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Behavioural Intervention

Cognitive Behavioral Therapy for Prediabetes

Q: Are individuals over 45 years old eligible to join this investigation?

The minimum age for enrollment in this study is 22 while the maximum age to take part is 79, according to its criteria.

Q: Am I eligible to be involved in this medical experiment?

In order to be considered for this <a href="https://www.withpower.com/clinical-trials/sleep">sleep</a>-focused trial, applicants must aged between 22 and 79. Thus far, approximately 300 individuals have been recruited into the program.

Q: Is enrollment in this clinical trial still open?

Affirmative. According to clinicaltrials.gov, this medical trial is still recruiting volunteers and was initially posted on August 1st 2023 before being modified on September 27th 2023. 300 individuals are needed for participation at one specified site.

Q: How many participants have enrolled in the experiment thus far?

Affirmative. The information on clinicaltrials.gov displays that this research project, which was initially published on August 1st 2023, is currently recruiting individuals for participation. Approximately 300 patients must be recruited from one medical center.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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 / 2Eligibility criteria met

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Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,292 Total Patients Enrolled

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,112,793 Total Patients Enrolled

Erin LeBlanc, MDPrincipal InvestigatorKaiser Permanente

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over 45 years old eligible to join this investigation?

"The minimum age for enrollment in this study is 22 while the maximum age to take part is 79, according to its criteria."

Answered by AI

Am I eligible to be involved in this medical experiment?

"In order to be considered for this sleep-focused trial, applicants must aged between 22 and 79. Thus far, approximately 300 individuals have been recruited into the program."

Answered by AI

Is enrollment in this clinical trial still open?

"Affirmative. According to clinicaltrials.gov, this medical trial is still recruiting volunteers and was initially posted on August 1st 2023 before being modified on September 27th 2023. 300 individuals are needed for participation at one specified site."

Answered by AI

How many participants have enrolled in the experiment thus far?

"Affirmative. The information on clinicaltrials.gov displays that this research project, which was initially published on August 1st 2023, is currently recruiting individuals for participation. Approximately 300 patients must be recruited from one medical center."

Answered by AI