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Search / Trial NCT03713996

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

Cognitive Behavioral Therapy For Insomnia Self Care Fatigue Diabetes Glycemic Control

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.

Locations

Kansas City, Kansas, United States

Kansas City, Kansas, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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