Clinical trial NCT03713996: The Effect of Cognitive Behavioral Therapy for Insomnia on Type 2 Diabetes Health Outcomes
Official title: Insomnia and Type 2 Diabetes: Measurement, Impact and Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Insomnia
Keywords: Cognitive Behavioral Therapy for Insomnia
Self-Care
Fatigue
Diabetes
Glycemic Control
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Detailed description: 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 people with T2D is unknown. Therefore, it is imperative to investigate the contributing factor that affects DSCB and health outcomes to help individuals with diabetes reach their goals.

Assessing sleep variability is very important clinically and practically for people with insomnia. People with insomnia have higher night to night sleep variability compared to healthy individuals. Compared to other populations, people with T2D might suffer from sleep disturbances due to diabetes symptoms such as frequency nocturnal urination, hyperglycemia, insulin resistance, obesity, pain and fatigue, which might influence the sleep variability. The nature of insomnia is not representable by using mean values, as the reduction in the sleep variability values is a predictor for insomnia and depression recovery. Therefore, understanding the sleep variability in people with T2D with or without insomnia symptoms may add complementary evidence for future studies.

An effective treatment for people with insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is superior to sleep medications in terms of cost and long term benefits. Although there is currently limited evidence about the effect of CBT-I on people with T2D, CBT-I is a potentially effective intervention given insomnia's relationship with glucose metabolism. 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.

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

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: Insomnia severity will be assessed at the baseline and 8 weeks.
Secondary outcomes:
measure: Change in the Variability of Total Sleep Time in Minutes using Objective Measure, Actigraph
timeFrame: The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
measure: Change in the Variability of Wake after Sleep Onset in Minutes using Objective Measure, Actigraph
timeFrame: The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
measure: Change in the Variability of Sleep Latency in Minutes using Objective Measure, Actigraph
timeFrame: The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
measure: Change in the Variability of Sleep Efficiency using Objective Measure, Actigraph
timeFrame: The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
measure: Change in the Variability of Total Sleep Time in Minutes using Subjective Measure, Sleep Diary
timeFrame: The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
measure: Change in the Variability of Wake after Sleep Onset in Minutes using Subjective Measure, Sleep Diary
timeFrame: The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
measure: Change in the Variability of Sleep Latency in Minutes using Subjective Measure, Sleep Diary
timeFrame: The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
measure: Change in the Variability of Sleep Efficiency using Subjective Measure, Sleep Diary
timeFrame: The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
measure: Change in Fatigue Severity Scale Total Score
timeFrame: Fatigue severity will be assessed at the baseline and 8 weeks.
measure: Change in Diabetes Self-Care Behavior using Diabetes Care Profile
timeFrame: Change in each sub-scale on the Diabetes Care Profile from the baseline and at 8 weeks
measure: Change in Glycemic Control Level
timeFrame: A1C will be assessed at the baseline and 8 weeks.
measure: Change in Epworth Daytime Sleepiness Scale Total Score
timeFrame: Daytime sleepiness will be assessed at the baseline and 8 weeks.
measure: Change in The Pittsburgh Sleep Quality Index Global Score
timeFrame: Sleep quality will be assessed at the baseline and 8 weeks.
measure: Change in Random Glucose Level
timeFrame: Random glucose level will be assessed at the baseline and 8 weeks.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
citation: Alshehri MM, Alothman SA, Alenazi AM, Rucker JL, Phadnis MA, Miles JM, Siengsukon CF, Kluding PM. The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes. BMC Endocr Disord. 2020 Sep 5;20(1):136. doi: 10.1186/s12902-020-00612-6.
citation: Alshehri MM, Alenazi AM, Hoover JC, Alothman SA, Phadnis MA, Rucker JL, Befort CA, Miles JM, Kluding PM, Siengsukon CF. Effect of Cognitive Behavioral Therapy for Insomnia on Insomnia Symptoms for Individuals With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 19;8(12):e14647. doi: 10.2196/14647.