Recruiting

CBT-I

Sponsor:

Tulane University

Code:

NCT07062406

Conditions

Diabetes Type 2

Insomnia

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy for Insomnia

Usual care for diabetes management

Usual care for treatment of insomnia

Study Details

Brief summary:

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

Diabetes Type 2

Insomnia

Study ID

NCT07062406

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Behavioral Therapy for Insomnia

active comparator: Usual Care

Interventions

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

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)

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)

Primary outcome measure

  • Between-group difference in change in HbA1c from baseline to 3 months [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Erin Peacock, PhD, MPH

504-988-1075epeacoc@tulane.edu

Locations

Southeast Community Health Systems

Recruiting

Zachary, Louisiana, United States, 70791

Contacts

Erin Peacock, PhD, MPH

504-988-1075epeacoc@tulane.edu

More Information

Sponsor

Tulane University

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2026-09-02.