Hiv, Insomnia
Conditions
Brief summary
This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.
Detailed description
The primary objective of this pilot trial is to evaluate the effects of cognitive behavioral therapy for insomnia (CBT-I) on changes in circulating levels of hsCRP at 24 weeks in virologically-suppressed, HIV-positive adults with insomnia, defined as having an Insomnia Severity Index (ISI) score ≥ 11. Secondary objectives include comparing changes in hsCRP at 12 weeks, changes in other circulating inflammation biomarkers (IL-6, sCD14, sCD163, CD14+CD16+ monocytes) at both 12 and 24 weeks, and ISI scores and other self-reported patient outcomes at both 12 and 24 weeks.
Interventions
DEVICESHUTi
SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.
BEHAVIORALSleep Education/Hygiene
A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services.
Sponsors
National Institute of Mental Health (NIMH)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study outcomes will be analyzed and compared by blinded investigators and statisticians.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-1 infection, documented as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid HIV test, (2) HIV enzyme test kit at any time prior to study entry, (3) at least one detectable HIV-1 antigen, or (4) at least one detectable plasma HIV-1 RNA viral load. * Age equal to or greater than 18 years. * Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to the date of the HIV-1 RNA value determining eligibility. * HIV-1 RNA level \< 75 copies/mL at Screening. NOTE: There are no CD4 cell count eligibility criteria for this trial. -ISI score ≥ 11 at Screening. NOTE: Use of sleeping aids/medications is permitted as long as the ISI score criterion is met.
Exclusion criteria
* Inability to complete written, informed consent. * Incarceration at the time of any study visit. * Active suicidality at Entry, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions (for Question #3, the previous attempt must be within the past 10 years) on the Patient Suicidality Form (see Appendix). * Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases). NOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation. * End stage renal disease requiring renal replacement therapy (dialysis, transplantation). * Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit. NOTE: Localized treatment for skin cancers is not exclusionary. -Therapy for serious medical illnesses within 14 days prior to the Entry Visit. NOTE: Therapy for serious medical illnesses that overlaps with a study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation. * Pregnancy or breastfeeding during the course of the study. * Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit. NOTE: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors. * Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. * History of bipolar disorder or a psychotic disorder, including schizophrenia. NOTE: Depressive disorders are not exclusionary. * Current sleep disorder diagnosis other than insomnia disorder (e.g., sleep apnea). * Have a schedule requiring a bedtime earlier than 8:00pm or later than 2:00am or arising time earlier than 4:00am or later than 10:00am (thus preventing adoption of SHUTi interventions).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hsCRP Levels at 24 Weeks | Baseline and 24 weeks | Circulating high sensitivity C-reactive protein levels will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change is sCD14 Levels at 24 Weeks | Baseline and 24 weeks | Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation. |
| Change in sCD163 Levels at 24 Weeks | Baseline and 24 weeks | Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation. |
| Change in CD14+CD16+ Monocytes at 24 Weeks | Baseline and 24 weeks | Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes. |
| Change in hsCRP Levels at 12 Weeks | Baseline and 12 weeks | Circulating high sensitivity C-reactive protein (hsCRP) levels will be measured. hsCRP is a measure of systemic inflammation. |
| Change in Insomnia Severity Index (ISI) at 24 Weeks | Baseline and 24 weeks | The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome. |
| Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks | Baseline and 24 weeks | Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality. |
| Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks | Baseline and 24 weeks | The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep. |
| Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks | Baseline and 24 weeks | Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity. |
| Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks | Baseline and 24 weeks | The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms. |
| Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks | Baseline and 24 weeks | The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. |
| Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks | Baseline and 24 weeks | The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue. |
| Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks | Baseline and 24 weeks | Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence. |
| Change in Short Form-36 (SF-36) Health Survey and 24 Weeks | Baseline and 24 weeks | Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health. |
| Use of Sleep Medications at Week 12 | Week 12 | The number of sleep medications used by each participant at Week 12 |
| Use of Sleep Medications at Week 24 | Week 24 | The number of sleep medications used by each participant at Week 24 |
