The Effect of Cognitive Behavioral Therapy for Insomnia on Type 2 Diabetes Health Outcomes
Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Oct 18, 2018
Trial Information
Current as of June 13, 2025
Completed
Keywords
ClinConnect Summary
Insomnia is a common sleep disorder, with three main symptoms: difficulty in initiating sleep, difficulty in maintaining sleep, and/or waking up early without ability to return to sleep. Insomnia can contribute to metabolic dysfunction, which can lead to type 2 diabetes (T2D). Diabetes self-care behavior (DSCB) is important in attaining and maintaining glycemic control, which worsens as a result of fatigue. People with insomnia usually suffer from fatigue, which negatively influences quality of life. However, the additive effect of insomnia symptoms on diabetes outcomes and health status in...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age between 40 to 75 years
- • Self-reported diagnosis of type 2 diabetes
- • Insomnia Severity Index \>10 and self-reported symptoms of insomnia at least 3 nights/week for the past 3 months for insomnia and type 2 diabetes group
- • Insomnia Severity Index ≤10 for type 2 diabetes only group
- • Able to attend 6 sessions
- • Able to understand and follow verbal commands in English
- • Able to travel to our lab
- Exclusion Criteria:
- • Self-reported neurological diseases (e.g. Alzheimer's disease, Parkinson's disease, Traumatic Brain Injury, Stroke, Multiple Sclerosis)
- • Stop-Bang \> 4 indicating severe risk of sleep apnea
- • Failure to pass Restless Leg Syndrome Diagnostic Index
- • Severe pain ≥ 7 out of 10 on Brief Pain Inventory
- • Severe symptom level of depression scores ≥ 21 on Beck Depression Inventory
- • Severe symptom level of anxiety scores ≥ 15 on Generalized Anxiety Scale-7
- • Pregnant women
- • Self-reported following medical issues: Chronic Fatigue Syndrome, Fibromyalgia, and Rheumatic Diseases
- • Speech deficits or significant auditory impairment
- • Night-shift work
- • Self-reported Bipolar and Seizure Disorders
- • Heavy alcohol drinker (≥15 drinks per week for men and ≥ 8 drinks per week for women)
- • Dialysis/blindness/trans-femoral amputation
About University Of Kansas Medical Center
The University of Kansas Medical Center (KUMC) is a leading academic medical institution dedicated to advancing healthcare through innovative research, education, and clinical practice. As a prominent clinical trial sponsor, KUMC leverages its extensive expertise in diverse medical fields to conduct rigorous clinical research aimed at improving patient outcomes and developing new treatment modalities. With a commitment to ethical standards and patient safety, KUMC collaborates with multidisciplinary teams to facilitate groundbreaking studies that address significant health challenges, ultimately contributing to the advancement of medical knowledge and the enhancement of community health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kansas City, Kansas, United States
Kansas City, Kansas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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