Print

Purpose

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 a 6-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.

Conditions

Eligibility

Eligible Ages
Over 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • aged 40 or older - receive primary care from participating clinic - diagnosis of type 2 diabetes - most recent hemoglobin A1c (HbA1c) >7% within the past year - Insomnia Severity Index (ISI) score ≥15 - able to speak English

Exclusion Criteria

  • diagnosed or self-reported sleep apnea - pregnant or planning to become pregnant during the study period - having a psychiatric or medical condition that would interfere with the ability to complete study procedures - participating in another diabetes clinical trial - living in same household as another participant - required to work night shifts

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cognitive Behavioral Therapy for Insomnia
  • Behavioral: Cognitive Behavioral Therapy for Insomnia
    6 weekly sessions delivered by a Sleep Coaching Team comprised of a federally qualified health center behavioral health provider and a health coach, focusing on stimulus control, sleep restriction, and cognitive therapy
  • Other: Usual care for diabetes management
    Usual clinical care for management of diabetes (may include pharmacological and non-pharmacological approaches as determined by provider and patient)
  • Other: Usual care for treatment of insomnia
    Usual clinical care for treatment of insomnia (may include pharmacological and non-pharmacological approaches as determined by provider and patient)
Active Comparator
Usual Care
  • Other: Usual care for diabetes management
    Usual clinical care for management of diabetes (may include pharmacological and non-pharmacological approaches as determined by provider and patient)
  • Other: Usual care for treatment of insomnia
    Usual clinical care for treatment of insomnia (may include pharmacological and non-pharmacological approaches as determined by provider and patient)

Recruiting Locations

Southeast Community Health Systems
Zachary, Louisiana 70791
Contact:
Erin Peacock, PhD, MPH
504-988-1075
epeacoc@tulane.edu

More Details

Status
Recruiting
Sponsor
Tulane University

Study Contact

Erin Peacock, PhD, MPH
504-988-1075
epeacoc@tulane.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.