| Change in IL-6 Levels at 24 Weeks | Baseline and 24 weeks | Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation. |
| Insomnia Treatment Satisfaction at Week 24 | Week 24 | An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 24, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction. |
| Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks | Baseline and 12 weeks | Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality. |
| Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks | Baseline and 12 weeks | The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep. |
| Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks | Baseline and 12 weeks | Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity. |
| Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks | Baseline and 12 weeks | The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms. |
| Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks | Baseline and 12 weeks | The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. |
| Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks | Baseline and 12 weeks | The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue. |
| Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks | Baseline and 12 weeks | Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence. |
| Change in Short Form-36 (SF-36) Health Survey and 12 Weeks | Baseline and 12 weeks | Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health. |
| Change in IL-6 Levels at 12 Weeks | Baseline and 12 weeks | Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation. |
| Change is sCD14 Levels at 12 Weeks | Baseline and 12 weeks | Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation. |
| Change in sCD163 Levels at 12 Weeks | Baseline and 12 weeks | Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation. |
| Change in CD14+CD16+ Monocytes at 12 Weeks | Baseline and 12 weeks | Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes. |
| Change in Insomnia Severity Index (ISI) at 12 Weeks | Baseline and 12 weeks | The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome. |
| Insomnia Treatment Satisfaction at Week 12 | Week 12 | An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 12, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBT-I This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.
SHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program. | 16 |
| Sleep Education/Hygiene This arm will receive best practices education on sleep hygiene.
Sleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | Sleep Education/Hygiene | CBT-I |
|---|---|---|---|
| Age, Continuous | 50.2 years STANDARD_DEVIATION 11.3 | 52.6 years STANDARD_DEVIATION 9.2 | 48.1 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 14 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| High Sensitivity C-Reactive Protein | 4.7 mg/L STANDARD_DEVIATION 5.5 | 5.2 mg/L STANDARD_DEVIATION 6.4 | 4.3 mg/L STANDARD_DEVIATION 4.8 |
| Insomnia Severity Index (ISI) Score | 17.9 units on a scale STANDARD_DEVIATION 5.4 | 16.6 units on a scale STANDARD_DEVIATION 4.6 | 18.9 units on a scale STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 8 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Female | 8 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 22 Participants | 11 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
Change in hsCRP Levels at 24 Weeks
Circulating high sensitivity C-reactive protein levels will be measured
Time frame: Baseline and 24 weeks
Population: 12 and 9 participants, respectively, in the CBT-I and Sleep Education/Hygiene arms had hsCRP data collected at Week 24. The changes in hsCRP values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in hsCRP Levels at 24 Weeks | 2.19 mg/L | Standard Deviation 4.56 |
| Sleep Education/Hygiene | Change in hsCRP Levels at 24 Weeks | 4.47 mg/L | Standard Deviation 20.12 |
p-value: 0.60795% CI: [-15.14, 10.6]Regression, Logistic
Secondary
Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks
Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence.
Time frame: Baseline and 12 weeks
Population: The changes in AUDIT values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks | 0.70 score on a scale | Standard Deviation 3.27 |
| Sleep Education/Hygiene | Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks | -1.00 score on a scale | Standard Deviation 1.7 |
p-value: 0.1795% CI: [-0.83, 4.22]ANCOVA
Secondary
Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks
Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence.
Time frame: Baseline and 24 weeks
Population: The changes in AUDIT values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks | -0.22 score on a scale | Standard Deviation 1.72 |
| Sleep Education/Hygiene | Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks | -2.36 score on a scale | Standard Deviation 3.64 |
p-value: 0.0895% CI: [-0.24, 3.08]ANCOVA
Secondary
Change in CD14+CD16+ Monocytes at 12 Weeks
Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes.
Time frame: Baseline and 12 weeks
Population: The changes in CD14+16+ monocyte values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in CD14+CD16+ Monocytes at 12 Weeks | -1.75 percentage of total monocytes | Standard Deviation 9.83 |
| Sleep Education/Hygiene | Change in CD14+CD16+ Monocytes at 12 Weeks | 0.23 percentage of total monocytes | Standard Deviation 3.62 |
p-value: 0.9295% CI: [-4.52, 5]ANCOVA
Secondary
Change in CD14+CD16+ Monocytes at 24 Weeks
Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes.
