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The effect of telemedicine and cognitive behavioural therapy on sleep and health outcomes in type 2 diabetes patients: a randomized controlled trial

The effect of telemedicine and cognitive behavioural therapy on sleep and health outcomes in type 2 diabetes patients: a randomized controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000488606
Enrollment
227
Registered
2023-05-12
Start date
2023-05-31
Completion date
2024-03-21
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this project is to evaluate the effect of internet-delivered CBT intervention on sleep quality, blood glucose level, blood lipid level, kidney function, blood pressure, obesity, psychiatric diseases, fatigue and quality of life in adults with T2DM and insomnia. The detailed research objectives include: (1) To improve the overall sleep quality and sleep efficiency using internet-delivered CBT based intervention in adults with T2DM. (2) To improve the overall blood glucose level, blood lipid level, kidney function, blood pressure and obesity through internet-delivered CBT based intervention in adults with T2DM (3) To reduce depression, anxiety, fatigue and improve quality-of-life through internet-delivered CBT based intervention in adults with T2DM. The research hypothesis are as follows: (1) It is hypothesized that internet-delivered CBT-based intervention can provide positive effect in improving sleep outcomes, including insomnia severity measured by Insomnia Severity Index, sleep quality measured by Pittsburgh Sleep Quality Index, total sleep time, sleep efficiency, sleep onset latency, wake time after sleep onset and number of awakenings. (2) It is hypothesized that internet-delivered CBT-based intervention can improve biochemical indicators relating to T2DM, blood lipid and kidney function, including fasting blood glucose, Glycated Hemoglobin (HbA1c), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triglyceride (TG), serum creatinine, blood urea nitrogen, uric acid, blood pressure, body weight, body mass index (BMI) and waist-hip ratio (WHR). (3) It is also hypothesized that the internet-delivered CBT-based intervention can improve other health outcomes, including depression, anxiety, fatigue and quality of life.

Interventions

Cognitive behavioural therapy intervention targeting both type 2 diabetes and insomnia delivered by a therapist who have received full training for cognitive behavioural therapy intervention delivery. The intervention contains 10 online sessions delivered weekly in groups of 10 to 12. The approximate duration of each session is 60 minutes. Participants receive online reading materials before each session. The online reading materials are designed specifically for this study and participants ar

Cognitive behavioural therapy intervention targeting both type 2 diabetes and insomnia delivered by a therapist who have received full training for cognitive behavioural therapy intervention delivery. The intervention contains 10 online sessions delivered weekly in groups of 10 to 12. The approximate duration of each session is 60 minutes. Participants receive online reading materials before each session. The online reading materials are designed specifically for this study and participants are recommended (not compulsory) to read the materials prior to the session. Contents included in the intervention are knowledges and skills on sleep restriction, stimulus control, sleep hygiene, cognitive restructure, relaxation training, self-monitoring of blood glucose, diet, exercise and substance intake management. The skills participants are prescribed in the cognitive behavioural therapy include: (1) keep a sleep diary for self-monitoring of sleep quality; (2) develop and keep a regulated sleep schedule; (3) identify and avoid the behaviours that are not beneficial for sleep and blood glucose control; (4) identify and change the understandings and thoughts that are not beneficial for sleep and blood glucose control; (5) set up bedroom environment that promote sleep; (6) physical and mental relaxation skills; (7) skills for self-monitoring of blood glucose; (8) develop a balanced diet; (9) develop a healthy exercise plan; (10) communication skills to share own difficulties and feelings to others. Practice of these skills are part of the weekly sessions leaded by the therapist. Patients are also required to practice these skills after the weekly sessions and share their progress in the following sessions. Strategies used to monitor and ensure the adherence to the intervention include: (1) Participants are required to keep their sleep diary and record their blood glucose at least five days per week and report to the therapist every week. (2) Participants are required to complete a homework containing 3-5 multiple choice questions about the session contents after each session and report back to the therapist before the beginning of next session. (3) There will be a short telephone chat between each participant and the therapist every week (approximately 15 minutes). Therapist will give comments on sleep diaries, blood glucose records and homework from the previous session, and answer any questions raised during the intervention. (4) An attendance checklist will be used to record the participance of the weekly sessions. Participants completing all sessions will receive a certificate of completion at the end of the project. Polysomnography devices: Participants will be informed that they can use polysomnography devices provided by the hospital to monitor their sleep during the participant recruiting process. The PSG device used is the "Alice NightOne" home sleep testing device provided by PHILIPS RESPIRONICS (Primary DI Number: 00606959039797). Participants will receive full instructions on using the devices from the staff in the hospital. Participants will be required to use the devices for only one night at three timepoints in during the research (baseline, 3 months and 6 months), then return the device to the hospital.

Sponsors

School of Medicine and Dentistry, Griffith University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(1) Patients meet the diagnostic criteria for both type 2 diabetes and insomnia, and type 2 diabetes is the primary cause of insomnia (2) Patients aged over 18 (3) Patients not currently participating in similar intervention programs (4) Patients fully understand the program contents, willing to participate and signed the informed consent form (5) Patients able to use smart phones or computers to receive and view intervention materials Diagnostic criteria for type 2 diabetes: (1) Fasting plasma glucose greater than or equal to 7.0 mmol/l (fasting time >8 hours) (2) Two-hour postprandial blood glucose greater than or equal to 11.1mmol/l (3) Random plasma glucose greater than or equal to 11.1 mmol/L in patients with classic symptoms of hyperglycemia or hyperglycemic crisis (4) Glycated Hemoglobin (HbA1c) greater than or equal to 6.5% Screening for insomnia: Insomnia Severity Index score greater than 10 To determined if type 2 diabetes is the primary cause of insomnia: (1) Insomnia symptoms occurs or worsens after the diagnosis of type 2 diabetes. (2) Patients have worries about type 2 diabetes

Exclusion criteria

(1) Patients with severe primary diseases, including severe heart, liver or renal system diseases and cancer (2) Patients with severe psychiatric diseases that affect regular cognition and communication, including severe depression (HAMD score>18), anxiety (HAMA score>14) and schizophrenia (3) Patients diagnosed with sleep disorders other than insomnia, including obstructive sleep apnoea, restless leg syndrome, parasomnia and hypersomnia through self-report or PSG devices. (4) Patients who are pregnant (5) Patients who are illiterate and cannot understand the intervention contents.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026