Trial Outcomes & Findings for HIV-related Insomnia and Inflammation (NCT NCT04721067)

NCT ID: NCT04721067

Last Updated: 2025-05-29

Results Overview

Circulating high sensitivity C-reactive protein levels will be measured

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline and 24 weeks
• Results posted on: 2025-05-29

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	16	14
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIV-related Insomnia and Inflammation

Baseline characteristics by cohort

Measure	CBT-I n=16 Participants 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.	Sleep Education/Hygiene n=14 Participants 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.	Total n=30 Participants Total of all reporting groups
Age, Continuous	48.1 years STANDARD_DEVIATION 12.9 • n=5 Participants	52.6 years STANDARD_DEVIATION 9.2 • n=7 Participants	50.2 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Insomnia Severity Index (ISI) Score	18.9 units on a scale STANDARD_DEVIATION 6.0 • n=5 Participants	16.6 units on a scale STANDARD_DEVIATION 4.6 • n=7 Participants	17.9 units on a scale STANDARD_DEVIATION 5.4 • n=5 Participants
High Sensitivity C-Reactive Protein	4.3 mg/L STANDARD_DEVIATION 4.8 • n=5 Participants	5.2 mg/L STANDARD_DEVIATION 6.4 • n=7 Participants	4.7 mg/L STANDARD_DEVIATION 5.5 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Circulating high sensitivity C-reactive protein levels will be measured

Outcome measures

Measure	CBT-I n=12 Participants 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.	Sleep Education/Hygiene n=9 Participants 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.
Change in hsCRP Levels at 24 Weeks	2.19 mg/L Standard Deviation 4.56	4.47 mg/L Standard Deviation 20.12

SECONDARY outcome

Timeframe: 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.

Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=11 Participants 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.
Change in IL-6 Levels at 24 Weeks	0.66 pg/mL Standard Deviation 1.25	3.11 pg/mL Standard Deviation 11.03

SECONDARY outcome

Timeframe: 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.

Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=11 Participants 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.
Change is sCD14 Levels at 24 Weeks	1.37 ng/mL Standard Deviation 402.36	-112.10 ng/mL Standard Deviation 500.22

SECONDARY outcome

Timeframe: 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.

Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=11 Participants 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.
Change in sCD163 Levels at 24 Weeks	44.40 ng/mL Standard Deviation 212.58	-89.37 ng/mL Standard Deviation 208.93

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=9 Participants 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.
Change in CD14+CD16+ Monocytes at 24 Weeks	-0.30 percentage of total monocytes Standard Deviation 13.95	0.39 percentage of total monocytes Standard Deviation 3.13

SECONDARY outcome

Timeframe: 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.

Circulating high sensitivity C-reactive protein (hsCRP) levels will be measured. hsCRP is a measure of systemic inflammation.

Outcome measures

Measure	CBT-I n=11 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in hsCRP Levels at 12 Weeks	0.31 mg/L Standard Deviation 1.86	0.85 mg/L Standard Deviation 3.29

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Insomnia Severity Index (ISI) at 24 Weeks	-7.48 score on a scale Standard Deviation 8.10	-6.00 score on a scale Standard Deviation 3.59

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks	-3.40 score on a scale Standard Deviation 3.92	-2.17 score on a scale Standard Deviation 3.33

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks	-2.16 score on a scale Standard Deviation 1.45	-1.96 score on a scale Standard Deviation 1.47

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks	-5.64 score on a scale Standard Deviation 7.68	-4.27 score on a scale Standard Deviation 4.94

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks	-0.61 score on a scale Standard Deviation 0.75	-0.64 score on a scale Standard Deviation 0.66

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks	-3.08 score on a scale Standard Deviation 4.11	-4.29 score on a scale Standard Deviation 4.01

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks	3.21 score on a scale Standard Deviation 10.28	1.36 score on a scale Standard Deviation 5.85

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=9 Participants 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.	Sleep Education/Hygiene n=11 Participants 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.
Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks	-0.22 score on a scale Standard Deviation 1.72	-2.36 score on a scale Standard Deviation 3.64

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Short Form-36 (SF-36) Health Survey and 24 Weeks	7.50 score on a scale Standard Deviation 18.45	7.29 score on a scale Standard Deviation 11.45

SECONDARY outcome

Timeframe: Week 12

Population: This measure was mistakenly not collected by the study team and is considered a protocol deviation.

The number of sleep medications used by each participant at Week 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

Population: This measure was mistakenly not collected by the study team and is considered a protocol deviation.

The number of sleep medications used by each participant at Week 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Insomnia Treatment Satisfaction at Week 12	3.10 units on a scale Standard Deviation 0.74	2.67 units on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=9 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Insomnia Treatment Satisfaction at Week 24	3.00 units on a scale Standard Deviation 0.87	2.75 units on a scale Standard Deviation 1.22

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=11 Participants 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.
Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks	-3.00 score on a scale Standard Deviation 4.11	-1.91 score on a scale Standard Deviation 3.21

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=11 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks	-2.07 score on a scale Standard Deviation 2.52	-1.47 score on a scale Standard Deviation 1.58

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=11 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks	-1.82 score on a scale Standard Deviation 9.47	-3.10 score on a scale Standard Deviation 4.25

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=11 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks	-0.37 score on a scale Standard Deviation 1.01	-0.59 score on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=11 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks	-0.71 score on a scale Standard Deviation 5.16	-3.88 score on a scale Standard Deviation 5.32

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=11 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks	-0.02 score on a scale Standard Deviation 12.16	0.72 score on a scale Standard Deviation 5.38

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=10 Participants 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.	Sleep Education/Hygiene n=10 Participants 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.
Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks	0.70 score on a scale Standard Deviation 3.27	-1.00 score on a scale Standard Deviation 1.70

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=11 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Short Form-36 (SF-36) Health Survey and 12 Weeks	10.45 score on a scale Standard Deviation 17.24	7.19 score on a scale Standard Deviation 11.31

SECONDARY outcome

Timeframe: 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.

Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.

Outcome measures

Measure	CBT-I n=11 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in IL-6 Levels at 12 Weeks	0.05 pg/mL Standard Deviation 0.64	1.24 pg/mL Standard Deviation 3.99

SECONDARY outcome

Timeframe: 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.

Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.

Outcome measures

Measure	CBT-I n=11 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change is sCD14 Levels at 12 Weeks	57.43 ng/mL Standard Deviation 276.42	-63.31 ng/mL Standard Deviation 149.77

SECONDARY outcome

Timeframe: 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.

Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.

Outcome measures

Measure	CBT-I n=11 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in sCD163 Levels at 12 Weeks	95.00 ng/mL Standard Deviation 309.05	22.51 ng/mL Standard Deviation 143.62

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=9 Participants 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.	Sleep Education/Hygiene n=11 Participants 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.
Change in CD14+CD16+ Monocytes at 12 Weeks	-1.75 percentage of total monocytes Standard Deviation 9.83	0.23 percentage of total monocytes Standard Deviation 3.62

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CBT-I n=11 Participants 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.	Sleep Education/Hygiene n=12 Participants 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.
Change in Insomnia Severity Index (ISI) at 12 Weeks	-5.67 score on a scale Standard Deviation 8.62	-3.92 score on a scale Standard Deviation 5.07

Adverse Events

CBT-I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sleep Education/Hygiene

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Samir K. Gupta

Indiana University

Phone: 3172747926

Email: sgupta1@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place