Type 2 DiabetesNCT06202742
Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus
A study testing cognitive behavioral therapy for insomnia and Health education in people with Type 2 Diabetes and Insomnia, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Insomnia
- What is being tested?
- cognitive behavioral therapy for insomnia and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 8 Mar 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Ramathibodi Hospital Mahidol University
Bangkok, 10400
Similan Kirisri, 660805491645, similankirisri@gmail.com
Chutintorn Sriphrapradang, 660819876945, Chutins@gmail.com
About this study
Official title: Effects of Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Insomnia
- Being tested
- cognitive behavioral therapy for insomnia, Health education
- Keywords
- cognitive behavioral therapy for insomnia
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapy for insomniaBehavioural
Online meeting, weekly for 8 weeks, to deliver CBTI by psychologist/ psychiatrist
Health educationBehavioural
Online meeting, weekly for 8 weeks, to deliver general health knowledge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: cognitive behavioral therapy for insomnia |
| Health education | Active comparator | Health education group will attend online meeting, 1 hour weekly for 8 weeks. Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Sleep Quality
Subjective Sleep Quality as assessed by Pittsburgh Sleep Quality Index
Measured: 16 weeks
Secondary outcomes (4)
Metabolic parameters
Fasting glucose and insulin, hemoglobin A1C
Measured: 8 weeks
High sensitivity c-reactive protein
serum sample for Hs-CRP
Measured: 8 weeks
Patient reported outcomes
Questionnaires to assess depressive symptoms, stress, anxiety, daytime sleepiness, and quality of life
Measured: 16 weeks
Objective sleep parameters
Sleep will be obtained using 1-week accelerometer recording
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start8 Mar 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Similan Kirisri, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202742
- Sponsor's protocol ID
- MURA2023/873
- Status last verified
- Mar 2024
- First submitted
- 12 Dec 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41114778
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06202742
- Acronym / sponsor ID
- MURA2023/873
- Conditions
- Type 2 Diabetes, Insomnia
- Keywords
- cognitive behavioral therapy for insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Behavioral: cognitive behavioral therapy for insomniaCognitive 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 | Behavioral: Health educationHealth education group will attend online meeting, 1 hour weekly for 8 weeks. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral therapy for insomniaOnline meeting, weekly for 8 weeks, to deliver CBTI by psychologist/ psychiatrist | Behavioural | Cognitive behavioral therapy |
| Health educationOnline meeting, weekly for 8 weeks, to deliver general health knowledge | Behavioural | Health education |
Primary outcome
Subjective Sleep Quality
Time frame: 16 weeks
Subjective Sleep Quality as assessed by Pittsburgh Sleep Quality Index
4 secondary outcomes
Metabolic parameters
Time frame: 8 weeks
High sensitivity c-reactive protein
Time frame: 8 weeks
Patient reported outcomes
Time frame: 16 weeks
Objective sleep parameters
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 41114778Kirisri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Similan Kirisri principal investigator
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy for insomnia and Health education in people with Type 2 Diabetes and Insomnia, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Similan Kirisri (660805491645, similankirisri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Sleep Quality (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06202742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.