Time frame: Baseline and 24 weeks
Population: The changes in CD14+CD16+ monocyte values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in CD14+CD16+ Monocytes at 24 Weeks | -0.30 percentage of total monocytes | Standard Deviation 13.95 |
| Sleep Education/Hygiene | Change in CD14+CD16+ Monocytes at 24 Weeks | 0.39 percentage of total monocytes | Standard Deviation 3.13 |
p-value: 0.54895% CI: [-4.58, 8.31]ANCOVA
Secondary
Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks
The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.
Time frame: Baseline and 12 weeks
Population: The changes in DBAS-16 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks | -2.07 score on a scale | Standard Deviation 2.52 |
| Sleep Education/Hygiene | Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks | -1.47 score on a scale | Standard Deviation 1.58 |
p-value: 0.6195% CI: [-2.2, 1.32]ANCOVA
Secondary
Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks
The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.
Time frame: Baseline and 24 weeks
Population: The changes in DBAS-16 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks | -2.16 score on a scale | Standard Deviation 1.45 |
| Sleep Education/Hygiene | Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks | -1.96 score on a scale | Standard Deviation 1.47 |
p-value: 0.9195% CI: [-1.34, 1.2]ANCOVA
Secondary
Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks
The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: Baseline and 12 weeks
Population: The changes in GAD-7 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks | -0.71 score on a scale | Standard Deviation 5.16 |
| Sleep Education/Hygiene | Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks | -3.88 score on a scale | Standard Deviation 5.32 |
p-value: 0.0395% CI: [0.35, 7.41]ANCOVA
Secondary
Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks
The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: Baseline and 24 weeks
Population: The changes in GAD-7 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks | -3.08 score on a scale | Standard Deviation 4.11 |
| Sleep Education/Hygiene | Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks | -4.29 score on a scale | Standard Deviation 4.01 |
p-value: 0.1895% CI: [-0.9, 4.48]ANCOVA
Secondary
Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks
The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms.
Time frame: Baseline and 12 weeks
Population: The changes in SCL-20 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks | -0.37 score on a scale | Standard Deviation 1.01 |
| Sleep Education/Hygiene | Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks | -0.59 score on a scale | Standard Deviation 0.6 |
p-value: 0.1395% CI: [-0.13, 1]ANCOVA
Secondary
Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks
The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms.
Time frame: Baseline and 24 weeks
Population: The changes in SCl-20 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks | -0.61 score on a scale | Standard Deviation 0.75 |
| Sleep Education/Hygiene | Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks | -0.64 score on a scale | Standard Deviation 0.66 |
p-value: 0.4295% CI: [-0.3, 0.68]ANCOVA
Secondary
Change in hsCRP Levels at 12 Weeks
Circulating high sensitivity C-reactive protein (hsCRP) levels will be measured. hsCRP is a measure of systemic inflammation.
Time frame: Baseline and 12 weeks
Population: The changes in hsCRP values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in hsCRP Levels at 12 Weeks | 0.31 mg/L | Standard Deviation 1.86 |
| Sleep Education/Hygiene | Change in hsCRP Levels at 12 Weeks | 0.85 mg/L | Standard Deviation 3.29 |
p-value: 0.57995% CI: [-3.14, 1.8]ANCOVA
Secondary
Change in IL-6 Levels at 12 Weeks
Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.
Time frame: Baseline and 12 weeks
Population: The changes in IL-6 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in IL-6 Levels at 12 Weeks | 0.05 pg/mL | Standard Deviation 0.64 |
| Sleep Education/Hygiene | Change in IL-6 Levels at 12 Weeks | 1.24 pg/mL | Standard Deviation 3.99 |
p-value: 0.7495% CI: [-0.79, 1.1]ANCOVA
Secondary
Change in IL-6 Levels at 24 Weeks
Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.
