Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes

EP
Overseen ByErin Peacock, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Tulane University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how cognitive behavioral therapy for insomnia (CBT-I) can assist people with type 2 diabetes who struggle with sleep. The researchers aim to determine if better sleep can enhance diabetes control and overall health. Participants will either undergo an 8-week CBT-I program or continue their usual care. Ideal candidates have type 2 diabetes with recent poor blood sugar control (HbA1c over 7%) and significant sleep issues. This study seeks to determine if sleep therapy can be effectively integrated into regular diabetes care, especially in clinics serving high-risk populations.

As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance diabetes care for many.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Cognitive Behavioral Therapy for Insomnia is safe for individuals with type 2 diabetes?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is a safe and effective treatment for individuals with insomnia. Studies have found that CBT-I can improve sleep and may also aid in managing diabetes by better controlling blood sugar levels. As CBT-I does not involve medications, there are no drug-related side effects.

Most individuals find the treatment manageable. It works by helping change sleep habits and patterns, leading to better sleep without the need for pills. Reports of negative effects are rare, making it a safe choice for those seeking to improve their sleep and overall health.12345

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Type 2 Diabetes because it offers a non-drug approach to tackle sleep issues, unlike traditional treatments like sleep medications. CBT-I focuses on changing the thoughts and behaviors that cause insomnia, which can lead to long-lasting improvement in sleep quality without the side effects associated with medication. Additionally, improving sleep in Type 2 Diabetes patients can have a positive impact on blood sugar control and overall health, making it a promising holistic option.

What evidence suggests that Cognitive Behavioral Therapy for Insomnia might be an effective treatment for insomnia in type 2 diabetes?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive, can assist people with type 2 diabetes who struggle with sleep. Studies have found that CBT-I not only improves sleep quality but also aids in controlling blood sugar levels. For instance, one study found that CBT-I helped lower HbA1c levels, a measure of blood sugar over time. Another study noted improvements in sleep problems and mood, which can also aid in managing diabetes. Overall, CBT-I is considered a promising method to enhance both sleep and diabetes management.12346

Are You a Good Fit for This Trial?

This trial is for adults over 40 with uncontrolled type 2 diabetes (HbA1c >7%) and chronic insomnia (Insomnia Severity Index score ≥15). It's specifically designed for patients in Louisiana, aiming to address sleep disturbances that affect diabetes management. Participants must be able to attend an 8-week program at a federally qualified health center.

Inclusion Criteria

Receives primary care from participating clinic
Most recent hemoglobin A1c (HbA1c) >7% within the past year
Insomnia Severity Index (ISI) score ≥15
See 3 more

Exclusion Criteria

Having a psychiatric or medical condition that would interfere with the ability to complete study procedures
Pregnant or planning to become pregnant during the study period
Participating in another diabetes clinical trial
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week Cognitive Behavioral Therapy for Insomnia (CBT-I) program

8 weeks
Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for sleep and cardiometabolic outcomes post-treatment

3 months
1 visit (in-person) at 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Therapy for Insomnia
Trial Overview The study tests if Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep and diabetes-related outcomes compared to usual care. This randomized controlled trial will assign participants either to the CBT-I intervention or to receive standard treatment, measuring changes in sleep quality and blood sugar control.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Therapy for InsomniaExperimental Treatment3 Interventions
Group II: Usual CareActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials
129
Recruited
259,000+

Citations

The effects of cognitive behavioral therapy for insomnia in ...This study suggested CBT-I was effective in improving HbA1c, DSCB, and FSS for people with T2D and insomnia symptoms. Glucose blood levels, both before bedtime ...
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 ...
The Impact of Cognitive Behavioral Therapy for Insomnia ...A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two ...
Effect of Cognitive Behavioral Therapy for Insomnia on ...Promoting sleep for people with insomnia and T2D could improve insomnia severity and diabetes outcomes. Objective: The objective of this study ...
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 ...
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 ...
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