Insomnia, Type 2 Diabetes
Conditions
Keywords
cognitive behavioral therapy for insomnia
Brief summary
This study will explore the effects of cognitive behavioral therapy for insomnia (CBTI) compare to health educations in patients with type 2 diabetes (T2DM) with insomnia symptoms.
Detailed description
This study will recruit participants with T2DM with insomnia symptoms and randomize them to weekly CBTI or health education for 8 weeks. Outcomes will be measured at baseline and 8 week, and 16 weeks (8 weeks post intervention). Primary outcome will be subjective sleep quality as assessed by Pittsburgh Sleep Quality Index Secondary outcomes will be fasting glucose, hemoglobin A1C, insulin levels, high sensitivity c-reactive protein, objective sleep parameters from accelerometer, depressive symptoms, daytime sleepiness, quality of life, anxiety symptoms and stress symptoms.
Interventions
BEHAVIORALcognitive behavioral therapy for insomnia
Online meeting, weekly for 8 weeks, to deliver CBTI by psychologist/ psychiatrist
BEHAVIORALHealth education
Online meeting, weekly for 8 weeks, to deliver general health knowledge
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Type 2 diabetes mellitus age 30 to 65 years old * Hemoglobin A1C ≥ 6.5 but ≤ 10 % * Have poor sleep quality as assessed by Insomnia Severity Index ≥ 15 * Receive the same hypoglycemic treatments 3 months before the intervention * If using sleep aid, the dose needs to be stable for 3 months prior to the enrollment * Ability to use the electronic devices (computer, tablet) and assess the internet * Willing to attend all of the 8 sessions activities
Exclusion criteria
* Type 1 diabetes mellitus * Night shift work * Insulin therapy * Severe hypoglycemia who required hospitalization or emergency department visit in the past 6 months * History of diabetic ketoacidosis in the past 6 months * Medically unstable conditions eg. renal replacement therapy, liver failure, heart failure, active cancer, epilepsy, unstable cerebrovascular disease * Psychosis, uncontrolled depression * Untreated obstructive sleep apnea or STOP-BANG ≥ 5 * Language/communication/hearing/sight disability * Pregnancy or lactation * Care giver of infant * Harmful alcohol/smoking (≥15 standard-drink in men and ≥8 standard-drink in women)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Sleep Quality | 16 weeks | Subjective Sleep Quality as assessed by Pittsburgh Sleep Quality Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic parameters | 8 weeks | Fasting glucose and insulin, hemoglobin A1C |
| High sensitivity c-reactive protein | 8 weeks | serum sample for Hs-CRP |
| Patient reported outcomes | 16 weeks | Questionnaires to assess depressive symptoms, stress, anxiety, daytime sleepiness, and quality of life |
| Objective sleep parameters | 8 weeks | Sleep will be obtained using 1-week accelerometer recording |
Countries
Thailand
Contacts
Primary ContactSimilan Kirisri
Backup ContactChutintorn Sriphrapradang
Outcome results
None listed