Time frame: Baseline and 24 weeks
Population: The changes in IL-6 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in IL-6 Levels at 24 Weeks | 0.66 pg/mL | Standard Deviation 1.25 |
| Sleep Education/Hygiene | Change in IL-6 Levels at 24 Weeks | 3.11 pg/mL | Standard Deviation 11.03 |
p-value: 0.76695% CI: [-10.74, 4.76]ANCOVA
Secondary
Change in Insomnia Severity Index (ISI) at 12 Weeks
The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome.
Time frame: Baseline and 12 weeks
Population: The changes in ISI values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Insomnia Severity Index (ISI) at 12 Weeks | -5.67 score on a scale | Standard Deviation 8.62 |
| Sleep Education/Hygiene | Change in Insomnia Severity Index (ISI) at 12 Weeks | -3.92 score on a scale | Standard Deviation 5.07 |
p-value: 0.6695% CI: [-6.28, 4.06]ANCOVA
Secondary
Change in Insomnia Severity Index (ISI) at 24 Weeks
The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome.
Time frame: Baseline and 24 weeks
Population: The changes in ISI values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Insomnia Severity Index (ISI) at 24 Weeks | -7.48 score on a scale | Standard Deviation 8.1 |
| Sleep Education/Hygiene | Change in Insomnia Severity Index (ISI) at 24 Weeks | -6.00 score on a scale | Standard Deviation 3.59 |
p-value: 0.76695% CI: [-5, 3.74]ANCOVA
Secondary
Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks
Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity.
Time frame: Baseline and 12 weeks
Population: The changes in PHQ-9 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks | -1.82 score on a scale | Standard Deviation 9.47 |
| Sleep Education/Hygiene | Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks | -3.10 score on a scale | Standard Deviation 4.25 |
p-value: 0.1695% CI: [-1.61, 8.97]ANCOVA
Secondary
Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks
Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity.
Time frame: Baseline and 24 weeks
Population: The changes in PHQ-9 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks | -5.64 score on a scale | Standard Deviation 7.68 |
| Sleep Education/Hygiene | Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks | -4.27 score on a scale | Standard Deviation 4.94 |
p-value: 0.7395% CI: [-4.03, 5.6]ANCOVA
Secondary
Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks
Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality.
Time frame: Baseline and 12 weeks
Population: The changes in PSQI values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks | -3.00 score on a scale | Standard Deviation 4.11 |
| Sleep Education/Hygiene | Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks | -1.91 score on a scale | Standard Deviation 3.21 |
p-value: 0.5295% CI: [-4.42, 2.31]ANCOVA
Secondary
Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks
Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality.
Time frame: Baseline and 24 weeks
Population: The changes in PSQI values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks | -3.40 score on a scale | Standard Deviation 3.92 |
| Sleep Education/Hygiene | Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks | -2.17 score on a scale | Standard Deviation 3.33 |
p-value: 0.4295% CI: [-4.39, 1.93]ANCOVA
Secondary
Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks
The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue.
Time frame: Baseline and 12 weeks
Population: The changes in PROMIS FACIT-F values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks | -0.02 score on a scale | Standard Deviation 12.16 |
| Sleep Education/Hygiene | Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks | 0.72 score on a scale | Standard Deviation 5.38 |
p-value: 0.4195% CI: [-11.07, 4.66]ANCOVA
Secondary
Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks
The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue.
Time frame: Baseline and 24 weeks
Population: The changes in PROMIS FACIT-F values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks | 3.21 score on a scale | Standard Deviation 10.28 |
| Sleep Education/Hygiene | Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks | 1.36 score on a scale | Standard Deviation 5.85 |
p-value: 0.4895% CI: [-7.97, 3.9]ANCOVA
Secondary
Change in sCD163 Levels at 12 Weeks
Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.
Time frame: Baseline and 12 weeks
Population: The changes in sCD163 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in sCD163 Levels at 12 Weeks | 95.00 ng/mL | Standard Deviation 309.05 |
| Sleep Education/Hygiene | Change in sCD163 Levels at 12 Weeks | 22.51 ng/mL | Standard Deviation 143.62 |
p-value: 0.3195% CI: [-108.37, 327.78]ANCOVA
Secondary
Change in sCD163 Levels at 24 Weeks
Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.
