Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-03-01
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia
8 weekly sessions delivered by federally qualified health center behavioral health provider 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)
Usual Care
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)
Interventions
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Cognitive Behavioral Therapy for Insomnia
8 weekly sessions delivered by federally qualified health center behavioral health provider 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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Tulane University
OTHER
Responsible Party
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Locations
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Southeast Community Health Systems
Zachary, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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Erin Peacock, PhD, MPH
Role: primary
Other Identifiers
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2025-138
Identifier Type: -
Identifier Source: org_study_id