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Mindfulness Meditation for Sleep Disorders (REST Trial)

N/A

Recruiting

Led By Andrew Fuligni, Ph.D.

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post-intervention; 3, 6, and 12-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if a mindfulness intervention can help improve sleep, reduce anxiety, and prevent chronic health problems in college students.

Who is the study for?

The UCLA REST Study is for first-year undergraduate students at UCLA, aged 18-20, living in campus dorms and experiencing sleep issues as indicated by a score of 8+ on the Insomnia Severity Index. Students with mood or anxiety disorders, certain medical conditions, or prior mindfulness meditation instruction are not eligible.

What is being tested?

This study tests whether a six-week group-based mindfulness program (MAPs) can improve sleep and reduce inflammation compared to standard sleep education. It involves questionnaires, blood samples for immune analysis, and wrist actigraphs to track sleep before and after the intervention plus follow-ups.

What are the potential side effects?

While there are no direct side effects mentioned for MAPs or sleep education interventions being tested in this trial, participants should be aware that any changes in their routine could temporarily affect their sleeping patterns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post-intervention; 3, 6, and 12-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and post-intervention; 3, 6, and 12-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-intervention; 3, 6, and 12-month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in sleep quality from baseline to post-intervention on the Pittsburgh Sleep Quality Index (PSQI)

Secondary study objectives

Change in actigraphy-based objective sleep measures from baseline to post-intervention.

Change in anxiety from baseline to post-intervention on the Generalized Anxiety Disorder- 7 (GAD-7).

Change in depressive symptoms from baseline to post-intervention on the Center for Epidemiological Studies Depression Scale (CES-D)

+11 more

Side effects data

From 2016 Phase 2 trial • 413 Patients • NCT01654289

Musculoskeletal

Cardiac Disorders

General

100%

80%

60%

40%

20%

Study treatment Arm

Exercise

Wait-list Control

Mindfulness Meditation

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: Mindfulness MeditationExperimental Treatment1 Intervention

Half of the subjects will be randomly assigned to participate in the Mindfulness Meditation intervention. This class will meet once a week, for two hours, over the course of six weeks.

Group II: Sleep EducationActive Control1 Intervention

Half of the subjects will be randomly assigned to participate in the Sleep Education intervention. This class will meet once a week, for two hours, over the course of six weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness Meditation

2015

Completed Phase 2

~4040

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