~18 spots leftby Aug 2025

Lifestyle Interventions for Chronic Insomnia

Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byAlexa Kane
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Mayo Clinic
No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess subjective sleep quality, diet quality, physical activity in patients with chronic insomnia before and after a brief lifestyle intervention during a traditional course of Cognitive Behavioral Therapy for Insomnia (CBT-I)

Eligibility Criteria

This trial is for adults aged 18-70 with chronic insomnia, but not for those with untreated sleep disorders, cardiovascular issues limiting exercise, diabetes, pregnancy/lactation, current vegan/Mediterranean diet users, BMI ≤22, high depression scores (PHQ-8 >15), shift workers or those with circadian rhythm disorders.

Inclusion Criteria

I have been diagnosed with chronic insomnia.
I am between 18 and 70 years old.

Exclusion Criteria

I have a sleep disorder that hasn't been treated.
My heart condition prevents me from safely increasing my physical activity.
I have diabetes.
+6 more

Participant Groups

The study evaluates the effects of a lifestyle intervention on sleep quality in chronic insomnia patients. This includes physical activity and nutritional education alongside traditional Cognitive Behavioral Therapy for Insomnia (CBT-I).
2Treatment groups
Experimental Treatment
Group I: Physical Activity EducationExperimental Treatment1 Intervention
In addition to the traditional course of CBT-I, the PI will recommend patient to increase physical activity minutes per week. The increase in physical activity will be based on patient's current level of physical activity.
Group II: Nutritional EducationExperimental Treatment1 Intervention
In addition to the traditional course of CBT-I, the PI will provide education and materials regarding the Mediterranean Diet. Patient will be provided with the Mayo Clinic booklet on Mediterranean Diet and asked to increase their daily intake in two categories assessed by the Mini-EAT.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Mayo Clinic in FloridaJacksonville, FL
Mayo ClinicJacksonville, FL
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Who Is Running the Clinical Trial?

Mayo ClinicLead Sponsor

References