available data, including observations from participants who dropped out of the study, were used for primary and secondary analyses. Model parameters included a common intercept (baseline means constrained to be equal), with the model examining estimated group differences.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-Self CBTI | Objective Wake After Sleep Onset | Baseline | 48.7 minutes | Standard Error 1.8 |
| Tele-Self CBTI | Objective Wake After Sleep Onset | 8 week | 48.7 minutes | Standard Error 2.7 |
| Health Education Control | Objective Wake After Sleep Onset | Baseline | 48.7 minutes | Standard Error 1.8 |
| Health Education Control | Objective Wake After Sleep Onset | 8 week | 54.9 minutes | Standard Error 2.6 |
p-value: >0.0595% CI: [-12.5, 0.1]Mixed Models Analysis
Secondary
Subjective Sleep Efficiency (SE)
Sleep Diary sleep efficiency, calculated from the Consensus Sleep Diary (CSD), which is the percent of the time asleep out of amount of time spent in bed. The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data are averaged across each 2-week assessment period.
Time frame: Baseline to 8 week
Population: This is an intention to treat analysis. All subjects who completed baseline were included in analysis. Estimated means were calculated from a linear mixed model and used for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-Self CBTI | Subjective Sleep Efficiency (SE) | Baseline | 65.4 percentage of time in bed where asleep | Standard Error 1.2 |
| Tele-Self CBTI | Subjective Sleep Efficiency (SE) | 8 week | 79.0 percentage of time in bed where asleep | Standard Error 1.5 |
| Health Education Control | Subjective Sleep Efficiency (SE) | Baseline | 65.4 percentage of time in bed where asleep | Standard Error 1.2 |
| Health Education Control | Subjective Sleep Efficiency (SE) | 8 week | 68.0 percentage of time in bed where asleep | Standard Error 1.4 |
p-value: <0.0195% CI: [7.7, 14.3]Mixed Models Analysis
Secondary
Subjective Sleep Onset Latency (SOL)
Sleep Diary sleep onset latency, using the Consensus Sleep Diary (CSD), which is the amount of time asleep in bed divided by the amount of time in bed, averaged across days. The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data will then be averaged across each 2-week assessment period.
Time frame: Baseline to 8 week
Population: This is an intention to treat analysis. All subjects who completed baseline were included in analysis. Estimated means were calculated from a linear mixed model and used for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-Self CBTI | Subjective Sleep Onset Latency (SOL) | Baseline | 49.4 minutes | Standard Error 2.6 |
| Tele-Self CBTI | Subjective Sleep Onset Latency (SOL) | 8 week | 26.5 minutes | Standard Error 3.1 |
| Health Education Control | Subjective Sleep Onset Latency (SOL) | Baseline | 49.4 minutes | Standard Error 2.6 |
| Health Education Control | Subjective Sleep Onset Latency (SOL) | 8 week | 46.1 minutes | Standard Error 2.9 |
p-value: <0.0195% CI: [-26.7, -12.5]Mixed Models Analysis
Secondary
Subjective Wake After Sleep Onset (WASO)
Sleep Diary WASO, using the Consensus Sleep Diary (CSD). The investigators will use a call-in interactive Voice Response (IVR) approach to collect sleep diary data during each of the three 2-week assessment periods. Diary data will then be averaged across each 2-week assessment period to determine SOL, WASO and SE.
Time frame: Baseline to 8 week
Population: This is an intention to treat analysis. All subjects who completed baseline were included in analysis. Estimated means were calculated from a linear mixed model and used for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-Self CBTI | Subjective Wake After Sleep Onset (WASO) | Baseline | 58.8 minutes | Standard Error 3.1 |
| Tele-Self CBTI | Subjective Wake After Sleep Onset (WASO) | 8 week | 33.5 minutes | Standard Error 3.6 |
| Health Education Control | Subjective Wake After Sleep Onset (WASO) | Baseline | 58.8 minutes | Standard Error 3.1 |
| Health Education Control | Subjective Wake After Sleep Onset (WASO) | 8 week | 54.0 minutes | Standard Error 3.3 |
p-value: <0.0195% CI: [-29.1, -12]Mixed Models Analysis