Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
Insomnia is highly prevalent in individuals with type 2 diabetes (T2D) and is associated with poor glycemic control. Louisiana has one of the highest diabetes prevalence rates in the U.S., with significant disparities by race, income, and rural residence. Despite growing recognition of sleep's role in diabetes management, sleep disturbances remain largely unaddressed in diabetes care. Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment for chronic insomnia, yet it is underutilized in primary care clinics such as federally qualified health centers (FQHCs) that serve high-risk populations.
The long-term goal of this research is to improve cardiometabolic health and reduce diabetes disparities by integrating sleep interventions into diabetes care. This pilot study aims to: (1) evaluate the impact of CBT-I on sleep and diabetes-related outcomes, and (2) assess the acceptability, feasibility, and fidelity of implementing an 8-week CBT-I program in an FQHC setting.
The investigators will conduct a randomized controlled trial (RCT) with 30 FQHC patients (aged 40+) with uncontrolled T2D (HbA1c \>7%) and comorbid insomnia (Insomnia Severity Index (ISI) score ≥15). Participants will be randomly assigned to either the CBT-I intervention or usual care. Sleep (ISI scores, actigraphy) and cardiometabolic (HbA1c, fasting glucose, insulin) outcomes will be assessed at baseline and three months post-randomization. Implementation success will be evaluated using fidelity, feasibility, and acceptability measures. Findings will provide preliminary evidence for integrating CBT-I into primary care, informing larger trials to improve diabetes outcomes and reduce disparities in Louisiana.
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an 8-week Cognitive Behavioral Therapy for Insomnia (CBT-I) program
Follow-up
Participants are monitored for sleep and cardiometabolic outcomes post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Behavioral Therapy for Insomnia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tulane University
Lead Sponsor