Time frame: Baseline and 24 weeks
Population: The changes in sCD163 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in sCD163 Levels at 24 Weeks | 44.40 ng/mL | Standard Deviation 212.58 |
| Sleep Education/Hygiene | Change in sCD163 Levels at 24 Weeks | -89.37 ng/mL | Standard Deviation 208.93 |
p-value: 0.17895% CI: [-68.71, 344.3]ANCOVA
Secondary
Change in Short Form-36 (SF-36) Health Survey and 12 Weeks
Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health.
Time frame: Baseline and 12 weeks
Population: The changes in SFl-36 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Short Form-36 (SF-36) Health Survey and 12 Weeks | 10.45 score on a scale | Standard Deviation 17.24 |
| Sleep Education/Hygiene | Change in Short Form-36 (SF-36) Health Survey and 12 Weeks | 7.19 score on a scale | Standard Deviation 11.31 |
p-value: 0.5895% CI: [-9.58, 16.55]ANCOVA
Secondary
Change in Short Form-36 (SF-36) Health Survey and 24 Weeks
Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health.
Time frame: Baseline and 24 weeks
Population: The changes in SF-36 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change in Short Form-36 (SF-36) Health Survey and 24 Weeks | 7.50 score on a scale | Standard Deviation 18.45 |
| Sleep Education/Hygiene | Change in Short Form-36 (SF-36) Health Survey and 24 Weeks | 7.29 score on a scale | Standard Deviation 11.45 |
p-value: 0.9495% CI: [-13.5, 14.52]ANCOVA
Secondary
Change is sCD14 Levels at 12 Weeks
Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.
Time frame: Baseline and 12 weeks
Population: The changes in sCD14 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change is sCD14 Levels at 12 Weeks | 57.43 ng/mL | Standard Deviation 276.42 |
| Sleep Education/Hygiene | Change is sCD14 Levels at 12 Weeks | -63.31 ng/mL | Standard Deviation 149.77 |
p-value: 0.1795% CI: [-57.78, 315.92]ANCOVA
Secondary
Change is sCD14 Levels at 24 Weeks
Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.
Time frame: Baseline and 24 weeks
Population: The changes in sCD14 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Change is sCD14 Levels at 24 Weeks | 1.37 ng/mL | Standard Deviation 402.36 |
| Sleep Education/Hygiene | Change is sCD14 Levels at 24 Weeks | -112.10 ng/mL | Standard Deviation 500.22 |
p-value: 0.46595% CI: [-264.05, 555.14]ANCOVA
Secondary
Insomnia Treatment Satisfaction at Week 12
An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 12, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction.
Time frame: Week 12
Population: The changes in insomnia treatment satisfaction values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Insomnia Treatment Satisfaction at Week 12 | 3.10 units on a scale | Standard Deviation 0.74 |
| Sleep Education/Hygiene | Insomnia Treatment Satisfaction at Week 12 | 2.67 units on a scale | Standard Deviation 1.15 |
p-value: 0.3295% CI: [-0.45, 1.32]t-test, 2 sided
Secondary
Insomnia Treatment Satisfaction at Week 24
An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 24, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction.
Time frame: Week 24
Population: The changes in insomnia treatment satisfactin values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-I | Insomnia Treatment Satisfaction at Week 24 | 3.00 units on a scale | Standard Deviation 0.87 |
| Sleep Education/Hygiene | Insomnia Treatment Satisfaction at Week 24 | 2.75 units on a scale | Standard Deviation 1.22 |
p-value: 0.6195% CI: [-0.75, 1.25]t-test, 2 sided
Secondary
Use of Sleep Medications at Week 12
The number of sleep medications used by each participant at Week 12
Time frame: Week 12
Population: This measure was mistakenly not collected by the study team and is considered a protocol deviation.
Secondary
Use of Sleep Medications at Week 24
The number of sleep medications used by each participant at Week 24
Time frame: Week 24
Population: This measure was mistakenly not collected by the study team and is considered a protocol deviation.