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Behavioural Intervention

Cognitive Behavioral Therapy for Prediabetes

N/A

Recruiting

Led By Erin LeBlanc, MD

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 22 years and < 80 years of age

Prediabetes

Must not have

History of type 1 or type 2 diabetes or recent/planned use of hypoglycemic agents (e.g., metformin, insulin)

Current use of medication with glycemic effects

Timeline

Screening 3 weeks

Treatment Varies

Follow Up v1 (baseline), v2 (11 weeks after randomization), v3 (33 weeks from randomization)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if CBT-I helps lower glucose levels in people with prediabetes versus traditional learning.

Who is the study for?

This trial is for adults aged 22 to 79 with prediabetes and insomnia who have internet access. It's not for those with other sleep disorders, severe skin issues or allergies affecting sensor use, irregular sleep schedules due to shift work, risks from sleep restriction like heavy machinery operation, a BMI over 40, certain medication uses including recent CBT-I therapy or diabetes treatments.

What is being tested?

The study examines if cognitive behavioral therapy for insomnia (CBT-I) delivered online can lower blood sugar levels in prediabetic individuals compared to standard patient education about health. Participants will be randomly assigned to one of the two interventions.

What are the potential side effects?

Potential side effects are not specified but may include discomfort from changes in sleeping habits due to CBT-I techniques and possible skin irritation from continuous glucose monitoring sensors used in the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 79 years old.

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I have been diagnosed with prediabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes or I'm taking/planning to take diabetes medication.

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I am currently taking medication that affects my blood sugar levels.

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I have had weight loss surgery recently or plan to within a year.

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I am currently using or have recently used weight loss medications.

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I am at a high risk of falling.

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I have epilepsy.

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I am not pregnant, planning to become pregnant, breastfeeding, or less than a year postpartum.

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I am currently taking hydroxyurea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ v1 (baseline), v2 (11 weeks after randomization), v3 (33 weeks from randomization)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~v1 (baseline), v2 (11 weeks after randomization), v3 (33 weeks from randomization)

This trial's timeline: 3 weeks for screening, Varies for treatment, and v1 (baseline), v2 (11 weeks after randomization), v3 (33 weeks from randomization) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

2-hour post-load glucose (2hPG) (mg/dL)

Secondary study objectives

Fasting plasma glucose (FPG) (mg/dL)

Hemoglobin A1c (A1C) (percentage)

Insulin resistance score (probability ranking, Calculated using the insulin and C-peptide concentrations converted to pmol/L)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Digital cognitive behavioral therapy (dCBT-I)Experimental Treatment1 Intervention

CBT-I is designed to change sleep habits and scheduling factors that affect sleep, and to address misconceptions about sleep and insomnia that perpetuate sleep difficulties. The investigators will employ SHUTi, which is an extensively studied dCBT-I program. SHUTi is intended to improve insomnia symptoms by providing neurobehavioral intervention (cognitive behavioral therapy for insomnia - CBT-I) in adults with chronic insomnia. It is a six-core internet-delivered CBT-I web-based app that is run through a browser. It is accessible via iPhone/iPad, Android phone/tablet, computer or laptop (any device with a browser). SHUTi follows evidence-based CBT-I principles.

Group II: Patient Education (PE)Active Control1 Intervention

Participants will be given access to a patient education website. It will provide nontailored material about insomnia symptoms; the impact, prevalence, and causes of insomnia; and basic lifestyle, environmental, and behavioral strategies to improve sleep.

0 / 10Eligibility criteria met