Trial Outcomes & Findings for Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection (NCT NCT03390114)
NCT ID: NCT03390114
Last Updated: 2021-02-21
Results Overview
Change in the Insomnia Severity Index (ISI) score as measured by questionnaire. The ISI score ranges from 0 to 28 with higher scores indicating greater severity in insomnia symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
10 weeks
Results posted on
2021-02-21
Participant Flow
Participant milestones
| Measure |
SHUTi Cognitive Behavioral Therapy
SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia.
SHUTi: SHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points.
|
Usual Care
Patients randomized to the Usual Care group will be encouraged to follow-up with their primary care or HIV provider. There will be no formal interaction with the participants between the Entry Visit and the Week 10 Visit. However, the participants will be encouraged to contact the study team for any changes in their condition. There will be no restrictions on the care that can be received, although we will assess changes in care during the trial.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection
Baseline characteristics by cohort
| Measure |
SHUTi Cognitive Behavioral Therapy
n=10 Participants
SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia.
SHUTi: SHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points.
|
Usual Care
n=10 Participants
Patients randomized to the Usual Care group will be encouraged to follow-up with their primary care or HIV provider. There will be no formal interaction with the participants between the Entry Visit and the Week 10 Visit. However, the participants will be encouraged to contact the study team for any changes in their condition. There will be no restrictions on the care that can be received, although we will assess changes in care during the trial.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
46.6 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Those who completed both pre and post assessments
Change in the Insomnia Severity Index (ISI) score as measured by questionnaire. The ISI score ranges from 0 to 28 with higher scores indicating greater severity in insomnia symptoms.
Outcome measures
| Measure |
SHUTi Cognitive Behavioral Therapy
n=6 Participants
SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia.
SHUTi: SHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points.
|
Usual Care
n=8 Participants
Patients randomized to the Usual Care group will be encouraged to follow-up with their primary care or HIV provider. There will be no formal interaction with the participants between the Entry Visit and the Week 10 Visit. However, the participants will be encouraged to contact the study team for any changes in their condition. There will be no restrictions on the care that can be received, although we will assess changes in care during the trial.
|
|---|---|---|
|
Insomnia Severity Index
|
-9.0 score on a scale
Standard Deviation 9.4
|
-3.4 score on a scale
Standard Deviation 2.0
|
Adverse Events
SHUTi Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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
Samir K. Gupta, MD, MS
Indiana University School of Medicine
Phone: 3172747926
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place