The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. The questions this study aims to answer include: Will this intervention help the insomnia symptoms? Will obtaining better sleep aid in the control of diabetes through measures like sugar levels? Will the intervention help with quality of life factors like mood and fatigue? Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are different based on the treatment. Participants in the therapy intervention group will: * meet virtually with a therapist for 8 sessions via Zoom. Once a week for the first 4 weeks and then every other week for the last 4 sessions. Participants in the healthy living group will: * receive weekly health education emails * receive brief weekly calls from a coach to answer any questions Participants, regardless of intervention, over the 12 week study period will: * monitor their sleep for 2 weeks through a sleep-monitoring watch * share their continuous glucose monitoring data throughout the study * answer questionnaires prior to the intervention, halfway through the intervention and then after the intervention * attend 3 in person office visits
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
8 virtual CBTi sessions will be provided through a therapist weekly for the first four weeks and every other week for the last eight weeks of the study.
Health education emails and brief coaching calls will be provided weekly. The phone coaches will not provide counseling or goal setting but can clarify what participants had questions on like terms and concepts.
University of Illinois Chicago
Chicago, Illinois, United States
RECRUITINGAcceptability
Will be measured via the Acceptability of Intervention Measure (AIM) at the end of the interventions. AIM is measured through 4 questions on a scale of 1-5 resulting in scores from 4 to 20 points. The higher the score the higher the acceptability.
Time frame: From enrollment to the end of the intervention (12 weeks)
Glycemic Variability
Assessed as time in, above or below range as collected by the continuous glucose monitor.
Time frame: Week 0 (Baseline), 6 weeks (midpoint0 and 12 weeks (end of treatment)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a questionnaire that assesses sleep quality and disturbances within the last month. It consists of 18 questions that either have scaled questions with four options or asks the participant for input regarding factors like bed time, time to fall asleep, hours of sleep etc. Each participant answer, both on the scale and on input, is assigned a score between 0 and 3. Thus, the score range goes from 0 to 54, with a higher score indicating worse sleep quality.
Time frame: Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)
Glycemic Control
Assessed through A1C
Time frame: Week 0 (baseline) and Week 12 (end of treatment)
Sleep duration
Measured by actigraphy watch
Time frame: Week 0 (baseline) and Week 12 (end of treatment)
Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep Disturbance
The PROMIS questionnaire assesses self-reported sleep quality through the lens of depth and restoration. It contains 8 questions regarding the last 7 days and is scored on a scale of 1 to 5 for each question. The scores range from 8 to 40. A higher score indicates worse sleep quality.
Time frame: Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)
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