The Effect of Cognitive Behavioral Therapy for Insomnia on Type 2 Diabetes Health Outcomes

Completed · Not applicable

Conditions studied: Type2 Diabetes, Insomnia

In brief

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 and inconstant sleep schedule, which negatively influence quality of life. However, the additive effect of behavioral sleep intervention on diabetes outcomes and health status in people with T2D is unknown. Therefore, The overall purpose of this study is to investigate the impact of both insomnia symptoms and CBT-I on people with T2D. The central hypotheses are that people with T2D and insomnia symptoms will have worse sleep, diabetes measures and self-reported outcomes compared to people with T2D only, which might be adjusted with CBT-I.

Key facts

Study ID

NCT03713996

Run by

University of Kansas Medical Center

People needed

28

Starts

2019-01-16

Expected to finish

2019-06-01

Last updated by the study team

2019-08-28

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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