CBTi for the Treatment of Insomnia in Type 1 Diabetes

Обзор

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

Вмешательства

• Поведенческое Sleep quality improvement therapy
  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.
• Поведенческое Healthy Living
  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.

Первичные конечные точки

• Acceptability [Срок оценки: From enrollment to the end of the intervention (12 weeks)]

Вторичные конечные точки (5)

• Glycemic Variability [Срок оценки: Week 0 (Baseline), 6 weeks (midpoint0 and 12 weeks (end of treatment)]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)]
• Glycemic Control [Срок оценки: Week 0 (baseline) and Week 12 (end of treatment)]
• Sleep duration [Срок оценки: Week 0 (baseline) and Week 12 (end of treatment)]
• Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep Disturbance [Срок оценки: Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment)]

Критерии участия

Критерии включения

• Between 18 to 65 years old
• Have been diagnosed with Type 1 Diabetes for at least a year
• Use a continuous glucose monitor
• Have poor sleep quality
• Able to attend 3 office visits

Критерии исключения

• Currently or planning pregnancy or breast feeding
• Employed with a rotating or night shift
• Are at a high risk for obstructive sleep apnea
• Non-English speaking (unable to participate in therapy or questionnaire).
• Take medications for sleep
• moderately severe to severe depression
• Have a significant medical history that includes conditions like heart failure, cirrhosis, COPD, diseases requiring oxygen, active treatment for cancer or psychiatric problems, history of stroke with neurological deficits, cognitive impairment, kidney failure that requires dialysis, illicit drug use, use of ADHD stimulant medications.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Illinois Chicago — Chicago

Идентификаторы

NCT: NCT07091318 · 2024-0987

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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