Cognitive Behavioural Therapy for Insomnia in Type 1 Diabetes

Overseen By Jennifer Duffecy, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Illinois at Chicago

Must not be taking: Sleep medications, ADHD stimulants

Disqualifiers: Pregnancy, Sleep apnea, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cognitive behavioral therapy (CBT) for insomnia can help individuals with type 1 diabetes manage blood sugar levels, improve sleep, and enhance overall quality of life. Participants will either engage in virtual CBT sessions or receive general health tips through emails and calls. The researchers aim to determine if therapy specifically for sleep issues offers better outcomes than general health advice. Ideal candidates are those with type 1 diabetes who have trouble sleeping and use a continuous glucose monitor. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering a unique opportunity to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you take medications for sleep or ADHD stimulant medications.

What prior data suggests that this therapy intervention is safe for people with type 1 diabetes?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) is generally safe and well-tolerated for individuals with long-term health issues, such as type 1 diabetes. One study found that CBT-I significantly improved sleep problems without causing serious side effects. Another study reported that participants using CBT-I experienced better mood and sleep without notable harm. While these studies focus on insomnia, they suggest that the therapy is also safe for those with type 1 diabetes. As this is an early phase trial, the researchers will closely monitor the therapy's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Cognitive Behavioral Therapy for Insomnia (CBTi) in people with Type 1 Diabetes because it offers a tailored approach that directly addresses the unique sleep challenges faced by these patients. Unlike standard insomnia treatments, which often involve medication, this intervention uses virtual therapy sessions that are customized for those managing diabetes, potentially improving both sleep and overall health without the side effects of drugs. Additionally, the Healthy Living arm of the trial provides psychoeducation and support from a coach, promoting better sleep and health habits in a holistic manner.

What evidence suggests that this therapy might be an effective treatment for insomnia in type 1 diabetes?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I), which participants in this trial may receive, can be very effective. Studies have found that CBT-I helps improve sleep problems, reduce sleep disturbances, and boost mood. Some evidence suggests it might also help manage blood sugar levels, although this is less certain. In people with diabetes, CBT-I has been linked to better outcomes, such as improved HbA1c levels, an important measure of blood sugar control. Overall, CBT-I has shown promising results for improving sleep and possibly aiding diabetes management. Another group in this trial will receive psychoeducation about general health and sleep, along with brief calls from a coach, as part of the Healthy Living arm. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with type 1 diabetes who are experiencing insomnia. Participants should be willing to attend virtual therapy sessions or receive health education and coaching calls, monitor their sleep with a watch, share glucose data, and complete questionnaires.

Inclusion Criteria

Use a continuous glucose monitor

Have poor sleep quality

I am between 18 and 65 years old.

Exclusion Criteria

My depression is moderately severe to severe.

I do not have major health issues like heart failure, severe lung problems, or need dialysis.

I take medication to help me sleep.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either virtual CBTi sessions or healthy living education over a 12-week period

12 weeks

8 virtual sessions for CBTi group, weekly emails and calls for healthy living group

Monitoring

Participants monitor sleep and glucose levels, and complete questionnaires

12 weeks

3 in-person office visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep quality improvement therapy

Trial Overview The study tests if cognitive-behavioral therapy for insomnia (CBTi) can improve sleep quality, blood sugar control, and overall quality of life in people with type 1 diabetes compared to a 'healthy living' intervention involving health education emails and coaching calls.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy Intervention for Insomnia Experimental Treatment 1 Intervention

Virtual CBTi sessions will be tailored to be address the specific challenges that come with type 1 diabetes.

Group II: Healthy Living Active Control 1 Intervention

Psychoeducation about general health and sleep alongside brief calls from a coach will be provided.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7487570/

The effects of cognitive behavioral therapy for insomnia in ... Diabetes outcomes improved following CBT-I, with a clinically meaningful difference in HbA1c. Clinical improvement in HbA1c may have been due to reductions in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1389945724002442

The effect of cognitive behavioral therapy for insomnia on ... From this current study, we conclude that CBT-I might improve insomnia symptoms, sleep disturbance and mood, and perhaps improves glycemic control, albeit not ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2803668

Digital Cognitive Behavioral Therapy vs Medication ... In this study, clinical evidence suggested that combination therapy was optimal, and dCBT-I was more effective than medication therapy, with long-term benefits ...

4. patlynk.com patlynk.com/trial/NCT07091318

CBTi for Insomnia in Type 1 Diabetes The main aim is to find out if a specific therapy for insomnia can help improve sleep, control blood sugar levels, and enhance the overall quality of life, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10249334/

Cognitive Behavioral Sleep Self-Management Intervention for ... CB-sleep is a useful modality with the potential to support sleep self-management in young adults with T1D during this complex life transition.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07091318

CBTi for the Treatment of Insomnia in Type 1 Diabetes Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are ...

7. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/article-abstract/2839294

Cognitive Behavioral Therapy for Insomnia in People With ... CBT-I was associated with significantly improved outcomes for insomnia severity (g = 0.98; 95% CI, 0.81-1.16) and moderate effect sizes ...

8. hcplive.com hcplive.com/view/cbt-i-effective-for-insomnia-in-patients-with-chronic-diseases

CBT-I Effective for Insomnia in Patients with Chronic ... CBT-I was linked to significantly improved outcomes for insomnia severity (95% confidence interval [CI], 0.81 – 1.16), moderate effect sizes ...