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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavioral therapy | Experimental | Cognitive behavioral therapy for insomnia (CBTI) is non-medical treatment to improve insomnia. CBTI group will attend online meeting, 1 hour weekly for 8 weeks. |
|
| Health education | Active Comparator | Health education group will attend online meeting, 1 hour weekly for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive behavioral therapy for insomnia | Behavioral | Online meeting, weekly for 8 weeks, to deliver CBTI by psychologist/ psychiatrist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Sleep Quality | Subjective Sleep Quality as assessed by Pittsburgh Sleep Quality Index | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic parameters | Fasting glucose and insulin, hemoglobin A1C | 8 weeks |
| High sensitivity c-reactive protein | serum sample for Hs-CRP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Similan Kirisri | Contact | 660805491645 | similankirisri@gmail.com | |
| Chutintorn Sriphrapradang | Contact | 660819876945 | Chutins@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Similan Kirisri | Ramathibodi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ramathibodi Hospital Mahidol University | Recruiting | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41114778 | Derived | Kirisri S, Reutrakul S, Sriphrapradang C, Tiensuntisook S, Chirakalwasan N, Saetung S, Aonnuam C, Areevut C, Jerawatana R, Siritienthong J. Effects of remotely-delivered cognitive behavioral therapy for insomnia in type 2 diabetes: a randomized controlled trial. Sleep Breath. 2025 Oct 20;29(6):322. doi: 10.1007/s11325-025-03469-y. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Health education | Behavioral | Online meeting, weekly for 8 weeks, to deliver general health knowledge |
|
| 8 weeks |
| Patient reported outcomes | Questionnaires to assess depressive symptoms, stress, anxiety, daytime sleepiness, and quality of life | 16 weeks |
| Objective sleep parameters | Sleep will be obtained using 1-week accelerometer recording | 8 weeks |
| D004700 | Endocrine System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |